Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U19MH109988 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pontificia Universidad Javeriana | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Conduct systematic, multi-site mental health implementation research in both rural and urban primary care settings with a broad group of stakeholders in the US and Latin America.
The investigators plan to launch and evaluate a new mental health service delivery model in Latin America. Specifically, in this new multi-component, mental health service delivery intervention, the investigators propose to: (1) harness mobile behavioral health technology for mental health (with a primary focus on depression and a secondary focus on problematic alcohol and other substance abuse), (2) launch new workforce training and service delivery models (including the integration of technology into service delivery), (3) launch and evolve an integrated data management system for systematic data tracking and outcomes assessment, and (4) launch and grow a learning collaborative of organizations integrating mental health into primary care. The investigators will launch this project at multiple primary care sites in various parts of Colombia, with a plan to inform subsequent adoption in several other Latin American countries, including Chile and Peru.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Health Assisted Mental Healthcare | Experimental | This Digital Health Assisted Mental Healthcare intervention will be based on the novel mobile-based platform (Laddr® from Square2 Systems). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laddr | Behavioral | Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. Specifically, the core functionality of Laddr (e.g., problem-solving therapy) will be structured to focus on an end user's management of depression and its impact on their functioning and quality of life. The program will secondarily focus on problematic alcohol use and its relationship to depression management. |
| Measure | Description | Time Frame |
|---|---|---|
| The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument | This measure consists of 5 scales: Adoption, Appropriateness, Acceptability, Feasibility, and Reach/Access. All four scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). | At 6- and 12-month follow-up visits with a sub-sample of participants |
| The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | This measure consists of 8 scales: Adoption, Appropriateness, Feasibility, Reach/Access, Organizational climate, Leadership in Implementing, and General Leadership Skills. All eight scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). | At the time of the provider training, 6 months, 12 months, 18 months, and 24 months. |
| The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | This measure consists of 9 scales: 1) Adoption, Appropriateness, Acceptability, Feasibility, Reach/Access, Organizational climate, Leadership in Implementing, General Leadership Skills, and Knowledge. All nine scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). | At the time of the staff training, 6 months, 12 months, 18 months, and 24 months. |
| The Program Sustainability Assessment Tool (PSAT) Providers | This instrument was developed from the Program Sustainability Assessment and consists of 7 scales: Environmental Support, Partnerships, Organizational Capacity, Program Evaluation, Program Adaptation, Communication with Public, and Communications within the organization. All scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). The seven sub-scales are combined to an overall score by averaging the sub-scale scores. The computed overall scales have a range of 1 to 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-8) | A measure with 8 items used to assess depression. The total score of the scale ranges from 0 to 24, with 0 representing no significant depressive symptoms and 24 representing the most severe depressive symptoms. | This patient measure were assessed at baseline and every 3 months thereafter for a period of 12 months (for a total of 5 assessment timepoints per patient). |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQOL Five Dimensions Questionnaire (EQ-5D) (Only for Pilot Participants) | The EQ-5D. The EQ-5D is a standardized instrument that has been widely used and validated within Spanish speaking populations from several countries in Latin America, and assesses 5 key dimensions of health. | This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants). |
Inclusion Criteria:
Provider and administrative staff Inclusion Criteria:
Participant Inclusion Criteria:
Exclusion Criteria:
-Participant Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa A Marsch, PhD | Dartmouth College | Principal Investigator |
| Carlos Gomez-Restrepo, MD | Pontificia Universidad Javeriana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ESE Hospital San Antonio de Guatavita | Guatavita | Cundinamarca | Colombia | |||
| Hospital Mario Gaitán Yanguas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34347504 | Derived | Marsch LA, Gomez-Restrepo C, Bartels SM, Bell K, Camblor PM, Castro S, Cardenas Charry MP, Cepeda M, Cubillos L, John D, Jassir MP, Lemley SM, Suarez-Obando F, Torrey WC, Uribe JM, Williams MJ. Scaling Up Science-Based Care for Depression and Unhealthy Alcohol Use in Colombia: An Implementation Science Project. Psychiatr Serv. 2022 Feb 1;73(2):196-205. doi: 10.1176/appi.ps.202000041. Epub 2021 Aug 4. |
Not provided
Not provided
The investigators agree to share all data in accordance with NIH's data sharing policy and in accordance with the specific data sharing requirements of this NIMH Cooperative Agreement funding mechanism. The investigators agree to cooperate with the NIMH program staff to provide timely, accurate, and complete data for purposes of monitoring the progress of research activities conducted within the proposed project. The investigators will also work with NIH program staff to promote broad availability of policies, practices, materials, tools and data generated by the proposed project activities. At the conclusion of this study, the investigators plan to make available a public use file of all related study data (stripped of all personal identifiers and suitable for use by other investigators). The investigators will make the dataset available in one or more several common formats (e.g., ascii tab delimited, SAS and SPSS).
Not provided
Data will become available at the conclusion of the study. The investigators agree to retain records for each completed study for a minimum of 3 years (or more if necessary) after study data lock. The investigators will also comply with all relevant Institutional Review Board(s) IRB(s) and other regulatory entities regarding data sharing and records retention.
Although the final dataset will be stripped of identifiers prior to release for sharing, the investigators will further assure participants' confidentiality with a data sharing agreement that stipulates that all data and associated documentation will only be available to users who declare: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. The investigators understand that NIH has access to any and all data generated under the cooperative agreement and agree to provide a royalty-free, nonexclusive, and irrevocable license for the government to reproduce, publish, or otherwise use the material and data derived from research conducted under this cooperative agreement.
Not provided
Not provided
At the primary care site patients upon arrival were asked to complete screeners (for depression and problematic alcohol use). In the event of positive screen for depression and/or alcohol use problems, clinicians at site completed an in-depth diagnostic interview. Participants who met all inclusionary criteria were informed about this project and provided an informed consent form.
Providers and administrators who worked for the site for at least 3 months were asked to participate.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patients in Digital Health Assisted Mental Healthcare Intervention | Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management. |
| FG001 | Providers in Digital Health Assisted Mental Healthcare Intervention | Providers at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter. |
| FG002 | Administrative Staff in Digital Health Assisted Mental Healthcare Intervention | Administrative staff at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Seventeen of the Baseline measures are not administered to providers and administrative staff. Therefore, there are zero participants analyzed among providers and administrative staff for those measures.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patients in Digital Health Assisted Mental Healthcare Intervention | Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument | This measure consists of 5 scales: Adoption, Appropriateness, Acceptability, Feasibility, and Reach/Access. All four scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). | Posted | Mean | Standard Deviation | score on a scale | At 6- and 12-month follow-up visits with a sub-sample of participants |
|
12 months after baseline assessment.
The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients in Digital Health Assisted Mental Healthcare Intervention | Patients will be offered a multi-component model of science-based mental health care. All participants who consent to participate will be given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site will show them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program will secondarily focus on problematic alcohol use and its relationship to depression management. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidality | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical appointment due to non-serious diagnosis related symptoms | Psychiatric disorders | Systematic Assessment |
On March 23, 2020, our study staff paused participant recruitment and all face-to-face activities at all of our study's sites due to COVID-19 related safety concerns. The study has not recruited patient participants since that date. On May 15, 2020, the study implemented a remote consent process to allow study enrollment of eligible providers and administrators and a remote informed consent process to allow all participants to participate in the qualitative sub-study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa A. Marsch, PhD | Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College | 603-646-7092 | Lisa.a.marsch@dartmouth.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2021 | Dec 7, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patient Informed Consent form | May 3, 2019 | Dec 1, 2020 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Staff Informed Consent form | May 3, 2019 | Dec 1, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
The investigators will initially pilot test this mental health service delivery model at a single primary care site and then refine the model based on pilot data. The investigators will then expand implementation across 6 Colombia-based healthcare sites in urban and rural communities (including approximately 2000 participants). Consistent with a modified stepped wedge design (multiple baseline design), the investigators will implement the model across sites on a staggered basis and expand the number of sites in which the investigators implement over time. By conducting this multi-site implementation research project, the investigators can assess the extent to which the implementation model and associated outcomes are replicable across sites and/or the extent to which the model needs to be modified for differing contexts.
Not provided
Not provided
Not provided
Not provided
|
| At the time of the provider training, 6 months, 12 months, 18 months, and 24 months. |
| The Program Sustainability Assessment Tool (PSAT) Administrative Staff | This instrument was developed from the Program Sustainability Assessment and consists of 7 scales: Environmental Support, Funding Stability, Partnerships, Organizational Capacity, Program Evaluation, Program Adaptation, Communication with Public, Communications within the organization, and Communication with Government. All seven scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). The seven sub-scales are combined to an overall score by averaging the sub-scale scores. The computed overall scales have a range of 1 to 4. | At the time of the staff training, 6 months, 12 months, 18 months, and 24 months. |
| 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) | The WHODAS 2.0 assesses health-related difficulties across six different domains of functioning (cognition, mobility, self-care, socializing, life activities, and participation) that are linked conceptually and operationally to the International Classification of Functioning, Disability and Health (ICF). The scores assigned to 12 items are - "none" (1), "mild" (2) "moderate" (3), "severe" (4) and "extreme" (5). The scores for the 12 items are summed into a total score ranging from 12 (least severe) to 50 (most severe). The last 3 items of the assessment collect the number of days the reported health-related difficulties impact the participants in the past 90 days. | This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints-level assessments per patient). |
| General Anxiety Disorder Screener (GAD-7) | The GAD-7 is a 7-item self-reported screening questionnaire that has been validated to assess for generalized anxiety disorder (GAD) in outpatient and primary care settings. The measure is scored from 0 to 21, with 0 meaning minimal anxiety and 21 meaning most severe anxiety. | This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient). |
| The Quick Drinking Screen (QDS) (for Full Implementation Study Only) | The Quick Drinking Screen (QDS) is a 3-item questionnaire which asks about average drinking habits over the last ninety days. The responses are used to calculate the number of standard drinks consumed per week. In this measure, a standard drink is defined as 1-12 oz. regular can or glass of beer, or 1-5 oz. glass of regular wine, or 1 ½ oz. of regular proof hard liquor or spirits. Patients with alcohol use disorder will be asked to complete this measure as part of the baseline assessment and at every 3 months follow-up (a total of 5 assessment timepoints). | At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with implementation study participants). |
| EuroQol Visual Analogue Scale (EQ-VAS) (Only for Pilot Participants) | The EQ-VAS assess health-related quality of life. The EQ-VAS asks "how good or bad your health is today?" The scale ranges from 0 (worst health imaginable) to 100 (best health imaginable). The participants marks their number with an "X" on the scale and writes it in a box. | This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants). |
| Alcohol Timeline Follow-back (Alcohol TLFB) (Only for Pilot Participants) | A measure used to assess problematic alcohol use. The Alcohol TLFB asks patients about their alcohol use in the past 30 days. | This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants). |
| Behavioral Health Integration in Medical Care Index (BHIMC) | The BHIMC is an organizational measure of the level of behavioral health integration in medical practice settings. It evaluates policy, clinical practice and workforce dimensions of integration using mixed methods, i.e. combination of document review and observation. | Approximately every year prior to the time of implementation launch at a given site (starting with baseline in late 2017); at the time of implementation launch; and approximately every year thereafter at each site until study completion (April 2021). |
| The Time-driven Activity-based Costing (TDABC) Approach | The TDABC method measures costs of implementing the proposed model of care for depression and alcohol use disorders.The TDABC method will be used to determine the costs of the specific human, equipment, and facility resources used for delivering mental health care to patients as part of the model of care. | Approximately every year prior to the time of implementation launch at a given site (starting with baseline in late 2017); at the time of implementation launch; and approximately every year thereafter at each site until study completion (April 2021). |
| Non-Study Medical and Other Services (NSMOS) | The NSOMS assesses patients' medical resource use that is not part of the intervention, including non-treatment therapy visits, physician visits, residential and/or hospital detoxification, hospital and emergency department visits, and medication use through patient self-report. | At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient). |
| Non-Medical Expenses for Depression (NMED) | The NMED assesses the non-medical costs of depression. This measure is in Spanish and has been used in Latin America and used by our team at Javeriana. | At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient). |
| Health and Work Performance Questionnaire (HPQ) | The HPQ was developed by the World Health Organization, and assess the impact of depression on work performance (including sickness absence, presenteeism, and critical incidents). | At baseline, 6-month follow-ups, and 12-month follow-ups (for a total of 3 assessment timepoints per patient). |
| Administrative Interviews | Administrative interviews will assess implementation experiences, challenges to implementation and strategies used to facilitate implementation with different patient populations, changes made to workflow with use of the intervention, and salience of monitoring and feedback processes to inform providers and other stakeholders about the implementation success (approx. 5 at each site). The investigators will also assess the extent to which patients initiated use of the program via inquiry of their providers after learning of the program through patient channels. | At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date) |
| Patient Utilization Interviews/Observations | The investigators will recruit and follow a sample of patients (approx. 5 at each site) during the implementation project to explore feasibility issues regarding use, barriers and facilitating strategies for using the program, optimal dissemination strategies for promoting use of the program, and overall experiences using the program over time. These patient participants will be encouraged to document their experiences with the mental health service delivery model in an ongoing manner (e.g., note jotting, pictures, audio recording). | At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date) |
| Provider Interviews | Provider interviews will assess implementation experiences, challenges to implementation and strategies used to facilitate implementation with different patient populations, changes made to workflow with use of the intervention, and salience of monitoring and feedback processes to inform providers and other stakeholders about the implementation success (approx. 5 at each site). The investigators will also assess the extent to which patients initiated use of the program via inquiry of their providers after learning of the program through patient channels. | At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date) |
| COVID-19 Impact Survey | The COVID-19 Impact Survey is a self-reported questionnaire developed by the NIMH U19 Scale-Up Hubs and will assess the impact of COVID-19 among patients, providers, and administrators enrolled in this study. Given the unknown and widespread implications of the COVID-19 pandemic in Colombia, it is critical to understand the context of COVID-19 for interpreting the study's findings. | Patients will be assessed once at a follow-up visit every 3 months or at a separately scheduled visit. Providers and administrators will be assessed once at a follow-up visit every 6 months or at a separate visit. |
| Soacha |
| Cundinamarca |
| Colombia |
| Colombia |
| Salud de Tundama | Duitama | Departamento de Boyacá | Colombia |
| Empresa Social del Estado Hospital Regional de Duitama- Santa Rosa de Viterbo Branch | Santa Rosa de Viterbo | Departamento de Boyacá | Colombia |
| Empresa Social del Estado Hospital Nelson Restrepo Martinez | Guayabal | Tolima Department | Colombia |
| Javesalud | Bogotá | Colombia |
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| BG001 | Providers in Digital Health Assisted Mental Healthcare Intervention | Providers at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter. |
| BG002 | Administrative Staff in Digital Health Assisted Mental Healthcare Intervention | Administrative staff at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Name of Primary Care Center Site | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Socioeconomic Status | Socioeconomic stratification in Colombia is classified based on the residential neighborhood from 1-6, with 6 being the wealthiest and 1 the poorest. Official stratum in Colombia is found according to information on the participant's utility bill. | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| Employment Status | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| Marital Status | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| Number of persons in household | Count of Participants | Participants |
|
| Health Insurance Status | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| Length of time to reach healthcare center | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| History of previous depressive episodes | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| History of Traumatic Events | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| Family History of Depression | Count of Participants | Participants |
|
| Family History of Harmful Alcohol Use | Count of Participants | Participants |
|
| Smartphone Use | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| Internet Use | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| Tobacco Use | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| Antidepressants Use | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| Psychotherapy Treatment Use | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| Alcoholics Anonymous | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| Medication for controlling problematic alcohol use | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
| Substance Use | This measure is not administered to providers and administrative staff. | Count of Participants | Participants |
|
|
|
|
| Primary | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | This measure consists of 8 scales: Adoption, Appropriateness, Feasibility, Reach/Access, Organizational climate, Leadership in Implementing, and General Leadership Skills. All eight scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). | The study implementation timeline was designed to have staggered launch dates for the six sites. Specifically, Javesalud (Site 1) and Santa Rosa (Site 2) launched first and were able to complete all follow-ups. Tundama (Site 3) was only able to complete through 18-month follow-ups. Guasca (Site 4) and Armero (Site 5) were only able to complete through 12-month follow-ups. Soacha (Site 6) was only able to complete through the 6-month follow-ups. | Posted | Mean | Standard Deviation | score on a scale | At the time of the provider training, 6 months, 12 months, 18 months, and 24 months. |
|
|
|
|
| Primary | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | This measure consists of 9 scales: 1) Adoption, Appropriateness, Acceptability, Feasibility, Reach/Access, Organizational climate, Leadership in Implementing, General Leadership Skills, and Knowledge. All nine scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). | The study implementation timeline was designed to have staggered launch dates for the six sites. Specifically, Javesalud (Site 1) and Santa Rosa (Site 2) launched first and were able to complete all follow-ups. Tundama (Site 3) was only able to complete through 18-month follow-ups. Guasca (Site 4) and Armero (Site 5) were only able to complete through 12-month follow-ups. Soacha (Site 6) was only able to complete through the 6-month follow-ups. | Posted | Mean | Standard Deviation | score on a scale | At the time of the staff training, 6 months, 12 months, 18 months, and 24 months. |
|
|
|
|
| Primary | The Program Sustainability Assessment Tool (PSAT) Providers | This instrument was developed from the Program Sustainability Assessment and consists of 7 scales: Environmental Support, Partnerships, Organizational Capacity, Program Evaluation, Program Adaptation, Communication with Public, and Communications within the organization. All scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). The seven sub-scales are combined to an overall score by averaging the sub-scale scores. The computed overall scales have a range of 1 to 4. | The study implementation timeline was designed to have staggered launch dates for the six sites. For providers/staff, not all sites completed 18 and 24-month follow-up assessments. Also, baseline data is collected prior to site implementation launch. Some providers/administrators consented and provided data (at various follow-up times) after baseline implementation data collection took place at the sites. | Posted | Mean | Standard Deviation | score on a scale | At the time of the provider training, 6 months, 12 months, 18 months, and 24 months. |
|
|
|
|
| Primary | The Program Sustainability Assessment Tool (PSAT) Administrative Staff | This instrument was developed from the Program Sustainability Assessment and consists of 7 scales: Environmental Support, Funding Stability, Partnerships, Organizational Capacity, Program Evaluation, Program Adaptation, Communication with Public, Communications within the organization, and Communication with Government. All seven scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). The seven sub-scales are combined to an overall score by averaging the sub-scale scores. The computed overall scales have a range of 1 to 4. | The study implementation timeline was designed to have staggered launch dates for the six sites. For providers/staff, not all sites completed 18 and 24-month follow-up assessments. Also, baseline data was collected prior to site implementation launch. Some providers/administrators consented and provided data (at various follow-up times) after baseline implementation data collection took place at the sites. | Posted | Mean | Standard Deviation | score on a scale | At the time of the staff training, 6 months, 12 months, 18 months, and 24 months. |
|
|
|
|
| Secondary | Patient Health Questionnaire (PHQ-8) | A measure with 8 items used to assess depression. The total score of the scale ranges from 0 to 24, with 0 representing no significant depressive symptoms and 24 representing the most severe depressive symptoms. | Only patient participants with a depression diagnosis completed the PHQ assessment at all timepoints. The number of participants analyzed varies at each assessment timepoint due to participants unable to reach during the window of follow-up and participants who withdrew from the study. | Posted | Mean | Standard Deviation | score on a scale | This patient measure were assessed at baseline and every 3 months thereafter for a period of 12 months (for a total of 5 assessment timepoints per patient). |
|
|
|
|
| Secondary | 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) | The WHODAS 2.0 assesses health-related difficulties across six different domains of functioning (cognition, mobility, self-care, socializing, life activities, and participation) that are linked conceptually and operationally to the International Classification of Functioning, Disability and Health (ICF). The scores assigned to 12 items are - "none" (1), "mild" (2) "moderate" (3), "severe" (4) and "extreme" (5). The scores for the 12 items are summed into a total score ranging from 12 (least severe) to 50 (most severe). The last 3 items of the assessment collect the number of days the reported health-related difficulties impact the participants in the past 90 days. | The number of participants analyzed differs at each assessment timepoint due to a number of participants who were unable to reach during the designated window of assessment and participants who actively withdrew from the study for various non-safety related reasons. | Posted | Mean | Standard Deviation | score on a scale | This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints-level assessments per patient). |
|
|
|
|
| Secondary | General Anxiety Disorder Screener (GAD-7) | The GAD-7 is a 7-item self-reported screening questionnaire that has been validated to assess for generalized anxiety disorder (GAD) in outpatient and primary care settings. The measure is scored from 0 to 21, with 0 meaning minimal anxiety and 21 meaning most severe anxiety. | Number of participants analyzed differ at each assessment timepoint because some participants were unable to be reached during the designated window of follow-up and some participants withdrew from the study. | Posted | Mean | Standard Deviation | score on a scale | This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient). |
|
|
|
|
| Secondary | The Quick Drinking Screen (QDS) (for Full Implementation Study Only) | The Quick Drinking Screen (QDS) is a 3-item questionnaire which asks about average drinking habits over the last ninety days. The responses are used to calculate the number of standard drinks consumed per week. In this measure, a standard drink is defined as 1-12 oz. regular can or glass of beer, or 1-5 oz. glass of regular wine, or 1 ½ oz. of regular proof hard liquor or spirits. Patients with alcohol use disorder will be asked to complete this measure as part of the baseline assessment and at every 3 months follow-up (a total of 5 assessment timepoints). | The overall number of participants is different from the overall number of the patients arm, because this assessment was only administered to patients diagnosed with alcohol use disorder. There are different numbers of participants analyzed at each timepoint due to a number of participants who were unable to be reached in the designated window of follow-up and who withdrew from the study. | Posted | Mean | Standard Deviation | standard drinks per week | At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with implementation study participants). |
|
|
|
|
| Other Pre-specified | EuroQOL Five Dimensions Questionnaire (EQ-5D) (Only for Pilot Participants) | The EQ-5D. The EQ-5D is a standardized instrument that has been widely used and validated within Spanish speaking populations from several countries in Latin America, and assesses 5 key dimensions of health. | Not Posted | This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants). | Participants |
| Other Pre-specified | EuroQol Visual Analogue Scale (EQ-VAS) (Only for Pilot Participants) | The EQ-VAS assess health-related quality of life. The EQ-VAS asks "how good or bad your health is today?" The scale ranges from 0 (worst health imaginable) to 100 (best health imaginable). The participants marks their number with an "X" on the scale and writes it in a box. | Not Posted | This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants). | Participants |
| Other Pre-specified | Alcohol Timeline Follow-back (Alcohol TLFB) (Only for Pilot Participants) | A measure used to assess problematic alcohol use. The Alcohol TLFB asks patients about their alcohol use in the past 30 days. | Not Posted | This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants). | Participants |
| Other Pre-specified | Behavioral Health Integration in Medical Care Index (BHIMC) | The BHIMC is an organizational measure of the level of behavioral health integration in medical practice settings. It evaluates policy, clinical practice and workforce dimensions of integration using mixed methods, i.e. combination of document review and observation. | Not Posted | Approximately every year prior to the time of implementation launch at a given site (starting with baseline in late 2017); at the time of implementation launch; and approximately every year thereafter at each site until study completion (April 2021). | Participants |
| Other Pre-specified | The Time-driven Activity-based Costing (TDABC) Approach | The TDABC method measures costs of implementing the proposed model of care for depression and alcohol use disorders.The TDABC method will be used to determine the costs of the specific human, equipment, and facility resources used for delivering mental health care to patients as part of the model of care. | Not Posted | Approximately every year prior to the time of implementation launch at a given site (starting with baseline in late 2017); at the time of implementation launch; and approximately every year thereafter at each site until study completion (April 2021). | Participants |
| Other Pre-specified | Non-Study Medical and Other Services (NSMOS) | The NSOMS assesses patients' medical resource use that is not part of the intervention, including non-treatment therapy visits, physician visits, residential and/or hospital detoxification, hospital and emergency department visits, and medication use through patient self-report. | Not Posted | At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient). | Participants |
| Other Pre-specified | Non-Medical Expenses for Depression (NMED) | The NMED assesses the non-medical costs of depression. This measure is in Spanish and has been used in Latin America and used by our team at Javeriana. | Not Posted | At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient). | Participants |
| Other Pre-specified | Health and Work Performance Questionnaire (HPQ) | The HPQ was developed by the World Health Organization, and assess the impact of depression on work performance (including sickness absence, presenteeism, and critical incidents). | Not Posted | At baseline, 6-month follow-ups, and 12-month follow-ups (for a total of 3 assessment timepoints per patient). | Participants |
| Other Pre-specified | Administrative Interviews | Administrative interviews will assess implementation experiences, challenges to implementation and strategies used to facilitate implementation with different patient populations, changes made to workflow with use of the intervention, and salience of monitoring and feedback processes to inform providers and other stakeholders about the implementation success (approx. 5 at each site). The investigators will also assess the extent to which patients initiated use of the program via inquiry of their providers after learning of the program through patient channels. | Not Posted | At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date) | Participants |
| Other Pre-specified | Patient Utilization Interviews/Observations | The investigators will recruit and follow a sample of patients (approx. 5 at each site) during the implementation project to explore feasibility issues regarding use, barriers and facilitating strategies for using the program, optimal dissemination strategies for promoting use of the program, and overall experiences using the program over time. These patient participants will be encouraged to document their experiences with the mental health service delivery model in an ongoing manner (e.g., note jotting, pictures, audio recording). | Not Posted | At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date) | Participants |
| Other Pre-specified | Provider Interviews | Provider interviews will assess implementation experiences, challenges to implementation and strategies used to facilitate implementation with different patient populations, changes made to workflow with use of the intervention, and salience of monitoring and feedback processes to inform providers and other stakeholders about the implementation success (approx. 5 at each site). The investigators will also assess the extent to which patients initiated use of the program via inquiry of their providers after learning of the program through patient channels. | Not Posted | At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date) | Participants |
| Other Pre-specified | COVID-19 Impact Survey | The COVID-19 Impact Survey is a self-reported questionnaire developed by the NIMH U19 Scale-Up Hubs and will assess the impact of COVID-19 among patients, providers, and administrators enrolled in this study. Given the unknown and widespread implications of the COVID-19 pandemic in Colombia, it is critical to understand the context of COVID-19 for interpreting the study's findings. | Not Posted | Patients will be assessed once at a follow-up visit every 3 months or at a separately scheduled visit. Providers and administrators will be assessed once at a follow-up visit every 6 months or at a separate visit. | Participants |
| 7 |
| 1,264 |
| 107 |
| 1,264 |
| 615 |
| 1,264 |
| Paralysis due to Parkinson's Disease | Nervous system disorders | Non-systematic Assessment |
|
| Hospitalization due to Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| Hospitalization due to Hyperglycemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Spinal Surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Heart Dysfunction | Cardiac disorders | Non-systematic Assessment |
|
| Thyroidectomy | Endocrine disorders | Non-systematic Assessment |
|
| Removal of Gallbladder | Gastrointestinal disorders | Non-systematic Assessment |
|
| Catheterization | Surgical and medical procedures | Non-systematic Assessment |
|
| Liver Complications | Gastrointestinal disorders | Non-systematic Assessment |
|
| Renal Procedure | Renal and urinary disorders | Non-systematic Assessment |
|
| Broken Limb | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Colon Procedure | Surgical and medical procedures | Non-systematic Assessment |
|
| Breast Cancer Related Surgery and Treatment | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Shingles | Infections and infestations | Non-systematic Assessment |
|
| Manic Episode | Psychiatric disorders | Non-systematic Assessment |
|
| Total Knee Replacement | Surgical and medical procedures | Non-systematic Assessment |
|
| Caesarean Section Procedure | Surgical and medical procedures | Non-systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Infection in Leg | Infections and infestations | Non-systematic Assessment |
|
| Facial Paralysis | Nervous system disorders | Non-systematic Assessment |
|
| Curettage Biopsy | Surgical and medical procedures | Non-systematic Assessment |
|
| Hernia Repair | Surgical and medical procedures | Non-systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Worsening Depression without Suicidality | Psychiatric disorders | Non-systematic Assessment |
|
| Surgery for Hand Trauma | Surgical and medical procedures | Non-systematic Assessment |
|
| Blood Transfusion for Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Cysts | General disorders | Non-systematic Assessment |
|
| Hip Replacement | Surgical and medical procedures | Non-systematic Assessment |
|
| Endoscopic retrograde cholangiopancreatography | Surgical and medical procedures | Non-systematic Assessment |
|
| Hospitalization due to COVID-19 Infection | Infections and infestations | Non-systematic Assessment |
|
| Herniated Disc | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthroscopy Procedure | Surgical and medical procedures | Non-systematic Assessment |
|
| Appendectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Gastritis | General disorders | Non-systematic Assessment |
|
| Abdominal Pain | Surgical and medical procedures | Non-systematic Assessment | Hospitalization for related tests and scans |
|
| COVID-19 Infection | Infections and infestations | Non-systematic Assessment |
|
| Headaches | General disorders | Non-systematic Assessment |
|
| Vertigo Episode | Nervous system disorders | Non-systematic Assessment |
|
| Resection of Malignant Mass on Face | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Displacement and imbalance | Nervous system disorders | Non-systematic Assessment |
|
| Facial Paralysis | Nervous system disorders | Non-systematic Assessment |
|
| Fever and face rash | General disorders | Non-systematic Assessment |
|
| Complication of chronic venous insufficiency | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Worsening of Depressive Symptoms | Psychiatric disorders | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | Non-systematic Assessment |
|
| Suicide ideation with risk of self-harm | Psychiatric disorders | Non-systematic Assessment |
|
| Worsening of depression symptoms secondary to autoimmune disease complication | Psychiatric disorders | Non-systematic Assessment |
|
| Parasuicide behavior | Psychiatric disorders | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Excision of Uterine Fibroid | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Tubal ligation surgery | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Ovary and thyroid cysts | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Excision of ovarian myoma | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Post-abortion difficulties | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Pregnancy miscarriage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Bleeding related to pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Vaginal bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Resection of endometrial polyps | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Trauma related to fall injuries | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Work accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Accident under alcohol influence | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Eye Procedure | Eye disorders | Non-systematic Assessment |
|
| Ocular hemorrhage | Eye disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Resection of Gastric and Duodenal Polyps | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomach virus | Gastrointestinal disorders | Non-systematic Assessment |
|
| Liquid stools | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Respiratory problems | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acute bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Pacemaker procedure | Cardiac disorders | Non-systematic Assessment |
|
| Arrythmia Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | Non-systematic Assessment |
|
| Varicose Vein Surgery | Cardiac disorders | Non-systematic Assessment |
|
| Heart murmur | Cardiac disorders | Non-systematic Assessment |
|
| Ankle trauma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Mild Carpal Tunnel | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hyperextension in Spine | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Broken Finger | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Spinal surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Broken arm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Vocal cords surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Diabetes diagnosis | Renal and urinary disorders | Non-systematic Assessment |
|
| Kidney stone | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Tiroidectomy | Endocrine disorders | Non-systematic Assessment |
|
| Biopsy of thyroid nodules | Endocrine disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hospital Regional de Duitama |
|
| Hospital Santa Rosa de Viterbo |
|
| Hospital Granja de Lerida |
|
| Hospital de Chaparral |
|
| Hospital Armero Guayabal |
|
| Prefer not to respond |
|
| Preschool |
|
| Kindergarten |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 6 |
|
| Grade 7 |
|
| Grade 8 |
|
| Grade 9 |
|
| Grade 10 |
|
| Grade 11 |
|
| Secondary Education Diploma |
|
| Technical Studies |
|
| Less than one year of university |
|
| Diploma |
|
| University Degree |
|
| Master's Degree |
|
| Professional Degree |
|
| Doctorate |
|
| At least one year in two-year university program |
|
| One year in four-year university program |
|
| Two years in four-year university program |
|
| At least three years in four-year university program |
|
| Unknown or prefers not to respond |
|
| Stratum 1 |
|
| Stratum 2 |
|
| Stratum 3 |
|
| Stratum 4 |
|
| Stratum 5 |
|
| Stratum 6 |
|
| Prefers not to respond |
|
| Self-employed |
|
| Part-time Employed |
|
| Unemployed, seeking jobs |
|
| Unemployed, not seeking jobs |
|
| Unable to work |
|
| Pensioner |
|
| Housekeeper |
|
| Student |
|
| Prefers not to respond |
|
| Married or Free Union |
|
| Separated |
|
| Divorced |
|
| Widowed |
|
| Prefers not to respond |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Subsidized plan (ARS, SISBEN, EPS-S) |
|
| Contributory plan (EPS) |
|
| Indigenous Health plan |
|
| Supplemental plan or prepaid medical plan |
|
| Special plan (Armed Forces, Ecopetrol) |
|
| Prefers not to respond |
|
| 30-59 minutes |
|
| 60-120 minutes |
|
| More than 120 minutes |
|
| Prefers not to respond |
|
| 1 episode |
|
| 2 episodes |
|
| 3 episodes |
|
| Prefers not to respond |
|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| 9 |
|
| 10 |
|
| Prefers not to respond |
|
|
|
|
| Title | Measurements |
|---|---|
|
|
|
|
| Title | Measurements |
|---|---|
|
| No - does not have a smartphone |
|
| No, does not use the Internet |
|
| Former smoker |
|
| Never smoked |
|
| Prefers not to respond |
|
| No |
|
| Prefers not to respond |
|
| No |
|
| Prefers not to respond |
|
| No |
|
| Prefers not to respond |
|
| No |
|
| Prefers not to respond |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Adoption at 12 months |
|
|
| Adoption at 18 months |
|
|
| Adoption at 24 months |
|
|
| Accessibility at Baseline |
|
|
| Accessibility at 6 months |
|
|
| Accessibility at 12 months |
|
|
| Accessibility at 18 months |
|
|
| Accessibility at 24 months |
|
|
| Appropriateness at Baseline |
|
|
| Appropriateness at 6 months |
|
|
| Appropriateness at 12 months |
|
|
| Appropriateness at 18 months |
|
|
| Appropriateness at 24 months |
|
|
| Feasibility at Baseline |
|
|
| Feasibility at 6 months |
|
|
| Feasibility at 12 months |
|
|
| Feasibility at 18 months |
|
|
| Feasibility at 24 months |
|
|
| Resources at Baseline |
|
|
| Resources at 6 months |
|
|
| Resources at 12 months |
|
|
| Resources at 18 months |
|
|
| Resources at 24 months |
|
|
| Reach/Access at Baseline |
|
|
| Reach/Access at 6 months |
|
|
| Reach/Access at 12 months |
|
|
| Reach/Access at 18 months |
|
|
| Reach/Access at 24 months |
|
|
| Organizational Climate at Baseline |
|
|
| Organizational Climate at 6 months |
|
|
| Organizational Climate at 12 months |
|
|
| Organizational Climate at 18 months |
|
|
| Organizational Climate at 24 months |
|
|
| Leadership in Implementing at Baseline |
|
|
| Leadership in Implementing at 6 months |
|
|
| Leadership in Implementing at 12 months |
|
|
| Leadership in Implementing at 18 months |
|
|
| Leadership in Implementing at 24 months |
|
|
| General Leadership Skills at Baseline |
|
|
| General Leadership Skills at 6 months |
|
|
| General Leadership Skills at 12 months |
|
|
| General Leadership Skills at 18 months |
|
|
| General Leadership Skills at 24 months |
|
|
| Regression, Linear |
| 0.492 |
p<0.05 is the threshold for statistical significance. |
| Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results. | Regression, Linear | 0.285 | p<0.05 is the threshold for statistical significance. | Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results. | Regression, Linear | 0.964 | p<0.05 is the threshold for statistical significance. | Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Resources subscale results. | Regression, Linear | 0.942 | p<0.05 is the threshold for statistical significance. | Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Scope subscale results. | Regression, Linear | 0.366 | p<0.05 is the threshold for statistical significance. | Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results. | Regression, Linear | 0.021 | p<0.05 is the threshold for statistical significance. | Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results. | Regression, Linear | 0.832 | p<0.05 is the threshold for statistical significance. | Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results. | Regression, Linear | 0.827 | p<0.05 is the threshold for statistical significance. | Other |
|
| Adoption at 12 months |
|
|
| Adoption at 18 months |
|
|
| Adoption at 24 months |
|
|
| Accessibility at Baseline |
|
|
| Accessibility at 6 months |
|
|
| Accessibility at 12 months |
|
|
| Accessibility at 18 months |
|
|
| Accessibility at 24 months |
|
|
| Appropriateness at Baseline |
|
|
| Appropriateness at 6 months |
|
|
| Appropriateness at 12 months |
|
|
| Appropriateness at 18 months |
|
|
| Appropriateness at 24 months |
|
|
| Feasibility at Baseline |
|
|
| Feasibility at 6 months |
|
|
| Feasibility at 12 months |
|
|
| Feasibility at 18 months |
|
|
| Feasibility at 24 months |
|
|
| Reach/Access at Baseline |
|
|
| Reach/Access at 6 months |
|
|
| Reach/Access at 12 months |
|
|
| Reach/Access at 18 months |
|
|
| Reach/Access at 24 months |
|
|
| Organizational Climate at Baseline |
|
|
| Organizational Climate at 6 months |
|
|
| Organizational Climate at 12 months |
|
|
| Organizational Climate at 18 months |
|
|
| Organizational Climate at 24 months |
|
|
| Leadership in Implementing at Baseline |
|
|
| Leadership in Implementing at 6 months |
|
|
| Leadership in Implementing at 12 months |
|
|
| Leadership in Implementing at 18 months |
|
|
| Leadership in Implementing at 24 months |
|
|
| General Leadership Skills at Baseline |
|
|
| General Leadership Skills at 6 months |
|
|
| General Leadership Skills at 12 months |
|
|
| General Leadership Skills at 18 months |
|
|
| General Leadership Skills at 24 months |
|
|
| Knowledge at Baseline |
|
|
| Knowledge at 6 months |
|
|
| Knowledge at 12 months |
|
|
| Knowledge at 18 months |
|
|
| Knowledge at 24 months |
|
|
| Regression, Linear |
| 0.896 |
p<0.05 is the threshold for statistical significance. |
| Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results. | Regression, Linear | 0.739 | p<0.05 is the threshold for statistical significance. | Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results. | Regression, Linear | 0.724 | p<0.05 is the threshold for statistical significance. | Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results. | Regression, Linear | 0.301 | p<0.05 is the threshold for statistical significance. | Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results. | Regression, Linear | 0.034 | p<0.05 is the threshold for statistical significance. | Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results. | Regression, Linear | 0.015 | p<0.05 is the threshold for statistical significance. | Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results. | Regression, Linear | 0.081 | p<0.05 is the threshold for statistical significance. | Other |
| We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Knowledge subscale results. | Regression, Linear | 0.790 | p<0.05 is the threshold for statistical significance. | Other |
|
| 12 months follow-up overall |
|
|
| 18 months follow-up overall |
|
|
| 24 months follow-up overall |
|
|
|
| 12 months follow-up overall |
|
|
| 18 months follow-up overall |
|
|
| 24 months follow-up overall |
|
|
|
| 6-Month |
|
|
| 9-Month |
|
|
| 12-Month |
|
|
|
| 6-Month Total Sum Score |
|
|
| 9-Month Total Sum Score |
|
|
| 12-Month Total Sum Score |
|
|
|
| 6-Month |
|
|
| 9-Month |
|
|
| 12-Month |
|
|
|
| 6-Month Standard Drinks per Week |
|
|
| 9-Month Standard Drinks per Week |
|
|
| 12-Month Standard Drinks per Week |
|
|