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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA034279-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Dartmouth College | OTHER |
| Center for Health Enhancement System Studies | OTHER |
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Implementing a mobile-phone based system for drug use disorders in primary care settings.
The purpose of the research is to study the impact of a recovery support system called Seva on primary care organizations, where issues such as coordination of care, job satisfaction, and the cost of adopting and operating new technologies are critical. The study will also investigate how to best implement this kind of technology into health care delivery systems that care for people diagnosed with substance abuse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seva | Experimental | Up to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seva | Behavioral | Patients were given access to use Seva. This is a mobile application that uses social and behavioral theories to help support people after alcohol use disorder recovery. |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation Status | The number of implementation milestones completed | up to 3 years |
| Any Drinking Days in Last 30 Days | 6 months | |
| Risky Drinking Days in the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | 6 months |
| Illicit Drug-use Within the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | 6 months |
| Overall Quality of Life | Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. Value was calculated by adding the mental and physical subscale values. Values could range from 8 to 40. | 6 months |
| Physical Subscale Quality of Life | Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This scare consisted of 4 questions that had scales ranging from 1 to 5. The scores were summed and values could range from 4 to 20. | 6 months |
| Mental Subscale Quality of Life | Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This consisted of 4 questions that had scaled ranging from 1 to 5. The scores of the scales were summed and values could range from 4 to 20. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Using System | Analysis for measure was done for the total of all three sites combined. | up to 3 years |
| Clinical Adoption | We analyzed computerized system log files to produce patterns of system adoption of the staff. |
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Inclusion Criteria:
Patient subjects must be 1) age 18 or older 2) meet criteria for Substance Use Disorder (SUD) according to the clinic. Clinician subjects referring patients will ensure that patients: 3) have no current psychotic disorder severe enough to prevent participation, 4) have no acute medical problem requiring immediate inpatient treatment, 5) are willing to use Seva, and 6) can understand and sign a consent form in English.
Clinician subjects include MDs, behavioral health providers, nurses and management staff from the clinics' primary care and behavioral health departments. Clinician must have an interest in the research objectives.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partnership Health Center | Missoula | Montana | United States | |||
| Institute for Family Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31237841 | Derived | Quanbeck A. Using Stakeholder Values to Promote Implementation of an Evidence-Based Mobile Health Intervention for Addiction Treatment in Primary Care Settings. JMIR Mhealth Uhealth. 2019 Jun 7;7(6):e13301. doi: 10.2196/13301. | |
| 27687632 | Derived | Mares ML, Gustafson DH, Glass JE, Quanbeck A, McDowell H, McTavish F, Atwood AK, Marsch LA, Thomas C, Shah D, Brown R, Isham A, Nealon MJ, Ward V. Implementing an mHealth system for substance use disorders in primary care: a mixed methods study of clinicians' initial expectations and first year experiences. BMC Med Inform Decis Mak. 2016 Sep 29;16(1):126. doi: 10.1186/s12911-016-0365-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Seva - Patients | Up to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders. |
| FG001 | Seva - Clinicians | We will analyze data of clinicians who use Seva (e.g. clinical adoption). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Seva - Madison Site | Patients will receive access to the Seva mobile health system for drug use disorders. Data on clinician participants were not collected due to the focus of the study being the patient. |
| BG001 | Seva - Missoula |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Implementation Status | The number of implementation milestones completed | These are milestones achieved for each site. | Posted | Number | milestones | up to 3 years | Milestones | Milestones |
|
Up to 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Seva - Patients | Patients will receive access to the Seva mobile health system for drug use disorders. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | These deaths were non-study related. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Quanbeck | University of Wisconsin - Madison | 6082627385 | arquanbe@wisc.edu |
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| 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 | May 5, 2015 | Feb 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 6 months |
| Patient Had Any Drink Within the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | 6 months |
| Patient Had Illicit Drug Use Within the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | 6 months |
| Patient Had Any Drink or Drug Use Within the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | 6 months |
| Patients, Within the Last 6 Months Have Received Other Addiction Treatment | Analysis for measure was done for the total of all three sites combined. | 6 months |
| Patients Partook in HIV Risky Behavior in the Last 6 Months | Analysis for measure was done for the total of all three sites combined. | 6 months |
| Patients Partook in HIV Testing in the Last 6 Months | Analysis for measure was done for the total of all three sites combined. | 6 months |
| up to 3 years |
| Total Costs for Clinic | This includes the clinic operating costs and clinic implementation costs of the intervention. | 6 months |
| The Bronx |
| New York |
| United States |
| UW Health Access Clinic | Madison | Wisconsin | 53706 | United States |
| 24884976 | Derived | Quanbeck AR, Gustafson DH, Marsch LA, McTavish F, Brown RT, Mares ML, Johnson R, Glass JE, Atwood AK, McDowell H. Integrating addiction treatment into primary care using mobile health technology: protocol for an implementation research study. Implement Sci. 2014 May 29;9:65. doi: 10.1186/1748-5908-9-65. |
Patients will receive access to the Seva mobile health system for drug use disorders. Data on clinician participants were not collected due to the focus of the study being the patient.
| BG002 | Seva - Bronx | Patients will receive access to the Seva mobile health system for drug use disorders. Data on clinician participants were not collected due to the focus of the study being the patient. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
| Insured by medicare | Count of Participants | Participants |
|
| Insured by medicaid | Count of Participants | Participants |
|
| Insured by private/other | Count of Participants | Participants |
|
| Not insured | Count of Participants | Participants |
|
| Patient-centered medical home (PCMH) designation | Three levels of recognition exist, based on practice sites meeting six standards. Level three clinics have the best adherence to the standards. Those standards include team-based care and practice organization, knowing and managing patients, patient-centered access and continuity, care management and support, care coordination and care transitions, and performance measurement and quality improvement. | Number | Level |
|
| Patients enrolled in Seva | Count of Participants | Participants |
|
| Any drinking days | within the last 30 days. | Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics. | Mean | Standard Deviation | days |
|
| Risky drinking days | within the last 30 days. | Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics. | Mean | Standard Deviation | days |
|
| Illicit drug-use days | within the last 30 days. | Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics. | Mean | Standard Deviation | days |
|
| Overall quality of life (QoL) | Higher scores on the scale indicate higher quality of life. Scale ranges from 8 to 40. It includes mental and physical health sub scale values. These values are summed | Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics. | Mean | Standard Deviation | score on a scale |
|
| Physical subscale Quality of Life | Higher scores on the scale indicate higher quality of life. It includes 4 items on overall physical health, physical function, pain, and fatigue that each has a scale ranging from 1 to 5. These values are summed. Scale ranges from 4 to 20. | Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics. | Mean | Standard Deviation | score on a scale |
|
| Mental subscale Quality of Life | Higher scores on the scale indicate higher quality of life. There are 4 questions that have scales that range from values of 1 to 5. These values are summed to give the score for the mental subscale quality of life. Scale ranges from 4 to 20. | Participants dropped out of the study over the duration. | Mean | Standard Deviation | score on a scale |
|
| Number of hospitalizations | Within the last 6 months. | Participants dropped out of the study over the duration. | Mean | Standard Deviation | hospitalizations |
|
| Number of ER visits | within the past 6 months. | Participants dropped out over the duration of the study. | Mean | Standard Deviation | ER visits |
|
| Any drink | within the last 30 days. | Participants dropped out over the duration of the study. | Number | participants |
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| Illicit drug use | within the last 30 days. | Participants dropped out of the study over time. | Number | participants |
|
| Any drink or drug | within the last 30 days. | Participants dropped out of the study over time. | Number | participants |
|
| Currently receive other addiction treatment | within the last 6 months. | Participants dropped out over time. | Number | participants |
|
| HIV risky behavior | within the last 6 months. | Participants dropped out over time. | Number | participants |
|
| HIV testing | within the past 6 months. | Participants dropped out over time. | Number | participants |
|
| Drug of choice is alcohol | Count of Participants | Participants |
|
| Drug of choice is Opiates | Count of Participants | Participants |
|
| Drug of choice is crack cocaine | Count of Participants | Participants |
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| Drug of choice is marijuana | Count of Participants | Participants |
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| Drug of choice is methamphetamine | Count of Participants | Participants |
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| Drug of choice is multiple drugs | Count of Participants | Participants |
|
We identified 12 milestones for to meet for each site.
|
|
| Primary | Any Drinking Days in Last 30 Days | Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others. | Posted | Mean | Standard Deviation | days | 6 months |
|
|
|
| Primary | Risky Drinking Days in the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others. | Posted | Mean | Standard Deviation | days | 6 months |
|
|
|
| Primary | Illicit Drug-use Within the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others. | Posted | Mean | Standard Deviation | days | 6 months |
|
|
|
| Primary | Overall Quality of Life | Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. Value was calculated by adding the mental and physical subscale values. Values could range from 8 to 40. | Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Primary | Physical Subscale Quality of Life | Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This scare consisted of 4 questions that had scales ranging from 1 to 5. The scores were summed and values could range from 4 to 20. | Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Primary | Mental Subscale Quality of Life | Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This consisted of 4 questions that had scaled ranging from 1 to 5. The scores of the scales were summed and values could range from 4 to 20. | Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Primary | Patient Had Any Drink Within the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Patient Had Illicit Drug Use Within the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Patient Had Any Drink or Drug Use Within the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | Overall number of participants analyzed because data was self reported and patients were allowed to not answer questions if they chose. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Patients, Within the Last 6 Months Have Received Other Addiction Treatment | Analysis for measure was done for the total of all three sites combined. | Posted | Count of Participants | Participants | 6 months |
|
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| Primary | Patients Partook in HIV Risky Behavior in the Last 6 Months | Analysis for measure was done for the total of all three sites combined. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Patients Partook in HIV Testing in the Last 6 Months | Analysis for measure was done for the total of all three sites combined. | Overall number of participants analyzed is lower because data is self reported and patients could chose not to answer some questions. | Posted | Count of Participants | Participants | 6 months |
|
|
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| Secondary | Number of Patients Using System | Analysis for measure was done for the total of all three sites combined. | Posted | Count of Participants | Participants | up to 3 years |
|
|
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| Secondary | Clinical Adoption | We analyzed computerized system log files to produce patterns of system adoption of the staff. | This is the number of primary care clinical staff at the 3 sites who adopted using Seva. | Posted | Count of Participants | Participants | up to 3 years |
|
|
|
| Secondary | Total Costs for Clinic | This includes the clinic operating costs and clinic implementation costs of the intervention. | This outcome measure was analyzed at the clinic level. Thus, NA is indicated for "Overall number of participants analyzed." | Posted | Number | US dollars | 6 months | clinic | clinic |
|
|
|
| 3 |
| 268 |
| 3 |
| 268 |
| 0 |
| 268 |
| EG001 | Seva - Clinicians | Clinicians who worked at Seva sites were also monitored for Adverse events. | 0 | 171 | 0 | 171 | 0 | 171 |
| Death | General disorders | Systematic Assessment | This was a non-study related death. This participant died of Chronic Obstructive Pulmonary Disease and emphysema. |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|