Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to rigorously assess a program designed to empower patient living with HIV, to improve their health care and health, and to reduce disparities.
Our project has four major aims:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient activation training | Experimental | Patient activation training involves six, 90-minute, group (8-12 person) training sessions facilitated by trained peers and training staff and one (20-30 minute) pre-visit coaching session conducted by staff. The hands on group training includes: 1) HIV education; 2) use of a handheld smart device; 3) use of an HIV electronic personal health record app that runs on the smart device; 4) identification of patients' visit need priorities and skills for communicating with their HIV provider. The pre-visit coaching includes identification patient concerns and patient behavioral rehearsal for asking about these concerns. |
|
| Usual Care | Experimental | Usual care for HIV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patient activation training | Behavioral | Patient activation training involves six, 90-minute, group (8-12 person) training sessions facilitated by trained peers and training staff and one (20-30 minute) pre-visit coaching session conducted by staff. The hands on group training includes: 1) HIV education; 2) use of a handheld smart device; 3) use of an HIV electronic personal health record app that runs on the smart device; 4) identification of patients' visit need priorities and skills for communicating with their HIV provider. The pre-visit coaching includes identification of patient concerns and patient behavioral rehearsal for asking about these concerns. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Activation Measure (PAM) | Our primary outcome measure is patient empowerment based on changes in the Patient Activation Measure or PAM. The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management. People who score high on the PAM normally understand the importance of taking an active role in managing their health and have the skills and confidence to do so.The scores for the 13-item measure range in value from 0-100, with higher scores indicating greater activation. LEVEL 1 (0-47): May not yet believe that the patient role is important LEVEL 2 (47.1 - 55.1): Lacks confidence and knowledge to take action LEVEL 3 (55.2 - 67.0): Beginning to take action LEVEL 4 (67.1 - 100): Adapting new behaviors, but may have difficulty maintaining over time | Baseline and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in eHealth Literacy Scale (eHEALS) | Our first secondary outcome measure is eHealth literacy based on changes in the eHealth Literacy Scale or eHEALS. The eHealth Literacy Scale (eHEALS) is an 8-item measure that assesses patient comfort, knowledge, and skills at finding health information on the internet and evaluating whether or not it is reliable. People who score high on the eHEALS normally are very comfortable finding reliable information on the internet. The scores for the 8-item measure range in value from 8-40, with higher scores indicating greater perceived skills at using online health information to help solve health problems. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kevin A Fiscella, MD MPH | University of Rochester | Principal Investigator |
| Jonathan Tobin, PhD | Clinical Directors Network CDN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Directors Network | New York | New York | 10018 | United States | ||
| University of Rochester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31240605 | Derived | Carroll JK, Tobin JN, Luque A, Farah S, Sanders M, Cassells A, Fine SM, Cross W, Boyd M, Holder T, Thomas M, Overa CC, Fiscella K. "Get Ready and Empowered About Treatment" (GREAT) Study: a Pragmatic Randomized Controlled Trial of Activation in Persons Living with HIV. J Gen Intern Med. 2019 Sep;34(9):1782-1789. doi: 10.1007/s11606-019-05102-7. Epub 2019 Jun 25. | |
| 26474979 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patient Empowerment | Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships. Patient Empowerment and Autonomy Training |
| FG001 | Standard Care | Participants will be followed through usual source of care, without receiving the empowerment training. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One patient that was randomized to Standard Care was subsequently found to be ineligible for the study. This resulted in 179 participants in the Standard Care arm, rather than 180.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patient Empowerment | Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships. Patient Empowerment and Autonomy Training |
| 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 | Change in Patient Activation Measure (PAM) | Our primary outcome measure is patient empowerment based on changes in the Patient Activation Measure or PAM. The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management. People who score high on the PAM normally understand the importance of taking an active role in managing their health and have the skills and confidence to do so.The scores for the 13-item measure range in value from 0-100, with higher scores indicating greater activation. LEVEL 1 (0-47): May not yet believe that the patient role is important LEVEL 2 (47.1 - 55.1): Lacks confidence and knowledge to take action LEVEL 3 (55.2 - 67.0): Beginning to take action LEVEL 4 (67.1 - 100): Adapting new behaviors, but may have difficulty maintaining over time | Multiple imputation was used to account for those with missing or incomplete data | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 year |
|
1 year
Not provided
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 | Patient Empowerment | Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships. Patient Empowerment and Autonomy Training |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin Fiscella, PI | University of Rochester | 5853244563 | kevin_fiscella@urmc.rochester.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Usual care | Other | Usual HIV care |
|
| Baseline and 1 year |
| Change in Decisional Self-Efficacy Scale (DSES) | Our next secondary outcome measure is decision making based on changes in the Decisional Self-Efficacy Scale or DSES. The Decisional Self-Efficacy Scale (DSES) is an 11-item measure that assesses patient confidence in their ability to make health care decisions. People who score high on the DSES normally have an easier time making health care decisions. The scores for the 11-item measure range in value from 0-100, with higher scores indicating greater confidence in making an informed choice. | Baseline and 1 year |
| Change in Perceived Involvement in Care Scale (PICS) | Our third secondary outcome measure is involvement in care based on changes in the Perceived Involvement in Care Scale or PICS. The Perceived Involvement in Care Scale (PICS) is an 8-item measure that assesses patient perceived proficiency in communicating concerning their health care with the doctor. People who score high on the PICS normally are satisfied with how well they feel they communicate with the doctor about their care. The scores for the 8-item measure range in value from 8-40, with higher scores indicating greater perceived involvement in their care. | Baseline and 1 year |
| Change in Instrument on Doctor Patient Communication Skills (IDPCS) | Our fourth secondary outcome measure is clinician patient centeredness based on changes in the Instrument on Doctor Patient Communication Skills or IDPCS. The Instrument on Doctor Patient Communication Skills (IDPCS) is a 19-item measure that assesses patient perception of the doctor's communication proficiency with them. People who score high on the IDPCS normally are satisfied with the way the doctor speak with them about their care. The scores for the 19-item measure range in value from 19-95, with higher scores indicating greater quality communication by the doctor. | Baseline and 1 year |
| Change in HIV Adherence Self-Efficacy Scale (ASES) | Our fifth secondary outcome measure is HIV adherence self-efficacy based on changes in the HIV Adherence Self-Efficacy Scale or ASES. The HIV Adherence Self-Efficacy Scale (ASES) is a 15-item measure that assesses patient self-efficacy for adherence to HIV treatment plan including but not limited to taking HIV medications. People who score high on the ASES normally are very confident of sticking to their HIV treatment plan even when it is hard. The scores for the 15-item measure range in value from 0-150, with higher scores indicating greater adherence self-efficacy. | Baseline and 1 year |
| Change in Self-Reported Adherence | Our sixth secondary outcome measure is adherence to combination antiretroviral treatment (cART) based on changes on survey of recommended items for assessing self-reported antiretroviral adherence. Our survey included two recommended assessment items with the focus on one-item measure that assesses patient self-reported adherence to taking HIV medications. People who score high on the self-reported adherence cART normally are very confident of being more adherent to taking their HIV medications. The score for the one-item measure range in value from 0-100 percent, with higher scores indicating greater adherence to cART. | Baseline and 1 year |
| Change in Undetectable Viral Load | Our seventh secondary outcome measure is undetectable viral load based on changes to participants' HIV viral load. The HIV viral load measurements were abstracted from the participants' personal health record (PHR). In our study, people who had a HIV viral load of <50 were considered to have undetectable viral load. | Baseline and 1 year |
| Change in Evidence-based Preventative Care | Our eighth secondary outcome measure is prevention-seeking behavior based on chart abstracted information based on our preventive care index. We created a preventive care index for each participant by assigning one point of each intervention they received post-randomization divided by the total number of interventions for which they were eligible. The index included eleven preventive care measures: Human Papillomavirus, Influenza, Tetanus, Hepatitis A, B, C testing, Hepatitis A & B vaccinations, cervical cancer screening (PAP), mammography and any colon cancer screening. People who score high on the evidence-based preventative care normally are more able to prevent illnesses or diseases. The score for the measure range in value from 0-1, with higher scores indicating greater ability to stay healthy. | Baseline and 1 year |
| Change in Short Form Health Survey: [Mental Health] (SF12) | Our ninth secondary outcome measure is mental well-being and quality of life based on changes on the Short Form Health Survey or SF12. The Short Form Health Survey (SF12) is a 12-item measure with 6 items that assesses patient mental well-being/quality of life and 6 items that assesses patient physical well-being/quality of life. People who score high on the SF-12 are normally in good mental and physical health. The scores for the 12-item measure includes two scales whose range in value from 0-100, with higher scores indicating a better health state. | Baseline and 1 year |
| Change in Short Form Health Survey: [Physical Health] (SF12) | Our final secondary outcome measure is physical well-being and quality of life based on changes on the Short Form Health Survey or SF12. The Short Form Health Survey (SF12) is a 12-item measure with 6 items that assesses patient mental well-being/quality of life and 6 items that assesses patient physical well-being/quality of life. People who score high on the SF-12 are normally in good mental and physical health. The scores for the 12-item measure includes two scales whose range in value from 0-100, with higher scores indicating a better health state. | Baseline and 1 year |
| Rochester |
| New York |
| 14642 |
| United States |
| Fiscella K, Boyd M, Brown J, Carroll J, Cassells A, Corales R, Cross W, El'Daher N, Farah S, Fine S, Fowler R, Hann A, Luque A, Rodriquez J, Sanders M, Tobin J. Activation of persons living with HIV for treatment, the great study. BMC Public Health. 2015 Oct 16;15:1056. doi: 10.1186/s12889-015-2382-1. |
| Participant indicated lack of time |
|
| Protocol Violation |
|
| BG001 | Standard Care | Participants will be followed through usual source of care, without receiving the empowerment training. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Patient Empowerment |
Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships. |
| OG001 | Standard Care | Participants will be followed through usual source of care, without receiving the empowerment training. |
|
|
| Secondary | Change in eHealth Literacy Scale (eHEALS) | Our first secondary outcome measure is eHealth literacy based on changes in the eHealth Literacy Scale or eHEALS. The eHealth Literacy Scale (eHEALS) is an 8-item measure that assesses patient comfort, knowledge, and skills at finding health information on the internet and evaluating whether or not it is reliable. People who score high on the eHEALS normally are very comfortable finding reliable information on the internet. The scores for the 8-item measure range in value from 8-40, with higher scores indicating greater perceived skills at using online health information to help solve health problems. | Multiple imputation was used to account for those with missing or incomplete data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 year |
|
|
|
| Secondary | Change in Decisional Self-Efficacy Scale (DSES) | Our next secondary outcome measure is decision making based on changes in the Decisional Self-Efficacy Scale or DSES. The Decisional Self-Efficacy Scale (DSES) is an 11-item measure that assesses patient confidence in their ability to make health care decisions. People who score high on the DSES normally have an easier time making health care decisions. The scores for the 11-item measure range in value from 0-100, with higher scores indicating greater confidence in making an informed choice. | Multiple imputation was used to account for those with missing or incomplete data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 year |
|
|
|
| Secondary | Change in Perceived Involvement in Care Scale (PICS) | Our third secondary outcome measure is involvement in care based on changes in the Perceived Involvement in Care Scale or PICS. The Perceived Involvement in Care Scale (PICS) is an 8-item measure that assesses patient perceived proficiency in communicating concerning their health care with the doctor. People who score high on the PICS normally are satisfied with how well they feel they communicate with the doctor about their care. The scores for the 8-item measure range in value from 8-40, with higher scores indicating greater perceived involvement in their care. | Multiple imputation was used to account for those with missing or incomplete data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 year |
|
|
|
| Secondary | Change in Instrument on Doctor Patient Communication Skills (IDPCS) | Our fourth secondary outcome measure is clinician patient centeredness based on changes in the Instrument on Doctor Patient Communication Skills or IDPCS. The Instrument on Doctor Patient Communication Skills (IDPCS) is a 19-item measure that assesses patient perception of the doctor's communication proficiency with them. People who score high on the IDPCS normally are satisfied with the way the doctor speak with them about their care. The scores for the 19-item measure range in value from 19-95, with higher scores indicating greater quality communication by the doctor. | Multiple imputation was used to account for those with missing or incomplete data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 year |
|
|
|
| Secondary | Change in HIV Adherence Self-Efficacy Scale (ASES) | Our fifth secondary outcome measure is HIV adherence self-efficacy based on changes in the HIV Adherence Self-Efficacy Scale or ASES. The HIV Adherence Self-Efficacy Scale (ASES) is a 15-item measure that assesses patient self-efficacy for adherence to HIV treatment plan including but not limited to taking HIV medications. People who score high on the ASES normally are very confident of sticking to their HIV treatment plan even when it is hard. The scores for the 15-item measure range in value from 0-150, with higher scores indicating greater adherence self-efficacy. | Multiple imputation was used to account for those with missing or incomplete data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 year |
|
|
|
| Secondary | Change in Self-Reported Adherence | Our sixth secondary outcome measure is adherence to combination antiretroviral treatment (cART) based on changes on survey of recommended items for assessing self-reported antiretroviral adherence. Our survey included two recommended assessment items with the focus on one-item measure that assesses patient self-reported adherence to taking HIV medications. People who score high on the self-reported adherence cART normally are very confident of being more adherent to taking their HIV medications. The score for the one-item measure range in value from 0-100 percent, with higher scores indicating greater adherence to cART. | Multiple imputation was used to account for those with missing or incomplete data. | Posted | Mean | Standard Deviation | percentage of cART adherence in past mth | Baseline and 1 year |
|
|
|
| Secondary | Change in Undetectable Viral Load | Our seventh secondary outcome measure is undetectable viral load based on changes to participants' HIV viral load. The HIV viral load measurements were abstracted from the participants' personal health record (PHR). In our study, people who had a HIV viral load of <50 were considered to have undetectable viral load. | Multiple imputation was used to account for those with missing or incomplete data. | Posted | Mean | Standard Deviation | percentage of participants | Baseline and 1 year |
|
|
|
| Secondary | Change in Evidence-based Preventative Care | Our eighth secondary outcome measure is prevention-seeking behavior based on chart abstracted information based on our preventive care index. We created a preventive care index for each participant by assigning one point of each intervention they received post-randomization divided by the total number of interventions for which they were eligible. The index included eleven preventive care measures: Human Papillomavirus, Influenza, Tetanus, Hepatitis A, B, C testing, Hepatitis A & B vaccinations, cervical cancer screening (PAP), mammography and any colon cancer screening. People who score high on the evidence-based preventative care normally are more able to prevent illnesses or diseases. The score for the measure range in value from 0-1, with higher scores indicating greater ability to stay healthy. | Multiple imputation was used to account for those with missing or incomplete data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 year |
|
|
|
| Secondary | Change in Short Form Health Survey: [Mental Health] (SF12) | Our ninth secondary outcome measure is mental well-being and quality of life based on changes on the Short Form Health Survey or SF12. The Short Form Health Survey (SF12) is a 12-item measure with 6 items that assesses patient mental well-being/quality of life and 6 items that assesses patient physical well-being/quality of life. People who score high on the SF-12 are normally in good mental and physical health. The scores for the 12-item measure includes two scales whose range in value from 0-100, with higher scores indicating a better health state. | Multiple imputation was used to account for those with missing or incomplete data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 year |
|
|
|
| Secondary | Change in Short Form Health Survey: [Physical Health] (SF12) | Our final secondary outcome measure is physical well-being and quality of life based on changes on the Short Form Health Survey or SF12. The Short Form Health Survey (SF12) is a 12-item measure with 6 items that assesses patient mental well-being/quality of life and 6 items that assesses patient physical well-being/quality of life. People who score high on the SF-12 are normally in good mental and physical health. The scores for the 12-item measure includes two scales whose range in value from 0-100, with higher scores indicating a better health state. | Multiple imputation was used to account for those with missing or incomplete data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 year |
|
|
|
| 0 |
| 180 |
| 0 |
| 180 |
| 0 |
| 180 |
| EG001 | Standard Care | Participants will be followed through usual source of care, without receiving the empowerment training. | 0 | 180 | 0 | 180 | 0 | 180 |
Not provided
Not provided