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Get Ready And Empowered About Treatment (GREAT)

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ClinicalTrials.gov Identifier: NCT02165735
Recruitment Status : Completed
First Posted : June 17, 2014
Results First Posted : October 9, 2018
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Kevin Fiscella, University of Rochester

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: patient activation training Other: Usual care Not Applicable

Detailed Description:

Our project has four major aims:

  1. Assess improvement in patient empowerment
  2. Assess improvement in patients' receipt of evidence-based care
  3. Assess improvement in patients' health
  4. Assess reduction in disparities in empowerment

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Addressing HIV Tx Disparities Through Patient Empowerment
Actual Study Start Date : August 20, 2014
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: patient activation training
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.
Behavioral: patient activation training
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.

Experimental: Usual Care
Usual care for HIV
Other: Usual care
Usual HIV care




Primary Outcome Measures :
  1. Change in Patient Activation Measure (PAM) [ Time Frame: Baseline and 1 year ]

    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



Secondary Outcome Measures :
  1. Change in eHealth Literacy Scale (eHEALS) [ Time Frame: Baseline and 1 year ]
    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.

  2. Change in Decisional Self-Efficacy Scale (DSES) [ Time Frame: Baseline and 1 year ]
    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.

  3. Change in Perceived Involvement in Care Scale (PICS) [ Time Frame: Baseline and 1 year ]
    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.

  4. Change in Instrument on Doctor Patient Communication Skills (IDPCS) [ Time Frame: Baseline and 1 year ]
    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.

  5. Change in HIV Adherence Self-Efficacy Scale (ASES) [ Time Frame: Baseline and 1 year ]
    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.

  6. Change in Self-Reported Adherence [ Time Frame: Baseline and 1 year ]
    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.

  7. Change in Undetectable Viral Load [ Time Frame: Baseline and 1 year ]
    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.

  8. Change in Evidence-based Preventative Care [ Time Frame: Baseline and 1 year ]
    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.

  9. Change in Short Form Health Survey: [Mental Health] (SF12) [ Time Frame: Baseline and 1 year ]
    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.

  10. Change in Short Form Health Survey: [Physical Health] (SF12) [ Time Frame: Baseline and 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age18 years or older,
  • confirmed HIV diagnosis
  • receipt of care within a participating site.

Exclusion Criteria:

  • inability to provide informed consent
  • limited English proficiency (Trainings and Personal Health Record are currently only available in English)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165735


Locations
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United States, New York
Clinical Directors Network
New York, New York, United States, 10018
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Kevin A Fiscella, MD MPH University of Rochester
Principal Investigator: Jonathan Tobin, PhD Clinical Directors Network CDN
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kevin Fiscella, MD, MPH, University of Rochester
ClinicalTrials.gov Identifier: NCT02165735    
Other Study ID Numbers: AD-1306-03104
First Posted: June 17, 2014    Key Record Dates
Results First Posted: October 9, 2018
Last Update Posted: March 15, 2019
Last Verified: February 2019