• J Gen Intern Med · Sep 2019

    Multicenter Study Pragmatic Clinical Trial

    "Get Ready and Empowered About Treatment" (GREAT) Study: a Pragmatic Randomized Controlled Trial of Activation in Persons Living with HIV.

    • Jennifer K Carroll, Jonathan N Tobin, Amneris Luque, Subrina Farah, Mechelle Sanders, Andrea Cassells, Steven M Fine, Wendi Cross, Michele Boyd, Tameir Holder, Marie Thomas, Cleo Clarize Overa, and Kevin Fiscella.
    • Department of Family Medicine, University of Colorado, Aurora, CO, USA.
    • J Gen Intern Med. 2019 Sep 1; 34 (9): 1782-1789.

    BackgroundLittle is known about strategies to improve patient activation, particularly among persons living with HIV (PLWH).ObjectiveTo assess the impact of a group intervention and individual coaching on patient activation for PLWH.DesignPragmatic randomized controlled trial.SitesEight practices in New York and two in New Jersey serving PLWH.ParticipantsThree hundred sixty PLWH who received care at participating practices and had at least limited English proficiency and basic literacy.InterventionSix 90-min group training sessions covering use of an ePersonal Health Record loaded onto a handheld mobile device and a single 20-30 min individual pre-visit coaching session.Main MeasuresThe primary outcome was change in Patient Activation Measure (PAM). Secondary outcomes were changes in eHealth literacy (eHEALS), Decision Self-efficacy (DSES), Perceived Involvement in Care Scale (PICS), health (SF-12), receipt of HIV-related care, and change in HIV viral load (VL).Key ResultsThe intervention group showed significantly greater improvement than the control group in the primary outcome, the PAM (difference 2.82: 95% confidence interval [CI] 0.32-5.32). Effects were largest among participants with lowest quartile PAM at baseline (p < 0.05). The intervention doubled the odds of improving one level on the PAM (odds ratio 1.96; 95% CI 1.16-3.31). The intervention group also had significantly greater improvement in eHEALS (difference 2.67: 95% CI 1.38-3.9) and PICS (1.27: 95% CI 0.41-2.13) than the control group. Intervention effects were similar by race/ethnicity and low education with the exception of eHealth literacy where effects were stronger for minority participants. No statistically significant effects were observed for decision self-efficacy, health status, adherence, receipt of HIV relevant care, or HIV viral load.ConclusionsThe patient activation intervention modestly improved several domains related to patient empowerment; effects on patient activation were largest among those with the lowest levels of baseline patient activation.Trial RegistrationThis study is registered at Clinical Trials.Gov (NCT02165735).

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