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

Abstract

Background: Little is known about strategies to improve patient activation, particularly among persons living with HIV (PLWH). Objective: To assess the impact of a group intervention and individual coaching on patient activation for PLWH. Design: Pragmatic randomized controlled trial. Sites: Eight practices in New York and two in New Jersey serving PLWH. Participants: Three hundred sixty PLWH who received care at participating practices and had at least limited English proficiency and basic literacy. Intervention: Six 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 Measures: The 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 Results: The 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. Conclusions: The 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 Registration: This study is registered at Clinical Trials.Gov (NCT02165735).