"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.

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).

Keywords: HIV; computer literacy; health literacy; patient participation; self-care.

Publication types

  • Multicenter Study
  • Pragmatic Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Counseling / organization & administration
  • Electronic Health Records
  • Female
  • HIV Infections / psychology*
  • Humans
  • Male
  • Middle Aged
  • Mobile Applications
  • Patient Participation / methods*
  • Self Efficacy
  • Self-Management / education*

Associated data

  • ClinicalTrials.gov/NCT02165735