“准备并获得治疗”（GREAT）研究：一项针对 HIV 感染者的激活的实用随机对照试验。
"Get Ready and Empowered About Treatment" (GREAT) Study: a Pragmatic Randomized Controlled Trial of Activation in Persons Living with HIV.
机构信息
Department of Family Medicine, University of Colorado, Aurora, CO, USA.
Clinical Directors Network, Inc. (CDN), New York, NY, USA.
出版信息
J Gen Intern Med. 2019 Sep;34(9):1782-1789. doi: 10.1007/s11606-019-05102-7. Epub 2019 Jun 25.
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).
背景
对于如何提高患者的积极性，我们知之甚少，尤其是在感染艾滋病毒的人群（PLWH）中。
目的
评估小组干预和个人辅导对 PLWH 患者积极性的影响。
设计
实用随机对照试验。
地点
在纽约的八家诊所和新泽西的两家诊所，为 PLWH 提供服务。
参与者
360 名在参与实践中接受护理的 PLWH，他们至少有一定程度的英语水平和基本读写能力。
干预措施
六次 90 分钟的小组培训课程，涵盖使用加载到手持移动设备的电子个人健康记录和单次 20-30 分钟的个人就诊前辅导课程。
主要措施
主要结果是患者积极性衡量表（PAM）的变化。次要结果包括电子健康素养（eHEALS）、决策自我效能（DSES）、参与护理量表（PICS）、健康状况（SF-12）、艾滋病毒相关护理的接受情况以及艾滋病毒病毒载量（VL）的变化。
主要结果
干预组在主要结果（PAM）方面的改善明显优于对照组，差异为 2.82（95%置信区间[CI] 0.32-5.32）。在基线 PAM 最低四分位数的参与者中，效果最大（p<0.05）。干预使 PAM 提高一个等级的可能性增加了一倍（优势比 1.96；95%CI 1.16-3.31）。干预组在 eHEALS（差异 2.67：95%CI 1.38-3.9）和 PICS（1.27：95%CI 0.41-2.13）方面的改善也明显优于对照组。除了电子健康素养外，种族/族裔和低教育程度的干预效果相似，而电子健康素养的效果在少数族裔参与者中更强。决策自我效能、健康状况、依从性、接受艾滋病毒相关护理或艾滋病毒病毒载量方面没有观察到统计学上显著的效果。
结论
患者积极性干预适度改善了与患者赋权相关的几个领域；在基线患者积极性最低的人群中，效果最大。
试验注册
本研究在 ClinicalTrials.Gov 注册（NCT02165735）。
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