Effect of the PREPARE Website vs an Easy-to-Read Advance Directive on Advance Care Planning Documentation and Engagement Among Veterans: A Randomized Clinical Trial

Abstract

Importance: Documentation rates of patients' medical wishes are often low. It is unknown whether easy-to-use, patient-facing advance care planning (ACP) interventions can overcome barriers to planning in busy primary care settings.

Objective: To compare the efficacy of an interactive, patient-centered ACP website (PREPARE) with an easy-to-read advance directive (AD) to increase planning documentation.

Design, setting, and participants: This was a comparative effectiveness randomized clinical trial from April 2013 to July 2016 conducted at multiple primary care clinics at the San Francisco VA Medical Center. Inclusion criteria were age of a least 60 years; at least 2 chronic and/or serious conditions; and 2 or more primary care visits; and 2 or more additional clinic, hospital, or emergency room visits in the last year.

Interventions: Participants were randomized to review PREPARE plus an easy-to-read AD or the AD alone. There were no clinician and/or system-level interventions or education. Research staff were blinded for all follow-up measurements.

Main outcomes and measures: The primary outcome was new ACP documentation (ie, legal forms and/or discussions) at 9 months. Secondary outcomes included patient-reported ACP engagement at 1 week, 3 months, and 6 months using validated surveys of behavior change process measures (ie, 5-point knowledge, self-efficacy, readiness scales) and action measures (eg, surrogate designation, using a 0-25 scale). We used intention-to-treat, mixed-effects logistic and linear regression, controlling for time, health literacy, race/ethnicity, baseline ACP, and clustering by physician.

Results: The mean (SD) age of 414 participants was 71 (8) years, 38 (9%) were women, 83 (20%) had limited literacy, and 179 (43%) were nonwhite. No participant characteristic differed significantly among study arms at baseline. Retention at 6 months was 90%. Advance care planning documentation 6 months after enrollment was higher in the PREPARE arm vs the AD-alone arm (adjusted 35% vs 25%; odds ratio, 1.61 [95% CI, 1.03-2.51]; P = .04). PREPARE also resulted in higher self-reported ACP engagement at each follow-up, including higher process and action scores; P <.001 at each follow-up).

Conclusions and relevance: Easy-to-use, patient-facing ACP tools, without clinician- and/or system-level interventions, can increase planning documentation 25% to 35%. Combining the PREPARE website with an easy-to-read AD resulted in higher planning documentation than the AD alone, suggesting that PREPARE may increase planning documentation with minimal health care system resources.

Trial registration: clinicaltrials.gov Identifier: NCT01550731.

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.. CONSORT Flow Diagram

AD indicates advance directive; PI, principal investigator; PREPARE, patient-centered, advance care planning website. aOne person consented but did not undergo any study procedures and was excluded from the analysis.

Figure 2.. Values Reflect Mean Advance Care Planning (ACP) Engagement Process Scores From Repeated Measures, Mixed-Effects Linear Regression Models Adjusted for Race, Literacy, Baseline ACP Documentation, and Clustering by Physician

P values reflect significance for overall group × time interactions. AD indicates advance directive; PREPARE, patient-centered, advance care planning website.

Figure 3.. Values Reflect Total Advance Care Planning (ACP) Engagement Action Scores From Repeated Measures, Mixed-Effects Linear Regression Models Adjusted for Race, Literacy, Baseline ACP Documentation, and Clustering by Physician

P values reflect significance for overall group × time interactions. AD indicates advance directive; PREPARE, patient-centered, advance care planning website.