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 PARTICIPANTSThis 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 MEASURESThe 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. RESULTSThe 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 clinicianand/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

IMPORTANCE: Advance care planning improves the receipt of medical care aligned with patients’ values; yet, it remains sub-optimal among diverse patient populations. To mitigate literacy, cultural, and language barriers to advance care planning, we created easy-to-read advance directives and a patient-directed, online advance care planning program called PREPARE in English and Spanish. OBJECTIVE: To compare the efficacy of PREPARE plus an easy-to-read advance directive to an advance directive alone to increase advance care planning documentation and patient-reported engagement. DESIGN: Comparative efficacy randomized trial from February 2014 to November 2017. SETTING: Four San Francisco, safety-net, primary-care clinics. PARTICIPANTS: English- or Spanish-speaking primary care patients, age ≥55 years, with ≥2 chronic or serious illnesses. INTERVENTIONS: Participants were randomized to PREPARE plus an easy-to-read advance directive (PREPARE) or the advance directive alone. There were no clinician/system-level interventions. Staff were blinded for all follow-up measurements. MAIN OUTCOMES AND MEASURES: The primary outcome was new advance care planning documentation (i.e., legal forms and/or documented discussions) at 15 months. Patient-reported outcomes included advance care planning engagement at baseline, 1 week, and 3, 6, and 12-months using validated surveys. We used intention-to-treat, mixed-effects logistic and linear regression, controlling for time, health literacy and baseline advance care planning, clustering by physician, and stratifying by language. RESULTS: The mean (SD) age of 986 participants was 63.3 years (± 6.4), 39.7% had limited health literacy, and 45% were Spanish-speaking. No participant characteristic differed between arms; retention was 85.9%. Compared to the advance directive alone, PREPARE resulted in higher advance care planning documentation (adjusted 43% vs. 32%; p<0.001) and higher self-reported increased advance care planning engagement scores (98.1% vs. 89.5%; p<0.001). Results remained significant among English and Spanish-speakers. CONCLUSIONS AND RELEVANCE: The patient-facing PREPARE program and an easy-to-read advance directive, without clinician/system-level interventions, increased advance care planning documentation and patient-reported engagement, with statistically higher gains for PREPARE. These tools may mitigate literacy and language barriers to advance care planning, allow patients to begin planning on their own, and could substantially improve the process for diverse, English- and Spanish-speaking populations.