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Improving a Full Range of Advance Care Planning Behavior Change and Action Domains: The PREPARE Randomized Trial.

ABSTRACT: CONTEXT:Advance care planning (ACP) engagement includes a wide range of behaviors and actions related to discussions and documentation, yet few ACP intervention studies measure the full process. OBJECTIVES:The objective of the study was to compare the effects of an easy-to-read advance directive (AD) versus an ACP web site plus the AD (PREPARE + AD) on Behavior Change Processes and Actions, including discussions and documentation. METHODS:Secondary data were from a completed ACP trial. Participants were primary care patients, ?60 years old, with two comorbidities. We used the validated ACP Engagement Survey to examine six-month change in subscales measuring Behavior Change Processes (knowledge, contemplation, self-efficacy, readiness) and Actions (decision makers, quality of life, flexibility for decision makers, asking clinicians questions), specifically related to discussions and documentation. We used adjusted mixed-effects linear models to compare mean change and engagement over time. RESULTS:Compared to the AD-only, PREPARE + AD resulted in greater increases in all Behavior Change Processes subscales and Actions related to decision makers, quality of life, and flexibility (all P-values ?0.005). Both interventions significantly increased the proportion of participants who engaged in ACP discussions (PREPARE + AD, 99.5%; AD-only, 93.3%) and documentation (PREPARE + AD, 99.5%; AD-only, 90.4%), with greater increases for PREPARE + AD (all P-values <0.001). CONCLUSION:Both PREPARE plus an easy-to-read AD and an AD-only markedly increased ACP engagement in a full range of ACP behaviors, including discussions and documentation, and engagement was nearly 100% with PREPARE + AD. Future ACP studies should examine a full range of ACP behaviors beyond ADs and the impact of PREPARE and easy-to-read AD implementation on health care systems.

SUBMITTER: Lum HD

PROVIDER: S-EPMC6138565 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Improving a Full Range of Advance Care Planning Behavior Change and Action Domains: The PREPARE Randomized Trial.

Lum Hillary D HD Barnes Deborah E DE Katen Mary T MT Shi Ying Y Boscardin John J Sudore Rebecca L RL

Journal of pain and symptom management 20180627 4

<h4>Context</h4>Advance care planning (ACP) engagement includes a wide range of behaviors and actions related to discussions and documentation, yet few ACP intervention studies measure the full process.<h4>Objectives</h4>The objective of the study was to compare the effects of an easy-to-read advance directive (AD) versus an ACP web site plus the AD (PREPARE + AD) on Behavior Change Processes and Actions, including discussions and documentation.<h4>Methods</h4>Secondary data were from a complete ...[more]

PMID: 29940209

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Project description:IntroductionAdvance care planning (ACP) is a process that allows patients to identify their goals for medical care. Traditionally, ACP has focused on completing advance directives; however, we have expanded the ACP paradigm to also prepare patients to communicate their wishes and make informed decisions. To this end, we created an ACP website called PREPARE (http://www.prepareforyourcare.org) to prepare diverse English-speaking and Spanish-speaking older adults for medical decision-making. Here, we describe the study protocol for a randomised controlled efficacy trial of PREPARE in a safety-net setting. The goal is to determine the efficacy of PREPARE to engage diverse English-speaking and Spanish-speaking older adults in a full spectrum of ACP behaviours.Methods and analysisWe include English-speaking and Spanish-speaking adults from an urban public hospital who are ≥55 years old, have ≥2 chronic medical conditions and have seen a primary care physician ≥2 times in the last year. Participants are randomised to the PREPARE intervention (review PREPARE and an easy-to-read advance directive) or the control arm (only the easy-to-read advance directive). The primary outcome is documentation of an advance directive and/or ACP discussion. Secondary outcomes include ACP behaviour change processes measured with validated surveys (eg, self-efficacy, readiness) and a broad range of ACP actions (eg, choosing a surrogate, identifying goals for care, discussing ACP with clinicians and/or surrogates). Using blinded outcome ascertainment, outcomes will be measured at 1 week and at 3, 6 and 12 months, and compared between study arms using mixed-effects logistic regression and mixed-effects linear, Poisson or negative binomial regression.Ethics and disseminationThis study has been approved by the appropriate Institutional Review Boards and is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of this study will be disseminated to academic and community stakeholders.Trial registration numbersNCT01990235; NCT02072941; Pre-results.

Project description:Background/objectivesA patient-directed, online program (PREPARE for Your Care [PREPARE]; prepareforyourcare.org) has been shown to increase advance care planning (ACP) documentation. However, the mechanisms underlying PREPARE are unknown. Our objectives were to compare the efficacy of PREPARE plus an easy-to-read advance directive (AD) vs an AD alone to increase active patient participation in ACP discussions during clinic visits and to examine effects of active patient participation on ACP documentation.DesignAudio recordings of postintervention primary care visits from two randomized trials (2013-2016).SettingSeven primary care clinics at a veterans affair and safety-net hospital in San Francisco, CA.ParticipantsEnglish- and Spanish-speaking adults, aged 55 years and older, with two or more chronic/serious conditions.InterventionPREPARE plus an easy-to-read AD or an AD alone.MeasurementsThe primary outcome was the number of active patient participation utterances about ACP (eg, asking questions, stating preferences) measured by the validated Active Patient Participation Coding Scheme. We examined differences in utterances by study arm using mixed effects negative binomial models and utterances as a mediator of PREPARE's effect on documentation using adjusted logistic regression. Models were adjusted for health literacy, prior care planning, and clinician.ResultsAmong 393 participants, the mean (SD) age was 66 (8.1) years, 120 (30.5%) had limited health literacy, and 99 (25.2%) were Spanish speaking. PREPARE plus the AD resulted in 41% more active patient participation in ACP discussions compared with the AD alone (mean [SD] = 10.1 [16.8] vs 6.6 [13.4] utterances; incidence rate ratio = 1.41; 95% confidence interval = 1.00-1.98). For every additional utterance, participants had 15% higher odds of ACP documentation, and active patient participation accounted for 16% of PREPARE's effect on documentation.ConclusionsThe PREPARE program and easy-to-read AD empowered patients to actively participate in ACP discussions during clinical visits more than the AD alone. Increased activation was associated with increased ACP documentation. Therefore, PREPARE may mitigate barriers to ACP among English- and Spanish-speaking older adults.Trial registrationClinicalTrials.gov identifiers: "Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making (PREPARE)" NCT01990235 and "Preparing Spanish-Speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)" NCT02072941. J Am Geriatr Soc 68:1210-1217, 2020.

Project description:ImportanceAdvance care planning improves the receipt of medical care aligned with patients' values; however, it remains suboptimal among diverse patient populations. To mitigate literacy, cultural, and language barriers to advance care planning, easy-to-read advance directives and a patient-directed, online advance care planning program called PREPARE For Your Care (PREPARE) were created in English and Spanish.ObjectiveTo compare the efficacy of PREPARE plus an easy-to-read advance directive with an advance directive alone to increase advance care planning documentation and patient-reported engagement.Design, setting, and participantsA comparative efficacy randomized clinical trial was conducted from February 1, 2014, to November 30, 2017, at 4 safety-net, primary-care clinics in San Francisco among 986 English-speaking or Spanish-speaking primary care patients 55 years or older with 2 or more chronic or serious illnesses.InterventionsParticipants were randomized to PREPARE plus an easy-to-read advance directive (PREPARE arm) or the advance directive alone. There were no clinician-level or system-level interventions. Staff were blinded for all follow-up measurements.Main outcomes and measuresThe primary outcome was documentation of new advance care planning (ie, legal forms and/or documented discussions) at 15 months. Patient-reported outcomes included advance care planning engagement at baseline, 1 week, 3 months, 6 months, and 12 months using validated surveys. Intention-to-treat analyses were performed using mixed-effects logistic and linear regression, controlling for time, health literacy, and baseline advance care planning, clustering by physician, and stratifying by language.ResultsAmong the 986 participants (603 women and 383 men), the mean (SD) age was 63.3 (6.4) years, 387 of 975 (39.7%) had limited health literacy, and 445 (45.1%) were Spanish speaking. No participant characteristic differed between the 2 groups, and retention was 85.9% (832 of 969) among survivors. Compared with the advance directive alone, PREPARE resulted in a higher rate of advance care planning documentation (unadjusted, 43.0% [207 of 481] vs 33.1% [167 of 505]; P < .001; adjusted, 43.0% vs 32.0%; P < .001) and higher self-reported increased advance care planning engagement scores (98.1% vs 89.5%; P < .001). Results remained significant among English speakers and Spanish speakers.Conclusions and relevanceThe patient-facing PREPARE program and an easy-to-read advance directive, without clinician-level or system-level interventions, increased documentation of advance care planning and patient-reported engagement, with statistically higher gains for PREPARE vs advance directive alone. 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-speaking and Spanish-speaking populations.Trial registrationClinicalTrials.gov identifiers: NCT01990235 and NCT02072941.

Project description:Introduction/objectivesIn February 2019, recruitment began in Iowa Research Network offices for a Patient-Centered Outcomes Research Institute (PCORI) funded Advance Care Planning (ACP) study to be conducted in 7 primary care practice-based research networks across the United States and Canada. The main study trained clinicians and nursing staff in serious illness care conversations and requested they refer eligible patients. Eligible patients were those with serious illness or frailty expected to live 1 to 2 years. Clinicians indicated it was difficult to identify eligible patients. This study aimed to find better methods for increasing patient recruitment for the ACP study.MethodsResearch staff brainstormed and implemented strategies to increase patient referrals from clinicians. Participating offices used Epic for their medical record and the Gagne Index was used to generate a list of eligible patients in Epic SlicerDicer. When patients from the Epic SlicerDicer report appeared on the schedule, clinicians and nursing staff were notified that they might be eligible for ACP. Clinicians and nursing staff were asked to complete a survey identifying their perception of implemented strategies. A Wilcoxon signed-rank test was conducted to compare referral numbers before and after the Gagne Index/Epic SlicerDicer intervention.ResultsSeven clinicians referred patients prior to and 11 after the Gagne Index/Epic SlicerDicer intervention. Clinicians referred a total of 120 patients; 31 patients prior to and 89 patients after the Gagne Index/Epic SlicerDicer implementation (P = .002). Survey results indicated that several strategies facilitated clinician referrals, including patients identified as potentially appropriate on the schedule, quarterly meetings with researchers, and e-mails with a list of potentially eligible patients.ConclusionsNotifying clinical staff about potential study participants increased patient referrals in this ACP study. Research staff must have time, funding, and patience to support clinical staff who are expected to refer patients to studies.

Project description: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.

Project description:Advance care planning (ACP) is a process whereby patients prepare for medical decision-making. The traditional objective of ACP has focused on the completion of advance directives. We have developed a new paradigm of ACP focused on preparing patients and their loved ones for communication and informed medical decision-making. To operationalize this new paradigm of ACP, we created an interactive, patient-centered website called PREPARE ( www.prepareforyourcare.org ) designed for diverse older adults.This randomized controlled trial with blinded outcome assessment is designed to determine the efficacy of PREPARE to engage older Veterans in the ACP process. Veterans who are???60 years of age, have???two medical conditions, and have seen a primary care physician???two times in the last year are being randomized to one of two study arms. The PREPARE study arm reviews the PREPARE website and an easy-to-read advance directive. The control arm only reviews the advance directive. The primary outcome is documentation of an advance directive and ACP discussions. Other clinically important outcomes using validated surveys include ACP behavior change process measures (knowledge, contemplation, self-efficacy, and readiness) and a full range of ACP action measures (identifying a surrogate, identifying values and goals, choosing leeway or flexibility for the surrogate, communicating with clinicians and surrogates, and documenting one's wishes). We will also assess satisfaction with decision-making and Veteran activation within primary care visits by direct audio recording. To examine the outcomes at 1 week, 3 months, and 6 months between the two study arms, we will use mixed effects linear, Poisson, or negative binomial regression and mixed effects logistic regression.This study will determine whether PREPARE increases advance directive completion rates and engagement with the ACP process. If PREPARE is efficacious, it could prove to be an easy and effective intervention to help older adults engage in the ACP process within or outside of the medical environment. PREPARE may also help older adults communicate their medical wishes and goals to their loved ones and clinicians, improve medical decision-making, and ensure their wishes are honored over the life course.ClinicalTrials.gov NCT01550731 . Registered on 8 December 2011.

Dataset Information

Improving a Full Range of Advance Care Planning Behavior Change and Action Domains: The PREPARE Randomized Trial.

Publications

Improving a Full Range of Advance Care Planning Behavior Change and Action Domains: The PREPARE Randomized Trial.

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