Abstract
BackgroundAdvance 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.Methods/DesignThis 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.DiscussionThis 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.Trial registrationClinicalTrials.gov NCT01550731. Registered on 8 December 2011.
Highlights
Advance care planning (ACP) is a process whereby patients prepare for medical decision-making
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
Summary
This is the first study to test the efficacy of a new paradigm of ACP focused on preparing chronically ill older Veterans for communication and medical decision-making as operationalized in the PREPARE website. Other Veterans or the clinic will cancel a primary care appointment after the baseline interview has occurred resulting in a time frame beyond the three-week ideal. Because follow-up of the 1-week, 3-month and 6-month interviews within defined time frames was proving challenging, we decided to allow a range of dates that were acceptable. As described in the methods, surrogate recruitment was initially challenging without the ability to obtain verbal consent This was approved by the IRB office part way through the study. Because PREPARE can be used outside of the clinical environment, in future studies it may save clinicians time and prove to be cost-effective. Trial status This trial is in the active recruitment phase. All authors read, contributed to, and approved the final manuscript
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