Preparing Older Veterans With Serious and Chronic Illness for Decision Making — PREPARE  

Aging Clinical Trial

Official title: Preparing Older Veterans With Serious and Chronic Illness for Decision Making

Status Completed

Clinical Trial Summary

Millions of diverse Veterans live with severe and chronic illness for which they will face complex, ongoing decisions. Although the VHA has been at the forefront of patient-centered chronic care, interventions to prepare Veterans for complex decision-making over the course of chronic illness are lacking. This proposal addresses this gap by testing the efficacy of a novel preparation guide designed to prepare Veterans to communicate with their surrogates and to work with clinicians to make complex, ongoing decisions. The multi-media guide teaches communication and preparation skill behaviors (e.g., how to choose a surrogate and ask clinicians questions) in a culturally appropriate, easy-to-use format (targeted to a 5th grade reading level). This study aims to provide an impetus for changing the paradigm of advance care planning policies within the VA by moving beyond documentation of end-of-life wishes to the activation of Veterans to participate in ongoing communication of their values and goals - a process that is essential to fully realize patient-centered care.

Clinical Trial Description

4.5 million Veterans are over age 65 and an increasing number are living with chronic and serious illness. Most older Veterans and their surrogate decision makers will eventually face complex, ongoing decisions over the course of chronic illness. These decisions are difficult, especially for the 50% of older Veterans with limited health literacy. The old paradigm of advance care planning has focused on making decisions about life- prolonging procedures (e.g., resuscitation) by completing advance directives. Yet, this old paradigm is problematic. The forms are difficult to understand and often culturally insensitive. They also fail to prepare patients with concrete skills, such as how to identify one's values and communicate with surrogates and clinicians. The investigators have published a new paradigm of advance care planning that focuses instead on preparing patients to communicate with their surrogates and to actively participate with clinicians in making the best possible in-the-moment decisions. The new paradigm seeks to ensure that complex, ongoing decisions are based on a comprehensive set of considerations including the current clinical context, evolving goals, and patients' and surrogates' needs. To do this effectively, Veterans need to prepare. However, an easy-to-use, culturally-appropriate preparation guide does not exist. The investigators have created an easy-to-understand (5th grade reading level) preparation guide based on the investigators' new paradigm called PREParation, Activation, Reflection, and Engagement in advance care planning or PREPARE. PREPARE is designed to teach Veterans preparation skills including how to choose a surrogate and discuss surrogate decision making, clarify personal values for specific health states, and ask clinicians questions to make informed choices. The aims of this study are: (1) to conduct a randomized control trial to determine the efficacy of PREPARE to engage older Veterans with chronic illness in preparation skill behaviors (i.e., did they choose a surrogate, clarify their values, ask clinicians questions); (2) to determine the efficacy of PREPARE to activate Veterans and clinicians within clinical encounters (i.e., did Veterans ask clinicians questions or discuss preparation topics and did clinicians respond) and to improve satisfaction with decision making; and (3) to obtain input from Veterans, surrogates, and clinicians about implementation of PREPARE within the VA. To achieve Aim 1, 205 Veterans will be randomly assigned to the intervention (PREPARE materials plus an advance directive) and 205 will be assigned to the control group (advance directive only). Veterans in the PREPARE arm will view the easy-to-understand, multi-media PREPARE website during the study interview and then take home PREPARE materials in photo booklet and pamphlet format to ensure universal access to the information. The primary outcome is Veteran-reported engagement in preparation skill behaviors at 3 and 6 months, which will be measured with standard cognitive behavioral measures. For Aim 2, activation within the clinical encounters will be measured with validated quantitative analysis techniques of audio-recordings. Satisfaction with decision making will be measured with validated, self-reported measures. For Aim 3, the investigators will ask Veterans randomized to the PREPARE arm and their surrogates and clinicians how best to implement PREPARE within the clinical setting. The investigators will use standard parametric or non-parametric statistical tests to assess group differences, will control for demographic or other variables that differ between randomization groups, and adjust for potential clustering by clinician. For Aims 1 and 2 the investigators will assess differences in engagement and satisfaction by race/ethnicity, literacy, and gender. The research team has extensive experience testing literacy-appropriate, multi-media health education materials in randomized trials. The study team is poised to test the efficacy of PREPARE, and findings from this study will pave the way for multi-site effectiveness testing and widespread VA dissemination of PREPARE. ;

Related Conditions & MeSH terms

• Aging
• Chronic Disease

• NCT number: NCT01550731
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Completion date: July 2016