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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01550731
First received: December 8, 2011
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Aging
Behavioral: PREPARE website
Behavioral: Advance directive
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Preparing Older Veterans With Serious and Chronic Illness for Decision Making

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Advance directive documentation [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Documentation of any advance care planning forms or discussions in the medical record.


Secondary Outcome Measures:
  • Engagement in advance care planning behaviors [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Whether subjects chose a surrogate decision maker, discussed leeway in decision making, informed other family, friends, and physicians about one's wishes, and asked clinicians questions to help them make appropriate medical decisions.


Estimated Enrollment: 410
Study Start Date: July 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
The intervention group will review the PREPARE advance care planning website and PREPARE materials plus receive an advance directive. The control group will only receive an advance directive.
Behavioral: PREPARE website
Advance care planning website and materials plus an advance directive.
Active Comparator: Arm 2
The control group will only receive an advance directive.
Behavioral: Advance directive
The control group will only receive an advance directive.

Detailed 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 our 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans
  • 60 years of age
  • who have been seen in the General Medicine, Geriatrics, and Women's Clinics twice in the past year
  • and have 2 or more serious or chronic medical conditions as determined by ICD-9 codes

Exclusion Criteria:

  • Veterans will be excluded if they are:

    • deaf
    • blind
    • demented
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550731

Contacts
Contact: Rebecca Sudore, MD (415) 221-4810 ext 3475 rebecca.sudore@va.gov

Locations
United States, California
San Francisco Recruiting
San Francisco, California, United States, 94121-1598
Contact: Rebecca Sudore, MD    415-221-4810 ext 3475    rebecca.sudore@va.gov   
Sub-Investigator: Deborah E Barnes, PhD         
Principal Investigator: Rebecca Sudore, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Rebecca Sudore, MD San Francisco
  More Information

Publications:
Flint LA, Sudore R, Widera E. Assessing Financial Capacity Impairment in Older Adults. Generations (San Francisco, Calif.). 2012 Jul 1; 36(2):59-65.

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01550731     History of Changes
Other Study ID Numbers: IIR 11-110
Study First Received: December 8, 2011
Last Updated: July 22, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
advance care planning
health communication
aging

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014