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Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making (PREPARE)

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ClinicalTrials.gov Identifier: NCT01990235
Recruitment Status : Unknown
Verified May 2016 by University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : November 21, 2013
Last Update Posted : May 24, 2016
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, San Francisco

November 4, 2013
November 21, 2013
May 24, 2016
January 2013
March 2018   (Final data collection date for primary outcome measure)
Change in engagement in advance care planning behavior using validated surveys at 12 months from baseline [ Time Frame: 12 months from baseline ]

Engagement in 5 behaviors that is a composite outcome of ACP engagement.

  1. Advance Directive completion - An advance directive form, a living will, a durable power of attorney for health care, Physicians Orders of Life Sustaining Treatment, or other documentation, such as code status.
  2. Advance care planning discussions with surrogates - Asking someone to be a surrogate, talking about goals for medical care, whether to grant leeway, or discussions relating to medical decision making or prognosis.
  3. Advance care planning discussions with clinicians - Discussions concerning a surrogate, goals for medical care, whether to grant surrogates leeway, or discussions relating to medical decision making or prognosis.
  4. Inform others (friends/family member identified as important) - Discussions about advance care planning-related topics
  5. Ask doctors questions - risks, benefits, options.

These behaviors will be measured using validated surveys on a 1 to 5 scale.

Same as current
Complete list of historical versions of study NCT01990235 on ClinicalTrials.gov Archive Site
Change in advance care planning behavior at 12 months from baseline [ Time Frame: 12 months from baseline ]

Investigators will measure the following, which will be extracted from one validated survey:

  1. Advance care planning behavior change
  2. Self-efficacy with advance care planning behaviors
  3. Engagement in medical decision making
  4. Satisfaction with medical decision making
  5. Surrogate-reports of patient engagement in advance care planning
Same as current
Not Provided
Not Provided
 
Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making
Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making
The objective of this proposal is to test whether a multi-media website (www.prepareforyourcare.org) that is focused on preparing older adults for communication and medical decision making can help people engage in advance care planning.
PREPARE is a website (www.prepareforyourcare.org) that teaches patients how to identify what is most important in life, how to communicate their preferences to clinicians and loved ones, and how to make informed decisions. It is written at a 5th grade level and includes voice-overs of text and closed captioning of videos that model advance care planning behaviors. The goal of this proposal is to test the efficacy of PREPARE plus an easy-to-read advance directive, versus an advance directive alone, to improve patient engagement in multiple advance care planning behaviors including discussions with surrogate decision makers and clinicians in addition to advance directive completion. The investigators will also determine whether PREPARE can empower and activate patients within clinical encounters with their clinicians and help to decrease health disparities in advance care planning.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Chronic Disease
Behavioral: PREPARE Intervention
At week 1, 3, 6, and 12 months, interviews (telephone or in person based on preference) by blinded staff will assess engagement in advance care planning(ACP), self-efficacy with ACP, and activation in and satisfaction with decision making. Blinded telephone interviews will also assess surrogate reports of patient engagement in ACP.
  • Experimental: PREPARE intervention
    The PREPARE arm will review the PREPARE website plus the easy-to-read advance directive (AD). Participants will review PREPARE on their own for ≥ 20 minutes with staff present to answer questions. During PREPARE, participants answer preference questions and make an action plan (i.e., commitment to engage in advance care planning). To ensure home access to PREPARE content, participants will be given a website login and PREPARE content in digital video disc (DVD), booklet, and pamphlet format as well as the action plan and AD. One to three days before a primary care visit, the PREPARE arm will receive a reminder to come to their appointment and to bring their action plan.
    Intervention: Behavioral: PREPARE Intervention
  • No Intervention: Control
    The Control arm will review an easy-to-read AD. Controls will review the AD for ≥ 15 minutes with study staff present to answer questions and will take the AD home to complete if desired. One to three days before a primary care visit, controls will receive a reminder to come to their appointment.
Sudore RL, Barnes DE, Le GM, Ramos R, Osua SJ, Richardson SA, Boscardin J, Schillinger D. Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial. BMJ Open. 2016 Jul 11;6(7):e011705. doi: 10.1136/bmjopen-2016-011705.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
500
Same as current
June 2018
March 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • English-speaking older adults (≥55 years)
  • ≥ 2 chronic illnesses determined by International Classification of Diseases-9 (ICD-9) codes
  • ≥ 2 visits with an outpatient primary care clinician at San Francisco General Hospital in the past year
  • ≥2 additional outpatient/inpatient visits to San Francisco General Hospital in the past year

Exclusion Criteria:

  • deaf, blind, or demented as determined by ICD-9 codes
  • too mentally or physically ill to participate as determined by their clinicians
  • Moderate or severe cognitive impairment as determined by the Short Portable Mental Status Questionnaire (SPMSQ), and mild cognitive impairment as determined by the SPMSQ plus an abnormal Mini-Cog
  • self-reported poor vision and inability to see the words on a newspaper
  • lack of a telephone
  • traveling or moving out of the area for ≥3 months during the study follow- up period
Sexes Eligible for Study: All
55 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01990235
13-10847
R01AG045043 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of California, San Francisco
University of California, San Francisco
National Institute on Aging (NIA)
Principal Investigator: Rebecca Sudore, MD University of California, San Francisco
Principal Investigator: Dean Schillinger, MD University of California, San Francisco
Principal Investigator: Deborah E Barnes, PhD University of California, San Francisco
Principal Investigator: W. John Boscardin, PhD San Francisco Veteran Affairs Medical Center
University of California, San Francisco
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP