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OpenTrials
Completed

NCT Number: NCT01990235

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PREPARE Intervention

Behavioral

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.

Primary outcomes

  1. New advance care planning documentation in the medical record

    Time frame: 15 months after study enrollment

    The primary outcome is documentation of ACP wishes in the medical record. ACP documentation for the purposes of this study includes legal advance directive forms or other documentation of patients wishes for medical care in clinical notes.

Secondary outcomes

  1. Self-reported engagement in advance care planning behaviors

    Time frame: 12 months from baseline

    Secondary outcomes were chosen to measure the full process of ACP. Using validated questionnaires, we will measure ACP behavior change processes, such as knowledge, contemplation, self-efficacy, and readiness, as well as several ACP actions, such as identifying a surrogate decision maker, identifying values and goals for medical care, choosing the level of leeway in surrogate decision making, discussing one's wishes with clinicians and surrogates, and documenting one's wishes in an advance directive.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: PREPARE

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2013
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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