Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making

Chronic Disease Clinical Trial

— PREPARE  

Official title:

Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990235
• Other study ID #: 13-10847
• Secondary ID: R01AG045043
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: November 2017

Study information

• Verified date: October 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 541
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

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.

Locations

Country	Name	City	State
United States	San Francisco General Hospital and Trauma Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New advance care planning documentation in the medical record	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.	15 months after study enrollment
Secondary	Self-reported engagement in advance care planning behaviors	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.	12 months from baseline

External Links

•   PREPARE