Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT02072941
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 445
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 14.9

Study Details

Study Description

Brief Summary

In partnership with patients, caregivers, advocacy groups and clinicians, the investigators plan to:

Aim 1: Adapt and refine PREPARE in Spanish through cognitive interviews with Spanish-speaking Latinos and stakeholders.

Aim 2: Conduct a randomized clinical trial (RCT) to compare the efficacy of PREPARE plus a previously-tested, easy-to-read- AD (intervention) versus the AD alone (control) to:

2a. Engage older Spanish-speaking Latinos in multiple ACP behaviors (i.e., identify and discuss wishes with surrogates and clinicians and complete ADs) measured by self-report, chart review, surrogate reports, and

2b. Direct observation.

2c. Improve self-efficacy and satisfaction with medical decision making.

2d. Determine whether PREPARE efficacy varies by literacy, decision control preferences, and clinician-patient language concordance.

Aim 3: Disseminate PREPARE with input from patients, surrogates, and stakeholders.

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease	Behavioral: PREPARE Intervention	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 445 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.

Outcome Measures

Primary Outcome Measures

1. New Advance Care Planning Documentation in the Medical Record at 15 Months [15 months after study enrollment]

   The primary outcome is documentation of advance care planning wishes in the medical record. ACP documentation for the purposes of this study includes the easy-to-read advance directive or other valid advance directives or living wills, a durable power of attorney for healthcare document (DPOAHC), a physicians orders for life sustaining treatment (POLST) form, or other documentation of patients wishes for medical care (ie, documentation of oral directives by a physician, or code status, such as full code or do not resuscitate or do not intubate orders or notes by a physician).

Secondary Outcome Measures

1. Self-reported Engagement in Advance Care Planning Behaviors [12 months]

   Secondary outcomes were chosen to measure the full process of Advance Care Planning (ACP) using validated questionnaires, such as the patient-reported ACP Engagement Survey. This questionnaire includes both Behavior Change Process and ACP Action measures. Behavior Change Process measures include knowledge, contemplation, self-efficacy, and readiness for several ACP actions. The Process measures are assessed on an average 5-point Likert scale with a low of 1 and a high of 5, with high scores indicating more ACP engagement. Action measures include 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. Action measures use "yes" or "no" response options and are measured on a 0- to 25-point scale, where 0 is no action and 25 means they have engaged in more ACP actions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Spanish-speaking adults ≥ 55 years of age

• ≥ 2 chronic illnesses determined by 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, demented or psychotic 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 by the SPMSQ plus an abnormal Mini-Cog (scores minimally affected by education/ethnicity)

• Self-reported poor vision and inability to see the words on a newspaper

• Lack of a telephone (for follow-up)

• Traveling or moving out of the area for ≥3 months during the study follow-up period.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco General Hospital and Trauma Center	San Francisco	California	United States	94110

Sponsors and Collaborators

• University of California, San Francisco
• Patient-Centered Outcomes Research Institute

Investigators

• 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: John Boscardin, PhD, University of California, San Francisco
• Principal Investigator: Janet Shim, PhD, University of California, San Francisco

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 1, 2017

More Information

Additional Information:

• PREPARE

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02072941
• Other Study ID Numbers: P0061026; R-1306-01500
• First Posted: Feb 27, 2014
• Last Update Posted: Jul 11, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by University of California, San Francisco: Advance care planning; Latino Health; Medical decision making; Health Literacy; Limited English proficiency; Aging
• Additional relevant MeSH terms: Chronic Disease

Study Results

Participant Flow

Recruitment Details	Study participants were enrolled from four primary care clinics associated with the San Francisco Health Network from November 2014 - March 2017. They were included if they were ≥55 years old, had ≥2 chronic medical conditions, had ≥2 visits with a PCP in the past year, and had ≥2 additional outpatient/inpatient visits in the past year.

Arm/Group Title	PREPARE Intervention	Control
Arm/Group Description	The PREPARE arm reviewed the PREPARE website plus the easy-to-read advance directive (AD). While reviewing the PREPARE website, 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 were 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, participants in the PREPARE arm received a reminder phone call to come to their primary care appointment and to bring their action plan.	The control arm reviewed an easy-to-read advance directive (AD) and took the AD home to complete if desired. One to three days before a primary care visit, participants in the control arm received a reminder to come to their primary care appointment.
Period Title: Overall Study
STARTED	219	226
COMPLETED	181	197
NOT COMPLETED	38	29

Baseline Characteristics

Arm/Group Title	PREPARE Intervention	Control	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	219	226	445
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	127 58%	138 61.1%	265 59.6%
>=65 years	92 42%	88 38.9%	180 40.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (6.8)	64 (7.2)	64 (7.0)
Sex: Female, Male (Count of Participants)
Female	157 71.7%	163 72.1%	320 71.9%
Male	62 28.3%	63 27.9%	125 28.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	216 98.6%	224 99.1%	440 98.9%
Not Hispanic or Latino	3 1.4%	2 0.9%	5 1.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	219 100%	226 100%	445 100%
Prior ACP Documentation (Count of Participants)
Count of Participants [Participants]	44 20.1%	64 28.3%	108 24.3%

Outcome Measures

1. Primary Outcome

Title	New Advance Care Planning Documentation in the Medical Record at 15 Months
Description	The primary outcome is documentation of advance care planning wishes in the medical record. ACP documentation for the purposes of this study includes the easy-to-read advance directive or other valid advance directives or living wills, a durable power of attorney for healthcare document (DPOAHC), a physicians orders for life sustaining treatment (POLST) form, or other documentation of patients wishes for medical care (ie, documentation of oral directives by a physician, or code status, such as full code or do not resuscitate or do not intubate orders or notes by a physician).
Time Frame	15 months after study enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PREPARE Intervention	Control
Arm/Group Description	The PREPARE arm reviewed the PREPARE website plus the easy-to-read advance directive (AD). While reviewing the PREPARE website, 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 were 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, participants in the PREPARE arm received a reminder phone call to come to their primary care appointment and to bring their action plan.	The control arm reviewed an easy-to-read advance directive (AD) and took the AD home to complete if desired. One to three days before a primary care visit, participants in the control arm received a reminder to come to their primary care appointment.
Measure Participants	219	226
Count of Participants [Participants]	83 37.9%	58 25.7%

2. Secondary Outcome

Title	Self-reported Engagement in Advance Care Planning Behaviors
Description	Secondary outcomes were chosen to measure the full process of Advance Care Planning (ACP) using validated questionnaires, such as the patient-reported ACP Engagement Survey. This questionnaire includes both Behavior Change Process and ACP Action measures. Behavior Change Process measures include knowledge, contemplation, self-efficacy, and readiness for several ACP actions. The Process measures are assessed on an average 5-point Likert scale with a low of 1 and a high of 5, with high scores indicating more ACP engagement. Action measures include 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. Action measures use "yes" or "no" response options and are measured on a 0- to 25-point scale, where 0 is no action and 25 means they have engaged in more ACP actions.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PREPARE Intervention	Control
Arm/Group Description	The PREPARE arm reviewed the PREPARE website plus the easy-to-read advance directive (AD). While reviewing the PREPARE website, 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 were 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, participants in the PREPARE arm received a reminder phone call to come to their primary care appointment and to bring their action plan.	The control arm reviewed an easy-to-read advance directive (AD) and took the AD home to complete if desired. One to three days before a primary care visit, participants in the control arm received a reminder to come to their primary care appointment.
Measure Participants	219	226
Self-reported ACP Behavior Change Process Measures	3.2 (.07)	2.9 (.07)
Self-reported ACP Action Measures	12.4 (0.53)	10.1 (0.49)

Adverse Events

Time Frame	Adverse even data were collected from the day of enrollment until completion of the 12-month follow-up interview.
Arm/Group Title	PREPARE Intervention		Control
Arm/Group Description	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.		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.
All Cause Mortality
	PREPARE Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/219 (1.4%)		2/226 (0.9%)
Serious Adverse Events
	PREPARE Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/219 (0%)		0/226 (0%)
Other (Not Including Serious) Adverse Events
	PREPARE Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/219 (0%)		0/226 (0%)

Limitations/Caveats

Participants could not be blinded. In addition, this study took place in one area of the country among Spanish-speaking, older patients who obtain care from safety-net settings. This may affect the generalizability of our findings.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.