Trial Outcomes & Findings for Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE) (NCT NCT02072941)

NCT ID: NCT02072941

Last Updated: 2019-07-11

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

445 participants

Primary outcome timeframe

15 months after study enrollment

Results posted on

2019-07-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure
PREPARE Intervention
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.
Control
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.
Overall Study
STARTED
219
226
Overall Study
COMPLETED
181
197
Overall Study
NOT COMPLETED
38
29

Reasons for withdrawal

Reasons for withdrawal
Measure
PREPARE Intervention
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.
Control
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.
Overall Study
Withdrawal by Subject
29
21
Overall Study
Lost to Follow-up
4
4
Overall Study
Death
3
2
Overall Study
Removed by Study Staff
2
2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PREPARE Intervention
n=219 Participants
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.
Control
n=226 Participants
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
n=445 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
127 Participants
n=99 Participants
138 Participants
n=107 Participants
265 Participants
n=206 Participants
Age, Categorical
>=65 years
92 Participants
n=99 Participants
88 Participants
n=107 Participants
180 Participants
n=206 Participants
Age, Continuous
64 years
STANDARD_DEVIATION 6.8 • n=99 Participants
64 years
STANDARD_DEVIATION 7.2 • n=107 Participants
64 years
STANDARD_DEVIATION 7.0 • n=206 Participants
Sex: Female, Male
Female
157 Participants
n=99 Participants
163 Participants
n=107 Participants
320 Participants
n=206 Participants
Sex: Female, Male
Male
62 Participants
n=99 Participants
63 Participants
n=107 Participants
125 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
216 Participants
n=99 Participants
224 Participants
n=107 Participants
440 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants
n=99 Participants
2 Participants
n=107 Participants
5 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
219 participants
n=99 Participants
226 participants
n=107 Participants
445 participants
n=206 Participants
Prior ACP Documentation
44 Participants
n=99 Participants
64 Participants
n=107 Participants
108 Participants
n=206 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
PREPARE Intervention
n=219 Participants
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.
Control
n=226 Participants
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.
New Advance Care Planning Documentation in the Medical Record at 15 Months
83 Participants
58 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
PREPARE Intervention
n=219 Participants
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.
Control
n=226 Participants
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.
Self-reported Engagement in Advance Care Planning Behaviors
Self-reported ACP Behavior Change Process Measures
3.2 score on a scale
Standard Deviation .07
2.9 score on a scale
Standard Deviation .07
Self-reported Engagement in Advance Care Planning Behaviors
Self-reported ACP Action Measures
12.4 score on a scale
Standard Deviation 0.53
10.1 score on a scale
Standard Deviation 0.49

Adverse Events

PREPARE Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rebecca Sudore

University of California San Francisco

Phone: (415) 221-4810

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place