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Trial Outcomes & Findings for Preparing Older Veterans With Serious and Chronic Illness for Decision Making (NCT NCT01550731)

NCT ID: NCT01550731

Last Updated: 2019-07-18

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

414 participants

Primary outcome timeframe

9 months after study enrollment

Results posted on

2019-07-18

Participant Flow

Veterans were enrolled from a women's, geriatrics, and several general medicine clinics at the San Francisco VA from April 2013 through July 2016. Veterans had to be 60 years or older, have had at least 2 chronic medical conditions, and had 2 or more visits with a primary care clinician, plus 2 VA clinic, ER, or hospital visits in the past year.

Participant milestones

Participant milestones
Measure
PREPARE
The intervention group will review the PREPARE advance care planning website and PREPARE materials plus receive an advance directive. The control group will only receive an advance directive. PREPARE website: Advance care planning website and materials plus an advance directive.
CONTROL
The control group will only receive an advance directive. Advance directive: The control group will only receive an advance directive.
Overall Study
STARTED
205
209
Overall Study
COMPLETED
205
209
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preparing Older Veterans With Serious and Chronic Illness for Decision Making

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PREPARE
n=205 Participants
The intervention group will review the PREPARE advance care planning website and PREPARE materials plus receive an advance directive. The control group will only receive an advance directive. PREPARE website: Advance care planning website and materials plus an advance directive.
CONTROL
n=209 Participants
The control group will only receive an advance directive. Advance directive: The control group will only receive an advance directive.
Total
n=414 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
46 Participants
n=5 Participants
50 Participants
n=7 Participants
96 Participants
n=5 Participants
Age, Categorical
>=65 years
159 Participants
n=5 Participants
159 Participants
n=7 Participants
318 Participants
n=5 Participants
Age, Continuous
70.7 years
STANDARD_DEVIATION 7.7 • n=5 Participants
71.5 years
STANDARD_DEVIATION 7.9 • n=7 Participants
71.1 years
STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male
Female
19 Participants
n=5 Participants
19 Participants
n=7 Participants
38 Participants
n=5 Participants
Sex: Female, Male
Male
186 Participants
n=5 Participants
190 Participants
n=7 Participants
376 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
16 Participants
n=5 Participants
17 Participants
n=7 Participants
33 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
189 Participants
n=5 Participants
192 Participants
n=7 Participants
381 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Race (NIH/OMB)
Asian
13 Participants
n=5 Participants
12 Participants
n=7 Participants
25 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
46 Participants
n=5 Participants
42 Participants
n=7 Participants
88 Participants
n=5 Participants
Race (NIH/OMB)
White
129 Participants
n=5 Participants
139 Participants
n=7 Participants
268 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
14 Participants
n=5 Participants
12 Participants
n=7 Participants
26 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
United States
205 Participants
n=5 Participants
209 Participants
n=7 Participants
414 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 9 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
n=205 Participants
The intervention group will review the PREPARE advance care planning website and PREPARE materials plus receive an advance directive. The control group will only receive an advance directive. PREPARE website: Advance care planning website and materials plus an advance directive.
CONTROL
n=209 Participants
The control group will only receive an advance directive. Advance directive: The control group will only receive an advance directive.
New Advance Care Planning Documentation in the Medical Record at 9 Months
35 percentage of participants
25 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Secondary outcome was 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 Behavior Change Process 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. The investigators used mixed effects models to create an overall adjusted score.

Outcome measures

Outcome measures
Measure
PREPARE
n=205 Participants
The intervention group will review the PREPARE advance care planning website and PREPARE materials plus receive an advance directive. The control group will only receive an advance directive. PREPARE website: Advance care planning website and materials plus an advance directive.
CONTROL
n=209 Participants
The control group will only receive an advance directive. Advance directive: The control group will only receive an advance directive.
Self-reported Engagement in Advance Care Planning (ACP) Behaviors
3.78 score on a scale
Standard Deviation 3.67
3.64 score on a scale
Standard Deviation 3.53

Adverse Events

PREPARE

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

CONTROL

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rebecca Sudore

Veterans Administration

Phone: (415) 221-4810

Results disclosure agreements

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