Trial Outcomes & Findings for STAMP: Sharing and Talking About My Preferences (NCT NCT03137459)
NCT ID: NCT03137459
Last Updated: 2021-09-29
Results Overview
The primary outcome of the study is to assess the proportion of participants that have completed the four ACP behaviors. The measure will be coded as a binary outcome where 'yes' indicates the completion of all 4 behaviors and 'no' indicates no completing the 4 behaviors.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
909 participants
Primary outcome timeframe
6 months
Results posted on
2021-09-29
Participant Flow
20 ambulatory internal medicine practices, matched in pairs according to practice type and percentage of patients age 65+, non-White, and receiving Medicaid
Because randomization occurred at the level of the practice, participants' assignment to group was determined before any information was known about them. However, there were participants who were excluded from they study before beginning any study procedures. These included: 1 matched set of practices was excluded for failing to meet minimum enrollment with 12 participants; 6 participants consented in error; 25 participants refused the baseline interview.
Participant milestones
| Measure |
STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report
Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.
Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete advance care planning (ACP) engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.
|
Usual Care
Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.
Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
|
|---|---|---|
|
2-month Assessment
STARTED
|
455
|
454
|
|
2-month Assessment
COMPLETED
|
387
|
412
|
|
2-month Assessment
NOT COMPLETED
|
68
|
42
|
|
4-month Assessment
STARTED
|
442
|
451
|
|
4-month Assessment
COMPLETED
|
364
|
405
|
|
4-month Assessment
NOT COMPLETED
|
78
|
46
|
|
6-months
STARTED
|
434
|
447
|
|
6-months
COMPLETED
|
413
|
430
|
|
6-months
NOT COMPLETED
|
21
|
17
|
Reasons for withdrawal
| Measure |
STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report
Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.
Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete advance care planning (ACP) engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.
|
Usual Care
Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.
Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
|
|---|---|---|
|
2-month Assessment
Withdrawal by Subject
|
13
|
3
|
|
2-month Assessment
Unable to reach
|
42
|
32
|
|
2-month Assessment
Refused assessment
|
7
|
5
|
|
2-month Assessment
Acutely ill
|
6
|
2
|
|
4-month Assessment
Death
|
4
|
2
|
|
4-month Assessment
Withdrawal by Subject
|
4
|
2
|
|
4-month Assessment
Unable to reach
|
44
|
29
|
|
4-month Assessment
Refused assessment
|
24
|
10
|
|
4-month Assessment
Acutely ill
|
2
|
3
|
|
6-months
Lost to Follow-up
|
14
|
11
|
|
6-months
Death
|
0
|
2
|
|
6-months
Refused assessment
|
6
|
3
|
|
6-months
Acutely ill
|
1
|
1
|
Baseline Characteristics
STAMP: Sharing and Talking About My Preferences
Baseline characteristics by cohort
| Measure |
STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report
n=455 Participants
Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.
Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.
|
Usual Care
n=454 Participants
Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.
Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
|
Total
n=909 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 8.5 • n=99 Participants
|
67.8 years
STANDARD_DEVIATION 8.0 • n=107 Participants
|
68.3 years
STANDARD_DEVIATION 8.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
292 Participants
n=99 Participants
|
262 Participants
n=107 Participants
|
554 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
163 Participants
n=99 Participants
|
192 Participants
n=107 Participants
|
355 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
441 Participants
n=99 Participants
|
439 Participants
n=107 Participants
|
880 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
76 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
167 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
352 Participants
n=99 Participants
|
339 Participants
n=107 Participants
|
691 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Education
<=12th grade
|
137 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
233 Participants
n=206 Participants
|
|
Education
>12th grade
|
318 Participants
n=99 Participants
|
358 Participants
n=107 Participants
|
676 Participants
n=206 Participants
|
|
Employment
Employed
|
157 Participants
n=99 Participants
|
194 Participants
n=107 Participants
|
351 Participants
n=206 Participants
|
|
Employment
Unemployed
|
298 Participants
n=99 Participants
|
260 Participants
n=107 Participants
|
558 Participants
n=206 Participants
|
|
Baseline stage of change: living will
Precontemplation
|
64 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Baseline stage of change: living will
Contemplation
|
224 Participants
n=99 Participants
|
224 Participants
n=107 Participants
|
448 Participants
n=206 Participants
|
|
Baseline stage of change: living will
Preparation
|
59 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Baseline stage of change: living will
Action/maintenance
|
108 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
228 Participants
n=206 Participants
|
|
Baseline stage of change: living will
Missing
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Baseline stage of change: healthcare agent
Precontemplation
|
69 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
168 Participants
n=206 Participants
|
|
Baseline stage of change: healthcare agent
Contemplation
|
227 Participants
n=99 Participants
|
217 Participants
n=107 Participants
|
444 Participants
n=206 Participants
|
|
Baseline stage of change: healthcare agent
Preparation
|
76 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Baseline stage of change: healthcare agent
Action/maintenance
|
83 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
188 Participants
n=206 Participants
|
|
Baseline stage of change: healthcare agent
Missing
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Baseline stage of change: communication about quality versus quantity of life
Precontemplation
|
80 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
192 Participants
n=206 Participants
|
|
Baseline stage of change: communication about quality versus quantity of life
Contemplation
|
60 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Baseline stage of change: communication about quality versus quantity of life
Preparation
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Baseline stage of change: communication about quality versus quantity of life
Action/maintenance
|
304 Participants
n=99 Participants
|
289 Participants
n=107 Participants
|
593 Participants
n=206 Participants
|
|
Baseline stage of change: communication about quality versus quantity of life
Missing
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe primary outcome of the study is to assess the proportion of participants that have completed the four ACP behaviors. The measure will be coded as a binary outcome where 'yes' indicates the completion of all 4 behaviors and 'no' indicates no completing the 4 behaviors.
Outcome measures
| Measure |
STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report
n=455 Participants
Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.
Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.
|
Usual Care
n=454 Participants
Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.
Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
|
|---|---|---|
|
Number of Participants Who Completed Four ACP Activities: Communication With Loved Ones About Quality Versus Quantity of Life, Completion of a Living Will, Assignment of a Healthcare Agent, and Confirmation of Documents in the Electronic Health Record.
|
64 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: Participants who had not completed a living will at baseline
Outcome measures
| Measure |
STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report
n=347 Participants
Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.
Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.
|
Usual Care
n=334 Participants
Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.
Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
|
|---|---|---|
|
Number of Participants Who Complete a Living Will
|
99 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Individuals who had not assigned a healthcare agent at baseline
Outcome measures
| Measure |
STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report
n=372 Participants
Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.
Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.
|
Usual Care
n=349 Participants
Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.
Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
|
|---|---|---|
|
Number of Participants Who Assign a Healthcare Agent
|
122 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Individuals who had not communicated about quality versus quantity of life at baseline
Outcome measures
| Measure |
STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report
n=151 Participants
Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.
Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.
|
Usual Care
n=165 Participants
Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.
Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
|
|---|---|---|
|
Number of Participants Who Communicate With a Loved One About Quality Versus Quantity of Life
|
93 Participants
|
90 Participants
|
Adverse Events
STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place