Advanced Care Planning (ACP)
Conditions
Keywords
Transtheoretical Model (TTM)
Brief summary
The purpose of this study is to examine the effect of an individually transtheoretical model (TTM) tailored intervention on the completion of advance care planning (ACP) behaviors.
Detailed description
This will be a randomized controlled trial examining the effect of an individually TTM-tailored intervention on the proportion of middle-age and older persons recruited from primary care practices who complete four ACP behaviors (completion of a living will, assignment of a health care proxy, and communication with loved ones and with their clinician about views on quality versus quantity of life) over six months, compared with usual care.
Interventions
BEHAVIORALTranstheoretical 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.
OTHERUsual 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.
Sponsors
National Institute of Nursing Research (NINR)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants will be community-dwelling persons with an upcoming primary care visit in the study's practice settings.
Exclusion criteria
* Severe hearing impairment, defined as being unable to participate in a telephone conversation. * Severe visual impairment, defined as being unable to read large-print materials. * Moderate to severe cognitive impairment, defined as either a diagnosis of dementia and/or short-term recall of \<2/3 objects at 2 minutes. * Primary language other than English. * Having completed all of the four ACP behaviors that are the focus of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 6 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Complete a Living Will | 6-months |
| Number of Participants Who Assign a Healthcare Agent | 6 months |
| Number of Participants Who Communicate With a Loved One About Quality Versus Quantity of Life | 6 months |
Countries
United States
Participant flow
Recruitment details
20 ambulatory internal medicine practices, matched in pairs according to practice type and percentage of patients age 65+, non-White, and receiving Medicaid
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 455 |
| 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. | 454 |
| Total | 909 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 2-month Assessment | Acutely ill | 6 | 2 |
| 2-month Assessment | Refused assessment | 7 | 5 |
| 2-month Assessment | Unable to reach | 42 | 32 |
| 2-month Assessment | Withdrawal by Subject | 13 | 3 |
| 4-month Assessment | Acutely ill | 2 | 3 |
| 4-month Assessment | Death | 4 | 2 |
| 4-month Assessment | Refused assessment | 24 | 10 |
| 4-month Assessment | Unable to reach | 44 | 29 |
| 4-month Assessment | Withdrawal by Subject | 4 | 2 |
| 6-months | Acutely ill | 1 | 1 |
| 6-months | Death | 0 | 2 |
| 6-months | Lost to Follow-up | 14 | 11 |
| 6-months | Refused assessment | 6 | 3 |
Baseline characteristics
| Characteristic | Total | Usual Care | STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report |
|---|---|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 8.3 | 67.8 years STANDARD_DEVIATION 8 | 68.9 years STANDARD_DEVIATION 8.5 |
| Baseline stage of change: communication about quality versus quantity of life Action/maintenance | 593 Participants | 289 Participants | 304 Participants |
| Baseline stage of change: communication about quality versus quantity of life Contemplation | 106 Participants | 46 Participants | 60 Participants |
| Baseline stage of change: communication about quality versus quantity of life Missing | 2 Participants | 2 Participants | 0 Participants |
| Baseline stage of change: communication about quality versus quantity of life Precontemplation | 192 Participants | 112 Participants | 80 Participants |
| Baseline stage of change: communication about quality versus quantity of life Preparation | 16 Participants | 5 Participants | 11 Participants |
| Baseline stage of change: healthcare agent Action/maintenance | 188 Participants | 105 Participants | 83 Participants |
| Baseline stage of change: healthcare agent Contemplation | 444 Participants | 217 Participants | 227 Participants |
| Baseline stage of change: healthcare agent Missing | 2 Participants | 2 Participants | 0 Participants |
| Baseline stage of change: healthcare agent Precontemplation | 168 Participants | 99 Participants | 69 Participants |
| Baseline stage of change: healthcare agent Preparation | 107 Participants | 31 Participants | 76 Participants |
| Baseline stage of change: living will Action/maintenance | 228 Participants | 120 Participants | 108 Participants |
| Baseline stage of change: living will Contemplation | 448 Participants | 224 Participants | 224 Participants |
| Baseline stage of change: living will Missing | 3 Participants | 3 Participants | 0 Participants |
| Baseline stage of change: living will Precontemplation | 150 Participants | 86 Participants | 64 Participants |
| Baseline stage of change: living will Preparation | 80 Participants | 21 Participants | 59 Participants |
| Education <=12th grade | 233 Participants | 96 Participants | 137 Participants |
| Education >12th grade | 676 Participants | 358 Participants | 318 Participants |
| Employment Employed | 351 Participants | 194 Participants | 157 Participants |
| Employment Unemployed | 558 Participants | 260 Participants | 298 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 10 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 880 Participants | 439 Participants | 441 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 167 Participants | 91 Participants | 76 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 10 Participants | 9 Participants |
| Race (NIH/OMB) White | 691 Participants | 339 Participants | 352 Participants |
| Sex: Female, Male Female | 554 Participants | 262 Participants | 292 Participants |
| Sex: Female, Male Male | 355 Participants | 192 Participants | 163 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 455 | 0 / 454 |
| other Total, other adverse events | 0 / 455 | 0 / 454 |
| serious Total, serious adverse events | 0 / 455 | 0 / 454 |
Outcome results
Primary
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.
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report | 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 |
| Usual Care | 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. | 37 Participants |
95% CI: [0.014, 0.105]
95% CI: [1.14, 2.93]
Secondary
Number of Participants Who Assign a Healthcare Agent
Time frame: 6 months
Population: Individuals who had not assigned a healthcare agent at baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report | Number of Participants Who Assign a Healthcare Agent | 122 Participants |
| Usual Care | Number of Participants Who Assign a Healthcare Agent | 68 Participants |
95% CI: [0.066, 0.201]
95% CI: [1.22, 2.47]
Secondary
Number of Participants Who Communicate With a Loved One About Quality Versus Quantity of Life
Time frame: 6 months
Population: Individuals who had not communicated about quality versus quantity of life at baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report | Number of Participants Who Communicate With a Loved One About Quality Versus Quantity of Life | 93 Participants |
| Usual Care | Number of Participants Who Communicate With a Loved One About Quality Versus Quantity of Life | 90 Participants |
95% CI: [-0.05, 0.188]
95% CI: [0.72, 1.85]
Secondary
Number of Participants Who Complete a Living Will
Time frame: 6-months
Population: Participants who had not completed a living will at baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report | Number of Participants Who Complete a Living Will | 99 Participants |
| Usual Care | Number of Participants Who Complete a Living Will | 68 Participants |
95% CI: [0.014, 0.15]
95% CI: [0.96, 2]