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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR016007-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TTM | Experimental | 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. |
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| Usual Care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transtheoretical Model (TTM) of health behavior change | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terri Fried, MD | Internal Medicine: Geriatrics: Claude D. Pepper Older Americans Independence Center; Dorothy Adler Geriatric Assessment Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Medical Groups | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34461035 | Derived | Fried TR, Paiva AL, Redding CA, Iannone L, O'Leary JR, Zenoni M, Risi MM, Mejnartowicz S, Rossi JS. Effect of the STAMP (Sharing and Talking About My Preferences) Intervention on Completing Multiple Advance Care Planning Activities in Ambulatory Care : A Cluster Randomized Controlled Trial. Ann Intern Med. 2021 Nov;174(11):1519-1527. doi: 10.7326/M21-1007. Epub 2021 Aug 31. | |
| 30099405 | Derived | Fried TR, Redding CA, Martino S, Paiva A, Iannone L, Zenoni M, Blakley LA, Rossi JS, O'Leary J. Increasing engagement in advance care planning using a behaviour change model: study protocol for the STAMP randomised controlled trials. BMJ Open. 2018 Aug 10;8(8):e025340. doi: 10.1136/bmjopen-2018-025340. |
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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.
20 ambulatory internal medicine practices, matched in pairs according to practice type and percentage of patients age 65+, non-White, and receiving Medicaid
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2-month Assessment |
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| 4-month Assessment |
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| 6-months |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Terri Fried | Yale School of Medicine | 203-932-5711 | 5412 | terri.fried@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2016 | May 18, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000083362 | Transtheoretical Model |
| ID | Term |
|---|---|
| D000083342 | Health Belief Model |
| D008962 | Models, Theoretical |
| D008919 | Investigative Techniques |
| D008960 | Models, Psychological |
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| Usual Care | Other | 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. |
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| 6 months |
| Refused assessment |
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| Acutely ill |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| Baseline stage of change: living will | Count of Participants | Participants |
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| Baseline stage of change: healthcare agent | Count of Participants | Participants |
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| Baseline stage of change: communication about quality versus quantity of life | Count of Participants | Participants |
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| OG001 | 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. |
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| Secondary | Number of Participants Who Complete a Living Will | Participants who had not completed a living will at baseline | Posted | Count of Participants | Participants | 6-months |
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| Secondary | Number of Participants Who Assign a Healthcare Agent | Individuals who had not assigned a healthcare agent at baseline | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants Who Communicate With a Loved One About Quality Versus Quantity of Life | Individuals who had not communicated about quality versus quantity of life at baseline | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 0 |
| 455 |
| 0 |
| 455 |
| 0 |
| 455 |
| EG001 | 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. | 0 | 454 | 0 | 454 | 0 | 454 |
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| Odds Ratio (OR) |
| 1.39 |
| 2-Sided |
| 95 |
| .96 |
| 2.0 |
Accounting for clustering and adjusted for covariates as described in primary outcome |
| Superiority |
| Odds Ratio (OR) |
| 1.73 |
| 2-Sided |
| 95 |
| 1.22 |
| 2.47 |
Accounting for clustering and adjusted for covariates as presenting for primary outcome |
| Superiority |
| Odds Ratio (OR) |
| 1.15 |
| 2-Sided |
| 95 |
| .72 |
| 1.85 |
Accounting for clustering and adjusting for covariates as described for primary outcome |
| Superiority |