- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04779684
Promoting Self-determination for Institutionalized Older People Without Decision-making Capacity: Advance Care Planning by Proxy (PROSPECT)
Study Overview
Status
Detailed Description
Patient-centered care involves treating patients in the way that is the most aligned with their values and their self-determination. This is the aim of Advance Care Planning (ACP), a communication-based complex intervention. ACP involves accompanied reflection about one's values, anticipation of potential health problems in future states of impaired decision-making capacity, consideration of a range of treatment and care options, anticipatory decision making and the documentation and communication of these decisions to family members and health care professionals. This process ensures that a person's self-determination is respected even when she is no longer able to make health care decisions. ACP programs are well established in the English-speaking world and are currently being developed across Asia and Europe.
Participation in ACP requires decision-making capacity. Yet, many people lose this capacity before having formally expressed their care preferences. In these cases, their health care proxies, families and health professionals are called upon to make decisions on their behalf, based on what they believe the person would have wanted (presumed will). This is problematic and distressing for both family members and health professionals. The fact that many people do not participate in ACP or complete advanced directives, along with an increasing prevalence of neuro-degenerative diseases entailing a loss of decision-making capacity, means that growing numbers of people are likely to require others to make medical decisions on their behalf.
The investigator's exploratory research, confirmed by the literature, highlights an urgent unmet need for comprehensive and systematic interventions to assist in promoting self-determination of older people who lack decision making capacity. ACP by proxy (ACP-bp) has been suggested as a model to help proxies of incapacitated patients plan ahead and prepare for future care decisions. However, this model has never been specifically developed nor tested. This is why the investigators have developed a specific model of ACP-bp and aim to test it in a pilot study among proxies of residential aged care facility (RACF) residents who lack decision making capacity, primarily due to advanced dementia.
The investigators aim to test the acceptability and feasibility of this intervention and the appropriateness of outcome measures through a pilot study in two RACFs in the Swiss canton of Vaud over a period of one year. A process evaluation will be conducted through the triangulation of mixed-method data: self-report scales, semi-structured interviews, document analyses, resident health care records and an economic cost analysis. This will form the basis for a subsequent cluster-randomized control trial to test the intervention's effectiveness. This novel approach of ACP-bp has potential to promote self-determination and patient-centered care that improves both the ethical appropriateness and economic sustainability of care. It may lead to patients being treated in accordance with their wishes, reduce unnecessary overtreatment and avoid distress for family members and health care professionals. This approach also responds to calls for models of ACP which can be used in people with dementia and people living in RACFs, vulnerable populations that have generally remained invisible in ACP research so far.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laura Jones, PhD
- Phone Number: +4479 556 51 57
- Email: laura.jones@chuv.ch
Study Contact Backup
- Name: Corinne Rime
- Phone Number: +4421 314 71 05
- Email: corinne.rime@chuv.ch
Study Locations
-
-
Vaud
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Lausanne, Vaud, Switzerland, 1011
- Lausanne University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Health Care Proxy Inclusion Criteria:
- Is the legally authorized health care proxy for an RACF resident who: no longer has medical decision making capacity (according to medical judgement), is over 70 years of age and lives in an RACF in the canton of Vaud;
- Has sufficient language proficiency to complete a written questionnaire and participate in discussions.
Health Care Proxy Exclusion Criteria:
- Has insufficient language proficiency to complete a written questionnaire and participate in discussions.
- Lacks decision making capacity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACP by proxy pilot intervention group
All participants are included in the intervention group
|
Two discussions between a trained health professional and a health care proxy of an RACF resident who no longer has decision making capacity.
First discussion focuses on life story, values, previous experiences with medical treatments, illness and death.
Second discussion also includes treating physician and focuses on establishing general goals of care and medical orders in case of emergency.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of the ACP by proxy intervention
Time Frame: 12 months
|
Acceptability of the intervention from the perspectives of health care proxies, RACF health professionals and physicians will be assessed through qualitative interviews asking about their experiences of the intervention.
Interviews will be conducted 12 months after the start of the intervention
|
12 months
|
Feasibility of the ACP by proxy intervention in RACFs
Time Frame: 18 month
|
Feasibility of the intervention from the perspectives of health care proxies, RACF health professionals and physicians will be assessed through qualitative interviews asking about their experiences of the intervention.
Interviews will be conducted 12 months after the start of the intervention.
|
18 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decisional conflict
Time Frame: 18 months
|
Health care proxy decisional conflict in making decisions on behalf of an RACF resident who no longer has medical decision making capacity (as measured by the Decisional Conflict Scale).
Higher scores indicate more decisional conflict (minimum score: 0, maximum score: 64).
|
18 months
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Self-efficacy in giving care concordent with resident wishes
Time Frame: 18 months
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Health professional self-efficacy in providing care that is consistent with the wishes of a person who no longer has medical decision making capacity will be assessed through a single item numerical rating scale from 1-10 (higher scores indicate more self-efficacy)
|
18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ralf J Jox, MD,PhD, Lausanne University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACPbp
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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