Advanced Care PlanningNCT05049291
Pilot Study of an Advance Care Planning Intervention Among Persons With Dementia
A study testing telehealth advance care planning in people with Advanced Care Planning and Dementia, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Advance care planning allows people to have their wishes taken into account even in the advanced stages of the persons' condition and at the end of life when the person may be unable to communicate. However, a recent review found an absence of high-quality guidelines for advanced care planning in dementia care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Care Planning, Dementia
- What is being tested?
- telehealth advance care planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 18 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Family member of a person with a diagnosis of dementia (any type)
- English-speaking family member
- Family member of a person with dementia admitted to a nursing home
Who cannot join
- Inability to understand/read English
- Advance directive already in patient chart
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Pilot Study of an Advance Care Planning Intervention Among Persons With Dementia in Long-term Services and Support Facilities
Advance care planning allows people to have their wishes taken into account even in the advanced stages of the persons' condition and at the end of life when the person may be unable to communicate. However, a recent review found an absence of high-quality guidelines for advanced care planning in dementia care. Since few evidence-based resources exist, the investigators propose a study to generate, refine, and pilot test an education information sheet designed to promote advanced care planning among families of persons with dementia.
Read the detailed description
To determine the feasibility, acceptability and preliminary efficacy of an education information sheet to promote advance care planning among family members of persons with advanced dementia in long-term services and support facilities.
Introducing an education information sheet containing prognosis and outcomes will be feasible, acceptable, and increase self-efficacy and do-not-hospitalize decision preferences among family members of persons with advanced dementia.
- Conditions
- Advanced Care Planning, Dementia
- Being tested
- telehealth advance care planning
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telehealth advance care planningBehavioural
An education information sheet containing prognosis and outcomes of acute care and intensive treatments
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | One time receipt and review of an information sheet Receives: Behavioral: telehealth advance care planning |
| Non-Intervention | No intervention | Usual care will be delivered per standards of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Information Sheet among Study Population
Feasibility of the information sheet is defined as the consent rate of family members who are offered enrollment. This will be calculatd as a percent of family members (number of enrolled participants/number of eligible participants offered enrollment)
Measured: 6 months
Acceptibility of Decision Aid Tool
Acceptability using an adapted tool (https://decisionaid.ohri.ca/eval_accept.html) which measures the ratings of comprehensibility of the information sheet among participants in the intervention group. Responses are reported descriptively in terms of proportions responding positively or negatively on each criteria.
Measured: 6 months
Secondary outcomes (6)
Decision Self-efficacy Scale
Measures self-confidence or belief in one's abilities in decision making, including shared decision making. Eleven responses are measured on a 0-4 likert scale and a final summed scale is converted to a 0-100 range (scores are summed, divided by 11, then multiplied by 25). A score of zero means low self efficacy and score of 100 means extremely high self efficacy.
Measured: 6 months
Family Member Decision-Making Self-Efficacy Scale
Measures family member self-efficacy in medical decision-making on behalf of a loved one. This scale has two versions, one for conscious and one for unconscious loved ones, which we will use accordingly. Thirteen items are measured on a 0-5 Likert scale with 1 being "cannot do at all" and 5 being "certain I can do." Higher scores indicate higher decision making self-efficacy.
Measured: 6 months
Adaptation of Advance Care Planning Engagement Survey
Questions adapted from an 82-item questionnaire that measures advance care planning engagement in terms of knowledge, contemplation, self-efficacy and readiness. We include 10 questions from the measure. We used a mean imputation approach. All available data were included to create an average 5-point Likert score.
Measured: 6 months
Preparation for Decision-Making Scale
Measures perception of the usefulness of a decision support tool in preparing respondent for decision-making. Responses are on a Likert scale of 1-5 with one being "not at all" and five being " a great deal." Items are summed for scoring. A higher score indicates a higher level of perceived helpfulness in preparing for decision-making.
Measured: 6 months
Adaptation of Advance Care Planning Engagement for Surrogates Survey
We adapted 9 items from the 17-item Advance Care Planning for Surrogates survey. Response options are on a 5-point Likert scale. We will calculate a summary score, with higher scores indicates a higher level of engagement.
Measured: 6 months
Knowledge about Dementia
Six questions to assess family members' knowledge about dementia were developed for this pilot study. All questions are true/false. Each correct answer will be coded as 1, each incorrect answer will be scored as 0. Higher scores indicate more knowledge.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start10 Nov 2022
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Care PlanningStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Principal investigator, Donald Sullivan, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049291
- Sponsor's protocol ID
- STUDY00021951
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2021
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Advance Care Planning Intervention Among Persons With Dementia in Long-term Services and Support Facilities
- ClinicalTrials.gov ID
- NCT05049291
- Acronym / sponsor ID
- STUDY00021951
- Conditions
- Advanced Care Planning, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Advance care planning allows people to have their wishes taken into account even in the advanced stages of the persons' condition and at the end of life when the person may be unable to communicate. However, a recent review found an absence of high-quality guidelines for advanced care planning in dementia care. Since few evidence-based resources exist, the investigators propose a study to generate, refine, and pilot test an education information sheet designed to promote advanced care planning among families of persons with dementia.
Detailed description
To determine the feasibility, acceptability and preliminary efficacy of an education information sheet to promote advance care planning among family members of persons with advanced dementia in long-term services and support facilities.
Introducing an education information sheet containing prognosis and outcomes will be feasible, acceptable, and increase self-efficacy and do-not-hospitalize decision preferences among family members of persons with advanced dementia.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: telehealth advance care planningOne time receipt and review of an information sheet |
| Non-Intervention | No intervention | –Usual care will be delivered per standards of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Family member of a person with a diagnosis of dementia (any type)
- English-speaking family member
- Family member of a person with dementia admitted to a nursing home
Key exclusion criteria (2 listed)
- Inability to understand/read English
- Advance directive already in patient chart
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telehealth advance care planningAn education information sheet containing prognosis and outcomes of acute care and intensive treatments | Behavioural | Intervention |
Primary outcome
Feasibility of Information Sheet among Study Population
Time frame: 6 months
Feasibility of the information sheet is defined as the consent rate of family members who are offered enrollment. This will be calculatd as a percent of family members (number of enrolled participants/number of eligible participants offered enrollment)
Acceptibility of Decision Aid Tool
Time frame: 6 months
Acceptability using an adapted tool (https://decisionaid.ohri.ca/eval_accept.html) which measures the ratings of comprehensibility of the information sheet among participants in the intervention group. Responses are reported descriptively in terms of proportions responding positively or negatively on each criteria.
6 secondary outcomes
Decision Self-efficacy Scale
Time frame: 6 months
Family Member Decision-Making Self-Efficacy Scale
Time frame: 6 months
Adaptation of Advance Care Planning Engagement Survey
Time frame: 6 months
Preparation for Decision-Making Scale
Time frame: 6 months
Adaptation of Advance Care Planning Engagement for Surrogates Survey
Time frame: 6 months
Knowledge about Dementia
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telehealth advance care planning in people with Advanced Care Planning and Dementia, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Information Sheet among Study Population (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.