Patient EngagementNCT06081660
Advance Care Planning for Older Latinos With Chronic Illness
A study testing ACP-I Plan in people with Patient Engagement and End of Life, run by San Diego State University at 1 site in United States.
Trial summary
The goal of this study is to test the feasibility of a randomized controlled trial to learn about implementation of an intervention model, Advance Care Planning I Plan (ACP-I Plan), among older Latinos with chronic illnesses in community settings. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Engagement, End of Life, Chronic Disease
- What is being tested?
- ACP-I Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 16 Apr 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years old or older
- Latino/Latina or Hispanic?
- Have 1 or more chronic health conditions
Who cannot join
- Schizophrenia
- Schizoaffective Disorder
- Dementia
- Alzheimer's disease
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92182
About this study
Official title: Advance Care Planning for Older Latinos With Chronic Illness: A Feasibility Study
The goal of this study is to test the feasibility of a randomized controlled trial to learn about implementation of an intervention model, Advance Care Planning I Plan (ACP-I Plan), among older Latinos with chronic illnesses in community settings.
Read the detailed description
The goal of this study is to test the feasibility of a randomized controlled trial to learn about implementation of an intervention model, Advance Care Planning I Plan (ACP-I Plan), among older Latinos with chronic illnesses in community settings.
The questions of this study seek to explore implementation of the intervention model:
- To evaluate feasibility, acceptability, and preliminary impact of ACP-I Plan to improve AD documentation and increase engagement in ACP communication with family and providers among older Latinos with chronic diseases (cancers and non-cancers); and
- To evaluate implementation of ACP-I Plan in a community setting and examine further need for adaption.
Participants will be randomized into two groups:
- ACP education consisting of
- a brief social work screening,
- an educational pamphlet,
- advance directive forms (in English and Spanish), and
- community resource materials (i.e., handout); and
- ACP education plus counseling consisting of
- motivational interviewing
- decisional support, and
- patient navigation to address barriers We anticipate that ACP-I Plan will be feasibly and acceptable. Participants who receive ACP-I Plan will show 1) greater likelihood of documenting an AD, 2) greater importance of and concern for engaging in ACP communication with family members and providers, and 3) reduced distress at 4-week post intervention.
- Conditions
- Patient Engagement, End of Life, Chronic Disease, Communication
- Being tested
- ACP-I Plan
- Keywords
- Latino, Advance Care Planning, Advance Directive
- Medical subject headings
- Patient Participation, Death, Chronic Disease, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-I PlanBehavioural
ACP-I Plan consisting of education, counseling, decisional support, and patient navigation
| Study group | Role | What they receive |
|---|---|---|
| ACP education | Active comparator | ACP education consisting of
* a brief social work screening,
* an educational pamphlet,
* advance directive forms (in English and Spanish), and
* community resource materials (i.e., handout) Receives: Behavioral: ACP-I Plan |
| ACP education plus counseling | Experimental | ACP education plus counseling consisting of
* a brief social work screening,
* an educational pamphlet,
* advance directive forms (in English and Spanish), and
* community resource materials (i.e., handout);
* motivational interviewing
* decisional support, and
* patient navigation to address barriers Receives: Behavioral: ACP-I Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
Feasibility
We use benchmarks for feasibility.
- Number of Participants Recruited, and screening no more than 100 participants,
- tracking numbers of participants consented into the study,
- percent refused to participate and dropout, amount of time to screen participants and complete a baseline survey once consented into the study,
- ACP-I Plan intervention delivered for the first session <2 weeks from their recruitment and randomization date and second session <4 weeks from recruitment,
- identify missing data.
- Track the number of participants who indicate they returned a completed AD to their provider and/or talked with a family member regarding ACP.
Measured: 12 months
Satisfaction with intervention
Acceptability of the intervention
Satisfaction survey questions includes 14 questions using "I" statements and a 5-point Likert scale: Strongly Disagree to Strongly Agree). Improved scores at follow up indicate satisfaction of information delivery.
Reference
Lyon ME, Garvie PA, Briggs L, He J, McCarter R, D'Angelo LJJJopm. Development, feasibility, and acceptability of the Family/Adolescent-Centered (FACE) Advance Care Planning intervention for adolescents with HIV. 2009;12(4):363-372.
Measured: 1 month
Retention and Attrition Rates
Feasibility of recruitment and retention
Measured: 12 months
Secondary outcomes (3)
Completion Rates
Self report yes/no completed an advance directive document.
We use the method that Douglas \& Brown (2002) used ask about completion of advance directives at 2 points, baseline and 1-month follow-up. Questions have yes/no [Y/N], responses.
Reference Douglas R, Brown HN. Patients' attitudes toward advance directives. Journal of Nursing Scholarship.
2002;34(1):61-65.
We also use the Advance Directive Attitude Survey (ADAS) by Nolan has 16 items and asks questions (uses a 4-point Likert scale, Strongly Agree to Strongly Disagree with AD decision making). Sixteen questions are subscales and ask about: (a) opportunity for treatment choices, (b) effect of advance directives on the family, (c) effect of an AD on treatment, and (d) perception of illness.
Nolan MT, Bruder M. Patients' attitudes toward advance directives and end-of-life treatment decisions. Nursing outlook. 1997;45(5):204-208.
Measured: 1 month
Communication Readiness Provider
Barriers to ACP communication and readiness to talk with provider.
We use a barrier scale developed to identify Barriers to Communication about Advance Care Planning (Nedjat-Haiem, 2022) which has 19 questions and uses a scale from 0 to 4, asking how much of a concern is this for you? Readiness to engage in communication about ACP will be assessed by three yes/no questions that ask about: (1) fear of death and dying, (2) difficulty engaging in EOL care communication, and (3) worry about illness severity.
We also use a readiness scale (1-10) which asks: how ready are you to engage in ACP communication with your physician.
Measured: 1 month
Communication Readiness Family
Self Report yes/no - Readiness to talk with a family member
We also use one question to ask about about readiness using a scale (1-10) which asks: how ready are you to engage in ACP communication with your family member?
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start14 Sep 2022
- Primary completion16 Apr 2023
- Study completion16 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EngagementStudies of the same condition, open and under way.
- More trials run by San Diego State 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
- Factorial
- Model description
- 2 x 2 mixed factorial design, pre-test/posttest variables to examine impact on ACP
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frances Nedjat-Haiem, San Diego State University
- Investigators
- Ayala, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081660
- Sponsor's protocol ID
- HS-2020-0175
- Status last verified
- Oct 2023
- First submitted
- 21 Nov 2022
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advance Care Planning for Older Latinos With Chronic Illness: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06081660
- Acronym / sponsor ID
- HS-2020-0175
- Conditions
- Patient Engagement, End of Life, Chronic Disease, Communication
- Keywords
- Latino, Advance Care Planning, Advance Directive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 16 Apr 2023 (actual)
- Study completion
- 16 Apr 2023 (actual)
- First posted
- 13 Oct 2023 (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.
The goal of this study is to test the feasibility of a randomized controlled trial to learn about implementation of an intervention model, Advance Care Planning I Plan (ACP-I Plan), among older Latinos with chronic illnesses in community settings.
Detailed description
The goal of this study is to test the feasibility of a randomized controlled trial to learn about implementation of an intervention model, Advance Care Planning I Plan (ACP-I Plan), among older Latinos with chronic illnesses in community settings.
The questions of this study seek to explore implementation of the intervention model:
- To evaluate feasibility, acceptability, and preliminary impact of ACP-I Plan to improve AD documentation and increase engagement in ACP communication with family and providers among older Latinos with chronic diseases (cancers and non-cancers); and
- To evaluate implementation of ACP-I Plan in a community setting and examine further need for adaption.
Participants will be randomized into two groups:
- ACP education consisting of
- a brief social work screening,
- an educational pamphlet,
- advance directive forms (in English and Spanish), and
- community resource materials (i.e., handout); and
- ACP education plus counseling consisting of
- motivational interviewing
- decisional support, and
- patient navigation to address barriers We anticipate that ACP-I Plan will be feasibly and acceptable. Participants who receive ACP-I Plan will show 1) greater likelihood of documenting an AD, 2) greater importance of and concern for engaging in ACP communication with family members and providers, and 3) reduced distress at 4-week post intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 x 2 mixed factorial design, pre-test/posttest variables to examine impact on ACP
| Arm | Type | Receives |
|---|---|---|
| ACP education | Active comparator | Behavioral: ACP-I PlanACP education consisting of * a brief social work screening, * an educational pamphlet, * advance directive forms (in English and Spanish), and * community resource materials (i.e., handout) |
| ACP education plus counseling | Experimental | Behavioral: ACP-I PlanACP education plus counseling consisting of * a brief social work screening, * an educational pamphlet, * advance directive forms (in English and Spanish), and * community resource materials (i.e., handout); * motivational interviewing * decisional support, and * patient navigation to address barriers |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50 years old or older
- Latino/Latina or Hispanic?
- Have 1 or more chronic health conditions
Key exclusion criteria (4 listed)
- Schizophrenia
- Schizoaffective Disorder
- Dementia
- Alzheimer's disease
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 |
|---|---|---|
| ACP-I PlanACP-I Plan consisting of education, counseling, decisional support, and patient navigation | Behavioural | ACP education, ACP education plus counseling |
Primary outcome
Intervention Feasibility
Time frame: 12 months
Feasibility We use benchmarks for feasibility. 1. Number of Participants Recruited, and screening no more than 100 participants, 2. tracking numbers of participants consented into the study, 3. percent refused to participate and dropout, amount of time to screen participants and complete a baseline survey once consented into the study, 4. ACP-I Plan intervention delivered for the first session <2 weeks from their recruitment and randomization date and second session <4 weeks from recruitment, 5. identify missing data. 6. Track the number of participants who indicate they returned a completed AD to their provider and/or talked with a family member regarding ACP.
Satisfaction with intervention
Time frame: 1 month
Acceptability of the intervention Satisfaction survey questions includes 14 questions using "I" statements and a 5-point Likert scale: Strongly Disagree to Strongly Agree). Improved scores at follow up indicate satisfaction of information delivery. Reference Lyon ME, Garvie PA, Briggs L, He J, McCarter R, D'Angelo LJJJopm. Development, feasibility, and acceptability of the Family/Adolescent-Centered (FACE) Advance Care Planning intervention for adolescents with HIV. 2009;12(4):363-372.
Retention and Attrition Rates
Time frame: 12 months
Feasibility of recruitment and retention
3 secondary outcomes
Completion Rates
Time frame: 1 month
Communication Readiness Provider
Time frame: 1 month
Communication Readiness Family
Time frame: 1 month
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 13 Oct 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.
Ayala, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACP-I Plan in people with Patient Engagement and End of Life, run by San Diego State 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 4 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 13 Oct 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?
Intervention Feasibility (time frame: 12 months). The study lists 3 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 13 Oct 2023.