DementiaADVANCE-PCNCT05322317
Advance Care Planning (ACP) in Primary Care for Dementia
A study testing ADVANCE-PC training via ECHO in people with Dementia and Advance Care Planning, run by Oregon Health and Science University at 1 site in United States.
Trial summary
ADVANCE-PC: Aligning Dementia \& adVANce Care planning Education in Primary Care, is a communications and implementation support intervention that builds on existing ACP programs, understanding of dementia, and clinical expertise to provide training and technical assistance tailored to the needs of primary care… Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Dementia, Advance Care Planning
- What is being tested?
- ADVANCE-PC training via ECHO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to 9 Nov 2022
- 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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinic Level
- The program will be offered to six primary care clinics. Each must meet the following criteria:
- Be a member in a practice-based research network (PBRN) within the Meta-network Learning and Research Center (Meta-LARC),
- Have a functional EHR,
- Have leadership that agrees to clinic participation, and
- Is willing to attempt to track and report the number of eligible patients (those with dementia seen in the clinic by program-trained clinicians) and the number of these patients and/or care partners that received ACP from these program-trained clinicians during a 5-month follow-up period.
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- Clinician/Staff Level
- Within participating clinics, primary care clinicians and other staff must meet all the following inclusion criteria to participate in the training program and the research questionnaire/interview:
- Willing to participate in ECHO sessions,
- Willing to work on ACP implementation between sessions, and
- Be highly likely to have visits with at least 8 patients with dementia and/or their care partners in a 5-month follow-up period.
- Adults of any age and pregnant people will be allowed to participate. Primary care clinicians and staff will all be over 18 years old and there is no maximum age limit for participation. It is possible that a primary care clinician or staff member who participates may be pregnant. This research does not inquire about pregnancy status and there is no added risk to the fetus in including a pregnant person in professional training.
Who cannot join
- Anyone meeting one or more of the exclusion criteria listed here will be excluded. We will exclude:
- Children and adolescents, as the target population is primary care clinicians, patient care team members, and primary care clinic staff;
- Clinicians who do not provide primary care;
- Primary care clinicians who do not care for patients with dementia; and
- Primary care clinics that do not have sufficient clinicians (6 clinicians or team members) or sufficient patients (at least 8 patients each) with dementia to meet the pilot test targets.
- There will be no systematic exclusion of participants based on age, gender or race, and/or ethnicity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Testing Critical Components for a Trial of Advance Care Planning in Primary Care for Dementia
ADVANCE-PC: Aligning Dementia \& adVANce Care planning Education in Primary Care, is a communications and implementation support intervention that builds on existing ACP programs, understanding of dementia, and clinical expertise to provide training and technical assistance tailored to the needs of primary care clinicians and clinics that are often over-burdened and under-resourced. For this pilot, we will recruit six primary care clinics to test the ADVANCE-PC delivered using remote technology (ECHO). The pilot will include conducting one ECHO cycle and assessing the feasibility and acceptability of the program content and this mode of delivery (Aim 1) and testing pragmatic outcome assessment for the intervention (Aim 2).
Read the detailed description
Aim 1: To assess the feasibility, acceptability, and content utility of the ECHO program among the clinicians in the participating primary care clinics. Data will be collected to assess successful program implementation and participant engagement. We will document outreach efforts, reporting why clinics decline to participate and as well as the initial motivations of those who agree. Data will be collected from participating clinicians: a pre-training questionnaire about their prior experience with ACP and dementia; feedback at the end of each session; and a longer questionnaire at the end of the training that measures intentions to engage in ACP, their understanding of dementia, their confidence in engaging patients and families in ACP, and what barriers they expect to encounter. Attendance will be documented, and ECHO sessions will be recorded so participation and trainee engagement can be assessed. At the end of the follow-up period, clinicians will participate in interviews focused on barriers to and facilitators of ACP in the context of dementia. Feasibility and acceptability of this intervention will be evaluated using descriptive and qualitative analyses of these data.
Aim 2: To pilot test the ascertainment of outcomes for the ADVANCE-PC program in the 3-month period when trained clinicians are attempting to conduct ACP routinely in their clinics. The primary outcome will be the proportion of patients with dementia and/or their care partners seen by participating clinicians who are engaged in ACP. To pilot test pragmatic assessment of this outcome, we will work with clinics to determine how the number of patients with dementia seen in a defined period (the denominator) and number who are engaged in ACP (the numerator) can be efficiently identified in by each clinic using their electronic health record (EHR). We will collect information on EHR functionality and current dementia and ACP documentation during Months 1-3 and integrate support for documentation and measurement into the training. Our secondary outcomes are clinician confidence, intentions, and behavior related to ACP. These will be evaluated during the ECHO program using questionnaires modeled after data collection activities routinely used by clinics for quality improvement and formally measured and analyzed using research questionnaires pre and post completion of the ECHO program and a semi structured interview at the end of the follow-up period.
- Conditions
- Dementia, Advance Care Planning
- Being tested
- ADVANCE-PC training via ECHO
- Keywords
- dementia, advance care planning, primary care, ECHO
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADVANCE-PC training via ECHOOther
To assess the feasibility of using a technology-based platform to deliver the ADVANCE-PC program to multiple primary care clinics. This model will be based on the ECHO program, a tele-mentoring program which uses communications technology to provide facilitated education, case review, and peer-to-peer problem solving remotely. Our working hypothesis is that the use of ECHO will be efficient (allowing several clinicians and teams to be supported simultaneously while creating a community of practice), feasible (that clinicians will enroll and share experiences via mentoring, guidance, feedback, and didactic education), and have the potential to impact patients as clinicians perceptions shift to favor ACP, their skills increase, and they are able to integrate ACP for patients with dementia into their clinic.
| Study group | Role | What they receive |
|---|---|---|
| Pilot participants | Other | Participants will participate in ADVANCE-PC training via ECHO and will receive practice facilitation support, if needed.
To assess the feasibility of the ADVANCE-PC training and implementation support, research data will be collected from participating clinicians at three time points. Two data collection points will be pre and post ECHO program training questionnaires about attitudes, experience, and intentions related to ACP and dementia. The third will be an interview at the end of the follow-up period, focusing on barriers to and facilitators of ACP in the context of dementia and the impact of the training and implementation support. Feasibility and acceptability of this intervention will be evaluated using descriptive and qualitative analyses of these data. Receives: Other: ADVANCE-PC training via ECHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of enrolled participants who attend 80% of ECHO program sessions
number of participants who attended 80% of sessions/number of enrolled participants
Measured: 5 months after start of program
Proportion of patients with dementia and/or their care partners seen by participating clinicians who are engaged in ACP.
Primary care clinics will identify: patients with dementia and/or their care partners who have visits with participating clinicians during the study period (denominator) and track the number of these people who are engaged in advance planning during the project period (numerator)
Measured: 8 months after start of program
Secondary outcomes (2)
Participating clinician satisfaction rating: questionnaire designed for this study
A score created by combining 3 items from our study questionnaire: willingness to recommend the program to others, rating of relevance to their practice, and satisfaction with program content.
Measured: 8 months from start of ECHO program
Percentage of enrolled participants who plan to continue to engage patients with dementia in ACP
number of participants who respond Yes to an item on the project questionnaire that asks if they will continue with ACP.
Measured: 8 months after start of program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start21 Apr 2022
- Primary completion3 Nov 2022
- Study completion9 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective pilot study designed to achieve the objectives listed above. This project focuses on implementing ACP (which is an accepted best practice) and using ECHO (which is an evidence-based existing professional development model in healthcare). The research component involves data collection from clinicians and clinics in addition to what would be normally collected for as part of the training program and for quality improvement (QI).
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Annette Totten, Oregon Health and Science University
- Investigators
- Annette M Totten, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322317
- Sponsor's protocol ID
- STUDY00023109
- Acronym
- ADVANCE-PC
- Status last verified
- Nov 2022
- First submitted
- 10 Mar 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Critical Components for a Trial of Advance Care Planning in Primary Care for Dementia
- ClinicalTrials.gov ID
- NCT05322317
- Acronym / sponsor ID
- ADVANCE-PC / STUDY00023109
- Conditions
- Dementia, Advance Care Planning
- Keywords
- dementia, advance care planning, primary care, ECHO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 11 Apr 2022 (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-PC: Aligning Dementia \& adVANce Care planning Education in Primary Care, is a communications and implementation support intervention that builds on existing ACP programs, understanding of dementia, and clinical expertise to provide training and technical assistance tailored to the needs of primary care clinicians and clinics that are often over-burdened and under-resourced. For this pilot, we will recruit six primary care clinics to test the ADVANCE-PC delivered using remote technology (ECHO). The pilot will include conducting one ECHO cycle and assessing the feasibility and acceptability of the program content and this mode of delivery (Aim 1) and testing pragmatic outcome assessment for the intervention (Aim 2).
Detailed description
Aim 1: To assess the feasibility, acceptability, and content utility of the ECHO program among the clinicians in the participating primary care clinics. Data will be collected to assess successful program implementation and participant engagement. We will document outreach efforts, reporting why clinics decline to participate and as well as the initial motivations of those who agree. Data will be collected from participating clinicians: a pre-training questionnaire about their prior experience with ACP and dementia; feedback at the end of each session; and a longer questionnaire at the end of the training that measures intentions to engage in ACP, their understanding of dementia, their confidence in engaging patients and families in ACP, and what barriers they expect to encounter. Attendance will be documented, and ECHO sessions will be recorded so participation and trainee engagement can be assessed. At the end of the follow-up period, clinicians will participate in interviews focused on barriers to and facilitators of ACP in the context of dementia. Feasibility and acceptability of this intervention will be evaluated using descriptive and qualitative analyses of these data.
Aim 2: To pilot test the ascertainment of outcomes for the ADVANCE-PC program in the 3-month period when trained clinicians are attempting to conduct ACP routinely in their clinics. The primary outcome will be the proportion of patients with dementia and/or their care partners seen by participating clinicians who are engaged in ACP. To pilot test pragmatic assessment of this outcome, we will work with clinics to determine how the number of patients with dementia seen in a defined period (the denominator) and number who are engaged in ACP (the numerator) can be efficiently identified in by each clinic using their electronic health record (EHR). We will collect information on EHR functionality and current dementia and ACP documentation during Months 1-3 and integrate support for documentation and measurement into the training. Our secondary outcomes are clinician confidence, intentions, and behavior related to ACP. These will be evaluated during the ECHO program using questionnaires modeled after data collection activities routinely used by clinics for quality improvement and formally measured and analyzed using research questionnaires pre and post completion of the ECHO program and a semi structured interview at the end of the follow-up period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective pilot study designed to achieve the objectives listed above. This project focuses on implementing ACP (which is an accepted best practice) and using ECHO (which is an evidence-based existing professional development model in healthcare). The research component involves data collection from clinicians and clinics in addition to what would be normally collected for as part of the training program and for quality improvement (QI).
| Arm | Type | Receives |
|---|---|---|
| Pilot participants | Other | Other: ADVANCE-PC training via ECHOParticipants will participate in ADVANCE-PC training via ECHO and will receive practice facilitation support, if needed. To assess the feasibility of the ADVANCE-PC training and implementation support, research data will be collected from participating clinicians at three time points. Two data collection points will be pre and post ECHO program training questionnaires about attitudes, experience, and intentions related to ACP and dementia. The third will be an interview at the end of the follow-up period, focusing on barriers to and facilitators of ACP in the context of dementia and the impact of the training and implementation support. Feasibility and acceptability of this intervention will be evaluated using descriptive and qualitative analyses of these data. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Clinic Level
- The program will be offered to six primary care clinics. Each must meet the following criteria:
- Be a member in a practice-based research network (PBRN) within the Meta-network Learning and Research Center (Meta-LARC),
- Have a functional EHR,
- Have leadership that agrees to clinic participation, and
Key exclusion criteria (6 listed)
- Anyone meeting one or more of the exclusion criteria listed here will be excluded. We will exclude:
- Children and adolescents, as the target population is primary care clinicians, patient care team members, and primary care clinic staff;
- Clinicians who do not provide primary care;
- Primary care clinicians who do not care for patients with dementia; and
- Primary care clinics that do not have sufficient clinicians (6 clinicians or team members) or sufficient patients (at least 8 patients each) with dementia to meet the pilot test targets.
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 |
|---|---|---|
| ADVANCE-PC training via ECHOTo assess the feasibility of using a technology-based platform to deliver the ADVANCE-PC program to multiple primary care clinics. This model will be based on the ECHO program, a tele-mentoring program which uses communications technology to provide facilitated education, case review, and peer-to-peer problem solving remotely. Our working hypothesis is that the use of ECHO will be efficient (allowing several clinicians and teams to be supported simultaneously while creating a community of practice), feasible (that clinicians will enroll and share experiences via mentoring, guidance, feedback, and didactic education), and have the potential to impact patients as clinicians perceptions shift to favor ACP, their skills increase, and they are able to integrate ACP for patients with dementia into their clinic. | Other | Pilot participants |
Primary outcome
Percentage of enrolled participants who attend 80% of ECHO program sessions
Time frame: 5 months after start of program
number of participants who attended 80% of sessions/number of enrolled participants
Proportion of patients with dementia and/or their care partners seen by participating clinicians who are engaged in ACP.
Time frame: 8 months after start of program
Primary care clinics will identify: patients with dementia and/or their care partners who have visits with participating clinicians during the study period (denominator) and track the number of these people who are engaged in advance planning during the project period (numerator)
2 secondary outcomes
Participating clinician satisfaction rating: questionnaire designed for this study
Time frame: 8 months from start of ECHO program
Percentage of enrolled participants who plan to continue to engage patients with dementia in ACP
Time frame: 8 months after start of program
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 18 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Annette M Totten, PhD principal investigator
Oregon Health and Science 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 ADVANCE-PC training via ECHO in people with Dementia and Advance Care Planning, 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 12 inclusion and 6 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 18 Nov 2022. 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?
Percentage of enrolled participants who attend 80% of ECHO program sessions (time frame: 5 months after start of program). 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 18 Nov 2022.