Clinical trial NCT05322317: Advance Care Planning (ACP) in Primary Care for Dementia
Official title: Testing Critical Components for a Trial of Advance Care Planning in Primary Care for Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Advance Care Planning
Keywords: dementia
advance care planning
primary care
ECHO
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2022-04-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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.

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Percentage of enrolled participants who attend 80% of ECHO program sessions
timeFrame: 5 months after start of program
measure: Proportion of patients with dementia and/or their care partners seen by participating clinicians who are engaged in ACP.
timeFrame: 8 months after start of program
Secondary outcomes:
measure: Participating clinician satisfaction rating: questionnaire designed for this study
timeFrame: 8 months from start of ECHO program
measure: Percentage of enrolled participants who plan to continue to engage patients with dementia in ACP
timeFrame: 8 months after start of program
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Annette M Totten, PhD
role: PRINCIPAL_INVESTIGATOR
References: