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Clinical Trials/NCT05322317
NCT05322317
Completed
Not Applicable

Testing Critical Components for a Trial of Advance Care Planning in Primary Care for Dementia

Oregon Health and Science University1 site in 1 country17 target enrollmentApril 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Oregon Health and Science University
Enrollment
17
Locations
1
Primary Endpoint
Proportion of patients with dementia and/or their care partners seen by participating clinicians who are engaged in ACP.
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 21, 2022
End Date
November 9, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Annette Totten

Associate Professor and Core Investigator of Medical Informatics and Clinical Epidemiology, School of Medicine

Oregon Health and Science University

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

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.

Outcomes

Primary Outcomes

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)

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

Secondary Outcomes

  • Participating clinician satisfaction rating: questionnaire designed for this study(8 months from start of ECHO program)
  • Percentage of enrolled participants who plan to continue to engage patients with dementia in ACP(8 months after start of program)

Study Sites (1)

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