NCT05322317

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

April 21, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2022

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

March 10, 2022

Last Update Submit

November 16, 2022

Conditions

Keywords

dementiaadvance care planningprimary careECHO

Outcome Measures

Primary Outcomes (2)

  • Percentage of enrolled participants who attend 80% of ECHO program sessions

    number of participants who attended 80% of sessions/number of enrolled participants

    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)

    8 months after start of program

Secondary Outcomes (2)

  • 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 Arms (1)

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.

Other: ADVANCE-PC training via ECHO

Interventions

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.

Pilot participants

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Annette M Totten, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Core Investigator of Medical Informatics and Clinical Epidemiology, School of Medicine

Study Record Dates

First Submitted

March 10, 2022

First Posted

April 11, 2022

Study Start

April 21, 2022

Primary Completion

November 3, 2022

Study Completion

November 9, 2022

Last Updated

November 18, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations