Comparing Primary Care Clinician-Focused Versus Team-Based Implementation of Advance Care Planning: Protocol for a Cluster-Randomized Control Trial, United States and Canada, 2019-2022 (ICPSR 39033)

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Data Collection Notes View help for Data Collection Notes

Study Purpose View help for Study Purpose

The study aimed to:

1. Assess the comparative effectiveness in primary care of team-based implementation of Serious Illness Care Program (SICP) versus primary care clinician-focused implementation of SICP on concordance of care with patient goals and time spent at home (primary outcomes) and secondary outcomes (e.g., anxiety, depression, quality of life).
2. Explore contextual factors influencing the implementation of the two different models of SICP and how these vary across the primary care practices, with a focus on the comparison of practices in the United States and Canada and on practice-level characteristics (e.g., size, rural/urban, affiliation with an integrated health system, prior advance care planning activities, primary care practice staff disciplines and training).

Study Design View help for Study Design

This cluster randomized trial study compared team-based to clinician-focused advance care planning (ACP) using the Serious Illness Care Program (SICP) in 42 practices recruited from 7 practice-based research networks (PBRNs) in the United States and Canada. Practices were randomized to one of the two models and received a short initial training followed by practice facilitation that were specific to the assigned model. The initial training was designed based on SICP materials, with new videos and scenarios developed for the team-based model.

Clinicians and team members were surveyed after training and at one and two years later. Data about the participating practices (e.g., size, ownership, electronic health record (EHR), clinic care team composition, patient demographics) were collected at recruitment. Information about any disruptions at the practices likely to impact implementation (e.g., change in leadership, ownership, or EHR) were collected during quarterly visits.

Sample View help for Sample

Primary Care Practices: Primary care practices were approached by academic practice-based research networks (PBRNs) within the Meta-network Learning And Research Consortium. Practices were approached that represented diversity in location, ownership, and size. Eligible practices had the capacity to provide team-based care, were not solo practitioners, and who provided care for patients with serious illnesses. Leadership from interested practices completed application materials. Practices were then randomized.

Team Members and Clinicians: Clinic leadership identified clinicians and team members per randomization arm who provide care for patients with serious illnesses within the practice, and introduced the study. Those who were interested completed training and surveys, and conducted advance care planning with patients.

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Universe View help for Universe

Community-dwelling adults having serious illness receiving care at a participating clinic where clinicians alone or clinicians and clinical care teams have been trained in the Serious Illness Care Program (SICP).

Unit(s) of Observation View help for Unit(s) of Observation

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Mode of Data Collection View help for Mode of Data Collection

Response Rates View help for Response Rates

Primary Care Practices: The target recruitment was 42 randomized practices to retain 34. A total of 45 practices were randomized (23 team, 22 clinician). Of these, 40 (21 team, 19 clinician) completed training and referred patients to the study, and 38 practices continued through project completion.

Team Members and Clinicians:

• Training and time 0: Serious Illness Care Program (SICP) training was attended by 535 people. In the clinician arm, 209 primary care clinicians were trained (133 physicians, 40 advance practice providers, and 28 medical residents). In the team-based arm, 326 individuals were trained (120 physicians, 36 advance practice providers, 9 medical residents, 84 nurses, 46 medical assistants, 8 social workers and behavioral health specialists, 7 clinic managers and staff and 2 pharmacists).
• Year 1: In the clinician arm, 96 respondents completed the year 1 survey. In the team arm, 135 participants completed the year 1 survey.
• Year 2: In the clinician arm, 86 respondents completed the year 2 survey. In the team arm, 129 participants completed the year 2 survey.

Presence of Common Scales View help for Presence of Common Scales

Primary Care Practices: The research team created and administered a baseline survey to collect data on practice characteristics, patient panel demographics, current advance care planning (ACP) practice, and current electronic health record (EHR). Additionally, a Team Climate Inventory (TCI) was collected by team members involved in care to patients with serious illness. The TCI recorded team members' agreement on domains including "Participation in the Team," "Support for New Ideas," "Team Objectives," and "Task Orientation." Disruptions were recorded as Yes/No (e.g., changes in leadership, EHR) and a green/yellow/red assignment was made by the practice facilitator.

Team Members and Clinicians: Team members and clinicians completed training in the Serious Illness Care Program (SICP) and provided evaluation responses to SICP implementation questions on a 4-point Likert scale from Strongly Disagree to Strongly Agree, as well as intention responses on a scale of 1-10. Behavior and intention were measured using Continuing Professional Development-Reaction survey using a 1-7 scale for Strongly Disagree to Strongly Agree.

Original Release Date View help for Original Release Date

2025-01-07

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