DOI: 10.3886/icpsr39033.v1
title: 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
title: Version 1

description: For people with serious chronic conditions, healthcare that defaults to all available treatments without considering patient preferences risks harms that may exceed benefits. Advance care planning (ACP) has the potential to align healthcare with what is important to patients and maximize quality of life. While primary care is where most people receive most of their care, engaging patients in ACP is not routine in primary care given competing demands and limited resources. Primary care clinicians, patients, and families agree that it is preferred to make plans before there is a medical crisis. The research team's goal was to make ACP routine in primary care and to "move it upstream" so that it included improving the quality of the last years of life as well as respecting wishes for end of life care.
This study included a comparative effectiveness trial of team-based versus individual clinician-focused ACP in primary care practices. The research team adapted Ariadne Labs' Serious Illness Care Program (SICP) and aimed to determine if a team approach produces better patient outcomes and explore factors influencing implementation of ACP across practices.
Seven practice-based research networks (PBRNs) in the United States and Canada randomized their primary care practices to team-based or individual clinician-focused versions of SICP. Team members and clinicians completed training, and implementation was supported through practice facilitation. Consented patient participants completed a baseline survey after initial conversations and follow-up surveys at 6 and 12 months later. Forty practices (21 team, 19 clinician) completed training and referred patients to the study. Half of the practices were rural, 80 percent were family medicine, and 33 percent were medical residency training sites. 535 healthcare staff completed training. Both arms trained primary care providers; the team arm also trained nurses, medical assistants, and other roles. 1,321 patients and care partners were referred; and 917 consented and were enrolled (455 from team practices, 462 from clinician). Data from 802 patients were included in the primary analyses. Qualitative implementation data was collected during practice facilitation and from practice interviews.
This collection includes quantitative data collected from primary care practices (DS1) and team members and clinicians (DS2) from study sites located in the United States.
description: The study aimed to:
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).
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).
description: 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.
description: Response Rates: <strong>Primary Care Practices:</strong> 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.
<strong>Team Members and Clinicians:</strong>
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.
description: Presence of Common Scales: <strong>Primary Care Practices:</strong> 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.
<strong>Team Members and Clinicians:</strong> 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.
description: <strong>Primary Care Practices:</strong> 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.
<strong>Team Members and Clinicians:</strong> 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.
description: Datasets: 
DS0: Study-Level Files
DS1: Primary Care Practice Data
DS2: Clinician and Team Member Data
description: 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).
description: mail questionnaire; on-site questionnaire; web-based surveyThe project involved data collection in the United States and Canada from four data sources: 1) patients, 2) care partners, 3) primary care practices, and 4) clinicians and team members. Publications and the project's final research report contains information related to all of these data sources. However, requirements related to human subjects oversight by ethics boards in the U.S. and Canada limit the data that the research team was able to make available. This collection includes only data from primary care practices and clinicians and team members, and only from those participants in the U.S. The patient and care partner survey instruments are available in the study's Data Collection Instruments documentation.This project included implementation support to the participating primary care practices, and the research team collected data from monthly and quarterly visits, as well as key informant interviews after study implementation. These qualitative data components are not included with this collection. Users should contact the research team for additional information.The Meta-network Learning And Research Center provides additional information on the study trial website.