Relational Playbook Pilot Study

NCT06456021 | Completed

• 1 other identifier: PPO 23-029
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The Veterans Health Administration (VA) is prioritizing employee well-being due to crisis levels of clinician burnout and turnover. The VA aims to achieve this by becoming a "Best Place to Work" while delivering high quality, safe and equitable care to Veterans using learning health system (LHS) and high reliability organization (HRO) principles. The National Academy of Medicine (NAM) has proposed organizations create supportive learning environments to improve workforce well-being. However, there is no one-size-fits all solution. While the VA has invested in system level well-being efforts, including the Reduce Employee Burnout and Optimize Organizational Thriving (REBOOT) initiative, there is little guidance for teams on how to create supportive learning environments. To fill this gap, we developed The Relational Playbook. The Playbook consists of research-based resources and 50 evidence-based interventions for nurse managers to implement to change their team cultures including how to create joy in work and address difficult relationships. To support managers implementing the Playbook, the investigators propose leadership coaching as a novel implementation strategy. Significance: The significance of this project is the potential to provide frontline managers with resources and research-based tools to create supportive learning environments that enhance employee well-being. Additionally, the study will contribute to the fields of implementation, LHS and HRO science and the VA efforts to enhance employee well-being and reduce burnout and turnover. Innovation and Impact: The proposed research is innovative in that it attempts to shift the current model for the creation of supportive learning environments from an organization-level focus to the team level - where Veterans receive care. The investigators will partner with VA cardiac catheterization laboratories (CCLs) as a model LHS for this work. The investigators aim to implement and establish the feasibility and acceptability of the Relational Playbook intervention combined with leadership coaching. The hypothesis is that enhanced leadership coaching will be a more feasible and acceptable approach to support Playbook implementation and the cultivation of supportive learning environments than standard implementation support. Specific Aims: Aim 1: Test the implementation, feasibility and acceptability of the Playbook intervention, coaching strategy, and study procedures. The VA Collaborative Evaluation Center (VACE), an independent group of mixed methods experts, will collect the feasibility and acceptability measures developed by Weiner et al. and select Reach, Effectiveness, Adoption, Implementation and Maintenance (REAIM) measures. Aim 2: Conduct a mixed methods process evaluation of intervention implementation. VACE will collect interview data to understand 1) intervention adaptations, ease of use, engagement, usefulness, and 2) implementation speed, costs, barriers, facilitators, and unintended consequences. Methodology: The investigators propose a pilot, site randomized trial design with an embedded mixed methods process evaluation. The investigators have enrolled 6 CCLs and will collect staff and unit level data using surveys and interviews at baseline, 6 and 12 months. All 6 sites will implement the Playbook. CCLs will be randomized to enhanced leadership coaching implementation support (n=3) or standard implementation support (n=3). The enhanced implementation group will receive 6 months of virtual leadership coaching support. The standard implementation group will receive logistical support, but no advisement or coaching. Next steps: The study findings will 1) establish the feasibility and acceptability of the Playbook intervention combined with a leadership coaching implementation strategy, and 2) inform the design of a pragmatic adaptive effectiveness trial. This trial will test the impact of the Playbook and coaching on employee well-being and factors that contribute to employee burnout, which is a new VA research priority area. This project is relevant to all aspects of VA healthcare for it will test the feasibility and acceptability of a novel Relational Playbook combined with a leadership coaching implementation strategy for frontline managers to cultivate supportive learning environments. This work will inform national efforts to enhance employee wellbeing due to crisis levels of employee burnout and turnover. The investigators will pilot the Playbook with 1:1 virtual leadership coaching to inspire nurse managers to improve their team culture. The investigators will conduct a mixed methods process evaluation to inform a pragmatic adaptive effectiveness trial. The investigators expect this study to demonstrate the Playbook combined with coaching is a feasible and acceptable approach to create supportive learning environments that improve employee well-being and address factors contributing to employee burnout and turnover.

Conditions

Health Workforce; Burnout

Keywords

coaching; supportive learning environments

Outcome Measures

Primary Outcomes (2)

• Feasibility as assessed by interviews and survey trends

  At baseline, CCL managers will take the 64-item Learning Environment Survey (\>4-7 Likert) and 12-item Readiness to Change survey (\>4-5 Likert scale). At 6 months after Playbook implementation, CCL managers will be interviewed to understand progress on improvement goals. CCL managers will retake the 64-item Learning Environment Survey and a take the 15-item Acceptability, Appropriateness, Feasibility of Intervention Measures Survey (1-5 likert) to identify trends and changes over time. Feasibility is measured by survey trends in the Learning Environment survey, interview data, and responses to the Feasibility of Intervention Measures.

  6 months

• Acceptability as assessed by interviews and survey trends

  At baseline, CCL managers will take the 64-item Learning Environment Survey (\>4-7 Likert) and 12-item Readiness to Change survey (\>4-5 Likert scale). At 6 months after Playbook implementation, CCL managers will be interviewed to understand progress on improvement goals. CCL managers will retake the 64-item Learning Environment Survey and a take the 15-item Acceptability, Appropriateness, Feasibility of Intervention Measures Survey (1-5 likert) to identify trends and changes over time. Acceptability is measured by survey trends in the Learning Environment survey, interview data, and responses to the Acceptability Measures.

  6 months

Secondary Outcomes (9)

• Adoption/demand as assessed by number of interventions implemented and coaching attendance

  Monthly for the 6 months of Playbook implementation

• Fidelity as assessed by reported adaptations

  Monthly for the 6 months of Playbook implementation

• Ease of Use as assessed by ease of use rating

  6-9 months after Playbook implementation

• Engagement as assessed by interview reactions

  6-9 months after Playbook implementation

• Usefulness as assessed by usefulness ratings

  6-9 months after Playbook implementation

Study Arms (2)

Enhanced

EXPERIMENTAL

CCLs will be randomized to enhanced leadership coaching implementation support (n=3) or standard implementation support (n=3). All groups will implement the Playbook. The enhanced group will receive 6 months of leadership coaching support. The standard implementation group will receive logistical support, but no alternative to coaching, such as advisement.

Behavioral: The Relational Playbook; Behavioral: Leadership Coaching

Standard

ACTIVE COMPARATOR

The standard implementation group will receive logistical support, but no alternative to coaching, such as advisement.

Behavioral: The Relational Playbook

Interventions

The Relational Playbook BEHAVIORAL

The Relational Playbook consists of 5 chapters and hosts research-based resources and 50 evidence-based interventions presented in short, digestible content to create supportive learning environments. Implementation is guided by 4-steps: Step 1) Assess the current state: CCL managers assesses the current state of their learning environment through a 13-item Learning Environment Assessment Tool. Results are automatically scored and grouped by Playbook chapters. A summary report is immediately available with guidance on how to interpret results. Step 2) Select areas for improvement: CCL managers determine which Playbook chapters and interventions to adopt. Step 3) Implement/adapt interventions: Over the 6-month intervention period, CCL managers are required to implement interventions from 2-3 Playbook chapters. They may adapt the delivery method/implement additional interventions. Step 4) Evaluate the impact: CCL managers develop feedback loops to monitor intervention performance.

Enhanced; Standard

Leadership Coaching BEHAVIORAL

Leadership coaching is a novel implementation strategy that enables proactive, knowledgeable, and supportive leadership behaviors. Although coaching has been embraced in the VA, through Whole Health and the VA Leadership Coaching Program, no studies have examined the impact on innovation implementation with clinical managers.

Enhanced

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The primary human subjects are members of VA CCLs from 6 sites (6-50 members per site), generally consisting of CCL nurses, technicians, nurse practitioners, physician assistants, residents, fellows, and physicians. CCL nurse managers may also oversee affiliated departments that they may request to include in this study.
• Potential departments include interventional radiology, electrophysiology, and echocardiography.
• The investigators refer to these individuals and departments as the cath team.
• All members of the cath team from each site will be included.
• Female VA employee subjects may be pregnant during this study, but their involvement in this research will not impact a pregnancy.

You may not qualify if:

• Protected classes such as prisoners and institutionalized individuals are excluded.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Heather Marie Gilmartin, PhD NP BSN

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 6 sites will be stratified into 3 tiers (high, medium, low) based on 2022 percutaneous coronary intervention volume. Within each tier, one site will be randomized to the enhanced implementation group and the other to the standard implementation group. This will ensure equal allocation between groups with different site characteristics. An allocation table will be generated in R statistical software and uploaded to a password-protected folder. CCL managers' responsibility will be to implement the Playbook interventions, participate in coaching (Enhanced Group), and participate in data collection. Once randomization is complete, the Enhanced and Standard groups will be invited to participate in a site-specific study launch meeting. Both groups will be sent a link to the Playbook SharePoint site. The Enhanced Group will schedule their initial coaching session. Over the subsequent 6 months, both groups will receive nudges to continue Playbook implementation through a Qualtrics survey.

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 13, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)