跳至主要内容
临床试验/NCT06456021
NCT06456021已完成不适用

A Pilot Feasibility and Acceptability Study of a Relational Playbook and Coaching Intervention for Cardiology Teams to Enhance Employee Well-being and Veteran Care

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Feasibility as assessed by interviews and survey trends

研究概览

简要总结

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.

详细描述

Purpose: To implement and evaluate the Relational Playbook, an innovative workforce development intervention developed in Dr. Gilmartin's VA Career Development Award using a pilot, site randomized trial design with a mixed method process evaluation.

Aim 1: Test the implementation, feasibility and acceptability of the Relational Playbook intervention, coaching strategy, and study procedures in 6 VA Cardiac Catheterization Labs (CCL) and follow-them for 1 year. 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 group will receive 6 months of virtual leadership coaching support with Dr. Gilmartin, an associate leadership coach with the VA National Center for Organization Development. The feasibility and acceptability of the Playbook intervention and coaching strategy will be assessed by the VA Collaborative Evaluation Center (VACE) using measures developed by Weiner et al. and select Reach, Effectiveness, Adoption, Implementation and Maintenance (REAIM) measures.

Aim 2: VACE will conduct a mixed methods process evaluation of intervention implementation to understand 1) intervention adaptations, ease of use, engagement, usefulness, and 2) implementation speed, costs, barriers, facilitators, and unintended consequences, guided by Realist Evaluation. The hypothesis is that leadership coaching will optimize Playbook implementation compared to standard implementation support.

Background and Significance The Veterans Health Administration (VA) is prioritizing employee well-being due to crisis levels of clinician burnout and turnover. The National Academy of Medicine has proposed the creation of supportive work environments to enhance employee well-being. The study team conducted a longitudinal, sequential, mixed methods study that identified supportive learning environments in VA cardiac catheterization laboratories (CCLs). The team identified positive relationships between more supportive learning environments and increased job satisfaction, lower burnout, lower intent to leave, lower CCL turnover in the previous 12 months and increased perceived safety climate. Interviews and literature reviews were conducted to understand the survey findings. These data informed the creation of The Relational Playbook which includes research-based resources and 50 evidence-based practices that have been distilled into short, easily digestible content suitable for busy healthcare teams. The Playbook has been piloted in a single CCL but has not been rigorously implemented and evaluated in diverse clinical settings.

The purpose of the proposed study is to implement and evaluate The Relational Playbook in six CCLs and test leadership coaching as a novel implementation strategy. The hypothesis is that leadership coaching will optimize Playbook implementation. 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. All 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 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. Six sites are anticipated as sufficient to generate data to inform a future trial. The advantage of comparing leadership coaching to standard implementation support (e.g., no coaching), is the ability to rigorously evaluate an enhanced approach compared to "usual care" in a real-world setting. There are no data available that does not support the study hypothesis. There are no similar studies currently under way or completed, indicating the proposed study is unnecessary.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •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.
  • •Both Veteran and non-Veteran employee subjects will be invited to participate provided they meet the inclusion criteria of being a VA employee and member of a cath team.

排除标准

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

研究组 & 干预措施

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.

干预措施: The Relational Playbook (Behavioral)

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.

干预措施: Leadership Coaching (Behavioral)

Standard

Active Comparator

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

干预措施: The Relational Playbook (Behavioral)

结局指标

主要结局

Feasibility as assessed by interviews and survey trends

时间窗: 6 months

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.

Acceptability as assessed by interviews and survey trends

时间窗: 6 months

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.

次要结局

  • Ease of Use as assessed by ease of use rating(6-9 months after Playbook implementation)
  • Speed as assessed by number of days(Monthly for the 6 months of Playbook implementation)
  • Adoption/demand as assessed by number of interventions implemented and coaching attendance(Monthly for the 6 months of Playbook implementation)
  • Usefulness as assessed by usefulness ratings(6-9 months after Playbook implementation)
  • Fidelity as assessed by reported adaptations(Monthly for the 6 months of Playbook implementation)
  • Engagement as assessed by interview reactions(6-9 months after Playbook implementation)
  • Cost as assessed by mean time/wage(6-9 months after Playbook implementation)
  • Unintended Consequences as assessed by counting events/concerns/complaints(Through study completion, an average of 1.5 years)
  • Maintenance as assessed by the number of interventions sustained(1 year after Playbook implementation)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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