Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06456021 |
| Other study ID # |
PPO 23-029 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
VA Office of Research and Development |
| Contact |
Heather M Gilmartin, PhD NP BSN |
| Phone |
(303) 399-8020 |
| Email |
heather.gilmartin[@]va.gov |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
Preliminary Studies
The study team conducted a longitudinal, sequential, mixed methods study to identify
supportive learning environments in VA cardiac catheterization laboratories (CCLs). In 2018,
294 CCL physicians, nurses, and technicians from 68 VA CCLs were surveyed to examine
supportive learning environment factors. Respondents identified the presence of training
programs, openness to new ideas, and respectful interaction as strengths. The lack of
structured knowledge transfer (e.g., huddles, crisis communication) and low use of forums for
improvement were areas for improvement. The team also conducted unit-level analysis of 28
CCLs. One ranked as a supportive learning environment, 24 as mixed, and four as low learning
environments.
In 2020, the study team repeated the survey with 231 clinicians from 67 CCLs and 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. Based on preliminary work, the team
interviewed 13 CCL leaders and staff from 1 supportive, 4 mixed and 1 low ranked CCL to
understand how and why these learning environments were created. Five themes emerged. A
review of the literature revealed the scientific rationale for these themes, which are
conceptually grounded in the fields of positive psychology, team science, servant leadership
and the VA Whole Health and Clinical Team Training Models. 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. Six CCL and LHS-HRO experts reviewed the Playbook. The experts found the
interventions to be valid, acceptable (4.37/5; 1-5 ascending Likert scale), appropriate
(4.28/5) and feasible for implementation (3.94/5).
Research Methods
Study Design and Research Methods: This study is a pilot, site randomized trial of VA CCLs
with an embedded mixed methods process evaluation. Dr. Gilmartin and the implementation team
will oversee the launch of the Playbook intervention, then Dr. Gilmartin will deliver the 1:1
leadership coaching implementation strategy over 6 months. Dr. Leonard and the VA
Collaborative Center of Evaluation (VACE), an expert group of evaluators independent from Dr.
Gilmartin, will collect study measures from CCL managers, physicians and staff that will be
aggregated to the CCL level. Study measures will be collected at baseline, 6 and 12 months.
The primary aim is to implement and establish the feasibility and acceptability of the
Playbook intervention combined with a leadership coaching implementation strategy. The study
team will collect baseline and 6-month data from the Learning Environment Survey with
employee well-being items to determine power for an effectiveness trial. The secondary
objectives are to 1) evaluate adaptations and identify how and why the intervention was or
was not feasible and acceptable; 2) if CCL nurse managers integrate the Playbook
interventions into daily activities, making it part of the culture; and 3) to gain insight
into considerations and methods for a future trial. The central hypothesis is that leadership
coaching will be a more feasible and acceptable approach to support Playbook implementation
and the cultivation of supportive learning environments than implementation without coaching.
The inclusion of a mixed methods process evaluation to evaluate Playbook implementation, but
in which data will not be used during the conduct of the study to influence the process,
presents a novel contribution to the LHS-HRO literature. The process evaluation is a
methodological approach that will provide insight into how LHS-HRO interventions function
more generally, beyond their application in CCLs. VA CART, the Office of Cardiology, Office
of Nursing Services and REBOOT leaders will act as advisors, increasing the likelihood the
study results will impact VA policy and operations.
Interventions Relational Playbook. The Playbook consists of 5 chapters and hosts
research-based resources and 50 evidence-based interventions that are presented in short,
easily digestible content to create supportive learning environments. Playbook implementation
is guided by a 4-step process.
- Step 1: Assess the current state (10 minutes). The CCL manager and team assesses the
current state of their learning environment through completion of an on-line, 13-item
Learning Environment Assessment Tool. The results are automatically scored and grouped
by Playbook chapters. A summary report is immediately available and includes guidance on
how to interpret results.
- Step 2: Select areas for improvement (1 meeting). CCL manager works with team to
identify areas of strength, where their work is at its best and should be maintained or
spread. The CCL manager then will discuss opportunities for improvement and which
Playbook chapters and interventions they will adopt.
- Step 3: Implement and adapt interventions (standing item in meetings/huddles). CCL
manager works with their team to develop implementation and adaptation PDSA cycles for
the interventions. Over the 6-month intervention period, CCL managers are required to
implement interventions from 2-3 Playbook chapters, depending on the team Tool results.
Fidelity to the interventions is required and will be monitored by VACE to ensure the
critical aspects of each practice are delivered. However, a CCL team may adapt the
delivery method of the interventions and may implement additional interventions during
the intervention period.
- Step 4: Evaluate the impact (standing item in meetings/huddles). CCL manager and team
develop feedback loops to monitor the performance of the interventions. CCL managers
reflect on what they are learning, gauge impact while acknowledging any conflict or
tension, detect emerging problems, identify, and implement solutions, and adjust the
implementation process accordingly.
Leadership Coaching. The coaching implementation strategy will provide enhanced
implementation support to the three CCL nurse managers randomized to this group. The coaching
mindset for this study is that CCL manager's success is due to their own efforts (i.e.,
self-belief). The coaching approach is being curious, asking powerful questions and actively
listening. Leadership coaching was selected due to CCL manager input, prior success in the
literature, and perceived feasibility. Dr. Gilmartin will schedule and conduct the 1:1
60-minute coaching sessions every 4 weeks for 6 months on Microsoft Teams. The coaching
process is standardized and Dr. Gilmartin will follow the VA National Center for Organization
Development (NCOD) Coaching Curriculum, which uses the GROW Framework (Grow, Reality,
Options, Will). Dr. Gilmartin will follow the NCOD-GROW framework for every coaching session
and document specific details of the coaching conversation for each session in the NCOD
Coaching Portal. The documentation will be used by the VACE team to monitor fidelity using
the NCOD Coaching Curriculum Fidelity Assessment Guide. The documentation will also
facilitate replication of the method in subsequent studies. The literature indicates spacing
the sessions over 6 months and following the NCOD GROW manualized curriculum will allow new
leadership and team habits to form and fidelity assessment. 1:1 coaching was selected over
group coaching to cultivate a psychologically safe atmosphere with the manager. Any
adaptations to the coaching schedule or approach will be tracked as part of the coaching
records in the NCOD coaching portal to allow for comparison across sites.
This study is a pilot, site randomized trial with an embedded mixed methods process
evaluation. The team is piloting a randomized trial with embedded evaluation, compared to the
one-group, pre-post study design commonly used in feasibility studies, to determine if
randomization and the process evaluation is feasible in this context. The study team has
enrolled 6 CCLs and will collect staff level data (range: 8-40 per CCL) and follow-them for 1
year. 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.
Study Protocol The 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. All set-up, implementation, and evaluation activities will be
scheduled by the research team, at the convenience of participants, to reduce the burden on
nurse managers. The nurse managers' responsibility will be to implement the Playbook
interventions, participate in coaching (if in the Enhanced Group), and participate in data
collection. Once randomization is complete, the Enhanced and Standard groups will be invited
to watch at their convenience, brief introductory videos and participate in a site-specific
1-hour study launch meeting to learn about the Playbook intervention and data collection
expectations. VACE will collect baseline data, then both groups will be sent a link to the
Playbook SharePoint site which includes the 13-item Assessment Tool. CCL teams will complete
the Tool as step one of the four-step process outlined above. The Enhanced Group will
schedule their initial coaching session. Over the subsequent 6 months, both groups will
receive educational nudges to continue Playbook implementation through an automated monthly
Qualtrics survey. The survey is part of the Playbook and is designed to collect adoption and
fidelity data measures. Aim 1 (intervention phase) will end at 6 months and Aim 2 (evaluation
phase) will end at 1 year. Implementation of the interventions and data collection will be
deemed part of an employee's tour of duty. However, CCL physicians and staff can elect not to
participate in the Playbook interventions at any time. Participating CCLs will be responsible
for employee salaries. Dr. Gilmartin and team, plus VACE materials and salaries will be
covered by pilot IIR and Dr. Gilmartin's current research funds.
Methods
Research Aim 1 Data Collection: This study uses a mixed methods approach to evaluate the
feasibility and acceptability of the intervention and study procedures. The VACE team will
collect data from several sources, guided by the Reach, Effectiveness, Adoption,
Implementation and Maintenance (REAIM) framework. At baseline and 6 months (pre-post
intervention), trends in learning environment and employee well-being (i.e., job
satisfaction, burnout, turnover, and safety climate scores) will be collected from managers,
physicians, and staff (range: 8-40 per CCL) through the validated 64-item Learning
Environment Survey. At baseline, readiness for change will be collected from the nurse
manager through a brief, theory-based measure of organizational readiness to change. At 6
months, feasibility and acceptability will be assessed by nurse managers using the measures
developed by Weiner et al. At 6 months, managers will be interviewed regarding their progress
on quality improvement goals and manager growth and development. Additional measures will
include adoption and fidelity, time spent, and adaptations collected from managers using the
monthly Qualtrics survey (3-5 pre-populated items and open text option). Coaching notes will
be analyzed for the frequency of and attendance at coaching sessions, plus fidelity to the
NCOD GROW Model. Maintenance data will be collected from the manager at 1 year through a
one-time Qualtrics survey asking for the number of Playbook interventions still in use.
Research Aim 2 Data collection: For the interviews of CCL managers, physicians, and staff is
guided by the principles of Realist Evaluation, which seeks to understand what works, for
whom, and under what circumstances. The interview guide includes questions that query the
experience of learning about and participating in the intervention, coaching, changes to CCL
team workflow required to implement the Playbook, organizational barriers, or facilitators to
effective implementation. Participants will also be asked about the ease of use, engagement,
usefulness, adaptations, speed, and cost of implementation, any unintended consequences, and
maintenance. To capture multiple perspectives, VACE will interview the CCL manager, and a
sample of CCL staff and VAMC leaders who interact with CCL managers (e.g., Chief Nurse, Chief
of Cardiology, perioperative leaders - up to 4 per site). The interview guides will be pilot
tested to ensure clarity and relevance to the study questions. Interviews will last between
20-30 minutes. Interviews will be recorded and transcribed verbatim. Data will be analyzed
using rapid content analysis to identify themes related to contextual influences and
practices related to implementation and evaluation of the intervention.
Anticipated Risk & Potential Benefits This research study is funded by a VA research grant.
However, it is also part of CCL quality improvement efforts and takes place in the context of
clinical operations. As a result, if individuals choose to participate, their identity and
participation will be known by CCL leadership and co-workers. As the Playbook interventions
are team-focused, participants will be able to identify each other. Breach of confidentiality
is a risk for CCL managers and staff who will be identified by name during study launch and
data collection. There is a risk of disclosure of information about workplace relationships
and learning environment that could be perceived as sensitive, such as colleagues' attitudes
about new CCL procedures, or perceptions of CCL leader engagement or support.
Additionally, due to the project's association with VA operations, the following people or
groups may know the VA employees participating in the study:
I.The CCL manager, director and/or Chief of Nursing or Cardiology or other supervisors and
co-workers at participating facilities II.The research and evaluation team members III.VA (to
monitor studies) IV.The VA committees that oversee research, including the Institutional
Review Board that oversees the safety and ethics of VA studies.
Protection Against Risk While the study team will make every effort to keep information
confidential, no system for protecting confidentiality can be completely secure in this
operational context. Individuals may choose to share with others the fact of their
participation or opinions about the Playbook and coaching and process evaluation. However,
the study team will not disclose participation in the study or responses to any questions to
anyone outside the research team. Interviews and coaching sessions will be conducted via
Teams at a time convenient to the participants, and the recording and interview notes will be
saved directly to an access-controlled data folder on a secured server at VA Eastern Colorado
Healthcare System. The study team will take stringent precautions to protect the
confidentiality of subjects' personal information.
Informed Consent Procedures This project has received a Waiver of Documentation of Informed
Consent and a Waiver of HIPAA Authorization for this subject population. Participating sites
(VA employee subjects) have been recruited based on study site selection. Study information
statements emphasize that the site may withdraw from the study at any time.
Reporting Although methods to enhance relationships, communication, teamwork, and high
reliability are available to CCLs and fall within existing standards of care, and although
this study is a feasibility and acceptability pilot and not a clinical trial, there is a need
to have a system in place for identifying and reporting adverse clinical events that occur
during the study period. This will be accomplished through the existing real-time adverse
event system built into CART. All procedures done in VA CCLs, are monitored in real-time
through CART for adverse events as part of routine clinical care. CART information is
available in real-time and as a result, patient safety events are continuously reported and
reviewed. All adverse events are reported to the CART clinical committee and local facility
representatives.
The study team has stringent data safety procedures in place to ensure subject protection. A
data safety monitoring plan, even for non-clinical research, is required as per VHA Handbook
1200.05. Additionally, the Denver/Seattle Center of Innovation has an established Data
Security Plan and framework the team will work under. Under these circumstances, this study
will not have a Data Monitoring Committee.
Data Analysis Plan:
Data Analysis will be conducted in R statistical software and Atlas.ti. The feasibility,
acceptability, adoption, and fidelity data for both groups will be summarized, described, and
compared. Analysis of trends in the learning environment and employee well-being over time
will be based on a repeated-measures analysis framework. The model for each end point will
include a common intercept for both groups, indicator variables by month and interactions
between these time variables and an indicator variable for the intervention group. The
interview data will be analyzed using qualitative content analysis to pull out major concepts
with attention to differences between the two groups. The quantitative data will be
triangulated with the qualitative data to assess for points of convergence and help explain
how and why changes occurred. Integration of the mixed methods data will be achieved by
reporting results together. The quantitative results will be reported first, followed by
qualitative quotes or themes that support or refute the quantitative results.
Knowledge to be Gained:
This study will contribute to the LHS and HRO literature and practice by implementing and
establishing the feasibility and acceptability of a Playbook intervention combined with a
leadership coaching implementation strategy to cultivate supportive learning environments. To
create supportive learning environments and integrate research-based practices into care,
frontline leaders must use evidence-based methods. This is especially important as clinical
teams are expected to continuously learn, adapt, and maintain high reliability (2023 VA HSR&D
cross-cutting principles and research priorities). The potential impact of the Playbook
intervention and coaching strategy includes the creation of supportive learning environments
that enhance employee well-being. However, the Playbook has not been implemented in a
clinical setting. The study team must establish the feasibility and acceptability of the
Playbook combined with the coaching implementation strategy prior to effectiveness testing.
This will inform future studies to assess the impacts of the Playbook intervention on the
health of VA employees and the Veterans they serve.
