Dynamic Diffusion Network (DDN) QUERI program: a quality improvement project to support VA medical centers implementing moral injury groups and to evaluate strategies that foster successful group implementation

ISRCTN ISRCTN17341656
DOI https://doi.org/10.1186/ISRCTN17341656
Secondary identifying numbers QUE 20 – 012
Submission date
08/12/2021
Registration date
17/12/2021
Last edited
15/11/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Healthcare systems face the challenge of delivering care of the highest possible quality while, at the same time, ensuring broad access to services and responsible use of resources. Without thoughtfully designed implementation strategies, the impact of evidence-based practices cannot be fully realized. This quality improvement evaluation seeks to implement and test two different implementation support strategies to better address the needs of Veterans suffering from moral injury and pain (e.g., guilt, shame, betrayal) as a result of actions taken or not taken during their service (aka, moral injury).

The Veterans Affairs (VA) Dynamic Diffusion Network (DDN) QUERI Program is designed to support quality improvement efforts and provide information to VA to continue to better understand different implementation support strategies, especially for spreading complex clinical evidence-based practices (EBPs) beyond successful earlier adopters across the VA healthcare system.

Who can participate?
Facilities in the United States Veterans Health Administration (VHA) who are seeking to implement moral injury groups co-led by healthcare chaplains and mental health providers as part of a quality improvement program.

What does the study involve?
Participating facilities that are offering, or will be offering, collaborative (mental health and healthcare chaplain co-led) moral injury groups are assigned to one of two implementation support strategies. One of the support strategies involves participating in a Dynamic Diffusion Network and the other support strategy consists of technical assistance. The Dynamic Diffusion Network was developed as a method for implementing and adapting complex clinical interventions. It is designed to enhance the evidence-based implementation of clinical EBPs that utilize existing structures within facilities. The DDN recognizes the need to: 1) have engaged facilities; 2) plan to link quality goals and EBP components to the workflow; 3) facilitate rapid cycle quality improvement and 4) plan for sustainment and further spread. The DDN QUERI Program will evaluate the DDN with selected VA facilities in comparison to providing information about moral injury groups and responding to facility questions about the process of conducting and implementing moral injury groups (i.e., technical assistance).

What are the possible benefits and risks of participating?
This non-research quality improvement project seeks to improve the quality of care provided to Veterans who are experiencing moral injury.

Where is the study run from?
The Durham Veterans Affairs Health Care System (USA)

When is the study starting and how long is it expected to run for?
October 2020 to April 2024

Who is funding the study?
United States Department of Veterans Affairs Quality Enhancement Research Initiative (USA)

Who is the main contact?
George L. Jackson, PhD MHA
George.Jackson3@va.gov

Study website

Contact information

Dr George Jackson
Scientific

Durham VA Medical Center (152)
Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)
508 Fulton Street
Durham
27705
United States of America

ORCiD logoORCID ID 0000-0002-1221-647X
Phone +1 (919) 286-6936
Email George.Jackson3@va.gov
Dr Jason Nieuwsma
Scientific

Durham VA Medical Center (152)
VA Mid-Atlantic MIRECC
VA Integrative Mental Health
508 Fulton Street
Durham
27705
United States of America

ORCiD logoORCID ID 0000-0003-0856-1913
Phone +1 (0)919 286 0411 ext. 134048
Email Jason.Nieuwsma@va.gov
Ms Brandolyn White
Public

Durham VA Medical Center (152)
Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)
508 Fulton Street
Durham
27705
United States of America

ORCiD logoORCID ID 0000-0002-2939-212X
Phone +1 (0)919 286 0411 ext 174062
Email Brandolyn.White@va.gov
Ms Summer Anderson
Public

Durham VA Medical Center (152)
Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)
508 Fulton Street
Durham
27705
United States of America

ORCiD logoORCID ID 0000-0002-6764-8456
Phone +1 (0)919 286 0411 ext 175691
Email Summer.Anderson@va.gov

Study information

Study designMulticenter hybrid type 3 randomized quality improvement evaluation
Primary study designOther
Secondary study design
Study setting(s)Other
Study typeOther
Scientific titleDynamic Diffusion Network (DDN) QUERI Program: a randomized quality improvement evaluation comparing a network-based implementation facilitation strategy to technical assistance for the implementation and evaluation of mental health and chaplain co-led group-based care for moral injury among veterans receiving care within the Veterans Health Administration (VHA)
Study acronymDDN QUERI – MI QI Evaluation
Study objectivesThe purpose of this project is to compare an implementation strategy, the Dynamic Diffusion Network (DDN), as a way for operationalizing the EPIS (exploration, preparation, implementation, sustainment) Framework to technical assistance among a group of later adopter sites implementing mental health-chaplain co-led groups for moral injury. The primary outcome of this quality improvement evaluation will focus on successful clinical intervention implementation as measured by the delivery of an appropriate intervention dose (fidelity). Secondary outcomes include the use of evidence-based principles of moral injury care (i.e. "core components") and rapid improvement processes. Secondary clinical outcomes, specifically the impact on depression, will focus on the clinical impact of the moral injury groups. The researchers will also conduct: 1) a mixed-methods evaluation of factors influencing outcomes at each EPIS stage based on the Consolidated Framework for Implementation Research (CFIR) and 2) a detailed examination of budget impact to examine the potential business case.
Ethics approval(s)Per regulations outlined in VHA Program Guide 1200.21, this evaluation has been designated a non-research quality improvement activity by the VHA Office of Healthcare Innovation and Learning via a memorandum dated 07/05/2021
Health condition(s) or problem(s) studiedMoral injury
InterventionParticipating VA facilities, primarily represented by mental health-chaplain dyads, will be randomized into one of two implementation support strategies (i.e. network-based structured implementation facilitation called, a Dynamic Diffusion Network, or technical assistance). Stratification will include categorization of the chaplain within each dyad as having completed Mental Health Integration for Chaplain Services (MHICS) intensive training or not having completed MHICS training. Both of these non-research quality improvement evaluation arms will be conducted based on the following phases: exploration (approximately 3 months), preparation (approximately 6 months), implementation (approximately 12 months), and sustainment (approximately 12 months).
Intervention typeOther
Primary outcome measureAppropriate dose/adherence to group attendance determined by the electronic health record indicating that a patient attended 80% or more of intended moral injury group sessions at the end of the study
Secondary outcome measures1. Number and type of core and adaptable components of moral injury groups as measured by descriptions of group session contents provided by facilities in a combination of quarterly reports, qualitative interviews conducted with team members approximately 1 year after the beginning of implementation, and examples/descriptions of group materials and processes provided by participating facilities over approximately 1.5 years as they go through the implementation strategy (e.g. preparation and implementation phases).
2. Number and goal of initiated of quality improvements efforts undertaken by participating facilities as measured by self-report from the facility on quarterly reports for one year.
3. Intervention/moral injury group clinical effectiveness as measured by depressive symptomatology measured using the Patient Health Questionnaire-9 prior to or during the first session of moral injury group therapy and during or following the final session of moral injury group therapy (pre/post).
4. Process evaluation utilizing survey (Organizational Readiness for Change) and qualitative data from semi-structured qualitative interviews conducted at the start and completion of the one-year implementation phases to capture components of the Consolidated Framework for Implementation Research (CFIR).
5. Cost of the implementation strategy and intervention will be measured based on self-reported participant activities captured using reports of both implementation and intervention activities conducted by specific individuals over the course of the Dynamic Diffusion Network or technical assistance.
Overall study start date01/10/2020
Completion date30/04/2024

Eligibility

Participant type(s)Other
Age groupAdult
SexBoth
Target number of participants10 healthcare facilities with implementation teams led by a healthcare chaplain and mental health provider
Total final enrolment8
Key inclusion criteriaHealthcare facilities in the Veterans Health Administration will be randomly assigned as part of this quality improvement evaluation. The work of these facilities will be directed by teams led by individuals who are:
1. VHA-employed healthcare chaplain or VHA employed mental health provider
2. Willing and able to co-lead mental health and chaplain co-led collaborative moral injury group(s) for Veterans in VHA setting
3. Willing and able to be randomly assigned to one of two implementation support conditions (technical assistance or network-based structured implementation facilitation)
4. Willing and able to obtain clinic-level leadership and facility-level leadership support and approval to participate
5. Invited by DDN QUERI staff to participate in this QI program
Key exclusion criteriaMust meet all inclusion criteria noted above, including being invited to participate in this QI program by DDN QUERI staff
Date of first enrolment12/01/2022
Date of final enrolment02/05/2022

Locations

Countries of recruitment

  • United States of America

Study participating centre

Durham VA Health Care System
508 Fulton St
Durham
27705
United States of America

Sponsor information

United States Department of Veterans Affairs
Government

HSR&D (14RDH)
810 Vermont Ave
Washington D.C.
20420
United States of America

Phone +1 (0)202 441 9782
Email vacoqueri@va.gov
Website https://www.queri.research.va.gov/
ROR logo "ROR" https://ror.org/05rsv9s98

Funders

Funder type

Government

Quality Enhancement Research Initiative
Government organisation / National government
Alternative name(s)
VA Quality Enhancement Research Initiative, QUERI
Location
United States of America

Results and Publications

Intention to publish date30/04/2025
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publications in high-impact peer-reviewed journals
IPD sharing planThe datasets generated during and/or analyzed during the current study are not expected to be made available due to the QI/operations nature of the project

Editorial Notes

15/11/2023: The following changes were made:
1. The scientific contact was updated.
2. The total final enrolment was changed from 9 to 8.
03/05/2022: The recruitment end date was changed from 01/02/2022 to 02/05/2022. Total final enrolment added.
14/01/2022: The recruitment start date was changed from 03/01/2022 to 12/01/2022. Contact details updated.
17/12/2021: Trial's existence confirmed by Department of Veterans Affairs