Quality Improvement and Implementation Science for Mental and Physical Health in Women Veterans

(EMPOWER Trial)

Overseen By Alison B Hamilton, PhD MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve healthcare services for women Veterans by testing two strategies to implement effective practices at VA facilities. One strategy, REP, adapts proven methods like buprenorphine to local needs. The other, EBQI, provides more intensive support and training in quality improvement. The goal is to ensure women Veterans receive and are more likely to use the services they need. This trial does not recruit individual patients but collaborates with VA facilities that have leadership support to participate. As an unphased trial, it offers a unique opportunity to enhance healthcare services for women Veterans.

Will I have to stop taking my current medications?

The trial does not involve individual patients, so there is no requirement for participants to stop taking their current medications.

What prior data suggests that these implementation strategies are safe for women Veterans?

Research shows that both strategies being tested, EBQI and REP, have been used in past studies with women Veterans. EBQI involves training and support to enhance care quality. Studies have evaluated its effectiveness in health systems for women Veterans, and no specific safety concerns have emerged.

REP is a simpler method that adapts proven practices to local settings. Research on REP has focused on making health services more accessible and personalized. Previous studies have also not identified any specific safety issues with this approach.

Both strategies are not typical medical treatments but aim to improve healthcare delivery. Since they do not involve medication or direct medical procedures, they are generally well-tolerated and do not carry the same safety risks as new drugs or surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for implementing quality improvement strategies in mental and physical health care for women veterans because it explores innovative methods to enhance healthcare delivery. Unlike traditional treatments that focus solely on patient symptoms, the trial uses Evidence-Based Quality Improvement (EBQI) and Replicating Effective Practices (REP) to improve how care is provided. EBQI involves external facilitation and formal training, offering a high-intensity approach to ensure healthcare providers can continuously improve their services. REP, on the other hand, uses a structured framework to tailor practices locally, making it a flexible and adaptable strategy. These approaches aim to boost the overall quality of care and patient outcomes, offering a fresh perspective on healthcare improvement.

What evidence suggests that this trial's treatments could be effective for women Veterans?

This trial will compare two strategies: Evidence-Based Quality Improvement (EBQI) and Replicating Effective Practices (REP), to enhance healthcare for women Veterans. Research has shown that EBQI helps implement new care models to address gaps in primary care for women Veterans. This approach has improved the delivery of care sensitive to women's needs, leading to better quality and patient experiences. REP offers a clear method for adapting successful practices to local settings. Studies suggest that these methods can improve access to and the quality of healthcare services for women Veterans. Both strategies aim to reduce health disparities and enhance the overall well-being of women Veterans. ^{1 2 6 7 8}

Who Is on the Research Team?

Alison B Hamilton, PhD MPH

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Are You a Good Fit for This Trial?

This trial is for VA facilities that serve women veterans. It's not for individual patients. Facilities must have leadership support to participate and are prepared to implement evidence-based practices aimed at improving health outcomes in areas like diabetes, obesity, depression, and cardiovascular disease.

Inclusion Criteria

This study is recruiting VA sites - not individual patients. Prior to randomization, the study team will work with sites to ensure they have met the preconditions necessary to enroll in the study, which includes VISN, regional and/or facility level leadership support for participation.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Randomization of VA sites to REP or EBQI strategies to implement evidence-based practices for preventive services

12 months

Ongoing virtual and in-person meetings

Evaluation

Mixed methods implementation evaluation to compare effectiveness of REP and EBQI strategies

12 months

Follow-up

Participants are monitored for engagement and outcomes in virtual preventive services

6 months

What Are the Treatments Tested in This Trial?

Interventions

• DPP
• EBQI
• REP
• ROSE
• TLC

Trial Overview The EMPOWER QUERI 2.0 Program is testing two strategies (EBQI and REP) across up to 20 VA facilities to see which better supports the implementation of healthcare practices designed for women veterans' mental and physical health.

How Is the Trial Designed?

Group I: EBQI Experimental Treatment 1 Intervention

Evidence-Based Quality Improvement (EBQI) is a higher-intensity implementation strategy that entails external facilitation and formal training in quality improvement.

Group II: REP Active Control 1 Intervention

Replicating Effective Practices (REP) is a lower-intensity implementation strategy with explicit process framework for local tailoring

DPP is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Diabetes Prevention Program for:

• Prediabetes prevention
• Type 2 diabetes prevention

Approved in European Union as National Diabetes Prevention Program for:

• Prediabetes prevention
• Type 2 diabetes prevention

Approved in Canada as CDC Diabetes Prevention Program for:

• Prediabetes prevention
• Type 2 diabetes prevention

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The study reviewed 28 interventions related to the Diabetes Prevention Program (DPP) and found that various cultural adaptations did not significantly impact weight or BMI reduction outcomes, suggesting the DPP is robust to these modifications.

Programs that included a maintenance component showed significantly greater weight reduction over time, highlighting the importance of ongoing support in reducing the risk of developing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Program Modification Strategies of the Diabetes Prevention Program: A Systematic Review. Neamah, HH., Sebert Kuhlmann, AK., Tabak, RG.[2022]

A community-based faith-based diabetes prevention program (FDPP) significantly improved weight loss among African American women, with those attending at least 15 sessions losing an average of 6.1 pounds at 4 months and achieving a 5.8% reduction at 10 months.

Both the faith-based and standard diabetes prevention programs led to improvements in health behaviors and biometrics, but the FDPP met the CDC's weight loss recommendations for diabetes prevention, highlighting its effectiveness in this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better Me Within Randomized Trial: Faith-Based Diabetes Prevention Program for Weight Loss in African American Women. Kitzman, H., Mamun, A., Dodgen, L., et al.[2023]

A church-based Diabetes Prevention Program (DPP) effectively reduced fasting glucose levels from 108.1 to 101.7 mg/dL and led to weight loss in African American participants, with these benefits lasting for 12 months after the intervention.

The 6-session DPP was as effective as the 16-session version in lowering glucose and weight, while also being less expensive to implement, suggesting that shorter programs can be a viable option for community health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation of the National Institutes of Health Diabetes Prevention Program in African American churches. Boltri, JM., Davis-Smith, M., Okosun, IS., et al.[2022]

A pharmacist-led diabetes prevention service successfully integrated A1C screening into a wellness program for university employees, identifying 9.3% of participants as having prediabetes.

Despite the identification of at-risk individuals, participation in the National Diabetes Prevention Program (NDPP) was low, with only 12 out of 69 participants engaging, highlighting the need to address barriers to improve program effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description of a pharmacist-led diabetes prevention service within an employer-based wellness program. Gamston, CE., Kirby, AN., Hansen, RA., et al.[2022]

The National Diabetes Prevention Program (National DPP) is effective in preventing or delaying diabetes in at-risk patients, but its implementation in primary care settings faces significant challenges, including limited awareness and lack of standard referral processes among clinic personnel.

Using the Implementation Mapping framework, researchers identified barriers to the National DPP's adoption and developed tailored strategies, such as provider education and optimizing electronic health records, to enhance program implementation in four participating clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of implementation mapping to develop strategies for integrating the National Diabetes Prevention Program into primary care clinics. Perkison, WB., Rodriguez, SA., Velasco-Huerta, F., et al.[2023]

The Diabetes Prevention Program (DPP) has been adapted for ethnic minority communities in the U.S. to address the higher risk of type 2 diabetes, with only 6 studies specifically focusing on these translations identified in a review of 89 papers.

Successful translation strategies included group-based delivery and bilingual personnel, which enhanced the acceptability of the DPP among diverse ethnic groups, suggesting these methods should be prioritized in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation of the Diabetes Prevention Program to Ethnic Communities in the United States. Hall, DL., Lattie, EG., McCalla, JR., et al.[2022]

The study involved 31 community members from two Montana Indian reservations who provided insights on adapting the Diabetes Prevention Program (DPP) to be culturally relevant for American Indian youth.

Key strategies identified for effective translation of the DPP included incorporating cultural practices like berry picking and dancing, enhancing access to healthy foods, and using interactive learning methods led by tribal members and elders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the diabetes prevention program for Northern Plains Indian youth through community-based participatory research methods. Brown, BD., Harris, KJ., Harris, JL., et al.[2022]

Community interventions based on the NIH Diabetes Prevention Program (DPP) curriculum led to significant weight loss in participants, with some studies showing sustained results up to 12 months after the intervention.

The DPP-based programs also demonstrated improvements in physical activity levels and components of metabolic syndrome, indicating their potential effectiveness in preventing type 2 diabetes and promoting overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program into practice: a review of community interventions. Jackson, L.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11534949/

Enhancing Primary Care and Mental Health Integration for ... This study examines factors associated with the successful deployment of EBQI within integrated health systems to improve primary care for women Veterans.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05050266

Enhancing Mental and Physical Health of Women Veterans The study team will conduct a mixed methods implementation evaluation to compare the effectiveness of REP and EBQI in terms of: (a) improved access to and rates ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38689118/

Enhancing Primary Care and Mental Health Integration for ... Evidence-based quality improvement (EBQI) offers a systematic approach to implementing new care models that can address care gaps for women ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03238417

Evaluating Evidence-Based Quality Improvement of ... Gaps in delivery of gender-sensitive comprehensive care have resulted in disparities in quality and patient experience among women seen in VA.

5. researchgate.net researchgate.net/publication/380245570_Enhancing_Primary_Care_and_Mental_Health_Integration_for_Women_Veterans_with_Complex_Healthcare_Needs_Using_Evidence-Based_Quality_Improvement

Enhancing Primary Care and Mental Health Integration for ... This study examines factors associated with the successful deployment of EBQI within integrated health systems to improve primary care for women Veterans with ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833127

An Evidence Map of the Women Veterans' Health ... This systematic review examines the literature on health of women veterans published between 2016 and 2023.

7. hsrd.research.va.gov hsrd.research.va.gov/research/citations/pubbriefs/articles.cfm?RecordID=692

Study Highlights Mental Health Services Important to Women ... Compared to men, women Veterans are more likely to suffer from a mental health condition, as well as comorbid chronic health conditions. Using data from the VA ...

8. link.springer.com link.springer.com/article/10.1007/s11606-022-07585-3

Women Veterans' Healthcare Needs, Utilization, and ... Women Veterans who routinely utilize VA primary care have significant multimorbid physical and mental health conditions and trauma histories.