Collaborative Specialty Care for Gulf War Syndrome

Overseen By Amanda L Matteson

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Suicidal intent, Previous WRIISC evaluation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

281 Participants Needed

Trial Summary

What is the purpose of this trial?

Gulf War Veterans (GWVs) with Gulf War Illness (GWI) do not receive the care they should in the Veterans Affairs (VA). The investigators' data show 70% of GWVs with Gulf War Illness (GWI) do not receive treatment recommendations for their GWI and 78% are NOT very satisfied with their care. The quality of care GWVs receive must improve. VA and DoD have invested hundreds of millions of dollars to develop new treatments for GWVs, without effective delivery methods GWVs will not benefit. This study will be the first study to examine the best model of care to deliver treatments to GWVs with GWI. Determining the best model of care to translate research into practice is a key goal of the VA Gulf War Strategic Plan and a specific aim of this Request for Applications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Collaborative Specialty Care for Gulf War Syndrome?

Research shows that collaborative care models, like those used for cancer and depression, improve care coordination and patient satisfaction. For example, a study at Virginia Mason Medical Center demonstrated that collaboration among healthcare providers improved treatment quality and reduced costs for conditions like headaches, suggesting potential benefits for similar approaches in managing Gulf War Syndrome. ^{1 2 3 4 5}

Is Collaborative Specialty Care safe for humans?

The safety of Collaborative Specialty Care, including its use for Gulf War Syndrome, is not directly addressed in the available research articles. However, similar multidisciplinary care models have been used internationally for chronic pain and have shown stable improvements in various health outcomes, suggesting a general level of safety. ^{6 7 8 9 10}

How is the Collaborative Specialty Care treatment for Gulf War Syndrome different from other treatments?

The Collaborative Specialty Care treatment is unique because it involves a multidisciplinary team approach, where various healthcare professionals work together to provide coordinated care, similar to models used for managing complex conditions like depression and genetic disorders. This approach emphasizes collaboration and communication among specialists, which can improve patient outcomes and satisfaction. ^{5 11 12 13 14}

Research Team

Lisa Marie McAndrew, PhD

Principal Investigator

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

Scott E. Sherman, MD MPH

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Justeen K Hyde, PhD

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Eligibility Criteria

This trial is for Gulf War Veterans who served in Operation Desert Shield/Storm and meet the Kansas City (Steele) definition of Gulf War Illness. They should experience pain that limits their activities, rating at least a 3 out of 10 on a pain scale, and must have a VA primary care provider. Those with suicidal intent or previous specialized evaluations or participation in related trials are excluded.

Inclusion Criteria

My pain limits my activities at a level of 3 or more on a scale of 0 to 10.

Deployed to Operation Desert Shield/Storm

Meets Kansas City (Steele) definition of GWI (which excludes conditions that may account for GWI)

Exclusion Criteria

Suicidal intent

Previous evaluation at the WRIISC or participated in our clinical trial for GWVs with GWI

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive health coaching and problem-solving treatment, with monthly optimization of analgesics in collaborative specialty care or a onetime recommendation in e-consultation

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Collaborative Specialty Care
• e-consultation

Trial Overview The study is testing Collaborative Specialty Care versus standard care to improve treatment delivery for veterans with Gulf War Illness. It will use e-consultation methods to see if this improves satisfaction and health outcomes compared to current practices within the VA system.

Participant Groups

Group I: collaborative specialty care Experimental Treatment 1 Intervention

In specialty collaborative care, the specialty provider team will deliver health coaching and problem-solving treatment to GWVs and recommend the primary care team make monthly optimization of analgesics.

Group II: e-consultation Active Control 1 Intervention

In e-consultation the specialty provider team will make a onetime recommendation to the primary care team that the GWV locally receive health coaching and problem-solving treatment and analgesic optimization.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

The Partnership Study explored the effectiveness of video consultations involving patients, general practitioners (GPs), and oncologists, revealing that while the concept is seen as useful, addressing technical and organizational challenges is crucial for successful implementation.

Interviews with oncologists highlighted the need for better structuring of consultations and communication, as well as careful case selection to enhance the collaborative care model between GPs and oncologists in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-sectoral communication by bringing together patient with cancer, general practitioner and oncologist in a video-based consultation: a qualitative study of oncologists' and nurse specialists' perspectives. Hansen, DG., Trabjerg, TB., Sisler, JJ., et al.[2021]

Virginia Mason Medical Center's collaborative approach to patient care has led to a 91% patient satisfaction rate and same-day appointments for 95% of patients with uncomplicated headaches.

The initiative also resulted in a 23% reduction in the use of advanced imaging, demonstrating that standardized care can improve treatment quality while lowering costs for patients and providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

At Virginia Mason, collaboration among providers, employers, and health plans to transform care cut costs and improved quality. Blackmore, CC., Mecklenburg, RS., Kaplan, GS.[2011]

Developing personal relationships and gaining mutual respect with specialists are key motivators for general practitioners (GPs) to initiate and sustain collaboration in new care models, as revealed through interviews with 21 Dutch GPs.

GPs expressed a desire for diverse collaboration models that prioritize knowledge acquisition over organizational structure, indicating that once they achieve a certain level of expertise, the specific model of collaboration becomes less important than the professional relationships formed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motives and preferences of general practitioners for new collaboration models with medical specialists: a qualitative study. Berendsen, AJ., Benneker, WH., Meyboom-de Jong, B., et al.[2018]

The collaborative care model, which included a one-time consultation with a sleep specialist, significantly improved provider adherence to sleep-focused interventions, with referrals for polysomnography increasing from 6% to 49%.

Patients receiving the intervention reported better sleep outcomes, including a reduction in total wake time and improved sleep efficiency, with 41% showing significant improvement on the Pittsburgh Sleep Quality Index compared to 21% in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Collaborative Paradigm for Improving Management of Sleep Disorders in Primary Care: A Randomized Clinical Trial. Edinger, JD., Grubber, J., Ulmer, C., et al.[2018]

The study is evaluating the effectiveness and implementation of the Collaborative Behavioral Health Program (CBHP) in 11 primary care practices over a 30-month period, aiming to improve access to mental health services for depression.

It will provide insights into the barriers and facilitators of implementing the Collaborative Care Model (CoCM) and conduct economic analyses to assess the cost-effectiveness of the program, potentially benefiting both mental health outcomes and chronic health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative care for depression management in primary care: A randomized roll-out trial using a type 2 hybrid effectiveness-implementation design. Smith, JD., Fu, E., Rado, J., et al.[2022]

This clinical trial will involve 220 Gulf War Veterans and aims to compare the effectiveness of tele-collaborative specialty care against electronic consultation in reducing disability related to Gulf War Illness (GWI).

Tele-collaborative specialty care involves ongoing health coaching and treatment recommendations from specialists, potentially leading to better outcomes for Veterans compared to a one-time consultation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a type 1 hybrid effectiveness/implementation clinical trial of collaborative specialty care for Veterans with Gulf War Illness. Schneider, AH., Bair, MJ., Helmer, DA., et al.[2023]

The Gulf War Illness Common Data Elements (CDEs) were developed through collaboration among veterans, advocates, clinicians, and researchers to standardize data collection across GWI research, enhancing data quality and facilitating sharing.

The CDEs are organized into 12 domains with recommendations categorized as core, supplemental, and exploratory, ensuring that essential data is consistently collected while allowing for flexibility in research design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A common language for Gulf War Illness (GWI) research studies: GWI common data elements. Cohen, DE., Sullivan, KA., McNeil, RB., et al.[2022]

The Gulf War Health Center's Specialized Care Program is a 3-week intensive outpatient treatment designed for individuals with persistent Gulf War-related symptoms, utilizing a multidisciplinary approach that has been effective in chronic pain management.

This program aims to provide stable improvements in pain, mood, and overall health, and the report suggests establishing similar treatment centers for future deployments to support veterans experiencing long-term health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary treatment of persistent symptoms after Gulf War service. Engel, CC., Roy, M., Kayanan, D., et al.[2017]

A study of 178 Gulf War veterans revealed significant discrepancies in exposure reporting between self-reported data from veterans and documentation from healthcare providers, with nearly 50% of exposure categories showing inconsistencies.

The findings suggest that healthcare providers' documentation may not accurately reflect veterans' reports, indicating a need for improved reporting methods, such as standardized templates or electronic uploads, to enhance accuracy in exposure assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure reporting disparity in Gulf War Registry-related clinical assessments. Metzger-Smith, V., Lei, K., Javors, J., et al.[2022]

The Institute of Medicine has provided 12 reports addressing health concerns of Persian Gulf War veterans, focusing on exposures and illnesses, and recommending improvements in clinical programs and preventive strategies.

Key recommendations include the establishment of guidelines for treating medically unexplained symptoms, conducting longitudinal health studies, and maintaining electronic health records to track service members' health and exposures over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Institute of Medicine's independent scientific assessment of Gulf War health issues. Joellenbeck, LM., Hernandez, LM.[2019]

Multidisciplinary specialty clinics for genetic diseases vary in availability and effectiveness, with well-established networks for hemophilia and cystic fibrosis, but fewer resources for sickle cell disease.

Effective comanagement models are crucial for ensuring smooth communication between primary care and specialty services, especially during the transition from pediatric to adult care, highlighting the need for further evaluation of these models to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models of comprehensive multidisciplinary care for individuals in the United States with genetic disorders. Grosse, SD., Schechter, MS., Kulkarni, R., et al.[2009]

Multidisciplinary care for neurosurgical patients with genetic syndromes enhances patient outcomes and satisfaction, highlighting the importance of collaboration among various specialists.

Establishing a successful multidisciplinary team clinic involves clear goals, effective use of ancillary staff, and strong institutional support, with technology like telehealth playing a crucial role in improving communication and care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary Care of Neurosurgical Patients with Genetic Syndromes. Villegas, MA., Okenfuss, E., Savarirayan, R., et al.[2021]

The collaborative care management (CoCM) model can be successfully adapted for use in a low-barrier HIV clinic, which serves a complex patient population with high levels of mental illness and substance use, demonstrating its flexibility beyond traditional primary care settings.

Despite the need for significant adaptations to fit the unique context of the HIV clinic, the core structural elements of CoCM were preserved, indicating that effective behavioral health integration can be achieved even in nonconventional healthcare environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of the collaborative care model to integrate behavioral health care into a low-barrier HIV clinic. Dombrowski, JC., Halliday, S., Tsui, JI., et al.[2023]

Collaborative care is effective for treating depression, regardless of the presence, type, or number of chronic physical conditions, based on an analysis of data from 31 randomized clinical trials involving 10,962 participants.

The study suggests that existing guidelines recommending collaborative care only for those with both depression and chronic physical conditions are not supported, indicating that this care model can benefit all individuals with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Chronic Physical Conditions and the Effectiveness of Collaborative Care for Depression: An Individual Participant Data Meta-analysis. Panagioti, M., Bower, P., Kontopantelis, E., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Cross-sectoral communication by bringing together patient with cancer, general practitioner and oncologist in a video-based consultation: a qualitative study of oncologists' and nurse specialists' perspectives. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

At Virginia Mason, collaboration among providers, employers, and health plans to transform care cut costs and improved quality. [2011]

3. England pubmed.ncbi.nlm.nih.gov

Motives and preferences of general practitioners for new collaboration models with medical specialists: a qualitative study. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A Collaborative Paradigm for Improving Management of Sleep Disorders in Primary Care: A Randomized Clinical Trial. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Collaborative care for depression management in primary care: A randomized roll-out trial using a type 2 hybrid effectiveness-implementation design. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Protocol for a type 1 hybrid effectiveness/implementation clinical trial of collaborative specialty care for Veterans with Gulf War Illness. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A common language for Gulf War Illness (GWI) research studies: GWI common data elements. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Multidisciplinary treatment of persistent symptoms after Gulf War service. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Exposure reporting disparity in Gulf War Registry-related clinical assessments. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The Institute of Medicine's independent scientific assessment of Gulf War health issues. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Models of comprehensive multidisciplinary care for individuals in the United States with genetic disorders. [2009]

12. United States pubmed.ncbi.nlm.nih.gov

Multidisciplinary Care of Neurosurgical Patients with Genetic Syndromes. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Adaptation of the collaborative care model to integrate behavioral health care into a low-barrier HIV clinic. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Association Between Chronic Physical Conditions and the Effectiveness of Collaborative Care for Depression: An Individual Participant Data Meta-analysis. [2022]