Collaborative Specialty Care for Gulf War Syndrome
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Suicidal intent, Previous WRIISC evaluation, others
No Placebo Group
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.12345
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.678910
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.511121314
Research Team
LM
Lisa Marie McAndrew, PhD
Principal Investigator
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
SE
Scott E. Sherman, MD MPH
Principal Investigator
VA NY Harbor Healthcare System, New York, NY
JK
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)
See 1 more
Exclusion Criteria
Suicidal intent
Previous evaluation at the WRIISC or participated in our clinical trial for GWVs with GWI
Trial 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 (Behavioral Intervention)
- e-consultation (Behavioral Intervention)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: collaborative specialty careExperimental Treatment1 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-consultationActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJEast Orange, NJ
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Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Trials
1691
Patients Recruited
3,759,000+
References
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]Shared care models in the field of cancer aim to improve care coordination, role clarification and patient satisfaction. Cross-sectoral communication is pivotal. Involvement of patients may add to intended mechanisms.A randomised controlled trial 'The Partnership Study' tested the effect of bringing together patient, general practitioner (GP) and oncologist for a consultation conducted by video.
At Virginia Mason, collaboration among providers, employers, and health plans to transform care cut costs and improved quality. [2011]Virginia Mason Medical Center in Seattle has worked in collaboration with health plans and employers to facilitate development of standardized approaches to care of patients with common conditions. These efforts have eliminated unnecessary treatment and decreased costs to employers, health plans, patients, and providers. We describe our collaborative approach and illustrate it with the example of improved treatment for patients with uncomplicated headache, for which we have achieved 91 percent patient satisfaction, decreased use of advanced imaging by 23 percent, and provided same-day appointments in 95 percent of cases. As a model for improving quality while reducing cost, the Virginia Mason experience demonstrates that a multispecialty group practice, hospital, employers, and health plans can define quality and align performance and payment along common goals.
Motives and preferences of general practitioners for new collaboration models with medical specialists: a qualitative study. [2018]Collaboration between general practitioners (GPs) and specialists has been the focus of many collaborative care projects during the past decade. Unfortunately, quite a number of these projects failed. This raises the question of what motivates GPs to initiate and continue participating with medical specialists in new collaborative care models. The following two questions are addressed in this study: What motivates GPs to initiate and sustain new models for collaborating with medical specialists? What kind of new collaboration models do GPs suggest?
A Collaborative Paradigm for Improving Management of Sleep Disorders in Primary Care: A Randomized Clinical Trial. [2018]To test a collaborative care model for interfacing sleep specialists with primary care providers to enhance patients' sleep disorders management.
Collaborative care for depression management in primary care: A randomized roll-out trial using a type 2 hybrid effectiveness-implementation design. [2022]The Collaborative Care Model (CoCM) is a well-established treatment for depression in primary care settings. The critical drivers and specific strategies for improving implementation and sustainment are largely unknown. Rigorous pragmatic research is needed to understand CoCM implementation processes and outcomes.
Protocol for a type 1 hybrid effectiveness/implementation clinical trial of collaborative specialty care for Veterans with Gulf War Illness. [2023]We describe a clinical trial which is seeking to determine the effectiveness and understand implementation outcomes for tele-collaborative specialty care for Veterans with Gulf War Illness (GWI).
A common language for Gulf War Illness (GWI) research studies: GWI common data elements. [2022]The Gulf War Illness programs (GWI) of the United States Department of Veteran Affairs and the Department of Defense Congressionally Directed Medical Research Program collaborated with experts to develop Common Data Elements (CDEs) to standardize and systematically collect, analyze, and share data across the (GWI) research community.
Multidisciplinary treatment of persistent symptoms after Gulf War service. [2017]Research suggests that individuals commonly describe persistent symptoms or syndromes after a war. After the Persian Gulf War, the Department of Veterans Affairs and the Department of Defense initiated registries and expedited health care for those with Gulf War-related health concerns. At Walter Reed Army Medical Center, the Gulf War Health Center was created in mid-1994 to contribute a continuum of care for those with Gulf War-related health problems. The purpose of this report is to describe the Gulf War Health Center's Specialized Care Program, a 3-week intensive outpatient multidisciplinary treatment program for people with persistent, disabling Gulf War-related symptoms. The program uses an evidence-based model of multidisciplinary care employed at chronic pain centers internationally and shown to yield stable improvements in pain, mood, health care use, and return to work rates. A patient is described to illustrate how the program works. Finally, a Deployment Medicine Treatment Center is proposed, a multidisciplinary treatment center like the Specialized Care Program that would offer care to those with persistent, disabling symptoms after all future deployments.
Exposure reporting disparity in Gulf War Registry-related clinical assessments. [2022]The Gulf War Registry monitors related health conditions of veterans returning from the Persian Gulf Region. Enrollment consists of two phases: Phase I-veterans meet with their local VA Environmental Health Coordinator and complete the self-reported Gulf War Phase I Worksheet (VA Form 10-9009A). Phase II involves a physical exam, medical history review, and laboratory test analysis conducted by a licensed physician. The providers' documentations are frequently referred for exposure assessment and benefit claim. We conducted an initial comparison assessment to ascertain any potential disparity in exposure reporting between the applicants in Phase I and the providers in Phase II.
The Institute of Medicine's independent scientific assessment of Gulf War health issues. [2019]The Institute of Medicine has frequently been the source of expert advice to the government and others on questions related to health and medicine. Such has been the case as Congress, federal agencies, and veterans attempt to resolve conflicts and develop policies to address the health concerns of Persian Gulf War veterans. Twelve reports issued by Institute of Medicine committees address what is known about exposures and illnesses in Gulf War veterans and what additional information is needed, how clinical programs for Gulf War veterans could be improved, and what strategies could help prevent or better address similar health problems in the future. The Institute of Medicine reports recommend guidelines and interventions to treat sufferers of medically unexplained symptoms, longitudinal studies to measure changes in health status, and improved risk communication. They emphasize the need for the maintenance of retrievable electronic records of baseline health status, of exposures, and of health events that occur during a service member's career.
Models of comprehensive multidisciplinary care for individuals in the United States with genetic disorders. [2009]Approaches to providing comprehensive coordinated care for individuals with complex diseases include the medical home approach, the chronic care model in primary care, and disease-specific, multidisciplinary specialty clinics. There is uneven availability and utilization of multidisciplinary specialty clinics for different genetic diseases. For 2 disorders (ie, hemophilia and cystic fibrosis), effective national networks of specialty clinics exist and reach large proportions of the target populations. For other disorders, notably, sickle cell disease, fewer such centers are available, centers are less likely to be networked, and centers are used less widely. Models of comanagement are essential for promoting ongoing communication and coordination between primary care and subspecialty services, particularly during the transition from pediatric care to adult care. Evaluation of the effectiveness of different models in improving outcomes for individuals with genetic diseases is essential.
Multidisciplinary Care of Neurosurgical Patients with Genetic Syndromes. [2021]Neurosurgical patients with genetic syndromes often receive care from multidisciplinary teams. Successful models range from multiple providers in one clinic space seeing a patient together to specialists located at different institutions working together. Collaboration and bidirectional communication are key. Multidisciplinary care improves outcomes and patient satisfaction. Choosing the goal of the clinic, using ancillary staff, and obtaining institutional buy-in are important initial first steps to establishing a multidisciplinary team clinic. Multidisciplinary teams can leverage technology to expand care via telehealth in multidisciplinary clinics and more vitally communication between providers on the team.
Adaptation of the collaborative care model to integrate behavioral health care into a low-barrier HIV clinic. [2023]The collaborative care management (CoCM) model is an evidence-based intervention for integrating behavioral health care into nonpsychiatric settings. CoCM has been extensively studied in primary care clinics, but implementation in nonconventional clinics, such as those tailored to provide care for high-need, complex patients, has not been well described.
Association Between Chronic Physical Conditions and the Effectiveness of Collaborative Care for Depression: An Individual Participant Data Meta-analysis. [2022]Collaborative care is an intensive care model involving several health care professionals working together, typically a physician, a case manager, and a mental health professional. Meta-analyses of aggregate data have shown that collaborative care is particularly effective in people with depression and comorbid chronic physical conditions. However, only participant-level analyses can rigorously test whether the treatment effect is influenced by participant characteristics, such as chronic physical conditions.