Clinical trial NCT04403295: Collaborative Specialty Care for Gulf War Illness
Official title: Collaborative Specialty Care for Gulf War Illness
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gulf War Illness
Keywords: Veteran
Gulf War Illness
implementation
Chronic Pain
health coaching
problem-solving
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-05-27
Enrollment: 281
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In collaborative specialty 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
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: There is a quality chasm between the care Gulf War Veterans (GWVs) should receive and the care they do receive. 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. Reducing this quality chasm is essential. The VA and DoD have invested hundreds of millions of dollars to develop new treatments, including the second largest clinical trial for GWVs which is finding health coaching and problem-solving treatment both reduce the disability of GWI. Without effective models of healthcare to implement these treatments, GWVs will not benefit. In the current model of care, GWVs receive care locally through VA's primary care patient aligned care teams (PACTs). The VA War Related Illness and Injury Study Center (WRIISC) supports the current model of care by increasing local knowledge of the skills and treatments needed to manage GWI through national education efforts and electronic consultation (e-consultation) on difficult cases. The WRIISC and other stakeholders are currently questioning whether improving local knowledge of skills and treatments for GWI is enough to address the quality chasm, or if GWI is too complex to be treated in primary care without additional support from specialists in GWI. A potentially useful model of care for GWI is collaborative specialty care where specialists work with PACTs to synergistically treat patients. The local PACT is the lead of the team with the specialist providing some direct care to the patient (through tele-health) and also consulting with the PACT about other aspects of care. Collaborative specialty care is effective for other complex conditions (e.g., depression) with over 40 studies documenting its efficacy. The goal of this proposal is to conduct a hybrid type 1 randomized effectiveness/implementation trial for GWVs with GWI (n=220). The primary aim is to determine the effectiveness of tele-CSC as compared to e-consultation. In tele-CSC, the investigators' specialty provider team will deliver health coaching and problem-solving treatment to GWVs and recommend the PACT make monthly optimization of analgesics. In e-consultation the specialty provider team will make a onetime recommendation to the PACT that the GWV locally receive health coaching and problem-solving treatment and analgesic optimization. The secondary aim is to understand implementation outcomes. This information will be used to guide a future randomized (by VISN) multi-site implementation study. Throughout, an advisory committee of operations partners will be convened to ensure that the results of the study are able to directly and immediately improve care. Determining the best model of care to translate research into practice for GWVs with GWI is a key goal of the VA Gulf War Strategic Plan and a specific aim of this Request for Applications.

Eligibility criteria: Inclusion Criteria:

* deployed to Operation Desert Shield/Storm
* meets Kansas City (Steele) definition of GWI (which excludes conditions that may account for GWI)
* rates their activity limitations from pain at least 3 on a 0 to 10 point scale
* has a VA primary care provider

Exclusion Criteria:

* suicidal intent
* previous evaluation at the WRIISC or participated in our clinical trial for GWVs with GWI

Primary outcomes:
measure: Roland Morris Disability Scale
timeFrame: 6 months
measure: World Health Organization Disability Schedule
timeFrame: 6 months
Secondary outcomes:
measure: Brief Pain Inventory - Interference Scale
timeFrame: 6 months
measure: Patient Health Questionnaire Somatic Symptom Scale - 15
timeFrame: 6 months
measure: Patient Activation Measure
timeFrame: 6 months
measure: Satisfaction: Patient Satisfaction Questionnaire
timeFrame: 6 month
measure: Roland Morris Disability Scale
timeFrame: 9 month
measure: World Health Organization Disability Schedule
timeFrame: 9 month
measure: Brief Pain Inventory - Interference Scale
timeFrame: 9 month
measure: Patient Health Questionnaire Somatic Symptom Scale - 15
timeFrame: 9 month
measure: Patient Activation Measure
timeFrame: 9 month
measure: Satisfaction: Patient Satisfaction Questionnaire
timeFrame: 9 month
Other outcomes:
Locations:
city: East Orange
country: United States
facility: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
state: New Jersey
Study officials:
affiliation: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
name: Lisa Marie McAndrew, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Justeen K Hyde, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA NY Harbor Healthcare System, New York, NY
name: Scott E. Sherman, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schneider AH, Bair MJ, Helmer DA, Hyde J, Litke D, Lu SE, Rogers ES, Sherman SE, Sotolongo A, Anastasides N, Sullivan N, Graff F, McAndrew LM. Protocol for a type 1 hybrid effectiveness/implementation clinical trial of collaborative specialty care for Veterans with Gulf War Illness. Life Sci. 2022 Mar 1;292:120004. doi: 10.1016/j.lfs.2021.120004. Epub 2021 Sep 29.
citation: Lesnewich LM, Hyde JK, McFarlin ML, Bolton RE, Bayley PJ, Chandler HK, Helmer DA, Phillips LA, Reinhard MJ, Santos SL, Stewart RS, McAndrew LM. 'She thought the same way I that I thought:' a qualitative study of patient-provider concordance among Gulf War Veterans with Gulf War Illness. Psychol Health. 2025 Apr;40(4):616-634. doi: 10.1080/08870446.2023.2248481. Epub 2023 Sep 1.