Collaborative Specialty Care for Gulf War Illness

Gulf War Illness Clinical Trial

Official title:

Collaborative Specialty Care for Gulf War Illness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04403295
• Other study ID #: IIR 19-469
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: May 31, 2025

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: Lisa M McAndrew, PhD
• Phone: (862) 400-3317
• Email: Lisa.Mcandrew[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: May 31, 2025
• Est. primary completion date: March 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gulf War Illness

Intervention

Behavioral:
• Collaborative Specialty Care
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.
• e-consultation
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.

Locations

Country	Name	City	State
United States	East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ	East Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View 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 Vet — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roland Morris Disability Scale	Pain disability will be assessed with the RMDS a 24 item scale of disability from pain. The RMDS is a core outcome measure for patients with chronic pain. A change of 2-3 points is considered clinically significant. Pain is present in 99% of GWVs with GWI and previous collaborative care trials in the VA have used this measure. Scores range from 0-24 with higher scores = greater disability.	6 months
Primary	World Health Organization Disability Schedule	The WHO-DAS 2.0 measures disability which is due to physical and mental health conditions. The WHO-DAS 2.0 is a 40 item measure that assesses 6 life tasks. The composite score will be used as the dependent variable. The items of the WHO-DAS have a factor loading on composite score of 0.82 to 0.98. The WHO-DAS was the primary outcome in our previous trial of problem-solving treatment and captures all over health disability. Scores range from 0-100 with higher scores equaling greater disability.	6 months
Secondary	Brief Pain Inventory - Interference Scale	The 7 item scale measures pain interference on mood, physical activity, social activity and other life activities. A one-point change is clinically significant. Scores range from 0-10 with higher scores equaling greater pain interference.	6 months
Secondary	Patient Health Questionnaire Somatic Symptom Scale - 15	The PHQ-15 captures somatic symptoms. The PHQ-15 was validated on a sample of 6,000 and found to be reliable, valid and responsive to change. Scores range from 0-30 and higher scores are greater symptom severity.	6 months
Secondary	Patient Activation Measure	The PAM is a 13 item self-report measure of the patient's active engagement in self-management their health. The PAM is reliable and valid. Scores range from 0-100 with higher scores indicating greater activation.	6 months
Secondary	Satisfaction: Patient Satisfaction Questionnaire	The PSQ-III is a 50-item self-report measure with 7 subscales reliability with ranges from .77-.89. The investigators will use the composite score. Score range from 0-100 with higher scores indicating greater satisfaction.	6 month
Secondary	Roland Morris Disability Scale	Pain disability will be assessed with the RMDS a 24 item scale of disability from pain. The RMDS is a core outcome measure for patients with chronic pain. A change of 2-3 points is considered clinically significant. Pain is present in 99% of GWVs with GWI and previous collaborative care trials in the VA have used this measure. Scores range from 0-24 with higher scores = greater disability.	9 month
Secondary	World Health Organization Disability Schedule	The WHO-DAS 2.0 measures disability which is due to physical and mental health conditions. The WHO-DAS 2.0 is a 40 item measure that assesses 6 life tasks. The composite score will be used as the dependent variable. The items of the WHO-DAS have a factor loading on composite score of 0.82 to 0.98. The WHO-DAS was the primary outcome in our previous trial of problem-solving treatment and captures all over health disability. Scores range from 0-100 with higher scores equaling greater disability.	9 month
Secondary	Brief Pain Inventory - Interference Scale	The 7 item scale measures pain interference on mood, physical activity, social activity and other life activities. A one-point change is clinically significant. Scores range from 0-10 with higher scores equaling greater pain interference.	9 month
Secondary	Patient Health Questionnaire Somatic Symptom Scale - 15	The PHQ-15 captures somatic symptoms. The PHQ-15 was validated on a sample of 6,000 and found to be reliable, valid and responsive to change. Scores range from 0-30 and higher scores are greater symptom severity.	9 month
Secondary	Patient Activation Measure	The PAM is a 13 item self-report measure of the patient's active engagement in self-management their health. The PAM is reliable and valid. Scores range from 0-100 with higher scores indicating greater activation.	9 month
Secondary	Satisfaction: Patient Satisfaction Questionnaire	The PSQ-III is a 50-item self-report measure with 7 subscales reliability with ranges from .77-.89. The investigators will use the composite score. Score range from 0-100 with higher scores indicating greater satisfaction.	9 month