Pragmatic Trial of WHT vs. PC-GE to Promote Non-Pharmacological Strategies to Treat Chronic Pain in Veterans

Chronic Pain Clinical Trial

— wHOPE  

Official title:

Implementation of a Pragmatic Trial of Whole Health Team vs. Primary Care Group Education to Promote Non-Pharmacological Strategies to Improve Pain, Functioning, and Quality of Life in Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04330365
• Other study ID #: UH3AT009765
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2020
• Source: San Francisco Veterans Affairs Medical Center
• Contact: Akshaya Krishnaswamy, MPH
• Phone: 415-900-8196
• Email: akshaya.krishnaswamy[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overarching goal of this Pain Management Collaboratory Demonstration project is to test a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacological pain self-management that is hypothesized to reduce pain symptoms and improve overall functioning and quality of life in Veterans. In UH3 Aim 1, the investigators will conduct a 12-month pragmatic effectiveness trial at 5 VA sites across the country to test whether veterans with moderate to severe chronic pain randomized to receive the Whole Health Team (WHT) intervention are more likely than those receiving Primary Care Group Education (PC-GE) to: Hypothesis 1: Experience improved pain interference (primary outcome), pain intensity, functioning and quality of life (secondary outcomes); Hypothesis 2: Decrease use of higher-risk pain medications, including opioids, or high-risk combinations; Hypothesis 3: Engage in a greater number of non-pharmacological pain management activities; and Hypothesis 4: Experience improved mental health-related symptoms, including sleep problems and suicidality. In addition, both the WHT and PC-GE arms will be compared to a third group of veterans randomized to Usual Primary Care (UPC, Control) on the same primary and secondary outcomes above. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months. UH3 Aim 2 is to conduct a process evaluation of the two active interventions (WHT and PC-GE) and a budget impact analysis that includes costs to implement and execute the two active interventions as well as the control condition (UPC) to inform the development of an implementation toolkit for scaling and dissemination. Eligible participants are veterans reporting moderate to severe chronic pain present every day or nearly every day for ≥ 6 months. The total sample size for the population is based on our main study aim/hypothesis and is N=745. This breaks down to n=341 in each of the active interventions (WHT and PC-GE) and N=63 in the Usual Primary Care arm (Control). Results of this UG3/UH3 Pain Management Collaboratory Demonstration project will contribute to the overall mission of the NIH/VA/DoD initiative to build national-level infrastructure that supports non-pharmacologic pain management in veterans and military service personnel.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 745
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Participants must meet the following inclusion criteria to be enrolled in the study:

• Assigned to a VA PCP;

• Report pain present every day or nearly every day for = 6 months using a phone eligibility screener; and

• PEG score of = 5 (including at baseline assessment)

Exclusion Criteria:

Candidates with any of the exclusion criteria at baseline will be excluded from study participation:

• Moderate or severe cognitive impairment as determined by a failed 6-item, validated cognitive screener on initial phone screening (See Appendix A: Telephone Eligibility Screen/Script);

• Active suicidality as determined by medical record review, standardized assessment (PHQ-9) and/or is unable to attend study visits because of an unstable or severe psychiatric or medical condition or is receiving palliative or hospice care; or

• Any other factors that would interfere with study participation including inability to communicate by telephone, VTEL or VVC; being a non-English speaker; plans to relocate within 12 months and concurrent participation in another pain-related study.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm
Participants will be randomly assigned at the individual level to either WHT, PC-GE or Usual Primary Care, stratified by site, sex, and use of prescribed opioids for chronic pain. The follow-up period for the three arms will be 12 months. The primary outcome is change in pain interference. Secondary outcomes include change in pain intensity, functioning, quality of life, changes in use of pain medications, including opioids (if applicable) and changes in nonpharmacological pain self-management activities. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months.

Locations

Country	Name	City	State
United States	VAPHCS	Portland	Oregon
United States	VA St. Louis Health Care System	Saint Louis	Missouri
United States	SFVAHCS	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
San Francisco Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved pain interference	The total Brief Pain Inventory (BPI) interference sub-scale score is our primary outcome measure.	12 months
Secondary	Improved pain intensity	Pain intensity rating contained in the 3-item PEG and Brief Pain Inventory (BPI).	12 months
Secondary	Decreased use of higher-risk pain medications, including opioids or high-risk combinations of pain medications (i.e., co-prescription of opioids and benzodiazepines)	The investigators will utilize the VA administrative data/databases to obtain information on prescription medications, including generic name, dispensing information, dose, and instructions.	12 months
Secondary	Engagement in a greater number of non-pharmacological pain management activities	Past-year use of complementary therapies and self-management practices will be measured using the Nonpharmacological and Self-Care Approaches from PMC (NSCAP)185. The inventory assesses use of several CIH modalities such as yoga, etc. The investigators will also probe for other self-directed pain management activities.	12 months
Secondary	Improvement in mental health-related symptoms, including sleep problems and suicidality	The investigators will assess sleep and fatigue symptoms using the PROMIS - Sleep Disturbance. The investigators will be screening for suicidality using the PHQ-9.	12 months
Secondary	Functioning and quality of life	The investigators will assess functioning and quality of life using the THE VETERANS RAND 12-ITEM HEALTH SURVEY (VR-12)	12 months