Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04330365
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Karen Seal, San Francisco Veterans Affairs Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 745 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: Whole Health Team (WHT) Intervention Arm
The WHT intervention arm includes four core elements: 1) An interdisciplinary WHT collaborating with primary care; 2) Personalized Health Planning with prioritization of multi-modal non-pharmacological and CIH pain management approaches; 3) Whole Health Coaching sessions to assist patients in developing and implementing a Personalized Health Plan for chronic pain care; and 4) the web/mobile Whole Health Resource Directory provided to patient participants (in addition to their providers) to support non-pharmacologic/CIH chronic pain care.
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.

Active Comparator: Primary Care Group Education (PC-GE) Intervention Arm
Primary Care Group Education (PC-GE) iss the comparator arm, which is an abbreviated form of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) adapted for group use in primary care.
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.

Placebo Comparator: Usual Primary Care (UPC) Arm
In VA, patient-aligned care teams (PACTs) or primary care is step 1 of VA's Stepped Care Model in the treatment of chronic pain. PCPs are expected to possess the requisite skill set for management of common chronic pain-causing conditions, which includes biopsychosocial assessment, multi-modal treatment, and coordination of specialty pain care after shared-decision making that incorporates patient preferences and values. Participants randomized to this arm will continue to have their PCP and PACT serve in this role.
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.




Primary Outcome Measures :
  1. Improved pain interference [ Time Frame: 12 months ]
    The total Brief Pain Inventory (BPI) interference sub-scale score is our primary outcome measure.


Secondary Outcome Measures :
  1. Improved pain intensity [ Time Frame: 12 months ]
    Pain intensity rating contained in the 3-item PEG and Brief Pain Inventory (BPI).

  2. Decreased use of higher-risk pain medications, including opioids or high-risk combinations of pain medications (i.e., co-prescription of opioids and benzodiazepines) [ Time Frame: 12 months ]
    The investigators will utilize the VA administrative data/databases to obtain information on prescription medications, including generic name, dispensing information, dose, and instructions.

  3. Engagement in a greater number of non-pharmacological pain management activities [ Time Frame: 12 months ]
    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.

  4. Improvement in mental health-related symptoms, including sleep problems and suicidality [ Time Frame: 12 months ]
    The investigators will assess sleep and fatigue symptoms using the PROMIS - Sleep Disturbance. The investigators will be screening for suicidality using the PHQ-9.

  5. Functioning and quality of life [ Time Frame: 12 months ]
    The investigators will assess functioning and quality of life using the THE VETERANS RAND 12-ITEM HEALTH SURVEY (VR-12)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04330365


Contacts
Layout table for location contacts
Contact: Akshaya Krishnaswamy, MPH 415-900-8196 akshaya.krishnaswamy@va.gov
Contact: Nicole McCamish, MA 415-676-1547 nicole.mccamish@va.gov

Locations
Layout table for location information
United States, California
SFVAHCS Recruiting
San Francisco, California, United States, 94121
Contact: Travis Ramirez    415-917-9832    travis.ramirez@va.gov   
Principal Investigator: Karen H Seal, MD         
United States, Missouri
VA St. Louis Health Care System Recruiting
Saint Louis, Missouri, United States, 63125
Contact: Lei Guo    314-939-8097    lei.guo@va.gov   
Principal Investigator: Theresa Van Iseghem, PHD         
United States, Oregon
VAPHCS Recruiting
Portland, Oregon, United States, 97239
Contact: Melissa Adams    503-220-8262 ext 57415    melissa.adams@va.gov   
Principal Investigator: Benjamin Morasco, PHD         
Sponsors and Collaborators
San Francisco Veterans Affairs Medical Center
Layout table for additonal information
Responsible Party: Karen Seal, Chief of Integrative Medicine, San Francisco Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT04330365    
Other Study ID Numbers: UH3AT009765 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations