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Tests treatment safety and results for Chronic Pain
Official title Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial
ClinicalTrials.gov ID: NCT07149870
What this study is testing
- What it's testing
- The focus of this study is to determine whether adding Whole Health Coaching (WHC) improves pain care among adults with chronic pain and who are currently working with a pain management team (PMT) at the VA.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- High-impact chronic pain (defined using the Graded Chronic Pain Scale - Revised). -AND-
- Active prescription for LTOT (\>90 days continuous prescription). -AND-
- Exhibit evidence of at least ONE opioid safety concern (\ indicators of opioid safety concerns described below).
- Opioid safety concerns for inclusion purposes include:
- moderate-to-high dose opioid prescription (morphine equivalent daily dose \>60mg)
You likely can't join if
- Moderate to severe cognitive impairment as measured by the Blessed Orientation Memory Concentration (BOMC) screening tool. -OR-
- Current/active prescription for buprenorphine or receipt of buprenorphine in the previous 6-months. -OR-
- Inability to read or understand English. -OR-
- Severely impaired hearing or speech that would preclude participation in telephone interviews or appointments with the Whole Health Coach. -OR-
- Terminal illness/disease with a prognosis of \<12 months. -OR-
- Planned move/relocation outside of the treatment areas of the participating enrolling study sites. -OR-
See the full eligibility criteria
- High-impact chronic pain (defined using the Graded Chronic Pain Scale - Revised). -AND-
- Active prescription for LTOT (\>90 days continuous prescription). -AND-
- Exhibit evidence of at least ONE opioid safety concern (\ indicators of opioid safety concerns described below).
- Opioid safety concerns for inclusion purposes include:
- moderate-to-high dose opioid prescription (morphine equivalent daily dose \>60mg)
- comorbid conditions that increase the risk of opioids including chronic pulmonary disease (e.g., emphysema, chronic bronchitis, asthma, or other breathing problems), sleep apnea, chronic kidney disease, chronic...
- active high-risk co-prescriptions, including benzodiazepine prescription (any dose of long-term treatment), gabapentin prescription (1800mg or higher) or pregabalin prescription (150mg or higher)
- risk of substance use and/or potential opioid misuse as evidenced by unexpected urine toxicology findings in past 6-months OR any documented active substance use disorder (other than tobacco or caffeine) as evidenced by...
- a positive TAPS score
- a positive AUDIT-C score
- presence of any adverse events as measured by the adverse effects checklist administered during screening
- reported score of \>8 as measured by the Prescribed Opioids Difficulties Scale (PODS).
- Moderate to severe cognitive impairment as measured by the Blessed Orientation Memory Concentration (BOMC) screening tool. -OR-
- Current/active prescription for buprenorphine or receipt of buprenorphine in the previous 6-months. -OR-
- Inability to read or understand English. -OR-
- Severely impaired hearing or speech that would preclude participation in telephone interviews or appointments with the Whole Health Coach. -OR-
- Terminal illness/disease with a prognosis of \<12 months. -OR-
- Planned move/relocation outside of the treatment areas of the participating enrolling study sites. -OR-
- Participants actively working with a Whole Health Coach or who have worked with a Whole Health Coach in the 6-months prior to enrollment. -OR-
- Major surgical procedure planned during the study treatment or follow-up period. -OR-
- a recent suicide attempt, defined as documented and/or reported suicide attempt within 90 days of the screening date.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Aurora, Colorado, United States
- West Haven, Connecticut, United States
- Boise, Idaho, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Aurora, Colorado, United States; West Haven, Connecticut, United States; Boise, Idaho, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.