Trial studying safety and effects 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 study wants to find out whether adding Whole Health Coaching improves pain care for adults with chronic pain.
- Who it's for
- Adults with chronic pain who are already receiving care from a VA pain management team.
- What's involved
- Participants will receive Whole Health Coaching in addition to their usual pain care, and will have regular check‑ins with the coach.
- Time commitment
- The study runs for the duration of the coaching program, with scheduled visits as needed.
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).
- Active prescription for long-term opioid therapy (LTOT; including full agonist and buprenorphine) (\>90 days continuous prescription).
- Exhibit evidence of at least ONE opioid safety concern (\ indicators of opioid safety concerns described below).
- moderate-to-high dose opioid prescription (morphine equivalent daily dose \>60mg)
- comorbid conditions that increase the risk of full-agonist opioids including chronic pulmonary disease (e.g., emphysema, chronic bronchitis, asthma...
You likely can't join if
- Moderate to severe cognitive impairment as measured by the Blessed Orientation Memory Concentration (BOMC) screening tool.
- Inability to read or understand English.
- Severely impaired hearing or speech that would preclude participation in telephone interviews or appointments with the Whole Health Coach.
- Terminal illness/disease with a prognosis of \<12 months.
- Planned move/relocation outside of the treatment areas of the participating enrolling study sites.
- Participants actively working with a Whole Health Coach or who have worked with a Whole Health Coach in the 6-months prior to enrollment.
See the full eligibility criteria
- High-impact chronic pain (defined using the Graded Chronic Pain Scale - Revised).
- Active prescription for long-term opioid therapy (LTOT; including full agonist and buprenorphine) (\>90 days continuous prescription).
- Exhibit evidence of at least ONE opioid safety concern (\ indicators of opioid safety concerns described below).
- moderate-to-high dose opioid prescription (morphine equivalent daily dose \>60mg)
- comorbid conditions that increase the risk of full-agonist opioids including chronic pulmonary disease (e.g., emphysema, chronic bronchitis, asthma, or other breathing problems), sleep apnea, chronic kidney disease...
- active high-risk co-prescriptions, including long-term benzodiazepine prescription, gabapentin or pregabalin, nonbenzodiazepine hypnotic agents or sedative hypnotics, or skeletal muscle relaxants
- a positive TAPS or AUDIT-C score
- 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.
- Inability to read or understand English.
- Severely impaired hearing or speech that would preclude participation in telephone interviews or appointments with the Whole Health Coach.
- Terminal illness/disease with a prognosis of \<12 months.
- Planned move/relocation outside of the treatment areas of the participating enrolling study sites.
- Participants actively working with a Whole Health Coach or who have worked with a Whole Health Coach in the 6-months prior to enrollment.
- Major surgical procedure planned during the study treatment or follow-up period.
- 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 is enrolling
- Birmingham, Alabama, 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, but 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?
This study is enrolling now at Birmingham, Alabama, United States; Aurora, Colorado, United States; West Haven, Connecticut, United States; Boise, Idaho, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.