Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain (NCT03301623) | Clinical Trial Compass
CompletedNot Applicable
Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain
United States983 participantsStarted 2017-11-13
Plain-language summary
Investigators will compare Clinical Decision Support (CDS) versus Patient Education and Activation Tools (PEATs) in patients prescribed long-term or multiple opioids to measure outcomes that are important to patients. Primary outcomes are pain interference, physical function, and satisfaction with patient-physician communication. Secondary outcomes are overall Health-Related Quality of Life and high-risk prescribing, including prescriptions over 90 morphine milligram equivalents per day and co-prescribing of benzodiazepines and opioids.
Patients in the PEAT arm will receive patient materials during the intervention, developed to engage patients in chronic pain treatment, prior to Primary Care Physician office visits. In the provider-facing CDS arm, PCPs will receive computerized reminders about appropriate opioid use during office visits for enrolled patients. Patients in both groups will receive questionnaires about pain interference, quality of life, and physician-patient communication through the patient portal one month after each visit to their Primary Care Physician (PCP). Investigators will use multi-level regression models to compare the effectiveness of these two communication strategies.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Within a 90-day period prior to the patient recruitment date:
* ≥30 days of prescriptions for opioid medications; or
* 2 or more opioid prescriptions; or
* a total amount of ≥700 Morphine Milligram Equivalents (MME) in a single opioid prescription;
and
* Patients who have had 1 or more Cedars-Sinai Medical Group primary care physician in the year prior to the study start date; and
* At least 1 visit during the follow-up year (the follow-up year will start after they consent to be in the study).
Prescriptions in the inpatient setting will not make a patient eligible for this study.
Exclusion Criteria:
* Individuals less than 18 years of age; or
* Individuals with any cancer treatment (chemotherapy or radiotherapy) administered 180 days or less prior to patient recruitment; or
* Individuals with a cancer diagnosis in the Problem List 180 days or less prior to patient recruitment (patients with cancer surveillance only will be included in the study); or
* Individuals with palliative care treatment administered 180 days or less prior to patient recruitment; or
* Individuals with any end-of-life treatment (comfort care) prior to patient recruitment; or
* Patients currently taking prescription medications (e.g. Suboxone, subutex, Buprenex, Butrans, Probuphine, Belbuca, buprenorphine/naloxone, Zubsolv, and Bunavail) for Opioid Use or other Substance Use Disorder treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PROMIS - Pain Interference Short Form 8a
Timeframe: Assessed at baseline at randomization, monthly up to 20 months after start of intervention (i.e. repeated measures).
2
CG-CAHPS
Timeframe: 1-year pre-intervention vs. 1-year post-intervention (i.e. repeated measures).