N/A N=983 Randomized Health Services Research

Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain

Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT03301623 ↗

Enrolled (actual)

983

Serious AEs

0.4%

Results posted

Oct 2021

Primary outcome: Primary: PROMIS - Pain Interference Short Form 8a — 61.68; 60.26 score on a scale — p=.541

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Clinical Decision Support (Other); Patient Education and Activation Tools (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cedars-Sinai Medical Center
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY PROMIS - Pain Interference Short Form 8a	61.68; 60.26	.541
PRIMARY CG-CAHPS	188; 194; 34; 27	.019 sig
SECONDARY PROMIS Physical Function 6b v1.2	38.26; 39.35	.719
SECONDARY Number of Opioid Prescriptions Over 90 MME/Day Written by Physicians	208; 679; 3278; 3625	.010 sig
SECONDARY Number of Opioid Co-prescription of Opioids and Benzodiazepines Written by Physicians	196; 264; 139; 168	.510
SECONDARY Patient Health Questionnaire-9 (PHQ-9)	220; 270; 9; 16; 17; 23	.260

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03301623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.