Clinical trial NCT03301623: Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain
Official title: Integrating the Patient Voice Into Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Clinical Decision Support
Patient Education Materials
Opioid Use
Chronic Noncancer Pain
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2017-10-04
Enrollment: 983
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study team will randomize the study on the provider level and use a random number generator to assign providers to study arms.

Patients within the physicians randomized to the Informed Decision Making (IDM) arm will not receive the PEAT materials; their physicians will receive the CDS alerts via the EHR when certain order criteria are triggered appropriately.

Patients within the physicians randomized to the Shared Decision Making (SDM) arm will receive the PEAT materials via REDCap two days before their PCP office visit. They will receive these materials every time they have an office visit with their PCP.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Investigators will compare two strategies: (1) Engage PCPs with Clinical Decision Support at the point of care, raising active alerts through the Electronic Health Record (EHR) when there is risk of inappropriate opioid prescribing, thus leading to informed decision-making with the patient about alternative treatments; versus (2) Engage patients prior to their PCP visit using Patient Education and Activation Tools (PEATs) administered via REDCap, helping patients to prepare for their visit and encouraging discussion about treatment preferences, values and treatment goals at the time of the visit, thus leading to shared decision-making with the provider. Our CDS intervention will use "Choosing Wisely" and Centers for Disease Control and Prevention (CDC) guidelines, and our Patient Education and Activation Tool intervention will use widely disseminated material developed by Consumer Reports and the ACPA. Investigators will assess whether improved communication and patient activation through these strategies improve patient-reported outcomes related to pain interference and HRQOL. To assess these outcomes, investigators will use NIH Patient Reported Outcome Measurement Information System (PROMIS®) questionnaires to capture health domains identified by our patient partners as most important. Using PROs will also help capture whether the use of either of these strategies leads to unintended consequences for patients when opioids are reduced and other pain management strategies are not substituted.

Recruitment procedures: The study team mails study materials including an introductory brochure, information sheet, and initial contact letter to eligible participants. Eligible participants are then called and asked if they would like to enroll in the study, at which point the study team obtains consent over the phone. Non-responders, eligible participants who the study team has not been able to reach by phone and for whom a voicemail was left, are automatically enrolled in an abbreviated arm of the study after two weeks of non-response. Those enrolled in both the full study PEATs group and abbreviated PEATs group will be sent the PEATs materials two days before an appointment with their primary care clinician. Participants may choose to opt out of any arm of the study.

Data collection: Upon enrollment in the fully study, investigators will send patients an enrollment questionnaire, which includes questions on education, language proficiency, and health literacy. At this point, investigators will also send the two PROMIS questionnaires (pain interference and physical function) via REDCap. The study team has programmed the surveys to be sent via automatic email in REDCap. The email will contain a link where participants can access the questionnaire and redeem their Amazon gift card instantly. The total time to take this questionnaire is 2 minutes.

All enrolled participants will receive monthly PROMIS questionnaires during the 12-month intervention period. Enrolled patients who have any follow-up visits during this intervention period in both full study arms will be sent the Communication Questionnaire (COMRADE) via REDCap one day after each office visit with their PCP.

For participants enrolled in the abbreviated arm of the study, the study team will have access to medical records that will allow for a retrospective pull of relevant patient-reported outcome measures and PCP satisfaction data collected by the health system.

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.

Primary outcomes:
measure: 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).
measure: CG-CAHPS
timeFrame: 1-year pre-intervention vs. 1-year post-intervention (i.e. repeated measures).
Secondary outcomes:
measure: PROMIS Physical Function 6b v1.2
timeFrame: Assessed at baseline at randomization, monthly up to 20 months after start of intervention (i.e. repeated measures).
measure: Number of Opioid Prescriptions Over 90 MME/Day Written by Physicians
timeFrame: 1-year pre-intervention vs. 1 year post-intervention
measure: Number of Opioid Co-prescription of Opioids and Benzodiazepines Written by Physicians
timeFrame: 1-year pre-intervention vs. 1-year post-intervention
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 1-year pre-intervention vs. 1-year post-intervention at all appointments (i.e. repeated measures).
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Brennan Spiegel, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
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