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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Integrating the Patient Voice Into Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: Clinical Decision Support
* Other: Patient Education and Activation Tools


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical Decision Support<br>Patients within the physicians randomized to the IDM arm will receive the Clinical Decision Support alerts via the EHR when certain order criteria are triggered appropriately. | Other: Clinical Decision Support<br>* The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.<br>|
| Experimental: Patient Education and Activation Tools<br>Patients within the physicians randomized to SDM will receive the PEAT materials via REDCap two days prior to their PCP office visit. They will receive these materials every time they have an office visit with their PCP. | Other: Patient Education and Activation Tools<br>* The patient education materials selected for this study: Pain Management: Which Treatment is Right for You, Preparing for Your Health Care Visit, and a video from the American Chronic Pain Association (ACPA) named A Car with Four Flat Tires, which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS - Pain Interference Short Form 8a | PROMIS - Pain Interference instruments assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Pain Interference, a T-score of 60 is one SD higher pain than average. A t-score of 50 represents the mean pain interference reported by a representative US population. We report pre- and post-intervention means. Analysis featured a linear mixed model for repeated measures where the term of interest was an interaction term describing the change in the PEAT group during the post-intervention period. | Assessed at baseline at randomization, monthly up to 20 months after start of intervention (i.e. repeated measures). | 
| CG-CAHPS | The Consumer Assessment of Healthcare Providers and System Clinician and Group Survey (CG-CAHPS) is a widely used PRO for collecting and reporting information from patients' about their experiences of care. We used the How well providers communicate with patients 6-item composite score. The response scale for these items was Yes, definitely, Yes, somewhat, and No. The composite score was represented as a binary value indicating whether a PCP received all top-box scores (represented by Yes, definitely responses) on the 6 items. We report the count of top box responses in the pre- and post-intervention periods by group. Analysis featured a mixed effects logistic regression model for repeated measures where the term of interest was an interaction term describing the change in the odds of a top box score in the PEAT group during the post-intervention period. | 1-year pre-intervention vs. 1-year post-intervention (i.e. repeated measures). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Physical Function 6b v1.2 | PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. We report pre- and post-intervention means. Analysis featured a linear mixed model for repeated measures where the term of interest was an interaction term describing the change in the PEAT group during the post-intervention period. | Assessed at baseline at randomization, monthly up to 20 months after start of intervention (i.e. repeated measures). | 
| Number of Opioid Prescriptions Over 90 MME/Day Written by Physicians | Physicians should avoid increasing dosage to ≥90 MME/day, and this measure compares odds of writing prescriptions over 90mme pre- vs. post-intervention | 1-year pre-intervention vs. 1 year post-intervention | 
| Number of Opioid Co-prescription of Opioids and Benzodiazepines Written by Physicians | Physicians should avoid co-prescribing of opioids and benzodiazepines. This binary outcome captures the presence (or lack) of a written prescriptions for opioids within a 24-hour window on either side of a prescription for benzodiazepines. | 1-year pre-intervention vs. 1-year post-intervention | 
| Patient Health Questionnaire-9 (PHQ-9) | The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). The raw score was categorized by severity according to the scoring guide and analyzed as such. Raw scores were assigned the following categories: 0-4, None; 5-9, Mild; 10-14, Moderate; 15-19, Moderately severe; and 20 or greater, Severe. We report the count of categorized PHQ-9 responses in the pre- (baseline characteristics) and post-intervention periods by group. Analysis featured a mixed effects ordered logistic regression model for repeated measures where the term of interest was an interaction describing the change in the odds of a top box score in the PEAT group during the post-intervention period. Analysis did not require balanced data (i.e. any scores in any time period meant patient was included). | 1-year pre-intervention vs. 1-year post-intervention at all appointments (i.e. repeated measures). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical Decision Support, Patient Education Materials, Opioid Use, Chronic Noncancer Pain