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

September 17, 2021 updated by: Brennan Spiegel, Cedars-Sinai Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

983

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinical Decision Support
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
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.
Experimental: Patient Education and Activation Tools
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS - Pain Interference Short Form 8a
Time Frame: Assessed at baseline at randomization, monthly up to 20 months after start of intervention (i.e. repeated measures).

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
Time Frame: 1-year pre-intervention vs. 1-year post-intervention (i.e. repeated measures).

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
Time Frame: Assessed at baseline at randomization, monthly up to 20 months after start of intervention (i.e. repeated measures).

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
Time Frame: 1-year pre-intervention vs. 1 year post-intervention
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
Time Frame: 1-year pre-intervention vs. 1-year post-intervention
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)
Time Frame: 1-year pre-intervention vs. 1-year post-intervention at all appointments (i.e. repeated measures).

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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Brennan Spiegel, MD, MSHS, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

September 29, 2017

First Posted (Actual)

October 4, 2017

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00049085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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