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Voices in Pain Care

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ClinicalTrials.gov Identifier: NCT03301623
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : December 5, 2018
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
American Chronic Pain Association
Consumer Reports
Information provided by (Responsible Party):
Brennan Spiegel, Cedars-Sinai Medical Center

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. Investigators will use multi-level regression models to compare the effectiveness of these two communication strategies.


Condition or disease Intervention/treatment Phase
Chronic Pain Other: Clinical Decision Support Other: Patient Education and Activation Tools Not Applicable

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 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  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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 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 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)
Primary Purpose: Health Services Research
Official Title: Integrating the Patient Voice Into Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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).




Primary Outcome Measures :
  1. Hierarchical Linear Model (Longitudinal Analysis) - Which communication strategy used is more effective in improving pain interference in patients' daily life for patients with chronic pain? [ Time Frame: 1 Year ]
    Dependent variable: Pain interference Independent variable: Comparator received

  2. Hierarchical Linear Model (Longitudinal Analysis) - Which communication strategy used is more effective in improving physical function in patients' daily life for patients with chronic pain? [ Time Frame: 1 Year ]
    Dependent variable: Physical function

  3. Hierarchical Linear Model (Longitudinal Analysis)- Which communication strategy used is more effective in improving how satisfied patients feel after communicating with their physician about chronic pain treatment risks and benefits? [ Time Frame: 1 Year ]
    Dependent variable: COMRADE Scores Independent variable: Comparator received


Secondary Outcome Measures :
  1. Hierarchical Generalized Linear Model - Which communication strategy used during the clinical encounter is more effective in reducing opioid prescriptions of more than 90 Morphine Milligram Equivalents (MME) per day? [ Time Frame: 1 Year ]
    Dependent variable: Opioid Prescription over 90MME/day Independent variable: Comparator received

  2. Hierarchical Generalized Linear Model - Which communication strategy used during the clinical encounter is more effective in reducing co-prescriptions of opioids and benzodiazepines? [ Time Frame: 1 Year ]
    Dependent variable: Opioids and Benzodiazepines Independent variable: Comparator received

  3. Hierarchical Generalized Linear Model - Which communication strategy used during the clinical encounter is more effective in reducing depression scores as measured by the Patient Health Questionnaire-9 (PHQ-9)? [ Time Frame: 1 Year ]
    Dependent variable: PHQ-9 score Independent variable: Comparator received

  4. Hierarchical Linear Model (Longitudinal Analysis)- Which communication strategy used is more effective in improving how satisfied patients feel with their primary care physician as measured by CG-CAHPS? [ Time Frame: 1 Year ]
    Dependent variable: The Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Survey Independent variable: Comparator received

  5. Logistic Model - Which education content do patients find most useful and most actionable? [ Time Frame: 1 year ]
    Dependent variable: Content preference Potential Covariates: Age, gender, race, ethnicity, educational level, mental health comorbidities, chronic pain diagnosis, use of other prescribed pain medications (neuropathic pain medications, NSAIDS, antidepressants) benzodiazepine use, number of office visits during intervention period, baseline HRQOL, encounter month, physician years of practice, physician gender, employment, SES



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301623


Contacts
Contact: Mayra L Lopez, MSW, MPH 310-423-8943 ext 38943 mayra.lopez@cshs.org
Contact: Alma Jusufagic, MPH 310-423-6721 ext 36721 alma.jusufagic@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Mayra L Lopez, MPH         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Patient-Centered Outcomes Research Institute
American Chronic Pain Association
Consumer Reports
Investigators
Principal Investigator: Brennan Spiegel, MD, MSHS Cedars-Sinai Medical Center

Publications:

Responsible Party: Brennan Spiegel, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03301623     History of Changes
Other Study ID Numbers: Pro00049085
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brennan Spiegel, Cedars-Sinai Medical Center:
Clinical Decision Support
Patient Education Materials
Opioid Use
Chronic Noncancer Pain

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms