Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain
NCT ID: NCT03301623
Last Updated: 2021-10-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
983 participants
INTERVENTIONAL
2017-11-13
2019-12-31
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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.
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.
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).
Interventions
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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.
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).
Eligibility Criteria
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Inclusion Criteria
* ≥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 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.
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Cedars-Sinai Medical Center
OTHER
Responsible Party
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Brennan Spiegel
Principal Investigator
Principal Investigators
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Brennan Spiegel, MD, MSHS
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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References
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Ballantyne JC, Sullivan MD. Intensity of Chronic Pain--The Wrong Metric? N Engl J Med. 2015 Nov 26;373(22):2098-9. doi: 10.1056/NEJMp1507136. No abstract available.
Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92.
Daubresse M, Chang HY, Yu Y, Viswanathan S, Shah ND, Stafford RS, Kruszewski SP, Alexander GC. Ambulatory diagnosis and treatment of nonmalignant pain in the United States, 2000-2010. Med Care. 2013 Oct;51(10):870-8. doi: 10.1097/MLR.0b013e3182a95d86.
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Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.
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Hooten WM, Bruce BK. Beliefs and attitudes about prescribing opioids among healthcare providers seeking continuing medical education. J Opioid Manag. 2011 Nov-Dec;7(6):417-24. doi: 10.5055/jom.2011.0082.
Kavukcu E, Akdeniz M, Avci HH, Altug M, Oner M. Chronic noncancer pain management in primary care: family medicine physicians' risk assessment of opioid misuse. Postgrad Med. 2015 Jan;127(1):22-6. doi: 10.1080/00325481.2015.993572. Epub 2014 Dec 25.
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Luo X, Pietrobon R, Hey L. Patterns and trends in opioid use among individuals with back pain in the United States. Spine (Phila Pa 1976). 2004 Apr 15;29(8):884-90; discussion 891. doi: 10.1097/00007632-200404150-00012.
Ives TJ, Chelminski PR, Hammett-Stabler CA, Malone RM, Perhac JS, Potisek NM, Shilliday BB, DeWalt DA, Pignone MP. Predictors of opioid misuse in patients with chronic pain: a prospective cohort study. BMC Health Serv Res. 2006 Apr 4;6:46. doi: 10.1186/1472-6963-6-46.
Fredheim OMS, Borchgrevink PC, Mahic M, Skurtveit S. A pharmacoepidemiological cohort study of subjects starting strong opioids for nonmalignant pain: a study from the Norwegian Prescription Database. Pain. 2013 Nov;154(11):2487-2493. doi: 10.1016/j.pain.2013.07.033. Epub 2013 Sep 24.
Burgess DJ, Crowley-Matoka M, Phelan S, Dovidio JF, Kerns R, Roth C, Saha S, van Ryn M. Patient race and physicians' decisions to prescribe opioids for chronic low back pain. Soc Sci Med. 2008 Dec;67(11):1852-60. doi: 10.1016/j.socscimed.2008.09.009. Epub 2008 Oct 15.
Adams NJ, Plane MB, Fleming MF, Mundt MP, Saunders LA, Stauffacher EA. Opioids and the treatment of chronic pain in a primary care sample. J Pain Symptom Manage. 2001 Sep;22(3):791-6. doi: 10.1016/s0885-3924(01)00320-7.
Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715-24. doi: 10.1016/j.jpain.2012.03.009. Epub 2012 May 16.
Chapman JB, Lehman CL, Elliott J, Clark JD. Sleep quality and the role of sleep medications for veterans with chronic pain. Pain Med. 2006 Mar-Apr;7(2):105-14. doi: 10.1111/j.1526-4637.2006.00110.x.
King SA, Strain JJ. Benzodiazepine use by chronic pain patients. Clin J Pain. 1990 Jun;6(2):143-7. doi: 10.1097/00002508-199006000-00013.
Menefee LA, Frank ED, Doghramji K, Picarello K, Park JJ, Jalali S, Perez-Schwartz L. Self-reported sleep quality and quality of life for individuals with chronic pain conditions. Clin J Pain. 2000 Dec;16(4):290-7. doi: 10.1097/00002508-200012000-00003.
Ritzwoller DP, Crounse L, Shetterly S, Rublee D. The association of comorbidities, utilization and costs for patients identified with low back pain. BMC Musculoskelet Disord. 2006 Sep 18;7:72. doi: 10.1186/1471-2474-7-72.
Friedman BW, Chilstrom M, Bijur PE, Gallagher EJ. Diagnostic testing and treatment of low back pain in United States emergency departments: a national perspective. Spine (Phila Pa 1976). 2010 Nov 15;35(24):E1406-11. doi: 10.1097/BRS.0b013e3181d952a5.
Gilbert FJ, Grant AM, Gillan MG, Vale LD, Campbell MK, Scott NW, Knight DJ, Wardlaw D; Scottish Back Trial Group. Low back pain: influence of early MR imaging or CT on treatment and outcome--multicenter randomized trial. Radiology. 2004 May;231(2):343-51. doi: 10.1148/radiol.2312030886. Epub 2004 Mar 18.
Kerry S, Hilton S, Patel S, Dundas D, Rink E, Lord J. Routine referral for radiography of patients presenting with low back pain: is patients' outcome influenced by GPs' referral for plain radiography? Health Technol Assess. 2000;4(20):i-iv, 1-119. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00049085
Identifier Type: -
Identifier Source: org_study_id