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

NCT03301623 | Completed Results

• 1 other identifier: Pro00049085
• Study Type: interventional
• Target: 983
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Clinical Decision Support; Patient Education Materials; Opioid Use; Chronic Noncancer Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• PROMIS Physical Function 6b v1.2

  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

  1-year pre-intervention vs. 1 year post-intervention

• Number of Opioid Co-prescription of Opioids and Benzodiazepines Written by Physicians

  1-year pre-intervention vs. 1-year post-intervention

• Patient Health Questionnaire-9 (PHQ-9)

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

Study Arms (2)

Clinical Decision Support

EXPERIMENTAL

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

Patient Education and Activation Tools

EXPERIMENTAL

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

Interventions

Clinical Decision Support OTHER

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.

Clinical Decision Support

Patient Education and Activation Tools OTHER

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).

Patient Education and Activation Tools

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Within a 90-day period prior to the patient recruitment date:
• ≥30 days of prescriptions for opioid medications; or
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (26)

• 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.

  PMID: 26605926 BACKGROUND

• 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.

  PMID: 22048730 BACKGROUND

• 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.

  PMID: 24025657 BACKGROUND

• Dorn SD, Meek PD, Shah ND. Increasing frequency of opioid prescriptions for chronic abdominal pain in US outpatient clinics. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1078-85.e1. doi: 10.1016/j.cgh.2011.08.008. Epub 2011 Aug 18.

  PMID: 21854735 BACKGROUND

• 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.

  PMID: 26977696 BACKGROUND

• Wilsey BL, Fishman SM, Crandall M, Casamalhuapa C, Bertakis KD. A qualitative study of the barriers to chronic pain management in the ED. Am J Emerg Med. 2008 Mar;26(3):255-63. doi: 10.1016/j.ajem.2007.05.005.

  PMID: 18358933 BACKGROUND

• Bhamb B, Brown D, Hariharan J, Anderson J, Balousek S, Fleming MF. Survey of select practice behaviors by primary care physicians on the use of opioids for chronic pain. Curr Med Res Opin. 2006 Sep;22(9):1859-65. doi: 10.1185/030079906X132398.

  PMID: 16968589 BACKGROUND

• 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.

  PMID: 22320023 BACKGROUND

• 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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• McCarthy DM, Cameron KA, Courtney DM, Adams JG, Engel KG. Communication about opioid versus nonopioid analgesics in the emergency department. J Opioid Manag. 2015 May-Jun;11(3):229-36. doi: 10.5055/jom.2015.0271.

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• Morse JS, Stockbridge H, Egan KB, Mai J, Wickizer T, Franklin GM. Primary care survey of the value and effectiveness of the Washington State Opioid Dosing Guideline. J Opioid Manag. 2011 Nov-Dec;7(6):427-33. doi: 10.5055/jom.2011.0083.

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• Manchikanti L, Manchikanti KN, Pampati V, Cash KA. Prevalence of side effects of prolonged low or moderate dose opioid therapy with concomitant benzodiazepine and/or antidepressant therapy in chronic non-cancer pain. Pain Physician. 2009 Jan-Feb;12(1):259-67.

  PMID: 19165308 BACKGROUND

• Mahowald ML, Singh JA, Majeski P. Opioid use by patients in an orthopedics spine clinic. Arthritis Rheum. 2005 Jan;52(1):312-21. doi: 10.1002/art.20784.

  PMID: 15641058 BACKGROUND

• 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.

  PMID: 15082989 BACKGROUND

• 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.

  PMID: 16595013 BACKGROUND

• 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.

  PMID: 24075311 BACKGROUND

• 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.

  PMID: 18926612 BACKGROUND

• 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.

  PMID: 11532592 BACKGROUND

• 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.

  PMID: 22607834 BACKGROUND

• 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.

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• 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.

  PMID: 1983726 BACKGROUND

• 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.

  PMID: 11153783 BACKGROUND

• 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.

  PMID: 16982001 BACKGROUND

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  PMID: 21030902 BACKGROUND

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  PMID: 11044957 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Sample sizes for a number of outcomes (i.e. CG-CAHPS, PROMIS-PI, PROMIS-PF) were a fraction of the proposed targets due to low response rates associated with the survey phase of the study, threatening generalizability. Differences in satisfaction and prescribing rates between the two arms in the pre-intervention period pose challenges to interpreting difference in outcomes between arms. The presence of multiple interventions meant they may have been applied unevenly between the two arms.

Results Point of Contact

• Title: Brennan Spiegel
• Organization: Cedars-Sinai Medical Center

brennan.spiegel@cshs.org

310-423-6467

Study Officials

• Brennan Spiegel, MD, MSHS

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 4, 2017
• Study Start: November 13, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 13, 2021
• Results First Posted: October 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)