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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301623
• Other study ID #: Pro00049085
• Status: Completed
• Phase: N/A
• Start date: November 13, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2021
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 983
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (26)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Clin Gastroenterol Hepatol. 2012 Mar;10(3):332. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 Mar 18. — View Citation

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. — View Citation

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. — View Citation

Kavukcu E, Akdeniz M, Avci HH, Altug M, Öner 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. — View Citation

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. — View Citation

King SA, Strain JJ. Benzodiazepine use by chronic pain patients. Clin J Pain. 1990 Jun;6(2):143-7. — View Citation

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. — View Citation

Mahowald ML, Singh JA, Majeski P. Opioid use by patients in an orthopedics spine clinic. Arthritis Rheum. 2005 Jan;52(1):312-21. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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).
Secondary	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
Secondary	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
Secondary	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).