Opioid Treatment and Recovery Through a Safe Pain Management Program

• ClinicalTrials.gov Identifier: NCT03889418
• Recruitment Status: Enrolling by invitation
• First Posted: March 26, 2019
• Last Update Posted: January 4, 2022
• Sponsor: Ochsner Health System
• Collaborators: Tulane University School of Public Health and Tropical Medicine; Harvard University
• Information provided by (Responsible Party): Eboni Price-Haywood, Ochsner Health System

Study Description

Brief Summary:

Opioid prescription drug abuse has become a major public health concern in the United States with mortality rates from fatal overdoses reaching epidemic proportions. This opioid crisis coincides with national efforts to improve management of chronic non-cancer pain. The net result, however, has been ever-growing increases in medical expenditures related to prescription costs and increased healthcare service utilization among opioid abusers. Healthcare provider prescribing pattern, especially among non-pain management specialists such as primary care, is a major factor. Louisiana is a major contributor to the epidemic with the 7th highest opioid prescribing rates accompanied by a 12% increase in fatal overdoses.

Providers are overdue for implementing safe opioid management strategies in primary care to combat the opioid crisis. Recent practice guidelines provide recommendations on what to do for safe prescribing of opioids, but they do not provide guidance on how to translate them into practice. Health systems must find ways to accelerate guideline adoption in primary care in the face of an overdose crisis. Research that examines a combination workflow- and provider-focused strategies are needed. Given the high prevalence of psychiatric disorders among patients with chronic non-cancer pain, care team expansion with integration of collaborative mental/behavioral health services may be the solution. Collaborative care can extend opioid management beyond standardized monitoring of risk factors for opioid misuse or abuse and set clear protocols for next steps in management.

This study is aligned with the National Institute on Drug Abuse's interest in health systems research that examines approaches to screening, assessment, prevention, diagnosis and treatment for prescription drug abuse. It will examine the primary care practice redesign of managing chronic non-cancer pain within a large health system whose 40+ Accountable Care Network-affiliated, adult primary care clinics may serve as an example for transforming opioid management in primary care practices across the country. This four-year type 2 effectiveness-implementation hybrid stepped wedge cluster randomized control trial is designed to compare the clinical and cost effectiveness of electronic medical record-based clinical decision support guided care versus additional integrated, stepped collaborative care for opioid management of primary care patients with chronic non-cancer pain (clinical pharmacist for medication management; licensed clinical social worker for cognitive behavioral therapy and community health worker care coordination); and to examine facilitators and barriers to implementing this multi-component intervention. Investigators anticipate that our study results will elucidate the role of technology versus care team optimization in changing provider opioid prescribing behaviors. Investigators further anticipate that results of our study will demonstrate that integrated mental/behavioral health care for opioid management of chronic non-cancer pain increases value-based care and leads to greater efficiencies in the way that care is delivered.

Condition or disease	Intervention/treatment	Phase
Depression; Opioid Use; Chronic Pain; Anxiety	Behavioral: Electronic medical recorded clinical decision support [EMR CDS]; Behavioral: Stepped opioid collaborative care model [CCM]	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 490 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This proposal is a 4-year type 2 effectiveness-implementation hybrid stepped wedge cluster randomized control (cRCT) trial to evaluate a multi-component intervention to: electronic medical recorded (EMR)clinical decision support (CDS) guided care; and stepped opioid collaborative care model (CCM) to improve opioid management of primary care patients with chronic non-cancer pain. The stepped wedge cRCT design will allow us to examine the clinical impact of the intervention as the two components are implemented in a stepwise fashion across the health system. The EMR CDS guided care component went live in all primary care clinics as the health system's standard of practice in October 2017. The stepped opioid CCM component will require 15 months to scale up in 3-month intervals across five geographic regions of the health system in the state of Louisiana. We will randomize the order in which stepped opioid CCM becomes available in each region
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Opioid Treatment and Recovery Through a Safe Pain Management Program
• Actual Study Start Date: April 1, 2019
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: June 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Electronic medical recorded clinical decision support; Usual care only	Behavioral: Electronic medical recorded clinical decision support [EMR CDS]; The opioid management tool has quick links to the Opioid Risk Tool (ORT), health maintenance reminders for risk mitigation tasks (pain management agreements; urine drug screening; prescribing naloxone); Pain Scale and depression/anxiety screen. The frequency with which providers are prompted to complete mitigation tasks is based on patients' level of risk for aberrant drug behavior defined by the ORT score. Additionally, the EMR CDS flags patients as high risk if one of the following criteria are met: (1) co-prescriptions for benzodiazepines; (2) active diagnosis of substance abuse in the last 12 months; or (3) MEDD >=90 mg. The ORT score, morphine equivalent daily dose (MEDD), and hyperlinks to the Louisiana pharmacy drug monitoring program data are visible in the prescription writer. If MEDD >=90 mg, the calculated MEDD is displayed in red font to alert the prescribing provider of high dosage. An Epic banner appears in charts to alert providers of existing pain management agreements.
Active Comparator: stepped opioid collaborative care model; Usual care AND collaborative care with behavioral health integration	Behavioral: Electronic medical recorded clinical decision support [EMR CDS]; The opioid management tool has quick links to the Opioid Risk Tool (ORT), health maintenance reminders for risk mitigation tasks (pain management agreements; urine drug screening; prescribing naloxone); Pain Scale and depression/anxiety screen. The frequency with which providers are prompted to complete mitigation tasks is based on patients' level of risk for aberrant drug behavior defined by the ORT score. Additionally, the EMR CDS flags patients as high risk if one of the following criteria are met: (1) co-prescriptions for benzodiazepines; (2) active diagnosis of substance abuse in the last 12 months; or (3) MEDD >=90 mg. The ORT score, morphine equivalent daily dose (MEDD), and hyperlinks to the Louisiana pharmacy drug monitoring program data are visible in the prescription writer. If MEDD >=90 mg, the calculated MEDD is displayed in red font to alert the prescribing provider of high dosage. An Epic banner appears in charts to alert providers of existing pain management agreements.; Behavioral: Stepped opioid collaborative care model [CCM]; The licensed clinical social worker (LCSW) will provide counseling services as indicated (behavioral activation, psychotherapy, crisis planning, facilitating connection to substance abuse counseling and treatment); meet weekly with the consulting psychiatrist for complex case review and care plan adjustments; and supervise the community health worker (CHW) case management and depression/anxiety care management activities. The CHW will update assets and barriers to recovery and self-management and help patients navigate community resources. The clinical pharmacist will review and reconcile active medication lists, assess medication side effects, drug interactions and adverse events; monitor analgesia; recommend algorithm based anti-depression medication titration as indicated. The consulting psychiatrist will directly co-manage patients with severe mental illness, substance abuse and complex medication regimens.

Outcome Measures

Primary Outcome Measures :

1. Change in rate of high dose opioid prescribing [ Time Frame: Baseline, 6-months, 12-months ]
   Change in percent patients with Morphine equivalent daily dose (MEDD) >=50

Secondary Outcome Measures :

1. Change in average daily opioid prescription dosage [ Time Frame: Baseline, 6-months, 12-month ]
   Change in the population average MEDD
2. Change in rate of inpatient hospitalization [ Time Frame: Baseline, 12-months ]
   Change in rate of inpatient hospitalization visits
3. Change in rate of emergency department use [ Time Frame: Baseline, 12-months ]
   Change in rate of emergency department visits
4. Change in rate of depression symptom response to treatment [ Time Frame: Baseline, 3-months, 6-months, 12-months ]
   Change in Patient Health Questionnaire-9 scores
5. Change in rate of anxiety symptom response to treatment [ Time Frame: Baseline, 3-months, 6-months, 12-months ]
   Change in Generalized Anxiety Disorder-7 scores
6. Change in patient rating of Quality of Life [ Time Frame: Baseline, 6-months, 12-months ]
   Change in Global Health-10 scores
7. Change in patient rating of pain control [ Time Frame: Baseline, 3-months, 6-months, 12-months ]
   Change in Pain, Enjoyment, General Activity-3 scores
8. Change in rate of practice guideline adherence for pain agreements [ Time Frame: Baseline, 12-months ]
   Change in proportion of patients with pain agreements
9. Change in rate of practice guideline adherence for urine drug screening [ Time Frame: Baseline, 12-months ]
   Change in proportion of patients with urine drug screening
10. Change in rate of practice guideline adherence for naloxone prescriptions [ Time Frame: Baseline, 12-months ]
    Change in proportion of high risk patients with naloxone prescriptions
11. Change in rate of patient report of opioid misuse [ Time Frame: Baseline, 6-months, 12-months ]
    Change in Current Opioid Misuse Measure-9 scores
12. Change in rate of referral to specialty care [ Time Frame: Baseline, 12-months ]
    Change in proportion of patients referred to specialists for pain management
13. Change in rate of non-opioid prescriptions for pain management [ Time Frame: Baseline, 12-months ]
    Change in proportion of patients with non-opioid prescriptions for pain management
14. Change in provider experience with managing mental health conditions [ Time Frame: Baseline, 12-months ]
    Change in provider ratings of their experience

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Age 18 and older
2. Have a primary care provider at any of the study clinics
3. Receiving chronic opioid prescriptions (3 of the prior 4 months) for chronic non-cancer pain
4. Have a diagnosis of depression or anxiety

Exclusion Criteria:

1. Age less than 18 years
2. Active cancer or undergoing cancer treatment
3. Chronic cancer-related pain
4. Having a terminal illness
5. Receiving hospice care

Contacts and Locations

Locations

United States, Louisiana

Ochsner Health System - Research Dept

New Orleans, Louisiana, United States, 70121

Sponsors and Collaborators

Ochsner Health System

Tulane University School of Public Health and Tropical Medicine

Harvard University

More Information

Publications:

Price-Haywood EG, Robinson W, Harden-Barrios J, Burton J, Burstain T. Intelligent Clinical Decision Support to Improve Safe Opioid Management of Chronic Noncancer Pain in Primary Care. Ochsner J. 2018 Spring;18(1):30-35.

Price-Haywood EG, Burton J, Burstain T, Harden-Barrios J, Lefante J, Shi L, Jamison RN, Bazzano A, Bazzano L. Clinical Effectiveness of Decision Support for Prescribing Opioids for Chronic Noncancer Pain: A Prospective Cohort Study. Value Health. 2020 Feb;23(2):157-163. doi: 10.1016/j.jval.2019.09.2748. Epub 2019 Nov 22.

Price-Haywood EG, Burton J, Harden-Barrios J, Bazzano A, Lefante J, Shi L, Jamison RN. Depression, anxiety, pain and chronic opioid management in primary care: Type II effectiveness-implementation hybrid stepped wedge cluster randomized trial. Contemp Clin Trials. 2021 Feb;101:106250. doi: 10.1016/j.cct.2020.106250. Epub 2020 Dec 14.

• Responsible Party: Eboni Price-Haywood, Medical Director, Ochsner Health System
• ClinicalTrials.gov Identifier: NCT03889418
• Other Study ID Numbers: 1R01DA045029-01 ( U.S. NIH Grant/Contract )
• First Posted: March 26, 2019
• Last Update Posted: January 4, 2022
• Last Verified: January 2022

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

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents