Opioid Treatment and Recovery Through a Safe Pain Management Program

• ClinicalTrials.gov Identifier: NCT03889418
• Recruitment Status: Completed
• First Posted: March 26, 2019
• Results First Posted: December 12, 2023
• Last Update Posted: December 12, 2023
• 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)
• Actual 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
• Actual Primary Completion Date: June 30, 2022
• Actual Study Completion Date: June 30, 2023

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. Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg [ Time Frame: 12 months prior to index event (pre-index period) and 12 months following index event (post-index period) ]
   Participants' opioid medication orders were monitored for 12 months prior to and following entry into study (index event). This outcome represents the odds of having an average MEDD ≥ 50 mg in the pre-index and post-index periods for the collaborative care and usual care groups. Odds of an event is defined as the ratio of the probability that the event will happen (prescribed high dose opioid) to the probability that the event will not happen (not prescribed high dose opioid)

Secondary Outcome Measures :

1. Rate Ratios for Average Morphine Equivalent Daily Dose (MEDD) of Opioid Prescriptions in the Post-index Versus Pre-index Periods [ Time Frame: 12 months prior to index event (pre-index period) and 12 months following index event (post-index period) ]
   Participants' opioid medication orders were monitored for 12 months prior to and following entry into study (index event). This outcome represents the rate ratio of average MEDD in the post-index versus pre-index periods for the Behavioral Collaborative Care (BHI-CCM + EMR-CDS) and Usual Care (EMR-CDS only) groups. The rate ratio compares the average dose of opioid prescription in the post-index period to the pre-index period. A rate ratio less than 1 indicates that the average dose decreased.
2. Inpatient Hospital Admission Per 1000 Participants [ Time Frame: 12 months prior to index event (pre-index period) and 12 months following index event (post-index period) ]
   Participants' non-elective inpatient hospital admissions were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of admissions in the pre-index and post-index periods for the study groups
3. Emergency Department Visits Per 1000 Participants [ Time Frame: 12 months prior to index event (pre-index period) and 12 months following index event (post-index period) ]
   Participants' emergency department (ED) visits were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of ED visits in the pre-index and post-index periods for the study groups
4. Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Depression [ Time Frame: 12 months following index event (post-index period) ]
   Participants in the collaborative care group were administered the Patient Health Questionnaire (PHQ)-9 questionnaire at baseline and every 4 weeks following date of enrollment in study. The PHQ-9 is a nine item questionnaire. The total score ranges from 0 to 27 (scores of 5-9 mild depression; 10-14 moderate depression; 15-19 moderately severe depression; ≥ 20 severe depression). This single-group outcome represents the number of participants who entered the study with symptoms of moderate to severe depression (PHQ-9 score ≥ 10) and achieved a PHQ-9 score < 10 on the last completed questionnaire.
5. Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Anxiety [ Time Frame: 12 months following index event (post-index period) ]
   Participants in the collaborative care group were administered the Generalized Anxiety Disorder (GAD)-7 questionnaire at baseline and every 4 weeks following date of enrollment in study. The GAD-7 is a seven item questionnaire. The total score ranges from 0 to 21 (scores of 5-9 mild anxiety; 10-14 moderate anxiety; 15-21 severe anxiety).This single-group outcome represents the number of participants who entered the study with symptoms of moderate to severe anxiety (GAD-7 score ≥ 10) and achieved a GAD-7 score < 10 on the last completed questionnaire
6. Change in Patient Rating of Quality of Life [ Time Frame: Baseline, 12-months following index event (post-index period) ]
   Participants in the Collaborative Care group were administered the Patient Reported Outcomes Measurement Information System (PROMIS) 10 item questionnaire at baseline and every 12 weeks following enrollment in study. A PROMIS score of 50 is the average (or mean) score for the U.S. general population. This single-group outcome represents the average change in PROMIS-10 global mental health score from the first to the last completed questionnaire during the acute phase.
7. Change in the Average Pain Score Among Participants Exposed to Collaborative Care [ Time Frame: 12 months following index event (post-index period) ]
   Participants in the collaborative care group were administered the Pain Enjoyment of Life General Activity (PEG)-3 questionnaire at baseline and every 4 weeks during the acute phase of treatment. THE PEG-3 consists of 3 questions - each with a rating scale 0 (no pain; no interference) to 10 (worse pain; completely interferes). The score is generated by summing the score of the 3 scales (max 30 points) and then dividing by 3. The measure is reliable with construct validity and responsive among primary care patients. This single-group outcome represents the average change in PEG-3 score from the first to the last completed questionnaire during the acute phase.
8. New Post-index Documentation for Signed Pain Management Agreement (Pain Contract) [ Time Frame: 12 months following index event (post-index period) ]
   Participants' pain contracts were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of participants with a documented pain contract in the post-index period among those with no pain contract in the pre-index period
9. New Post-index Order for Urine Drug Screen (UDS) [ Time Frame: 12 months following index event (post-index period) ]
   Participants' UDS were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of participants with a documented UDS order in the post-index period among those with no UDS order in the pre-index period
10. New Post-index Naloxone Prescription Order [ Time Frame: 12 months following index event (post-index period) ]
    Participants' medication orders were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of participants with naloxone orders in the post-index period among those with no naloxone orders in the pre-index period
11. Change in Rate of Patient Report of Opioid Misuse [ Time Frame: Baseline, 12 months following index event (post-index period) ]
    Change in Current Opioid Misuse Measure-9 (COMM-9) scores: The COMM-9 is a 9-item questionnaire with a 5-item response scale (0=never; 4=very often) that captures a 30-day period and only includes behaviors that can change over time (score range 0 to 36). Scoring greater than 4 are identified as being at risk for medication misuse. Participants in the Collaborative Care group were administered the COMM-9 questionnaire at baseline and every 4 weeks during the acute phase of treatment. This single-group outcome represents the average change in COMM-9 score from the first to the last completed questionnaire during the acute phase.
12. New Post-index Documentation for Referral to Any Non-mental/Behavioral Health Specialty Service [ Time Frame: 12 months following index event (post-index period) ]
    Participants' non-mental/behavioral health specialty service referrals (e.g. physical therapy, orthopedics) were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of participants with referrals in the post-index period among those with no referrals in the pre-index period
13. New Post-index Orders for Antidepressant Medications [ Time Frame: 12 months following index event (post-index period) ]
    Participants' medication orders were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of participants with a new order for antidepressants in the post-index period among those with no orders in the pre-index period
14. Provider Experience With Managing Depression/Anxiety/Pain [ Time Frame: Baseline ]
    Provider ratings of their experience with managing depression/anxiety/pain

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

  Study Documents (Full-Text)

Documents provided by Eboni Price-Haywood, Ochsner Health System:

Study Protocol  [PDF] October 6, 2020

Statistical Analysis Plan  [PDF] October 8, 2023

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
• Results First Posted: December 12, 2023
• Last Update Posted: December 12, 2023
• Last Verified: November 2023

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