Clinical trial NCT03889418: Opioid Treatment and Recovery Through a Safe Pain Management Program
Official title: Opioid Treatment and Recovery Through a Safe Pain Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Opioid Use
Chronic Pain
Anxiety
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: Tulane University School of Public Health and Tropical Medicine
name: Harvard University
First posted: 2019-03-26
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg
timeFrame: 12 months prior to index event (pre-index period) and 12 months following index event (post-index period)
Secondary outcomes:
measure: Rate Ratios for Average Morphine Equivalent Daily Dose (MEDD) of Opioid Prescriptions in the Post-index Versus Pre-index Periods
timeFrame: 12 months prior to index event (pre-index period) and 12 months following index event (post-index period)
measure: Inpatient Hospital Admission Per 1000 Participants
timeFrame: 12 months prior to index event (pre-index period) and 12 months following index event (post-index period)
measure: Emergency Department Visits Per 1000 Participants
timeFrame: 12 months prior to index event (pre-index period) and 12 months following index event (post-index period)
measure: Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Depression
timeFrame: 12 months following index event (post-index period)
measure: Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Anxiety
timeFrame: 12 months following index event (post-index period)
measure: Change in Patient Rating of Quality of Life
timeFrame: Baseline, 12-months following index event (post-index period)
measure: Change in the Average Pain Score Among Participants Exposed to Collaborative Care
timeFrame: 12 months following index event (post-index period)
measure: New Post-index Documentation for Signed Pain Management Agreement (Pain Contract)
timeFrame: 12 months following index event (post-index period)
measure: New Post-index Order for Urine Drug Screen (UDS)
timeFrame: 12 months following index event (post-index period)
measure: New Post-index Naloxone Prescription Order
timeFrame: 12 months following index event (post-index period)
measure: Change in Rate of Patient Report of Opioid Misuse
timeFrame: Baseline, 12 months following index event (post-index period)
measure: New Post-index Documentation for Referral to Any Non-mental/Behavioral Health Specialty Service
timeFrame: 12 months following index event (post-index period)
measure: New Post-index Orders for Antidepressant Medications
timeFrame: 12 months following index event (post-index period)
measure: Provider Experience With Managing Depression/Anxiety/Pain
timeFrame: Baseline
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Health System - Research Dept
state: Louisiana
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: Price-Haywood EG, Burton JH, Harden-Barrios J, Bazzano A, Shi L, Lefante J, Jamison RN. Decision Support and Behavioral Health for Reducing High-Dose Opioids in Comorbid Chronic Pain, Depression and Anxiety: Stepped-Wedge Cluster Randomized Trial. J Gen Intern Med. 2024 Nov;39(15):2952-2960. doi: 10.1007/s11606-024-08965-7. Epub 2024 Aug 2.