Opioid Treatment and Recovery Through a Safe Pain Management Program

NCT03889418 | Completed Results

• 1 other identifier: 1R01DA045029-01
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Opioid Use; Chronic Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg

  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)

  12 months prior to index event (pre-index period) and 12 months following index event (post-index period)

Secondary Outcomes (14)

• Rate Ratios for Average Morphine Equivalent Daily Dose (MEDD) of Opioid Prescriptions in the Post-index Versus Pre-index Periods

  12 months prior to index event (pre-index period) and 12 months following index event (post-index period)

• Inpatient Hospital Admission Per 1000 Participants

  12 months prior to index event (pre-index period) and 12 months following index event (post-index period)

• Emergency Department Visits Per 1000 Participants

  12 months prior to index event (pre-index period) and 12 months following index event (post-index period)

• Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Depression

  12 months following index event (post-index period)

• Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Anxiety

  12 months following index event (post-index period)

Study Arms (2)

Electronic medical recorded clinical decision support

ACTIVE COMPARATOR

Usual care only

Behavioral: Electronic medical recorded clinical decision support [EMR CDS]

stepped opioid collaborative care model

ACTIVE COMPARATOR

Usual care AND collaborative care with behavioral health integration

Behavioral: Electronic medical recorded clinical decision support [EMR CDS]; Behavioral: Stepped opioid collaborative care model [CCM]

Interventions

Electronic medical recorded clinical decision support [EMR CDS] BEHAVIORAL

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.

Electronic medical recorded clinical decision support; stepped opioid collaborative care model

Stepped opioid collaborative care model [CCM] BEHAVIORAL

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.

stepped opioid collaborative care model

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Age less than 18 years
• Active cancer or undergoing cancer treatment
• Chronic cancer-related pain
• Having a terminal illness
• Receiving hospice care

Sponsors & Collaborators

• Ochsner Health System: lead
• Tulane University School of Public Health and Tropical Medicine: collaborator
• Harvard University: collaborator

Study Sites (1)

Ochsner Health System - Research Dept

New Orleans, Louisiana, 70121, United States

Location

Related Publications (4)

• 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.

  PMID: 29559866 BACKGROUND

• 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.

  PMID: 32113620 BACKGROUND

• 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.

  PMID: 33326877 BACKGROUND

• 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.

  PMID: 39095571 RESULT

MeSH Terms

Conditions

Depression; Chronic Pain; Anxiety Disorders

Interventions

MCC protocol

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Limitations and Caveats

All data collected for the study were extracted from the health system electronic medical system.

Results Point of Contact

• Title: Principal Investigator
• Organization: Ochsner Health

eboni.pricehaywood@ochsner.org

504-842-8256

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: 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

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 26, 2019
• Study Start: April 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: August 28, 2024
• Results First Posted: December 12, 2023

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)