Opioid Treatment and Recovery Through a Safe Pain Management Program

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Depression Opioid Use Chronic Pain Anxiety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Electronic medical recorded clinical decision support

Usual care only

Group Type ACTIVE_COMPARATOR

Electronic medical recorded clinical decision support [EMR CDS]

Intervention Type 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.

stepped opioid collaborative care model

Usual care AND collaborative care with behavioral health integration

Group Type ACTIVE_COMPARATOR

Electronic medical recorded clinical decision support [EMR CDS]

Intervention Type 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.

Stepped opioid collaborative care model [CCM]

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No