Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks

NCT ID: NCT02224508

Last Updated: 2017-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1588 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-01-31

Brief Summary

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Background: Sixty million American adults suffer from moderate to severe chronic pain. Of these, 5 to 8 million currently use opioids long-term. With increased opioid prescribing for chronic pain, an epidemic of prescription opioid addiction and overdose has arisen. This necessitates action to stem opioid-related morbidity and mortality. Group Health (GH), a large nonprofit health plan, developed and implemented opioid risk reduction strategies for doctors and patients in some, but not all, of its clinics. The risk reduction initiative achieved large opioid dose reductions, near universal documentation of care plans, and marked increases in patient monitoring. Rigorous evaluation of patient outcomes resulting from the opioid risk reduction initiative, incorporating patient perspectives, is needed to guide health care improvement efforts to reduce opioid risks regionally and nationally.

Research goal: The investigators will evaluate a major health plan initiative to reduce risks of long-term opioid use for chronic pain. Starting in 2008, some GH clinics reduced prescribing of high opioid doses. In 2010 the same clinics increased care planning and monitoring of chronic opioid therapy (COT) patients. Our research goal is to evaluate effects of this initiative on health and safety outcomes of COT patients. We will test whether the initiative influenced pain outcomes; patient-reported opioid benefits and problems; and opioid-related adverse events.

Design and Outcomes: The investigators will assess effects of GH's opioid risk reduction initiative among COT patients using opioids long-term. The investigators will compare COT patients from clinics that implemented the initiative with COT patients from care settings that did not implement the initiative. The investigators will use survey data to assess patient-reported outcomes including pain severity, depressive symptoms, and patient perceptions of opioid benefits and problems, including validated measures of prescription opioid use disorder. They will interview and compare 800 COT patients using opioids long-term from clinics that implemented the risk reduction initiative and 800 COT patients from care settings that did not.

Impact: This research will provide an urgently needed, rigorous evaluation of a major risk reduction initiative among COT patients. Evaluation results will guide efforts of health plans, clinicians and patients nationwide to ensure safe, effective and compassionate chronic pain care.

Detailed Description

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Detailed description not provided

Conditions

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Drug Use Disorders Drug Abuse Drug Addiction Drug Dependence Drug Habituation Pain Depressive Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Opioid Risk Reduction Initiative

Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.

No interventions assigned to this group

Usual Care

Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Enrolled for at least one year prior to sampling for survey
* Received 70+ days supply of opioids in 2 of 4 quarters, including the most recent 90 days
* Received 45+ days supply of opioids in the other 2 quarters

Exclusion Criteria

* Received cancer diagnoses, other than non-melanoma skin cancer, at least twice in the prior year
* Received any skilled nursing facility care in the prior year
* Received any hospice care or
* Received any opioids from an oncologist
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael R VonKorff, ScD

Role: PRINCIPAL_INVESTIGATOR

Group Health Research Institute

Other Identifiers

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PCORI-1306-02198

Identifier Type: -

Identifier Source: org_study_id