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

NCT02224508 | Completed Results

• 1 other identifier: PCORI-1306-02198
• Study Type: observational
• Target: 1,588
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria).

  Proportion with Prescription Opioid Use Disorder, which is defined by multiple indicators of opioid abuse and addiction from 9 criteria in the DSM5 manual of the American Psychiatric Association. In this research, it will be assessed using the Psychiatric Research Interview for Substance and Mental Disorders (PRISM5, Columbia University). Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.

  1 year prior to interview

Secondary Outcomes (2)

• Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale

  1 week prior to interview

• Depressive Symptoms

  2 weeks prior to interview

Study Arms (2)

Opioid Risk Reduction Initiative

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

Usual Care

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

Eligibility Criteria

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

Study Population

The study population is prevalent Chronic Opioid Therapy (COT) patients from Group Health clinics. Our initial goals was to 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. sample size targets were revised to enroll 950 COT patients from the clinics that implemented the risk reduction initiatives and 650 from the clinics that did not implement the risk reduction initiatives.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

MeSH Terms

Conditions

Substance-Related Disorders; Pain; Depressive Disorder

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mood Disorders

Limitations and Caveats

This phase of the evaluation reports after-only survey data comparing prevalent chronic opioid therapy patients who had been exposed or not exposed to the health plan opioid risk reduction initiatives for at least one year.

Results Point of Contact

• Title: Michael Von Korff, ScD
• Organization: Group Health Research Institute

vonkorff.m@ghc.org

206-287-2874

Study Officials

• Michael R VonKorff, ScD

  Group Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 25, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: November 13, 2017
• Results First Posted: May 5, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share