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 not provided

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

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.

A complete, cleaned, de-identified copy of the final dataset used in conducting the final analyses will be made available to other qualified researchers within nine months of the end of the final year of funding upon approval by the Group Health Human Subject's Review Committee.

Given the complexity of the final dataset, our expectation would be that other researchers using the data would require technical assistance from our research team to understand the data and to employ appropriate methods of data analysis. Or, other researchers may prefer to have us analyze the study data to produce analyses according to their specifications. Since use of the dataset by other investigators, or analyses carried out by us for other researchers, would occur after the grant award period has ended, we will expect necessary funding of technical support, data transfers and/or data analyses to be obtained by the research team requesting access to the final dataset.

The survey was cross-sectional. The prevalent Chronic Opioid Therapy (COT) patients were assessed at the time they were interviewed. The time frame was the year prior to the interview for prescription opioid use disorder, the two weeks prior to the interview for the depressive symptom scale (PHQ-8), and the prior week for the pain severity scale (PEG).

Since study subjects were not tracked over time, we did not assess adverse events occurring over time. The survey assessment did assess prevalent adverse outcomes relevant to chronic opioid therapy (prescription opioid use disorder, depressive symptoms, pain severity).

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.