Pain Clinical Trial
Official title:
Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks
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.
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