Clinical trial NCT02224508: Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks
Official title: Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Use Disorders
Drug Abuse
Drug Addiction
Drug Dependence
Drug Habituation
Pain
Depressive Disorder
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 1588
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: Detailed description not provided

Eligibility criteria: 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

Primary outcomes:
measure: Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria).
timeFrame: 1 year prior to interview
Secondary outcomes:
measure: Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale
timeFrame: 1 week prior to interview
measure: Depressive Symptoms
timeFrame: 2 weeks prior to interview
Other outcomes:
Locations:
Study officials:
affiliation: Group Health Research Institute
name: Michael R VonKorff, ScD
role: PRINCIPAL_INVESTIGATOR
References: