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

Pain Clinical Trial

— CARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224508
• Other study ID #: PCORI-1306-02198
• Status: Completed
• Phase: N/A
• First received: August 15, 2014
• Last updated: October 11, 2017
• Start date: September 2014
• Est. completion date: January 2016

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Detailed description not provided

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1588
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Disease
• Drug Abuse
• Drug Addiction
• Drug Dependence
• Drug Habituation
• Drug Use Disorders
• Pain
• Substance-Related Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale	PEG (Pain - Enjoyment - Interference with General Activities) pain scale consisting of the average of 3 0-10 ratings of pain intensity, interference with activities due to pain, and reduced enjoyment of life due to pain. 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 PEG score ranges from 0 to 30, with higher scores indicating greater pain severity. 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 week prior to interview
Secondary	Depressive Symptoms	Patient Health Questionnaire (PHQ-8) depression scale. The PHQ-8 is estimated by summing the 8 scale items. The total score ranges from 0 to 24, with higher scores indicating greater depression severity. 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.	2 weeks prior to interview