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

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ClinicalTrials.gov Identifier: NCT02224508
Recruitment Status : Completed
First Posted : August 25, 2014
Results First Posted : May 5, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente

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.


Condition or disease
Drug Use Disorders Drug Abuse Drug Addiction Drug Dependence Drug Habituation Pain Depressive Disorder

Detailed Description:
Detailed description not provided

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Study Type : Observational
Actual Enrollment : 1588 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks
Study Start Date : September 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Group/Cohort
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.



Primary Outcome Measures :
  1. Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria). [ Time Frame: 1 year prior to interview ]
    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.


Secondary Outcome Measures :
  1. Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale [ Time Frame: 1 week prior to interview ]
    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.

  2. Depressive Symptoms [ Time Frame: 2 weeks prior to interview ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224508


Sponsors and Collaborators
Kaiser Permanente
Investigators
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Principal Investigator: Michael R VonKorff, ScD Group Health Research Institute

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02224508     History of Changes
Other Study ID Numbers: PCORI-1306-02198
First Posted: August 25, 2014    Key Record Dates
Results First Posted: May 5, 2017
Last Update Posted: November 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Depressive Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Chemically-Induced Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents