Drug Use DisordersCARENCT02224508
Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks
An observational study of Drug Use Disorders and Drug Abuse, run by Kaiser Permanente.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Use Disorders, Drug Abuse, Drug Addiction
- How many people
- 1,588 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jan 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read more
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.
Read the detailed description
Detailed description not provided
- Conditions
- Drug Use Disorders, Drug Abuse, Drug Addiction, Drug Dependence, Drug Habituation, Pain
- Medical subject headings
- Substance-Related Disorders, Pain, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year prior to interview
Secondary outcomes (2)
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.
Measured: 1 week prior to interview
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.
Measured: 2 weeks prior to interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drug Use DisordersStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael R VonKorff, ScD, Principal investigator, Group Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224508
- Sponsor's protocol ID
- PCORI-1306-02198
- Acronym
- CARE
- Status last verified
- Oct 2017
- First submitted
- 15 Aug 2014
- Last updated
- 13 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks
- ClinicalTrials.gov ID
- NCT02224508
- Acronym / sponsor ID
- CARE / PCORI-1306-02198
- Conditions
- Drug Use Disorders, Drug Abuse, Drug Addiction, Drug Dependence, Drug Habituation, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,588 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale
Time frame: 1 week prior to interview
Depressive Symptoms
Time frame: 2 weeks prior to interview
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R VonKorff, ScD principal investigator
Group Health Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Use Disorders and Drug Abuse, run by Kaiser Permanente.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria). (time frame: 1 year prior to interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.