An observational study in Drug Use Disorders, Drug Abuse and Drug Addiction, sponsored by Kaiser Permanente. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-13.
Sponsored by Kaiser Permanente · Observational
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 not provided
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 1,588 is above the median of 250 across 296 observational studies indexed under Substance-Related Disorders.
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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.
Exclusion Criteria:
Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
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.
Time frame: 1 year prior to interview
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.
Time frame: 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.
Time frame: 2 weeks prior to interview
| Milestone | Opioid Risk Reduction Initiative | Usual Care |
|---|---|---|
| Started | 935 | 653 |
| Completed | 935 | 653 |
| Not completed | 0 | 0 |
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.
| proportion of COT patients | Opioid Risk Reduction Initiative | Usual Care |
|---|---|---|
| Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria). | 0.215 (0.189 to 0.244) | 0.239 (0.205 to 0.276) |
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.
| units on a scale | Opioid Risk Reduction Initiative | Usual Care |
|---|---|---|
| Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale | 5.79 (5.65 to 5.93) | 5.82 (5.65 to 5.99) |
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.
| units on a scale | Opioid Risk Reduction Initiative | Usual Care |
|---|---|---|
| Depressive Symptoms | 7.39 (7.04 to 7.74) | 7.91 (7.45 to 8.37) |
Collected over The survey was cross-sectional. The prevalent Chronic Opioid Therapy (COT) patients were assessed at the time they were interviewed. The time frame was the year prior to the interview for prescription opioid use disorder, the two weeks prior to the interview for the depressive symptom scale (PHQ-8), and the prior week for the pain severity scale (PEG).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Opioid Risk Reduction Initiative | 0/935 (0%) | 0/935 (0%) | 0/935 (0%) |
| Usual Care | 0/653 (0%) | 0/653 (0%) | 0/653 (0%) |
| Age, Categorical(Participants) | Opioid Risk Reduction Initiative | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 507 | 415 | 922 |
| >=65 years | 428 | 238 | 666 |
| Age, Continuous(years) | Opioid Risk Reduction Initiative | Usual Care | Total |
|---|---|---|---|
| Mean | 62.6 ± 12.1 | 61.0 ± 12.1 | 62.0 ± 12.1 |
| Sex: Female, Male(Participants) | Opioid Risk Reduction Initiative | Usual Care | Total |
|---|---|---|---|
| Female | 589 | 420 | 1009 |
| Male | 346 | 233 | 579 |
| Race/Ethnicity, Customized(Participants) | Opioid Risk Reduction Initiative | Usual Care | Total |
|---|---|---|---|
| Caucasian | 804 | 576 | 1380 |
| African American | 19 | 3 | 22 |
| Asian/Pacific Islander | 11 | 4 | 15 |
| Native American | 7 | 3 | 10 |
| Multiple or other | 83 | 54 | 137 |
| Missing | 11 | 13 | 24 |
| Education(Participants) | Opioid Risk Reduction Initiative | Usual Care | Total |
|---|---|---|---|
| High school graduate or less | 243 | 203 | 446 |
| Some college or technical school | 436 | 296 | 732 |
| College graduate or post-college graduate | 255 | 152 | 407 |
| Missing | 1 | 2 | 3 |
| Mental disorder diagnosis past 36 months(Participants) | Opioid Risk Reduction Initiative | Usual Care | Total |
|---|---|---|---|
| No | 312 | 230 | 542 |
| Yes | 623 | 423 | 1046 |
| Alcohol use disorder, past 36 months(Participants) | Opioid Risk Reduction Initiative | Usual Care | Total |
|---|---|---|---|
| No | 885 | 621 | 1506 |
| Yes | 50 | 32 | 82 |
| Non-opioid drug use disorder diagnosis past 36 months(Participants) | Opioid Risk Reduction Initiative | Usual Care | Total |
|---|---|---|---|
| No | 846 | 619 | 1465 |
| Yes | 89 | 34 | 123 |
10 further baseline measures are reported on the registry.
No study locations are listed for this record.
Plan to share: 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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