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

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Completed
• CT.gov ID: NCT02224508
• Collaborator: (none)
• Enrollment: 1,588
• Duration (Months): 16

Study Details

Study Description

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	Intervention/Treatment	Phase
Drug Use Disorders; Drug Abuse; Drug Addiction; Drug Dependence; Drug Habituation; Pain; Depressive Disorder

Detailed Description

Detailed description not provided

Study Design

• 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: Sep 1, 2014
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria). [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Kaiser Permanente

Investigators

• Principal Investigator: Michael R VonKorff, ScD, Group Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT02224508
• Other Study ID Numbers: PCORI-1306-02198
• First Posted: Aug 25, 2014
• Last Update Posted: Nov 13, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Disease; Substance-Related Disorders; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Opioid Risk Reduction Initiative	Usual Care
Arm/Group Description	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.
Period Title: Overall Study
STARTED	935	653
COMPLETED	935	653
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Opioid Risk Reduction Initiative	Usual Care	Total
Arm/Group Description	Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) 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.	Total of all reporting groups
Overall Participants	935	653	1588
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	507 54.2%	415 63.6%	922 58.1%
>=65 years	428 45.8%	238 36.4%	666 41.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.6 (12.1)	61.0 (12.1)	62.0 (12.1)
Sex: Female, Male (Count of Participants)
Female	589 63%	420 64.3%	1009 63.5%
Male	346 37%	233 35.7%	579 36.5%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	804 86%	576 88.2%	1380 86.9%
African American	19 2%	3 0.5%	22 1.4%
Asian/Pacific Islander	11 1.2%	4 0.6%	15 0.9%
Native American	7 0.7%	3 0.5%	10 0.6%
Multiple or other	83 8.9%	54 8.3%	137 8.6%
Missing	11 1.2%	13 2%	24 1.5%
Education (Count of Participants)
High school graduate or less	243 26%	203 31.1%	446 28.1%
Some college or technical school	436 46.6%	296 45.3%	732 46.1%
College graduate or post-college graduate	255 27.3%	152 23.3%	407 25.6%
Missing	1 0.1%	2 0.3%	3 0.2%
Mental disorder diagnosis past 36 months (Count of Participants)
No	312 33.4%	230 35.2%	542 34.1%
Yes	623 66.6%	423 64.8%	1046 65.9%
Alcohol use disorder, past 36 months (Count of Participants)
No	885 94.7%	621 95.1%	1506 94.8%
Yes	50 5.3%	32 4.9%	82 5.2%
Non-opioid drug use disorder diagnosis past 36 months (Count of Participants)
No	846 90.5%	619 94.8%	1465 92.3%
Yes	89 9.5%	34 5.2%	123 7.7%
Opioid drug use disorder diagnosis, past 36 months (Count of Participants)
No	834 89.2%	577 88.4%	1411 88.9%
Yes	101 10.8%	76 11.6%	177 11.1%
Tobacco use disorder diagnosis, past 36 months (Count of Participants)
No	711 76%	502 76.9%	1213 76.4%
Yes	224 24%	151 23.1%	375 23.6%
Location in Washington State (Count of Participants)
Eastern Washington	242 25.9%	295 45.2%	537 33.8%
Western Washington	693 74.1%	358 54.8%	1051 66.2%
Marital status (Count of Participants)
Not married	318 34%	214 32.8%	532 33.5%
Married	615 65.8%	438 67.1%	1053 66.3%
Missing	2 0.2%	1 0.2%	3 0.2%
Charlson Comorbidity Score (past 12 months) (Count of Participants)
0	426 45.6%	307 47%	733 46.2%
1	75 8%	73 11.2%	148 9.3%
2	144 15.4%	107 16.4%	251 15.8%
3-5	195 20.9%	127 19.4%	322 20.3%
6 or greater	95 10.2%	39 6%	134 8.4%
Hepatitis C or cirrhosis diagnosis (Count of Participants)
No	851 91%	607 93%	1458 91.8%
Yes	84 9%	46 7%	130 8.2%
Received excess days supply of 20% or greater in any of past 4 quarters (Count of Participants)
No	734 78.5%	493 75.5%	1227 77.3%
Yes	201 21.5%	160 24.5%	361 22.7%
Average daily opioid dose in morphine equivalents (Count of Participants)
No opioid use	0 0%	2 0.3%	2 0.1%
Less than 15 milligrams	232 24.8%	94 14.4%	326 20.5%
15 to less than 50 milligrams	432 46.2%	296 45.3%	728 45.8%
50 to less than 120 milligrams	199 21.3%	150 23%	349 22%
120 milligrams or greater	72 7.7%	111 17%	183 11.5%
Continuously enrolled in health plan for past 24 months (Count of Participants)
No	48 5.1%	98 15%	146 9.2%
Yes	887 94.9%	555 85%	1442 90.8%
Employment status (Count of Participants)
Employed full time/part time	314 33.6%	223 34.2%	537 33.8%
Disabled	182 19.5%	170 26%	352 22.2%
Retired	410 43.9%	245 37.5%	655 41.2%
Other	28 3%	15 2.3%	43 2.7%
Missing	1 0.1%	0 0%	1 0.1%

Outcome Measures

1. Primary Outcome

Title	Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria).
Description	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

Outcome Measure Data

Analysis Population Description

Prevalent chronic opioid therapy (COT) patients defined as having received at least 70 days supply of opioids in the 90 days prior to sample selection, at least 70 days supply of opioids in at least one of the 3 other quarters in the preceding year, and at least 45 days supply of opioids in the other two quarters.

Arm/Group Title	Opioid Risk Reduction Initiative	Usual Care
Arm/Group Description	Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) 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.
Measure Participants	934	652
Number (95% Confidence Interval) [proportion of COT patients]	0.215	0.239

2. Secondary Outcome

Title	Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid Risk Reduction Initiative	Usual Care
Arm/Group Description	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.
Measure Participants	929	647
Mean (95% Confidence Interval) [units on a scale]	5.79	5.82

3. Secondary Outcome

Title	Depressive Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid Risk Reduction Initiative	Usual Care
Arm/Group Description	Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) 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.
Measure Participants	932	652
Mean (95% Confidence Interval) [units on a scale]	7.39	7.91

Adverse Events

Time Frame	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).
Adverse Event Reporting Description	Since study subjects were not tracked over time, we did not assess adverse events occurring over time. The survey assessment did assess prevalent adverse outcomes relevant to chronic opioid therapy (prescription opioid use disorder, depressive symptoms, pain severity).
Arm/Group Title	Opioid Risk Reduction Initiative		Usual Care
Arm/Group Description	Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) 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.
All Cause Mortality
	Opioid Risk Reduction Initiative		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/935 (0%)		0/653 (0%)
Serious Adverse Events
	Opioid Risk Reduction Initiative		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/935 (0%)		0/653 (0%)
Other (Not Including Serious) Adverse Events
	Opioid Risk Reduction Initiative		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/935 (0%)		0/653 (0%)

Limitations/Caveats

This phase of the evaluation reports after-only survey data comparing prevalent chronic opioid therapy patients who had been exposed or not exposed to the health plan opioid risk reduction initiatives for at least one year.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.