Trial Outcomes & Findings for Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks (NCT NCT02224508)
NCT ID: NCT02224508
Last Updated: 2017-11-13
Results Overview
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.
COMPLETED
1588 participants
1 year prior to interview
2017-11-13
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
935
|
653
|
|
Overall Study
COMPLETED
|
935
|
653
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks
Baseline characteristics by cohort
| Measure |
Opioid Risk Reduction Initiative
n=935 Participants
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
n=653 Participants
Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
|
Total
n=1588 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
507 Participants
n=99 Participants
|
415 Participants
n=107 Participants
|
922 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
428 Participants
n=99 Participants
|
238 Participants
n=107 Participants
|
666 Participants
n=206 Participants
|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 12.1 • n=99 Participants
|
61.0 years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
62.0 years
STANDARD_DEVIATION 12.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
589 Participants
n=99 Participants
|
420 Participants
n=107 Participants
|
1009 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
346 Participants
n=99 Participants
|
233 Participants
n=107 Participants
|
579 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
804 Participants
n=99 Participants
|
576 Participants
n=107 Participants
|
1380 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
19 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple or other
|
83 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
137 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Missing
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Education
High school graduate or less
|
243 Participants
n=99 Participants
|
203 Participants
n=107 Participants
|
446 Participants
n=206 Participants
|
|
Education
Some college or technical school
|
436 Participants
n=99 Participants
|
296 Participants
n=107 Participants
|
732 Participants
n=206 Participants
|
|
Education
College graduate or post-college graduate
|
255 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
407 Participants
n=206 Participants
|
|
Education
Missing
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Mental disorder diagnosis past 36 months
No
|
312 Participants
n=99 Participants
|
230 Participants
n=107 Participants
|
542 Participants
n=206 Participants
|
|
Mental disorder diagnosis past 36 months
Yes
|
623 Participants
n=99 Participants
|
423 Participants
n=107 Participants
|
1046 Participants
n=206 Participants
|
|
Alcohol use disorder, past 36 months
No
|
885 Participants
n=99 Participants
|
621 Participants
n=107 Participants
|
1506 Participants
n=206 Participants
|
|
Alcohol use disorder, past 36 months
Yes
|
50 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Non-opioid drug use disorder diagnosis past 36 months
No
|
846 Participants
n=99 Participants
|
619 Participants
n=107 Participants
|
1465 Participants
n=206 Participants
|
|
Non-opioid drug use disorder diagnosis past 36 months
Yes
|
89 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Opioid drug use disorder diagnosis, past 36 months
No
|
834 Participants
n=99 Participants
|
577 Participants
n=107 Participants
|
1411 Participants
n=206 Participants
|
|
Opioid drug use disorder diagnosis, past 36 months
Yes
|
101 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
|
Tobacco use disorder diagnosis, past 36 months
No
|
711 Participants
n=99 Participants
|
502 Participants
n=107 Participants
|
1213 Participants
n=206 Participants
|
|
Tobacco use disorder diagnosis, past 36 months
Yes
|
224 Participants
n=99 Participants
|
151 Participants
n=107 Participants
|
375 Participants
n=206 Participants
|
|
Location in Washington State
Eastern Washington
|
242 Participants
n=99 Participants
|
295 Participants
n=107 Participants
|
537 Participants
n=206 Participants
|
|
Location in Washington State
Western Washington
|
693 Participants
n=99 Participants
|
358 Participants
n=107 Participants
|
1051 Participants
n=206 Participants
|
|
Marital status
Not married
|
318 Participants
n=99 Participants
|
214 Participants
n=107 Participants
|
532 Participants
n=206 Participants
|
|
Marital status
Married
|
615 Participants
n=99 Participants
|
438 Participants
n=107 Participants
|
1053 Participants
n=206 Participants
|
|
Marital status
Missing
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Charlson Comorbidity Score (past 12 months)
0
|
426 Participants
n=99 Participants
|
307 Participants
n=107 Participants
|
733 Participants
n=206 Participants
|
|
Charlson Comorbidity Score (past 12 months)
1
|
75 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
|
Charlson Comorbidity Score (past 12 months)
2
|
144 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
251 Participants
n=206 Participants
|
|
Charlson Comorbidity Score (past 12 months)
3-5
|
195 Participants
n=99 Participants
|
127 Participants
n=107 Participants
|
322 Participants
n=206 Participants
|
|
Charlson Comorbidity Score (past 12 months)
6 or greater
|
95 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Hepatitis C or cirrhosis diagnosis
No
|
851 Participants
n=99 Participants
|
607 Participants
n=107 Participants
|
1458 Participants
n=206 Participants
|
|
Hepatitis C or cirrhosis diagnosis
Yes
|
84 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Received excess days supply of 20% or greater in any of past 4 quarters
No
|
734 Participants
n=99 Participants
|
493 Participants
n=107 Participants
|
1227 Participants
n=206 Participants
|
|
Received excess days supply of 20% or greater in any of past 4 quarters
Yes
|
201 Participants
n=99 Participants
|
160 Participants
n=107 Participants
|
361 Participants
n=206 Participants
|
|
Average daily opioid dose in morphine equivalents
No opioid use
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Average daily opioid dose in morphine equivalents
Less than 15 milligrams
|
232 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
326 Participants
n=206 Participants
|
|
Average daily opioid dose in morphine equivalents
15 to less than 50 milligrams
|
432 Participants
n=99 Participants
|
296 Participants
n=107 Participants
|
728 Participants
n=206 Participants
|
|
Average daily opioid dose in morphine equivalents
50 to less than 120 milligrams
|
199 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
349 Participants
n=206 Participants
|
|
Average daily opioid dose in morphine equivalents
120 milligrams or greater
|
72 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
183 Participants
n=206 Participants
|
|
Continuously enrolled in health plan for past 24 months
No
|
48 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
|
Continuously enrolled in health plan for past 24 months
Yes
|
887 Participants
n=99 Participants
|
555 Participants
n=107 Participants
|
1442 Participants
n=206 Participants
|
|
Employment status
Employed full time/part time
|
314 Participants
n=99 Participants
|
223 Participants
n=107 Participants
|
537 Participants
n=206 Participants
|
|
Employment status
Disabled
|
182 Participants
n=99 Participants
|
170 Participants
n=107 Participants
|
352 Participants
n=206 Participants
|
|
Employment status
Retired
|
410 Participants
n=99 Participants
|
245 Participants
n=107 Participants
|
655 Participants
n=206 Participants
|
|
Employment status
Other
|
28 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Employment status
Missing
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 year prior to interviewPopulation: 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.
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.
Outcome measures
| Measure |
Opioid Risk Reduction Initiative
n=934 Participants
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
n=652 Participants
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).
|
0.215 proportion of COT patients
Interval 0.189 to 0.244
|
0.239 proportion of COT patients
Interval 0.205 to 0.276
|
SECONDARY outcome
Timeframe: 1 week prior to interviewPEG (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.
Outcome measures
| Measure |
Opioid Risk Reduction Initiative
n=929 Participants
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
n=647 Participants
Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
|
|---|---|---|
|
Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale
|
5.79 units on a scale
Interval 5.65 to 5.93
|
5.82 units on a scale
Interval 5.65 to 5.99
|
SECONDARY outcome
Timeframe: 2 weeks prior to interviewPatient 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.
Outcome measures
| Measure |
Opioid Risk Reduction Initiative
n=932 Participants
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
n=652 Participants
Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
|
|---|---|---|
|
Depressive Symptoms
|
7.39 units on a scale
Interval 7.04 to 7.74
|
7.91 units on a scale
Interval 7.45 to 8.37
|
Adverse Events
Opioid Risk Reduction Initiative
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place