Trial Outcomes & Findings for A Patient-Centered Intervention to Improve Opioid Safety (NCT NCT02791399)
NCT ID: NCT02791399
Last Updated: 2023-07-27
Results Overview
The Current Opioid Misuse Measure (COMM) is an assessment of self-reported risk of prescription opioid misuse. There are 17 items, each rated on a scale of 0 (never) to 4 (very often). Total scores range from 0 - 68, with higher scores indicating a greater risk of prescription opioid misuse.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
286 participants
Primary outcome timeframe
Data collected at baseline, 6 months, and 12 months.
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
Control
Treatment as usual
|
ISOP Intervention
Primary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring.
ISOP Intervention with the Nurse Care Manager: A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse.
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
150
|
|
Overall Study
COMPLETED
|
123
|
135
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Patient-Centered Intervention to Improve Opioid Safety
Baseline characteristics by cohort
| Measure |
Control
n=136 Participants
Treatment as usual
|
ISOP Intervention
n=150 Participants
Primary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring.
ISOP Intervention with the Nurse Care Manager: A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse.
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Native American or Alaska Native
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
136 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
286 Participants
n=206 Participants
|
|
Marital status
Single or never married
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Marital status
Divorced or separated
|
42 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Marital status
Married or living with partner
|
80 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Marital status
Widowed
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
61.2 years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
60.8 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=99 Participants
|
135 Participants
n=107 Participants
|
250 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
108 Participants
n=99 Participants
|
123 Participants
n=107 Participants
|
231 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African-American
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Data collected at baseline, 6 months, and 12 months.The Current Opioid Misuse Measure (COMM) is an assessment of self-reported risk of prescription opioid misuse. There are 17 items, each rated on a scale of 0 (never) to 4 (very often). Total scores range from 0 - 68, with higher scores indicating a greater risk of prescription opioid misuse.
Outcome measures
| Measure |
Control
n=123 Participants
Treatment as usual
|
ISOP Intervention
n=135 Participants
Primary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring.
ISOP Intervention with the Nurse Care Manager: A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse.
|
|---|---|---|
|
Current Opioid Misuse Measure (COMM)
Baseline
|
11.3 score on a scale
Standard Deviation 8.0
|
11.9 score on a scale
Standard Deviation 6.8
|
|
Current Opioid Misuse Measure (COMM)
6 month follow-up
|
9.4 score on a scale
Standard Deviation 6.4
|
9.5 score on a scale
Standard Deviation 6.7
|
|
Current Opioid Misuse Measure (COMM)
12 month follow-up
|
9.3 score on a scale
Standard Deviation 6.5
|
8.6 score on a scale
Standard Deviation 5.7
|
PRIMARY outcome
Timeframe: Data collected at baseline, 6 months, and 12 monthsPopulation: Smaller n due to missing values.
Participants will complete urine drug tests (UDTs) to evaluate for presence of substances. UDTs will evaluate for cannabis, cocaine, amphetamines, benzodiazepines, barbiturates, opioids, and opiates. Study results are dichotomous.
Outcome measures
| Measure |
Control
n=125 Participants
Treatment as usual
|
ISOP Intervention
n=138 Participants
Primary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring.
ISOP Intervention with the Nurse Care Manager: A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse.
|
|---|---|---|
|
Urine Drug Test
Baseline
|
12.8 percentage of aberrant UDT results
|
10.9 percentage of aberrant UDT results
|
|
Urine Drug Test
6 months
|
7.0 percentage of aberrant UDT results
|
14.0 percentage of aberrant UDT results
|
|
Urine Drug Test
12 months
|
16.2 percentage of aberrant UDT results
|
10.2 percentage of aberrant UDT results
|
SECONDARY outcome
Timeframe: One yearThe Chronic Pain Grade is a 7-item self-report measure that provides global scores of pain intensity and function. Scores for each subscale range from 0 - 100. Higher scores indicate more severe pain or more impairment in function. Pain intensity and function were tested in a non-inferiority analysis.
Outcome measures
| Measure |
Control
n=136 Participants
Treatment as usual
|
ISOP Intervention
n=150 Participants
Primary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring.
ISOP Intervention with the Nurse Care Manager: A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse.
|
|---|---|---|
|
Chronic Pain Grade
|
65.8 score on a scale
Standard Deviation 15.5
|
67.0 score on a scale
Standard Deviation 14.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Data collected at baseline, 6 months, and 12 monthsThe Trust in Physician Scale is an 11-item self-report measure. Scores range from 0 - 100, with higher scores indicating greater interpersonal trust between patients and their clinician
Outcome measures
| Measure |
Control
n=136 Participants
Treatment as usual
|
ISOP Intervention
n=150 Participants
Primary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring.
ISOP Intervention with the Nurse Care Manager: A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse.
|
|---|---|---|
|
Trust in Physician Scale
Baseline
|
66.3 score on a scale
Standard Deviation 18.6
|
66.8 score on a scale
Standard Deviation 20.2
|
|
Trust in Physician Scale
6 months
|
68.0 score on a scale
Standard Deviation 18.6
|
66.5 score on a scale
Standard Deviation 21.9
|
|
Trust in Physician Scale
12 months
|
68.1 score on a scale
Standard Deviation 18.0
|
65.9 score on a scale
Standard Deviation 21.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Data collected at baseline, 6 months, and 12 monthsThe Participatory Decision Making Style is a 4-item self-report measures. Scores range from 0 - 100, where higher scores indicate greater patient involvement in medical decision making.
Outcome measures
| Measure |
Control
n=136 Participants
Treatment as usual
|
ISOP Intervention
n=150 Participants
Primary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring.
ISOP Intervention with the Nurse Care Manager: A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse.
|
|---|---|---|
|
Participatory Decision Making Style
Baseline
|
50.3 score on a scale
Standard Deviation 32.4
|
50.4 score on a scale
Standard Deviation 35.7
|
|
Participatory Decision Making Style
6 months
|
57.6 score on a scale
Standard Deviation 31.9
|
51.9 score on a scale
Standard Deviation 36.9
|
|
Participatory Decision Making Style
12 months
|
54.3 score on a scale
Standard Deviation 33.5
|
55.1 score on a scale
Standard Deviation 34.9
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ISOP Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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