Trial Outcomes & Findings for Primary Care Intervention to Reduce Prescription Opioid Overdoses (NCT NCT02464410)
NCT ID: NCT02464410
Last Updated: 2023-07-27
Results Overview
This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 9 in one assessment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
299 participants
Primary outcome timeframe
3-, 6-, and 12-months post-baseline
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
Motivational Intervention
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.
Motivational intervention: The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Enhanced Usual Care
In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.
Psycho-educational control: The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
152
|
|
Overall Study
3-month Follow-up
|
137
|
138
|
|
Overall Study
6-month Follow-up
|
132
|
140
|
|
Overall Study
12-month Follow-up
|
125
|
136
|
|
Overall Study
COMPLETED
|
125
|
136
|
|
Overall Study
NOT COMPLETED
|
22
|
16
|
Reasons for withdrawal
| Measure |
Motivational Intervention
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.
Motivational intervention: The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Enhanced Usual Care
In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.
Psycho-educational control: The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
|---|---|---|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
7
|
9
|
|
Overall Study
Withdrawal by Subject
|
12
|
3
|
Baseline Characteristics
The number of participants analyzed are adjusted for missing data.
Baseline characteristics by cohort
| Measure |
Motivational Intervention
n=147 Participants
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.
Motivational intervention: The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Enhanced Usual Care
n=152 Participants
In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.
Psycho-educational control: The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Total
n=299 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=147 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=299 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=147 Participants
|
87 Participants
n=152 Participants
|
155 Participants
n=299 Participants
|
|
Age, Categorical
>=65 years
|
79 Participants
n=147 Participants
|
65 Participants
n=152 Participants
|
144 Participants
n=299 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=147 Participants
|
8 Participants
n=152 Participants
|
23 Participants
n=299 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=147 Participants
|
144 Participants
n=152 Participants
|
276 Participants
n=299 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=147 Participants
|
2 Participants
n=152 Participants
|
8 Participants
n=299 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
141 Participants
n=147 Participants
|
150 Participants
n=152 Participants
|
291 Participants
n=299 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=147 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=299 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=147 Participants
|
4 Participants
n=152 Participants
|
5 Participants
n=299 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=147 Participants
|
1 Participants
n=152 Participants
|
1 Participants
n=299 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=147 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=299 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=147 Participants
|
12 Participants
n=152 Participants
|
23 Participants
n=299 Participants
|
|
Race (NIH/OMB)
White
|
125 Participants
n=147 Participants
|
125 Participants
n=152 Participants
|
250 Participants
n=299 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=147 Participants
|
6 Participants
n=152 Participants
|
12 Participants
n=299 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=147 Participants
|
4 Participants
n=152 Participants
|
8 Participants
n=299 Participants
|
|
Region of Enrollment
United States
|
147 Participants
n=147 Participants
|
152 Participants
n=152 Participants
|
299 Participants
n=299 Participants
|
|
Overdose risk behaviors
|
1.63 units on a scale
STANDARD_DEVIATION 1.16 • n=147 Participants
|
1.75 units on a scale
STANDARD_DEVIATION 1.26 • n=152 Participants
|
1.69 units on a scale
STANDARD_DEVIATION 1.21 • n=299 Participants
|
|
Aberrant opioid use
|
4.16 units on a scale
STANDARD_DEVIATION 3.58 • n=146 Participants • The number of participants analyzed are adjusted for missing data.
|
3.77 units on a scale
STANDARD_DEVIATION 3.43 • n=152 Participants • The number of participants analyzed are adjusted for missing data.
|
3.96 units on a scale
STANDARD_DEVIATION 3.51 • n=298 Participants • The number of participants analyzed are adjusted for missing data.
|
|
Average number of days prescribed opioid use based on pharmacy records
|
51.57 Days of Prescribed Opioid Use
STANDARD_DEVIATION 39.75 • n=147 Participants
|
47.54 Days of Prescribed Opioid Use
STANDARD_DEVIATION 38.96 • n=152 Participants
|
49.52 Days of Prescribed Opioid Use
STANDARD_DEVIATION 39.34 • n=299 Participants
|
|
Participants with non-fatal overdose experiences
|
29 Number with Overdose Experiences
n=147 Participants • The number of participants analyzed are adjusted for missing data
|
29 Number with Overdose Experiences
n=149 Participants • The number of participants analyzed are adjusted for missing data
|
58 Number with Overdose Experiences
n=296 Participants • The number of participants analyzed are adjusted for missing data
|
|
Treatment utilization
|
1.29 Number of Visits to the Emergency Dept
STANDARD_DEVIATION 1.68 • n=81 Participants • Due to lost to follow-up, death, participant withdrawal, or the lack of visits to the emergency department, the number analyzed varied throughout the study.
|
1.28 Number of Visits to the Emergency Dept
STANDARD_DEVIATION 1.98 • n=75 Participants • Due to lost to follow-up, death, participant withdrawal, or the lack of visits to the emergency department, the number analyzed varied throughout the study.
|
1.28 Number of Visits to the Emergency Dept
STANDARD_DEVIATION 1.83 • n=156 Participants • Due to lost to follow-up, death, participant withdrawal, or the lack of visits to the emergency department, the number analyzed varied throughout the study.
|
|
Other (non-overdose) injuries from the Revised Injury Behavior Checklist Questionnaire
|
18 Participants
n=146 Participants • The number of participants analyzed are adjusted for missing data.
|
13 Participants
n=151 Participants • The number of participants analyzed are adjusted for missing data.
|
31 Participants
n=297 Participants • The number of participants analyzed are adjusted for missing data.
|
|
Scores on an opioid storage and disposal knowledge and behaviors questionnaire
|
1.4 units on a scale
STANDARD_DEVIATION 1.78 • n=147 Participants
|
1.16 units on a scale
STANDARD_DEVIATION 1.91 • n=152 Participants
|
1.28 units on a scale
STANDARD_DEVIATION 1.85 • n=299 Participants
|
|
Level of oversedation as an opioid side effect
|
2.80 units on a scale
STANDARD_DEVIATION 2.55 • n=142 Participants • The numbers of participants analyzed are adjusted for missing data.
|
2.29 units on a scale
STANDARD_DEVIATION 2.45 • n=147 Participants • The numbers of participants analyzed are adjusted for missing data.
|
2.54 units on a scale
STANDARD_DEVIATION 2.51 • n=289 Participants • The numbers of participants analyzed are adjusted for missing data.
|
|
General physical and mental functioning from Veteran Short Form questionnaire scores
|
3.49 units on a scale
STANDARD_DEVIATION 0.95 • n=147 Participants • The number of participants analyzed are adjusted for missing data.
|
3.62 units on a scale
STANDARD_DEVIATION 0.98 • n=151 Participants • The number of participants analyzed are adjusted for missing data.
|
3.55 units on a scale
STANDARD_DEVIATION 0.96 • n=298 Participants • The number of participants analyzed are adjusted for missing data.
|
|
Pain-specific disability score
|
5.19 units on a scale
STANDARD_DEVIATION 2.70 • n=147 Participants • The number of participants analyzed are adjusted for missing data.
|
5.55 units on a scale
STANDARD_DEVIATION 2.54 • n=151 Participants • The number of participants analyzed are adjusted for missing data.
|
5.38 units on a scale
STANDARD_DEVIATION 2.62 • n=298 Participants • The number of participants analyzed are adjusted for missing data.
|
PRIMARY outcome
Timeframe: 3-, 6-, and 12-months post-baselinePopulation: Due to lost to follow-up, death, missing data, or participant withdrawal, the number analyzed varied throughout the follow-up periods.
This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 9 in one assessment.
Outcome measures
| Measure |
Motivational Intervention
n=137 Participants
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.
Motivational intervention: The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Enhanced Usual Care
n=140 Participants
In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.
Psycho-educational control: The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
|---|---|---|
|
Overdose Risk Behaviors
3-Month Follow-up
|
1.31 score on a scale
Standard Deviation 1.14
|
1.21 score on a scale
Standard Deviation 1.09
|
|
Overdose Risk Behaviors
6-Month Follow-up
|
1.45 score on a scale
Standard Deviation 1.20
|
1.25 score on a scale
Standard Deviation 1.29
|
|
Overdose Risk Behaviors
12-Month Follow-up
|
1.38 score on a scale
Standard Deviation 1.29
|
1.07 score on a scale
Standard Deviation 1.05
|
PRIMARY outcome
Timeframe: 3-, 6-, and 12-months post-baselinePopulation: Due to lost to follow-up, death, missing data, or participant withdrawal, the number analyzed varied throughout the follow-up periods.
This measure contained 8 self-reported items from the Current Opioid Misuse Measure. Items were assessed on a scale of "never (0)," "rarely (1)," "sometimes (2)," "often (3)," and "very often (4)." A sum score took a range of 0 to 32, with higher numbers indicating more non-medical opioid use.
Outcome measures
| Measure |
Motivational Intervention
n=137 Participants
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.
Motivational intervention: The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Enhanced Usual Care
n=140 Participants
In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.
Psycho-educational control: The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
|---|---|---|
|
Aberrant Opioid Use
3-Month Follow-up
|
2.95 score on a scale
Standard Deviation 3.04
|
2.51 score on a scale
Standard Deviation 2.74
|
|
Aberrant Opioid Use
6-Month Follow-up
|
2.87 score on a scale
Standard Deviation 3.06
|
2.68 score on a scale
Standard Deviation 3.11
|
|
Aberrant Opioid Use
12-Month Follow-up
|
2.80 score on a scale
Standard Deviation 3.08
|
2.73 score on a scale
Standard Deviation 3.35
|
PRIMARY outcome
Timeframe: 3-, 6-, and 12-months post-baselinePopulation: All participants were included in this analysis as this was taken from Electronic Health Records and did not rely on follow-up survey responses.
Number of days prescribed opioid use was pulled from pharmacy records. For follow-up periods, times no dose were included to create averages over periods. Patients without medications during their follow-up period were included with a dose of zero.
Outcome measures
| Measure |
Motivational Intervention
n=147 Participants
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.
Motivational intervention: The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Enhanced Usual Care
n=152 Participants
In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.
Psycho-educational control: The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
|---|---|---|
|
Average Number of Days Prescribed Opioid Use Based on Pharmacy Records
3-Month Follow-up
|
48.23 Days of Prescribed Opioid Use
Standard Deviation 38.97
|
45.81 Days of Prescribed Opioid Use
Standard Deviation 41.06
|
|
Average Number of Days Prescribed Opioid Use Based on Pharmacy Records
6-Month Follow-up
|
44.75 Days of Prescribed Opioid Use
Standard Deviation 38.70
|
42.54 Days of Prescribed Opioid Use
Standard Deviation 41.08
|
|
Average Number of Days Prescribed Opioid Use Based on Pharmacy Records
12-Month Follow-up
|
42.19 Days of Prescribed Opioid Use
Standard Deviation 38.92
|
37.56 Days of Prescribed Opioid Use
Standard Deviation 38.83
|
SECONDARY outcome
Timeframe: 3-, 6-, and 12-months post-baselinePopulation: Due to lost to follow-up, death, missing data, or participant withdrawal, the number analyzed varied throughout the follow-up periods. The Overall Number of Participants Analyzed includes participants with at least one outcome assessment at each timepoint.
This scale is the number of overdose experiences as self-reported in the Overdose Experiences questionnaire. This item is a number of participants whom endorsed having experienced an overdose at that time period.
Outcome measures
| Measure |
Motivational Intervention
n=137 Participants
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.
Motivational intervention: The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Enhanced Usual Care
n=140 Participants
In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.
Psycho-educational control: The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
|---|---|---|
|
Number of Participants With Non-fatal Overdose Experiences
3-Month Follow-up
|
1 participants with OD
|
0 participants with OD
|
|
Number of Participants With Non-fatal Overdose Experiences
6-Month Follow-up
|
2 participants with OD
|
1 participants with OD
|
|
Number of Participants With Non-fatal Overdose Experiences
12-Month Follow-up
|
0 participants with OD
|
1 participants with OD
|
SECONDARY outcome
Timeframe: 3-, 6-, and 12-months post-baselinePopulation: Due to lost to follow-up, death, missing data, participant withdrawal, or the lack of visits to the emergency department, the number analyzed varied throughout the study.
Number of visits to the emergency department, for medical, mental health or substance use visits, across VA and non-VA hospitals from the Treatment Service Utilization Questionnaire. The numbers reported are the mean number of visits among those participants that had any emergency department visits at each time point.
Outcome measures
| Measure |
Motivational Intervention
n=137 Participants
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.
Motivational intervention: The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Enhanced Usual Care
n=140 Participants
In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.
Psycho-educational control: The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
|---|---|---|
|
Treatment Utilization
3-Month Follow-up
|
1.50 Visits to the Emergency Dept
Standard Deviation 0.84
|
1.81 Visits to the Emergency Dept
Standard Deviation 1.24
|
|
Treatment Utilization
6-Month Follow-up
|
1.61 Visits to the Emergency Dept
Standard Deviation 1.77
|
2.11 Visits to the Emergency Dept
Standard Deviation 2.31
|
|
Treatment Utilization
12-Month Follow-up
|
2.20 Visits to the Emergency Dept
Standard Deviation 3.27
|
2.04 Visits to the Emergency Dept
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: 3-, 6-, and 12-months post-baselinePopulation: Due to lost to follow-up, death, missing data, or participant withdrawal, the number analyzed varied throughout the follow-up periods.
This scale is the number of non-overdose injuries assessed through the Revised Injury Behavior Checklist questionnaire, focusing on 4 topics (Injury 1. by violence or by being physically attacked; 2. By falling; 3. By a motor vehicle or by being hit by a moving vehicle while walking; 4. While riding a bicycle, skateboard, or rollerblading). This item is a count of participants who responded that they were injured during any of these types of activities and received treatment.
Outcome measures
| Measure |
Motivational Intervention
n=137 Participants
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.
Motivational intervention: The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Enhanced Usual Care
n=140 Participants
In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.
Psycho-educational control: The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
|---|---|---|
|
Other (Non-overdose) Injuries From the Revised Injury Behavior Checklist Questionnaire
3-Month Follow-up
|
5 Participants
|
4 Participants
|
|
Other (Non-overdose) Injuries From the Revised Injury Behavior Checklist Questionnaire
6-Month Follow-up
|
4 Participants
|
5 Participants
|
|
Other (Non-overdose) Injuries From the Revised Injury Behavior Checklist Questionnaire
12-Month Follow-up
|
11 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 3-, 6-, and 12-months post-baselinePopulation: Due to lost to follow-up, death, missing data, or participant withdrawal, the number analyzed varied throughout the follow-up periods.
This scale assesses safe storage and disposal of prescription opioid medications with 6 items. Items were assessed on a scale of "never (0)," "rarely (1)," "sometimes (2)," "often (3)," and "very often (4)." A sum score took a range of 0 to 24, with higher numbers indicating less safe practices. The sum of the score of the 6 items was used to find the mean scores for those in each arm.
Outcome measures
| Measure |
Motivational Intervention
n=137 Participants
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.
Motivational intervention: The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Enhanced Usual Care
n=140 Participants
In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.
Psycho-educational control: The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
|---|---|---|
|
Scores on an Opioid Storage and Disposal Knowledge and Behaviors Questionnaire
3-Month Follow-up
|
0.95 score on a scale
Standard Deviation 1.47
|
0.68 score on a scale
Standard Deviation 1.28
|
|
Scores on an Opioid Storage and Disposal Knowledge and Behaviors Questionnaire
6-Month Follow-up
|
1.07 score on a scale
Standard Deviation 1.63
|
0.69 score on a scale
Standard Deviation 1.37
|
|
Scores on an Opioid Storage and Disposal Knowledge and Behaviors Questionnaire
12-Month Follow-up
|
1.13 score on a scale
Standard Deviation 1.82
|
0.76 score on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: 3-, 6-, and 12-months post-baselinePopulation: Due to lost to follow-up, death, missing data, or participant withdrawal, the number analyzed varied throughout the follow-up periods. The Overall Number of Participants Analyzed includes participants with at least one outcome assessment at each timepoint.
The level of oversedation as an opioid side effect was assessed using two items from the Pain Treatment Satisfaction Scale looking at side effects of opioid medications (excessive fatigue and drowsiness). Items were assessed on a scale of 0 (did not experience) to 5 (extremely bothered). A sum score ranged from 0 to 10 with a higher score indicating the potential for more oversedation.
Outcome measures
| Measure |
Motivational Intervention
n=137 Participants
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.
Motivational intervention: The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Enhanced Usual Care
n=140 Participants
In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.
Psycho-educational control: The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
|---|---|---|
|
Level of Oversedation as an Opioid Side Effect
3-Month Follow-up
|
1.66 score on a scale
Standard Deviation 2.20
|
1.96 score on a scale
Standard Deviation 2.59
|
|
Level of Oversedation as an Opioid Side Effect
6-Month Follow-up
|
1.57 score on a scale
Standard Deviation 2.05
|
2.08 score on a scale
Standard Deviation 2.55
|
|
Level of Oversedation as an Opioid Side Effect
12-Month Follow-up
|
2.36 score on a scale
Standard Deviation 2.46
|
2.25 score on a scale
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: 3-, 6-, and 12-months post-baselinePopulation: Due to lost to follow-up, death, missing data, or participant withdrawal, the number analyzed varied throughout the follow-up periods. The Overall Number of Participants Analyzed includes participants with at least one outcome assessment at each timepoint.
A modified Veterans RAND 12-item health survey was used to assess general health. One item was scored from 1 (Excellent) to 5 (Poor). Score means were compared at baseline and each follow-up.
Outcome measures
| Measure |
Motivational Intervention
n=137 Participants
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.
Motivational intervention: The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Enhanced Usual Care
n=140 Participants
In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.
Psycho-educational control: The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
|---|---|---|
|
General Physical and Mental Functioning From Short Form-12 Questionnaire Scores
3-Month Follow-up
|
3.57 score on a scale
Standard Deviation 0.89
|
3.70 score on a scale
Standard Deviation 0.95
|
|
General Physical and Mental Functioning From Short Form-12 Questionnaire Scores
6-Month Follow-up
|
3.63 score on a scale
Standard Deviation 0.94
|
3.76 score on a scale
Standard Deviation 0.99
|
|
General Physical and Mental Functioning From Short Form-12 Questionnaire Scores
12-Month Follow-up
|
3.71 score on a scale
Standard Deviation 0.81
|
3.79 score on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: 3-, 6-, and 12-months post-baselinePopulation: Due to lost to follow-up, death, missing data, or participant withdrawal, the number analyzed varied throughout the follow-up periods. The Overall Number of Participants Analyzed includes participants with at least one outcome assessment at each timepoint.
This scale is a sub-section of the Brief Pain Inventory that assesses the impact of pain on functioning across 7 different activities. Activities are assessed on a Likert scale from "Does not interfere (0)" to "Completely interferes (10)". BPI pain interference was scored as the mean of the seven interference items, scores range from 0 to 10, with a mean score of 10 (maximum score) indicating a complete interference in all activities.
Outcome measures
| Measure |
Motivational Intervention
n=137 Participants
The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.
Motivational intervention: The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
Enhanced Usual Care
n=140 Participants
In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.
Psycho-educational control: The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
Long-term opioid therapy informed consent: The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
|
|---|---|---|
|
Pain-specific Disability Score From an Adapted Version of Brief Pain Inventory Questionnaire
3-Month Follow-up
|
4.86 score on a scale
Standard Deviation 2.87
|
5.10 score on a scale
Standard Deviation 4.64
|
|
Pain-specific Disability Score From an Adapted Version of Brief Pain Inventory Questionnaire
6-Month Follow-up
|
4.89 score on a scale
Standard Deviation 2.66
|
5.16 score on a scale
Standard Deviation 2.88
|
|
Pain-specific Disability Score From an Adapted Version of Brief Pain Inventory Questionnaire
12-Month Follow-up
|
4.89 score on a scale
Standard Deviation 4.40
|
5.41 score on a scale
Standard Deviation 2.51
|
Adverse Events
Motivational Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Enhanced Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 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