Chronic Pain, Opioid Safety, Prescription Opioid Misuse
Conditions
Keywords
opioid safety, opioid misuse, opioid abuse, patient-centered, opioid, opiate, chronic pain, primary care, Veteran, clinical care
Brief summary
This is a randomized controlled trial of a multifaceted intervention designed to improve the safety of opioid prescribing. The specific aims of this study are to: (a) evaluate whether a multifaceted intervention (Improving the Safety of Opioid Prescribing; ISOP) enhances opioid safety, (b) assess whether participation in ISOP impacts the clinician-patient relationship, and (c) explore to what extent ISOP is associated with changes in pain and pain-related function.
Detailed description
The investigators will randomize primary care providers (PCPs) at the VA Portland Health Care System to either ISOP or the control condition; patients will be nested by clinician status. All PCPs who enroll will participate in either a two-hour educational workshop or the two-hour educational workshop + nurse care manager (NCM). The NCM will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to PCPs for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse. The investigators will recruit patients who are already prescribed chronic opioid therapy for chronic non-cancer pain. Participants will be enrolled for one year. Outcomes will be measured at baseline, and 6 and 12 months after enrollment.
Interventions
BEHAVIORALISOP 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enrollment in primary care at the VA Portland Health Care System * Receiving long-term opioid therapy (for at least 3 months) for chronic pain unrelated to a life-limiting disease * Able to read and write in English
Exclusion criteria
* Age younger than 18 years old * On opioid therapy for palliative or end-of-life care * Current enrollment in an opioid substitution program * Lack of access to a telephone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Current Opioid Misuse Measure (COMM) | 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. |
| Urine Drug Test | Data collected at baseline, 6 months, and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Pain Grade | One year | The 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Trust in Physician Scale | Data collected at baseline, 6 months, and 12 months | The 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 |
| Participatory Decision Making Style | Data collected at baseline, 6 months, and 12 months | The 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Treatment as usual | 136 |
| 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. | 150 |
| Total | 286 |
Baseline characteristics
| Characteristic | Control | ISOP Intervention | Total |
|---|---|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 11.8 | 61.2 years STANDARD_DEVIATION 10.9 | 60.8 years STANDARD_DEVIATION 11.1 |
| Marital status Divorced or separated | 42 Participants | 41 Participants | 83 Participants |
| Marital status Married or living with partner | 80 Participants | 89 Participants | 169 Participants |
| Marital status Single or never married | 8 Participants | 10 Participants | 18 Participants |
| Marital status Widowed | 6 Participants | 10 Participants | 16 Participants |
| Race/Ethnicity, Customized African-American | 6 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Native American or Alaska Native | 10 Participants | 15 Participants | 25 Participants |
| Race/Ethnicity, Customized Other | 11 Participants | 5 Participants | 16 Participants |
| Race/Ethnicity, Customized White | 108 Participants | 123 Participants | 231 Participants |
| Region of Enrollment United States | 136 Participants | 150 Participants | 286 Participants |
| Sex: Female, Male Female | 21 Participants | 15 Participants | 36 Participants |
| Sex: Female, Male Male | 115 Participants | 135 Participants | 250 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 136 | 0 / 150 |
| other Total, other adverse events | 0 / 136 | 0 / 150 |
| serious Total, serious adverse events | 0 / 136 | 0 / 150 |
Outcome results
Primary
Current Opioid Misuse Measure (COMM)
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.
Time frame: Data collected at baseline, 6 months, and 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Current Opioid Misuse Measure (COMM) | Baseline | 11.3 score on a scale | Standard Deviation 8 |
| Control | Current Opioid Misuse Measure (COMM) | 6 month follow-up | 9.4 score on a scale | Standard Deviation 6.4 |
| Control | Current Opioid Misuse Measure (COMM) | 12 month follow-up | 9.3 score on a scale | Standard Deviation 6.5 |
| ISOP Intervention | Current Opioid Misuse Measure (COMM) | Baseline | 11.9 score on a scale | Standard Deviation 6.8 |
| ISOP Intervention | Current Opioid Misuse Measure (COMM) | 6 month follow-up | 9.5 score on a scale | Standard Deviation 6.7 |
| ISOP Intervention | Current Opioid Misuse Measure (COMM) | 12 month follow-up | 8.6 score on a scale | Standard Deviation 5.7 |
p-value: <0.0595% CI: [-2.45, 0.2]Mixed Models Analysis
Primary
Urine Drug Test
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.
Time frame: Data collected at baseline, 6 months, and 12 months
Population: Smaller n due to missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Urine Drug Test | Baseline | 12.8 percentage of aberrant UDT results |
| Control | Urine Drug Test | 6 months | 7.0 percentage of aberrant UDT results |
| Control | Urine Drug Test | 12 months | 16.2 percentage of aberrant UDT results |
| ISOP Intervention | Urine Drug Test | Baseline | 10.9 percentage of aberrant UDT results |
| ISOP Intervention | Urine Drug Test | 6 months | 14.0 percentage of aberrant UDT results |
| ISOP Intervention | Urine Drug Test | 12 months | 10.2 percentage of aberrant UDT results |
p-value: <0.0595% CI: [-0.15, 0.06]Mixed Models Analysis
Secondary
Chronic Pain Grade
The 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.
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Chronic Pain Grade | 65.8 score on a scale | Standard Deviation 15.5 |
| ISOP Intervention | Chronic Pain Grade | 67.0 score on a scale | Standard Deviation 14.5 |
Other Pre-specified
Participatory Decision Making Style
The 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.
Time frame: Data collected at baseline, 6 months, and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Participatory Decision Making Style | Baseline | 50.3 score on a scale | Standard Deviation 32.4 |
| Control | Participatory Decision Making Style | 6 months | 57.6 score on a scale | Standard Deviation 31.9 |
| Control | Participatory Decision Making Style | 12 months | 54.3 score on a scale | Standard Deviation 33.5 |
| ISOP Intervention | Participatory Decision Making Style | Baseline | 50.4 score on a scale | Standard Deviation 35.7 |
| ISOP Intervention | Participatory Decision Making Style | 6 months | 51.9 score on a scale | Standard Deviation 36.9 |
| ISOP Intervention | Participatory Decision Making Style | 12 months | 55.1 score on a scale | Standard Deviation 34.9 |
p-value: <0.0595% CI: [-6.73, 8.8]Mixed Models Analysis
Other Pre-specified
Trust in Physician Scale
The 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
Time frame: Data collected at baseline, 6 months, and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Trust in Physician Scale | Baseline | 66.3 score on a scale | Standard Deviation 18.6 |
| Control | Trust in Physician Scale | 6 months | 68.0 score on a scale | Standard Deviation 18.6 |
| Control | Trust in Physician Scale | 12 months | 68.1 score on a scale | Standard Deviation 18 |
| ISOP Intervention | Trust in Physician Scale | Baseline | 66.8 score on a scale | Standard Deviation 20.2 |
| ISOP Intervention | Trust in Physician Scale | 6 months | 66.5 score on a scale | Standard Deviation 21.9 |
| ISOP Intervention | Trust in Physician Scale | 12 months | 65.9 score on a scale | Standard Deviation 21.2 |
p-value: <0.0595% CI: [-5.83, 1.85]Mixed Models Analysis