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| ID | Type | Description | Link |
|---|---|---|---|
| 9024 | Other Grant/Funding Number | VA - Health Services R&D |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Treatment as usual | |
| ISOP Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISOP Intervention with the Nurse Care Manager | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Data collected at baseline, 6 months, and 12 months. |
| 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. | Data collected at baseline, 6 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Data collected at baseline, 6 months, and 12 months |
| Participatory Decision Making Style |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin J. Morasco, PhD MA | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97207-2964 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31651495 | Result | Maloy PE, Iacocca MO, Morasco BJ. CE: Implementing Guidelines for Treating Chronic Pain with Prescription Opioids. Am J Nurs. 2019 Nov;119(11):22-29. doi: 10.1097/01.NAJ.0000605344.99391.78. | |
| 32061968 | Result | Morasco BJ, Adams MH, Maloy PE, Hooker ER, Iacocca MO, Krebs EE, Carr TP, Lovejoy TI, Saha S, Dobscha SK. Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial. Contemp Clin Trials. 2020 Mar;90:105957. doi: 10.1016/j.cct.2020.105957. Epub 2020 Feb 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Treatment as usual |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Treatment as usual |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Data collected at baseline, 6 months, and 12 months. |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Treatment as usual | 0 |
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Had planned to study changes in rates of substance use disorders (measured with the SCID). However, due to low enrollment of participants with SUD, groups comparisons on changes in SUD rates were not conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Morasco, PhD | VA Portland Health Care System | 5032208262 | benjamin.morasco@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2019 | Mar 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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. |
| Data collected at baseline, 6 months, and 12 months |
| 32673038 | Result | Morasco BJ, Iacocca MO, Lovejoy TI, Dobscha SK, Deyo RA, Cavese JA, Hyde S, Yarborough BJH. Utility of the Pain Medication Questionnaire to predict aberrant urine drug tests: Results from a longitudinal cohort study. Psychol Serv. 2021 Aug;18(3):319-327. doi: 10.1037/ser0000471. Epub 2020 Jul 16. |
| 32915020 | Result | Wilson AC, Morasco BJ, Holley AL, Feldstein Ewing SW. Patterns of opioid use in adolescents receiving prescriptions: The role of psychological and pain factors. Am Psychol. 2020 Sep;75(6):748-760. doi: 10.1037/amp0000697. |
| 33749499 | Result | Bryson WC, Morasco BJ, Cotton BP, Thielke SM. Cannabis Use and Nonfatal Opioid Overdose among Patients Enrolled in Methadone Maintenance Treatment. Subst Use Misuse. 2021;56(5):697-703. doi: 10.1080/10826084.2021.1892137. Epub 2021 Mar 22. |
| 34370491 | Result | Magaletta PR, Morasco BJ. Perspectives on opioid misuse from public service psychology: An introduction. Psychol Serv. 2021 Aug;18(3):285-286. doi: 10.1037/ser0000485. |
| 33405304 | Result | Borsari B, Li Y, Tighe J, Manuel JK, Gokbayrak NS, Delucchi K, Morasco BJ, Abadjian L, Cohen BE, Baxley C, Seal KH. A pilot trial of collaborative care with motivational interviewing to reduce opioid risk and improve chronic pain management. Addiction. 2021 Sep;116(9):2387-2397. doi: 10.1111/add.15401. Epub 2021 Jan 27. |
| 33145684 | Result | Morasco BJ, Smith N, Dobscha SK, Deyo RA, Hyde S, Yarborough BJ. Prospective Investigation of Factors Associated with Prescription Opioid Dose Escalation among Patients in Integrated Health Systems. J Gen Intern Med. 2020 Dec;35(Suppl 3):895-902. doi: 10.1007/s11606-020-06250-x. Epub 2020 Nov 3. |
| 35296983 | Result | Morasco BJ, Adams MH, Hooker ER, Maloy PE, Krebs EE, Lovejoy TI, Saha S, Dobscha SK. A Cluster-Randomized Clinical Trial to Decrease Prescription Opioid Misuse: Improving the Safety of Opioid Therapy (ISOT). J Gen Intern Med. 2022 Nov;37(15):3805-3813. doi: 10.1007/s11606-022-07476-7. Epub 2022 Mar 16. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| 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. | Smaller n due to missing values. | Posted | Number | percentage of aberrant UDT results | Data collected at baseline, 6 months, and 12 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | One year |
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|
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| 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 | Posted | Mean | Standard Deviation | score on a scale | Data collected at baseline, 6 months, and 12 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Data collected at baseline, 6 months, and 12 months |
|
|
|
|
| 136 |
| 0 |
| 136 |
| 0 |
| 136 |
| EG001 | 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. | 0 | 150 | 0 | 150 | 0 | 150 |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 12 months |
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| 12 months |
|
| 12 months |
|