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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02791399
Other study ID # IIR 14-020
Secondary ID 9024
Status Completed
Phase N/A
First received
Last updated
Start date March 23, 2016
Est. completion date October 31, 2020

Study information

Verified date July 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 286
Est. completion date October 31, 2020
Est. primary completion date October 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
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.

Locations

Country Name City State
United States VA Portland Health Care System, Portland, OR Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. 20 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. do — View Citation

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;9 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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. Data collected at baseline, 6 months, and 12 months
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. Data collected at baseline, 6 months, and 12 months.
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. 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. One year
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