NCT02791399

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 6, 2021

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

3.6 years

First QC Date

June 1, 2016

Results QC Date

April 26, 2021

Last Update Submit

July 19, 2023

Conditions

Opioid SafetyPrescription Opioid MisuseChronic Pain

Keywords

opioid safetyopioid misuseopioid abusepatient-centeredopioidopiatechronic painprimary careVeteranclinical care

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • Chronic Pain Grade

    One year

Other Outcomes (2)

  • Trust in Physician Scale

    Data collected at baseline, 6 months, and 12 months

  • Participatory Decision Making Style

    Data collected at baseline, 6 months, and 12 months

Study Arms (2)

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.

Behavioral: ISOP Intervention with the Nurse Care Manager

Interventions

ISOP Intervention with the Nurse Care ManagerBEHAVIORAL

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.

ISOP Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

Related Publications (9)

  • 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.

    PMID: 31651495RESULT

  • 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.

    PMID: 32061968RESULT

  • 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.

    PMID: 32673038RESULT

  • 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.

    PMID: 32915020RESULT

  • 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.

    PMID: 33749499RESULT

  • 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.

    PMID: 34370491RESULT

  • 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.

    PMID: 33405304RESULT

  • 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.

    PMID: 33145684RESULT

  • 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.

    PMID: 35296983RESULT

MeSH Terms

Conditions

Opioid-Related DisordersChronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

Title
Benjamin Morasco, PhD
Organization
VA Portland Health Care System
benjamin.morasco@va.gov
5032208262

Study Officials

  • Benjamin J. Morasco, PhD MA

    VA Portland Health Care System, Portland, OR

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2016

First Posted

June 6, 2016

Study Start

March 23, 2016

Primary Completion

October 15, 2019

Study Completion

October 31, 2020

Last Updated

July 27, 2023

Results First Posted

August 6, 2021

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)