Healthy Opioid Prescription Engagement

NCT05141266 | Active Not Recruiting DMC

• 1 other identifier: 141016
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial across 14 community pharmacies to test the efficacy of the Brief Intervention-Medication Therapy Management intervention (BI-MTM). The establishment of the BI-MTM model will result in a major impact for addressing the opioid epidemic, preventing opioid use disorder and overdose, and safeguarding patient health in a novel community-based service setting.

Conditions

Opioid Misuse; Opioid-Related Disorders; Pharmacist-Patient Relations

Keywords

Community Pharmacies; Patient Navigation; Opioid intervention

Outcome Measures

Primary Outcomes (1)

• Change in opioid medication misuse.

  This outcome will be assessed using the Prescription Opioid Misuse Index (POMI).

  6 months

Study Arms (2)

Brief Intervention Medication Therapy Management (BI-MTM)

EXPERIMENTAL

Brief Intervention Medication Therapy Management (BI-MTM) is the overarching model made up of 4 evidence-based components: Medication Therapy Management (MTM); Screening, Brief Intervention, and Referral to Treatment (SBIRT); naloxone dispensing, and Patient Navigation (PN). Each component is sequentially delivered within the model and addresses a critical aspect of opioid medication misuse and risk. The pharmacy-based portion of BI-MTM (MTM+SBIRT+naloxone) will be delivered by a PharmD level pharmacist, and PN will be delivered by a bachelor's level interventionist.

Behavioral: Patient Navigation

Standard of Care

OTHER

Standard of Care is the treatment as usual condition, which follows federal and Utah state pharmacy requirements for pharmacists where in patients filling prescriptions receive information and opt-in counseling. Specifically, SMC in Utah requires pharmacists to: (1) offer counseling, (2) document counseling has been offered, (3) offer a counseling process for patients not present, and (4) discuss generic substitution.The duration of SMC in the current study is a single 5-10 minute session delivered by a University of Utah pharmacist other than the study pharmacist that possesses a similar level of education and professional licensing.

Other: Standard Medication Counseling (SMC)

Interventions

Patient Navigation BEHAVIORAL

PN involves 8 weekly telephonic sessions lasting 30-45 minutes (telephonic to support lower-costs/sustainability). In session 1, the navigator reviews with the participant a report of scores from the baseline assessment to understand the participant's current health needs/challenges; session 1 also involves development of therapeutic alliance/rapport and goal setting. Sessions 2-4 focus on goal setting and identifying barriers and problem resolutions. The navigator elicits motivation and discusses this in context of readiness to change heath behavior and self-management skills. Sessions 2-4 also involve navigators supporting/assisting patients to fill out paperwork and enroll in needed social services and/or mental/behavioral/physical healthcare, including but not limited to primary care. Sessions 5-7 focus on encouraging and reinforcing treatment adherence, review-ing and identifying other care needs, and offering linkages to service providers as applicable

Brief Intervention Medication Therapy Management (BI-MTM)

Standard Medication Counseling (SMC) OTHER

SMC participants receive a single medication information/counseling session delivered by a University of Utah pharmacist to: (1) offer counseling, (2) document counseling was offered, (3) offer a counseling process for patients not present (not applicable to this study given all patients must screen in person), and (4) discuss generic substitution.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years)
• English speaking
• Not receiving cancer treatment
• Who have a positive opioid misuse screen on the POMI will be eligible to learn about this study

You may not qualify if:

• Are pregnant (given potential pre/post-natal opioid use complications among pregnant women/offspring
• Can-not provide collateral contact information for ≥2 contact persons (to ensure consistent contact/follow up)
• Do not have a reliable land line or mobile phone to be contacted by study staff
• Are filling only buprenorphine (given some formulations are not indicated for pain)
• Plan to leave the area for an extended period of time in the next 6 months
• Have had a psychotic and/or manic episode in the last 30 days (before consent, patients will be asked to screen for psychosis
• Do not provide permission to access their state prescription drug monitoring data.

Sponsors & Collaborators

• Jerry Cochran: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• Cochran G, Shen J, Cox N, Field C, Carlston K, Sengpraseut B, White A, Okifuji A, Jackman C, Haaland B, Ragsdale R, Gordon AJ, Tarter R. Addressing opioid medication misuse at point of service in community pharmacy: A study protocol for an interdisciplinary behavioral health trial. Contemp Clin Trials. 2022 May;116:106759. doi: 10.1016/j.cct.2022.106759. Epub 2022 Apr 11.

  PMID: 35417771 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Gerald Cochran, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Internal Medicine

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 2, 2021
• Study Start: November 8, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)