Healthy Opioid Prescription Engagement (HOPE)

Jerry Cochran

Status: Active, not recruiting

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

Treatments: Other: Standard Medication Counseling (SMC); Behavioral: Patient Navigation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05141266

141016

Details and patient eligibility

About

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.

Full description

This study examines a community pharmacy-based intervention to reduce opioid medication misuse. Despite a recent national decline in opioid prescribing, 10.3 million Americans in 2018 reported misusing a prescribed opioid, and within this population, >36% of those who misused obtained the opioid medication by filling a prescription. The point of medication dispensing, namely, the community pharmacy, is an untapped resource to address prescription opioid misuse-especially when considering the >60,000 pharmacies employing >170,000 pharmacists in the US. This study aims to conduct a fully-powered RCT of the BI-MTM intervention in community pharmacy settings that will accomplish 3 Specific Aims. The first Aim will demonstrate the pharmacist-led BI-MTM intervention is superior to standard medication counseling (SMC) for mitigating opioid medication misuse. This will be accomplished by conducting a powered single-blinded randomized trial to test the efficacy of BI-MTM (n=175) vs. SMC (n=175). Participants will be screened/recruited for eligibility at point of dispensing in 14 community pharmacies in Utah, a high opioid prescribing and opioid-adverse event state. Participants will be assessed at baseline, 2, and 6 months for opioid medication misuse. Participant-level state prescription drug monitoring data will also be linked with patient outcomes to assess objective changes in medication misuse behaviors (e.g., early refills and doctor/pharmacy shopping). The second Aim will identify the pathway by which BI-MTM results in improvements for depression, pain, and subsequently opioid misuse. To accomplish this, a path analysis will assess relationships of BI-MTM: (1) on depression, pain, and misuse, (2) depression on misuse, and (3) pain on misuse. The final Aim will explore latent transitions of baseline to post-intervention misuse classes by intervention group. This will be accomplished by using mixture modeling, specifically multi-group latent transition analysis. The observed misuse indicators will be used to estimate latent class transitions across time, grouping by treatment condition and adjusting for baseline covariates. Completing SA1- 3 advance the understanding of BI-MTM efficacy and set the stage for a national multisite trial.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Brief Intervention Medication Therapy Management (BI-MTM)

Experimental group

Description:

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.

Treatment:

Behavioral: Patient Navigation

Standard of Care

Other group

Description:

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.

Treatment:

Other: Standard Medication Counseling (SMC)