Pharmacist-Integrated Care for Opioid Use Disorder

(PharmICO Trial)

Recruiting at 3 trial locations

Overseen By Susan Vonderheide, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Trustees of Dartmouth College

Must be taking: MOUD

Disqualifiers: Non-English speakers, Legal issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

149 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to see if including pharmacists in the healthcare team can improve treatment for patients with opioid addiction. It will test this approach in several outpatient clinics to see how well it works and how acceptable it is to both patients and staff.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment PrIMO for opioid use disorder?

Research shows that involving pharmacists in care can increase access to medications for opioid use disorder, which may improve treatment outcomes. Additionally, integrating care for opioid use disorder in primary care settings has been associated with better patient outcomes. ^{1 2 3 4 5}

Is pharmacist-integrated care for opioid use disorder safe for humans?

Pharmacist-integrated care models, such as those involving naloxone distribution and opioid stewardship initiatives, have been implemented to enhance opioid safety and reduce overdose risks. Pharmacists are trained to manage medication errors and drug interactions, which supports the safe use of medications for opioid use disorder. ^{3 4 6 7 8}

How is the PrIMO treatment for opioid use disorder different from other treatments?

PrIMO is unique because it integrates pharmacists into the care team, improving access to medications like buprenorphine for opioid use disorder. This collaborative approach helps address the shortage of specialized physicians and enhances patient care by utilizing pharmacists' expertise in medication management. ^{1 3 9 10 11}

Research Team

Lisa A Marsch, PhD

Principal Investigator

Geisel School of Medicine at Dartmouth College

Eligibility Criteria

This trial is for adults over 18 who work at a clinic as providers, pharmacists, technicians, or administrators. It's also for adult patients at these clinics who are receiving or have received medication treatment for opioid use disorder (MOUD) and have been exposed to the PrIMO model. Participants must not be incarcerated or facing legal issues that prevent study involvement.

Inclusion Criteria

I am 18 or older and have been treated with MOUD at a clinic using the PrIMO model for at least 14 days.

I am over 18 and work at the clinic in a key role.

Exclusion Criteria

Patients Not able to speak English sufficiently to understand study procedures and provide written informed consent, unable or unwilling to provide consent or to participate in study procedures, or are currently in jail, prison, or other overnight facility as required by court of law; or have pending legal action that could prevent participation in study activities

Site Staff Unwilling or unable to provide consent or are currently in jail, prison, or other overnight facility as required by court of law; or have pending legal action that could prevent participation in study activities

Timeline

Pre-implementation

Data collection and preparation for the PrIMO model implementation

3 months

Implementation Launch

Launch of the PrIMO model at clinical sites and initial participant enrollment

2 weeks

Patient Enrollment and Treatment

Patients are enrolled and receive care under the PrIMO model

6 months

Follow-up at 3 and 6 months post-baseline

Follow-up

Participants are monitored for outcomes and sustainability of the PrIMO model

12 months post-launch

Treatment Details

Interventions

• PrIMO

Trial Overview The trial is testing a new way of treating opioid addiction by integrating pharmacists into the care team. This Phase 1 project will assess how feasible and acceptable it is to implement this pharmacist-integrated model in diverse outpatient clinical settings.

Participant Groups

Group I: Site Staff Experimental Treatment 1 Intervention

Providers, Pharmacists, Pharmacy Technicians, Administrators to receive survey assessments

Group II: Patients Experimental Treatment 1 Intervention

Subset of patients receiving PrIMO care to receive survey assessments

Who Is Running the Clinical Trial?

Trustees of Dartmouth College

Lead Sponsor

Trials

32

Recruited

14,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

A qualitative study involving 22 patients, 24 clinical staff, and 5 clinic leaders identified key themes for improving the integration of HIV and opioid use disorder (OUD) care, emphasizing the need to address social risks and knowledge gaps about treatments.

The development of a new measurement tool based on these insights aims to enhance service delivery for patients with HIV and OUD by focusing on patient-centered policies and effective communication between organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"No more falling through the cracks": A qualitative study to inform measurement of integration of care of HIV and opioid use disorder. Oldfield, BJ., Muñoz, N., Boshnack, N., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pharmacists on the front-line of solving a public health crisis: Increasing access to medications for opioid use disorder. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

"No more falling through the cracks": A qualitative study to inform measurement of integration of care of HIV and opioid use disorder. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacy-based expansion of buprenorphine access. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Predictors of Medication-Assisted Treatment Initiation for Opioid Use Disorder in an Interdisciplinary Primary Care Model. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The Integrating Medications for Addiction Treatment (IMAT) Index: A measure of capability at the organizational level. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Orienting patients to greater opioid safety: models of community pharmacy-based naloxone. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Research Priorities for Expansion of Opioid Use Disorder Treatment in the Community Pharmacy. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Evaluating a Pharmacist-Led Opioid Stewardship Initiative at an Urban Teaching Hospital. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Implementation of a pharmacist care manager model to expand availability of medications for opioid use disorder. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Buprenorphine physician-pharmacist collaboration in the management of patients with opioid use disorder: results from a multisite study of the National Drug Abuse Treatment Clinical Trials Network. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Opioid use disorder: Calling pharmacists to action for better preconception and pregnancy care. [2022]