Engaging Pharmacists to Advance Tobacco Treatment Service Delivery

N/AEnrolling By InvitationNCT07501624

Medical University of South Carolina172 enrolled

Overview

This research will test the effects of a novel program (ENHANCE-TTS) with tools, training, and clinic facilitation support that capitalizes on pharmacists' roles by expanding their scope of practice to deliver tobacco treatment. This effectiveness-implementation study will evaluate the effects of the ENHANCE-TTS program on implementation outcomes and patient-level smoking cessation outcomes in people living with HIV and concurrently identify key barriers and facilitators to implementing this program in practice.

The overall goal of this research is to improve care for people living with HIV through the delivery of high-quality tobacco treatment to address the high rates of smoking in this population. This research will test the effects of a novel program on pharmacists' roles by expanding their scope of practice to deliver tobacco treatment. Investigators will evaluate provider- and patient-level outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

172

Conditions

Smoking Cessation Tobacco Use Disorder Smoking

Interventions

ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS)BEHAVIORAL

The ENHANCE-TTS program includes team-building at each clinic, pharmacist training, facilitation (i.e., infrastructure planning for systems change, problem-solving, and coaching) and tools (clinic roadmap, readiness assessment, training workbook).

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Pharmacist, Clinic Administrator, and Patient Advocate inclusion criteria: Pharmacists, Clinic Administrators, and Patient Advocates from each of 6 Ryan White clinics who agree to participate in the study. Clinic patient inclusion criteria: 1. age 21 and older 2. current diagnosis of HIV 3. completed at least 1 visit with the clinical pharmacist for tobacco treatment, 4) English speaking; Exclusion: 1\) currently imprisoned.

Outcomes

Primary Outcomes

Adoption of the Intervention

Adoption is characterized as pharmacists' tobacco treatment care delivery adoption (comparing pre-implementation to post-implementation rates of tobacco use disorder diagnosis codes entered, tobacco treatment pharmacotherapy prescriptions written \[e.g., varenicline\], and tobacco treatment counseling codes entered).

Time frame: From baseline clinic engagement to 12 months following program launch

Acceptability of the Intervention

We will measure acceptability at the provider level via the 4-item Acceptability of Intervention Measure (AIM) and a training satisfaction survey.

Time frame: 3-Month Implementation Period

Fidelity to the Intervention

Fidelity at the clinic level is defined as the percentage of total program launch and implementation steps completed (i.e., kick-off, infrastructure build, training, coaching calls and systems change). Fidelity at the provider level is defined as the percentage of assessment and counseling steps completed (assessment of smoking history and current dependence, environmental triggers for smoking, pharmacotherapy options, and behavioral strategies for coping with urges to smoke).

Time frame: Implementation Period Through Study Completion (approximately 4 year study period)

Cost to Implement the Intervention

Cost is defined as costs to deliver the intervention (e.g., the sum of the costs of the TTS training, travel, hours of consultation participation and number of staff included, training and technical assistance).

Time frame: 3-Month Implementation Period

Penetration of the Intervention

Penetration of the intervention is defined as the total number of counseling appointments delivered over the total number of smoking patients and the pace of completed counseling appointments over the Implementation period compared to the Pre-Implementation period.

Time frame: From Study Start (Pre-Implementation Period) to Study Completion (Post-Implementation Period) (approximately 4 year study period)

Secondary Outcomes

Smoking Abstinence

Abstinence will be defined as self-reported 7-day point prevalence abstinence confirmed by breath carbon monoxide (CO). We will ask participants during follow-up, "Have you smoked a cigarette or used any type of combustible tobacco products in the past 7 days?" An answer of "no," coupled with a breath CO ≤5 ppm, will be considered abstinence.

Time frame: 3- and 6-month follow-up