AIDS, HIV, Pharmacy, Smoking, Smoking Cessation, Tobacco Use Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS)
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).
Sponsors
Medical University of South Carolina
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Stepped wedge design with sites randomized to start date
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adoption of the Intervention | From baseline clinic engagement to 12 months following program launch | 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). |
| Acceptability of the Intervention | 3-Month Implementation Period | We will measure acceptability at the provider level via the 4-item Acceptability of Intervention Measure (AIM) and a training satisfaction survey. |
| Fidelity to the Intervention | Implementation Period Through Study Completion (approximately 4 year study period) | 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). |
| Cost to Implement the Intervention | 3-Month Implementation Period | 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). |
| Penetration of the Intervention | From Study Start (Pre-Implementation Period) to Study Completion (Post-Implementation Period) (approximately 4 year study period) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | 3- and 6-month follow-up | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlana Rojewski, PhD
Medical University of South Carolina
Outcome results
None listed