Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENgaging pHarmacists to AdvANCE Tobacco Treatment Service delivery (ENHANCE-TTS) | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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). | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3- and 6-month follow-up |
Not provided
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:
Exclusion:
1) currently imprisoned.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alana Rojewski, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
Results will be shared in summary format with clinics; individual-level data will not be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
Stepped wedge design with sites randomized to start date
Not provided
Not provided
Not provided
Not provided
|
| From Study Start (Pre-Implementation Period) to Study Completion (Post-Implementation Period) (approximately 4 year study period) |
| D001523 |
| Mental Disorders |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |