PMID- 38343834 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240216 DP - 2024 Jan 23 TI - Implementing a Metabolism-Informed Approach for Smoking Cessation in an Alaska Tribal Health System: Study Protocol for a Single-Arm Implementation Pilot Trial. LID - rs.3.rs-3874126 [pii] LID - 10.21203/rs.3.rs-3874126/v1 [doi] AB - BACKGROUND: Individualized treatment for commercial tobacco smoking cessation, such as through the utilization of the nicotine metabolite ratio (NMR), offers substantial clinical benefit. NMR is a metabolism-informed biomarker that can be used to guide medication selection. NMR testing is particularly promising for tobacco cessation efforts in populations with high rates of smoking, such as some Alaska Native and American Indian (AN/AI) communities. To date, no prior study has evaluated the implementation of NMR-guided tobacco cessation with AN/AI populations. METHODS: The present "QUIT" protocol is a two-phase study that will occur at Southcentral Foundation (SCF), an Alaska Native-owned health system, serving 70,000 AN/AI people, based in Anchorage, Alaska. In Phase one, qualitative interviews with customer-owners (patients), providers and administrators (n = 36) and a 10-participant beta-test will be used to refine a strategy to implement NMR testing in the health system. Phase two will involve a single-arm pilot trial (n = 50) and qualitative interviews throughout data collection (n = 48) to evaluate the implementation strategy and explore the real-world acceptability and feasibility of NMR testing to guide tobacco cessation with AN/AI populations. DISCUSSION: This study utilizes a community-based participatory approach to refine and implement a nicotine metabolism-informed smoking cessation program in a Tribal healthcare setting. The process and findings from this study will reflect the importance of customer-owner choice and honor the lived experience involved in quitting commercial tobacco. Pilot study data will inform the effect and sample sizes required for a future pragmatic trial of NMR-guided smoking cessation. FAU - Jansen, Kelley AU - Jansen K AD - Southcentral Foundation. FAU - Tranby, Brianna AU - Tranby B AD - Mayo Clinic. FAU - Shane, Aliassa AU - Shane A AD - Southcentral Foundation. FAU - Takeno, Todd AU - Takeno T AD - Southcentral Foundation. FAU - Chadwick, Kelly AU - Chadwick K AD - University of Washington. FAU - Sinicrope, Pamela AU - Sinicrope P AD - Mayo Clinic. FAU - Shaw, Jennifer AU - Shaw J AD - University of Alaska Fairbanks. FAU - Tyndale, Rachel AU - Tyndale R AD - University of Toronto. FAU - Harris, Jeffrey AU - Harris J AD - University of Washington. FAU - Patten, Christi AU - Patten C AD - Mayo Clinic. FAU - Avey, Jaedon AU - Avey J AD - Southcentral Foundation. LA - eng GR - S06 GM142122/GM/NIGMS NIH HHS/United States PT - Preprint DEP - 20240123 PL - United States TA - Res Sq JT - Research square JID - 101768035 PMC - PMC10854299 OTO - NOTNLM OT - Alaska Native and American Indian OT - Health Services OT - Implementation OT - Nicotine Metabolite Ratio OT - Tobacco Cessation COIS- Competing Interests: None to declare. EDAT- 2024/02/12 15:42 MHDA- 2024/02/12 15:43 PMCR- 2024/02/09 CRDT- 2024/02/12 04:12 PHST- 2024/02/12 15:42 [pubmed] PHST- 2024/02/12 15:43 [medline] PHST- 2024/02/12 04:12 [entrez] PHST- 2024/02/09 00:00 [pmc-release] AID - rs.3.rs-3874126 [pii] AID - 10.21203/rs.3.rs-3874126/v1 [doi] PST - epublish SO - Res Sq [Preprint]. 2024 Jan 23:rs.3.rs-3874126. doi: 10.21203/rs.3.rs-3874126/v1.