QuitSMART Utah: an implementation study protocol for a cluster-randomized, multi-level Sequential Multiple Assignment Randomized Trial to increase Reach and Impact of tobacco cessation treatment in Community Health Centers.
Basic Helix-Loop-Helix Transcription Factors
Community Health Centers
/ organization & administration
Drosophila Proteins
Electronic Health Records
/ organization & administration
Health Behavior
Hotlines
/ organization & administration
Humans
Implementation Science
Inservice Training
/ organization & administration
Primary Health Care
/ organization & administration
Program Development
Socioeconomic Factors
Text Messaging
Tobacco Use Cessation
/ methods
Tobacco Use Cessation Devices
Utah
Adaptive intervention
Health information technology
Implementation science
Implementation strategy
Quitline
Tobacco cessation
Journal
Implementation science : IS
ISSN: 1748-5908
Titre abrégé: Implement Sci
Pays: England
ID NLM: 101258411
Informations de publication
Date de publication:
30 01 2020
30 01 2020
Historique:
received:
18
12
2019
accepted:
13
01
2020
entrez:
1
2
2020
pubmed:
1
2
2020
medline:
3
2
2021
Statut:
epublish
Résumé
Tobacco use remains the leading cause of death and disability in the USA and is disproportionately concentrated among low socioeconomic status (SES) populations. Community Health Centers (CHCs) are a key venue for reaching low SES populations with evidence-based tobacco cessation treatment such as Quitlines. Electronic health record (EHR)-based interventions at the point-of-care, text messaging (TM), and phone counseling have the potential to increase Quitline reach and are feasible to implement within CHCs. However, there is a lack of data to inform how, when, and in what combination these strategies should be implemented. The aims of this cluster-randomized trial are to evaluate multi-level implementation strategies to increase the Reach (i.e., proportion of tobacco-using patients who enroll in the Quitline) and Impact (i.e., Reach × Efficacy [efficacy is defined as the proportion of tobacco-using patients who enroll in Quitline treatment that successfully quit]) and to evaluate characteristics of healthcare system, providers, and patients that may influence tobacco-use outcomes. This study is a multilevel, three-phase, Sequential Multiple Assignment Randomized Trial (SMART), conducted in CHCs (N = 33 clinics; N = 6000 patients). In the first phase, clinics will be randomized to two different EHR conditions. The second and third phases are patient-level randomizations based on prior treatment response. Patients who enroll in the Quitline receive no further interventions. In phase two, patients who are non-responders (i.e., patients who do not enroll in Quitline) will be randomized to receive either TM or continued-EHR. In phase three, patients in the TM condition who are non-responders will be randomized to receive either continued-TM or TM + phone coaching. This project will evaluate scalable, multi-level interventions to directly address strategic national priorities for reducing tobacco use and related disparities by increasing the Reach and Impact of evidence-based tobacco cessation interventions in low SES populations. This trial was registered at ClinicalTrials.gov (NCT03900767) on April 4th, 2019.
Sections du résumé
BACKGROUND
Tobacco use remains the leading cause of death and disability in the USA and is disproportionately concentrated among low socioeconomic status (SES) populations. Community Health Centers (CHCs) are a key venue for reaching low SES populations with evidence-based tobacco cessation treatment such as Quitlines. Electronic health record (EHR)-based interventions at the point-of-care, text messaging (TM), and phone counseling have the potential to increase Quitline reach and are feasible to implement within CHCs. However, there is a lack of data to inform how, when, and in what combination these strategies should be implemented. The aims of this cluster-randomized trial are to evaluate multi-level implementation strategies to increase the Reach (i.e., proportion of tobacco-using patients who enroll in the Quitline) and Impact (i.e., Reach × Efficacy [efficacy is defined as the proportion of tobacco-using patients who enroll in Quitline treatment that successfully quit]) and to evaluate characteristics of healthcare system, providers, and patients that may influence tobacco-use outcomes.
METHODS
This study is a multilevel, three-phase, Sequential Multiple Assignment Randomized Trial (SMART), conducted in CHCs (N = 33 clinics; N = 6000 patients). In the first phase, clinics will be randomized to two different EHR conditions. The second and third phases are patient-level randomizations based on prior treatment response. Patients who enroll in the Quitline receive no further interventions. In phase two, patients who are non-responders (i.e., patients who do not enroll in Quitline) will be randomized to receive either TM or continued-EHR. In phase three, patients in the TM condition who are non-responders will be randomized to receive either continued-TM or TM + phone coaching.
DISCUSSION
This project will evaluate scalable, multi-level interventions to directly address strategic national priorities for reducing tobacco use and related disparities by increasing the Reach and Impact of evidence-based tobacco cessation interventions in low SES populations.
TRIAL REGISTRATION
This trial was registered at ClinicalTrials.gov (NCT03900767) on April 4th, 2019.
Identifiants
pubmed: 32000812
doi: 10.1186/s13012-020-0967-2
pii: 10.1186/s13012-020-0967-2
pmc: PMC6993416
doi:
Substances chimiques
Basic Helix-Loop-Helix Transcription Factors
0
Drosophila Proteins
0
cato protein, Drosophila
0
Banques de données
ClinicalTrials.gov
['NCT03900767']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
9Subventions
Organisme : NIDA NIH HHS
ID : R01 DA039901
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002538
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR003167
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1TR002538
Pays : United States
Organisme : NCI NIH HHS
ID : P30CA042014
Pays : United States
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