TY - JOUR
T1 - A Brief Intervention for Improving Alcohol Literacy and Addressing Harmful Alcohol Use Among Women Attending an Australian Breast Screening Service (Health4her)
T2 - Protocol for a Hybrid Effectiveness-Implementation Trial
AU - Grigg, Jasmin
AU - Manning, Victoria
AU - Lockie, Darren
AU - Giles, Michelle
AU - Robin, Bell
AU - Peta, Stragalinos
AU - Bernard, Chloe
AU - Volpe, Isabelle
AU - Greenwood, Christopher J.
AU - Smith, Liam
AU - Bragge, Peter
AU - Lubman, Dan I.
N1 - Funding Information:
This work was supported by research grants from VicHealth and Eastern Health Foundation. The funding agencies had no role in any part of the study. We thank BreastScreen Victoria for supporting this study. We thank the staff of Maroondah BreastScreen for their support with this project at their site, and we gratefully acknowledge all Maroondah BreastScreen clients who participated in this study. We thank Freya Horn for her assistance with preparing this manuscript. Nonhuman assistance was not used in any aspect of the study or for manuscript writing and editing.
Funding Information:
This research was funded in March 2019 (Eastern Health Foundation Research and Innovation Grant) and May 2019 (VicHealth Impact Research Grant). Data collection for the formative evaluation was conducted from January to April 2020 (retrospective analysis of alcohol consumption data from Lifepool, n=49,240; web-based survey with breast screening service consumers, n=391; focus group and interviews with breast screening service consumers, n=31). Trial recruitment was conducted from February to August 2021 (n=588), with follow-up data collection finalized in December 2021. Quantitative process evaluation data were collected during trial implementation, and the collection of participant and staff feedback was finalized in December 2021 (participant quantitative feedback, n=588; participant qualitative feedback, n=30; and breast screening site staff feedback, n=11). We anticipate that the results of the retrospective analysis of alcohol consumption data from Lifepool (part of the mixed methods formative evaluation) will be published in March 2023. We anticipate that the results of this RCT will be published in March 2023. The program evaluation (comprising the preimplementation web-based survey and focus groups and interviews with subsets of breast screening service consumers and mixed methods process evaluation using trial and site administrative data and feedback from trial participants and breast screening site staff) is also planned for publication.
Publisher Copyright:
© 2023 JMIR Publications Inc.. All Rights Reserved.
PY - 2023
Y1 - 2023
N2 - Background: Alcohol consumption is a major modifiable risk factor for female breast cancer, even in small amounts. However, awareness of this risk remains low. National breast screening programs are uniquely positioned to provide timely and targeted health information and behavior change strategies to improve alcohol literacy and reduce consumption. A breast screening service is a novel health care setting for brief alcohol intervention, with the potential for extensive reach. Objective: This study aimed to conduct a formative evaluation with breast screening service consumers to understand the need for, and acceptability of, brief alcohol intervention in the breast screening setting and collaboratively design a brief alcohol intervention (Health4Her); to test the effectiveness of Health4Her in improving knowledge of alcohol as a breast cancer risk factor (primary outcome), improving alcohol literacy, and reducing consumption among women attending a breast screening service; and to examine the implementation strategy through process evaluation. Methods: This was a hybrid type II effectiveness-implementation trial comprising a randomized controlled trial (RCT) alongside a mixed methods program evaluation guided by applicable elements of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework and Consolidated Framework for Implementation Research. Formative evaluation comprised a retrospective analysis of alcohol consumption data (n=49,240), a web-based survey (n=391), and focus groups and interviews (n=31) with breast screening service consumers. Women attending routine mammography, drinking at any level, were recruited to the single-site, double-blind RCT (n=558), and completed a baseline assessment before randomization (1:1) to receive Health4Her (alcohol brief intervention + lifestyle information) or control (lifestyle information) via animation on an iPad. Follow-up assessments were performed 4 and 12 weeks after randomization. The process evaluation included evaluation of trial administrative data, participant quantitative (n=497) and qualitative feedback (n=30), and site staff qualitative feedback (n=11). Results: This research was funded in March and May 2019. Data collection for the formative evaluation and trial recruitment occurred between January and April 2020 and February and August 2021, respectively, with finalization of follow-up data collection in December 2021. Quantitative process evaluation data were collected during trial implementation, and collection of participant and staff feedback was finalized in December 2021. Results of the retrospective analysis of alcohol consumption data from breast screening service consumers is anticipated to be published in March 2023 and the results of the RCT to be published in March 2023. Conclusions: This study is anticipated to generate new substantial knowledge on the alcohol consumption and literacy needs of women attending breast screening and the extent to which these can be addressed using a novel, tailored brief alcohol intervention. The study design permits the evaluation of the effectiveness and implementation of Health4Her to predict and facilitate uptake in breast screening services.
AB - Background: Alcohol consumption is a major modifiable risk factor for female breast cancer, even in small amounts. However, awareness of this risk remains low. National breast screening programs are uniquely positioned to provide timely and targeted health information and behavior change strategies to improve alcohol literacy and reduce consumption. A breast screening service is a novel health care setting for brief alcohol intervention, with the potential for extensive reach. Objective: This study aimed to conduct a formative evaluation with breast screening service consumers to understand the need for, and acceptability of, brief alcohol intervention in the breast screening setting and collaboratively design a brief alcohol intervention (Health4Her); to test the effectiveness of Health4Her in improving knowledge of alcohol as a breast cancer risk factor (primary outcome), improving alcohol literacy, and reducing consumption among women attending a breast screening service; and to examine the implementation strategy through process evaluation. Methods: This was a hybrid type II effectiveness-implementation trial comprising a randomized controlled trial (RCT) alongside a mixed methods program evaluation guided by applicable elements of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework and Consolidated Framework for Implementation Research. Formative evaluation comprised a retrospective analysis of alcohol consumption data (n=49,240), a web-based survey (n=391), and focus groups and interviews (n=31) with breast screening service consumers. Women attending routine mammography, drinking at any level, were recruited to the single-site, double-blind RCT (n=558), and completed a baseline assessment before randomization (1:1) to receive Health4Her (alcohol brief intervention + lifestyle information) or control (lifestyle information) via animation on an iPad. Follow-up assessments were performed 4 and 12 weeks after randomization. The process evaluation included evaluation of trial administrative data, participant quantitative (n=497) and qualitative feedback (n=30), and site staff qualitative feedback (n=11). Results: This research was funded in March and May 2019. Data collection for the formative evaluation and trial recruitment occurred between January and April 2020 and February and August 2021, respectively, with finalization of follow-up data collection in December 2021. Quantitative process evaluation data were collected during trial implementation, and collection of participant and staff feedback was finalized in December 2021. Results of the retrospective analysis of alcohol consumption data from breast screening service consumers is anticipated to be published in March 2023 and the results of the RCT to be published in March 2023. Conclusions: This study is anticipated to generate new substantial knowledge on the alcohol consumption and literacy needs of women attending breast screening and the extent to which these can be addressed using a novel, tailored brief alcohol intervention. The study design permits the evaluation of the effectiveness and implementation of Health4Her to predict and facilitate uptake in breast screening services.
UR - http://www.scopus.com/inward/record.url?scp=85151485249&partnerID=8YFLogxK
U2 - 10.2196/44867
DO - 10.2196/44867
M3 - Article
C2 - 36995739
AN - SCOPUS:85151485249
SN - 1929-0748
VL - 12
JO - JMIR Research Protocols
JF - JMIR Research Protocols
M1 - e44867
ER -