Recruitment best practices of a cardiovascular risk reduction randomised control trial in rural Alaska Native communities

ABSTRACT

Though not native to Alaska, tobacco use is common among Alaska Native people in the Norton Sound region, an area consisting of 16 communities with population size 107 to 3,695. We summarise best practices in recruiting Alaska Native adults who smoke for a randomised controlled tobacco treatment trial. Participants were Alaska Native, 19 years and older, smoking daily, with hypertension and/or high cholesterol, residing in the Norton Sound region of Alaska. Study staff travelled to the remote communities to recruit, typically staying 5 days. Screening and enrolment success was examined by day, season, and staffing level. From June 2015 – December 2018, the study team made 122 trips, screening 1089 individuals and enrolling 314 participants. In the field, days 2–3 (51%) were best for screening, while days 3–4 (53%) had the greatest enrolment. Community size correlated with enrolment (r = 0.83, p <.001). Recruitment was optimised in spring and with multiple staff in the field. Despite challenges (e.g., harsh weather, poor internet connectivity), with active outreach (e.g. tabling in busy areas, attending community events, utilising mixed media, collaborating with clinic staff), the project reached its recruitment goal. Study findings can inform community-based tobacco treatment research trials in remote areas.

Abbreviations

CVD: Cardiovascular disease; VTC: Video teleconferencing; ANMC: Alaska Native Medical Centre; HEALTHH: Healing and Empowering Alaskan Lives Towards Healthy Hearts; NSHC: Norton Sound Health Corporation; RERB: Research Ethics Review Board

KEYWORDS:

• Recruitment strategies
• rural
• Alaska Native
• cardiovascular health

Acknowledgments

We acknowledge with great appreciation the tribal representatives who make up the Norton Sound Health Corporation’s (NSHC) Research Ethics Review Board (RERB). The RERB has been central in approving, guiding, and overseeing this research. In addition, we appreciate Reba Lean, NSHC CEO Angela Gorn, RD, MBA, and Steven Daniel, MD for their support with study recruitment and study presence in the community. We recognize the dedicated efforts of the HEALTHH recruitment and counselling team members including Nicole Anzai, Amy Chieng, Dr. Maria Crouch, Nicole Jeffery, Colleen Johnson, Anne Michalek, Derek Searcy, Adrienne Lazaro, Dr. Anna Epperson, and Sarah Stinson; and our Data Safety Monitoring Board members Drs. Tina Woods, Teresa LaFromboise, and Andrew Pipe. The stage-tailored computer interventions and treatment manuals were developed by Pro-Change Behavior Systems. VIDYO has provided the telemedicine platform for intervention delivery. We also appreciate Amy Chieng’s assistance with manuscript formatting and submission.

Disclosure statement

Drs. JP and NB have served as expert witnesses against the tobacco companies in lawsuits for which they have received fees for the work. They have also provided consultation to pharmaceutical and technology companies that make medications and other treatments for quitting smoking. No other authors have disclosures to report related to this work.

Ethical approval and consent to participate

The manuscript has undergone tribal review and received approval for submission. All procedures performed in studies involving human participants were in accordance with the ethical standards of the Alaska Area Institutional Review Board (reference # 2014-05-023), Stanford Institutional Review Board (IRB #2,638), and University of California San Francisco Institutional Review Board (UCSF IRB #14-13,83) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent and permissions

Written informed consent was obtained from all participants in the study.

Authors’ contributions

MK analyzed and interpreted the data present in this paper, as well as composed the manuscript. JS assisted with data analysis and editing of the manuscript. NB and JP conceptualized the study design for HEALTHH. JP also oversaw the creation and editing of the manuscript. MS provided medical guidance to staff if questions arose. All authors have read and approved the manuscript.

Consort guidelines

We acknowledge that this study adheres to the CONSORT guidelines.

Disclaimers

The views expressed in this submission are solely the authors’, and do not reflect NHLBI nor any institutional views.

Data availability

The datasets generated and/or analyzed in the current study are not publicly available per community request. Inquiries should be sent to the corresponding author.

Additional information

Funding

This study was funded by the National Heart, Lung, and Blood Institute #R01HL117736 both in a parent award and three Diversity Supplement awards.