Subscribe to RSS
DOI: 10.1055/a-2090-5745
Assessing Equitable Recruitment in a Digital Health Trial for Asthma
Funding This project was supported by grant numbers R18HS026432 and R18HS026432–02S1 from the Agency for Healthcare Research and Quality. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or Agency for Healthcare Research and Quality.![](https://www.thieme-connect.de/media/10.1055-s-00035026/202304/lookinside/thumbnails/10-1055-a-2090-5745_202211ra0297-1.jpg)
Abstract
Objective This study aimed to assess a multipronged strategy using primarily digital methods to equitably recruit asthma patients into a clinical trial of a digital health intervention.
Methods We approached eligible patients using at least one of eight recruitment strategies. We recorded approach dates and the strategy that led to completion of a web-based eligibility questionnaire that was reported during the verbal consent phone call. Study team members conducted monthly sessions using a structured guide to identify recruitment barriers and facilitators. The proportion of participants who reported being recruited by a portal or nonportal strategy was measured as our outcomes. We used Fisher's exact test to compare outcomes by equity variable, and multivariable logistic regression to control for each covariate and adjust effect size estimates. Using grounded theory, we coded and extracted themes regarding recruitment barriers and facilitators.
Results The majority (84.4%) of patients who met study inclusion criteria were patient portal enrollees. Of 6,366 eligible patients who were approached, 627 completed the eligibility questionnaire and were less frequently Hispanic, less frequently Spanish-speaking, and more frequently patient portal enrollees. Of 445 patients who consented to participate, 241 (54.2%) reported completing the eligibility questionnaire after being contacted by a patient portal message. In adjusted analysis, only race (odds ratio [OR]: 0.46, 95% confidence interval [CI]: 0.28–0.77, p = 0.003) and college education (OR: 0.60, 95% CI: 0.39–0.91, p = 0.016) remained significant. Key recruitment barriers included technology issues (e.g., lack of email access) and facilitators included bilingual study staff, Spanish-language recruitment materials, targeted phone calls, and clinician-initiated “1-click” referrals.
Conclusion A primarily digital strategy to recruit patients into a digital health trial is unlikely to achieve equitable participation, even in a population overrepresented by patient portal enrollees. Nondigital recruitment methods that address racial and educational disparities and less active portal enrollees are necessary to ensure equity in clinical trial enrollment.
Protection of Human and Animal Subjects
The study was reviewed and performed in compliance with the Massachusetts General Brigham Institutional Review Board.
Publication History
Received: 16 November 2022
Accepted: 06 May 2023
Accepted Manuscript online:
10 May 2023
Article published online:
09 August 2023
© 2023. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
-
References
- 1 Cowie MR, Blomster JI, Curtis LH. et al. Electronic health records to facilitate clinical research. Clin Res Cardiol 2017; 106 (01) 1-9
- 2 Gleason KT, Ford DE, Gumas D. et al. Development and preliminary evaluation of a patient portal messaging for research recruitment service. J Clin Transl Sci 2018; 2 (01) 53-56
- 3 Bennett WL, Bramante CT, Rothenberger SD. et al. Patient recruitment into a multicenter clinical cohort linking electronic health records from 5 health systems: cross-sectional analysis. J Med Internet Res 2021; 23 (05) e24003
- 4 Zimmerman LP, Goel S, Sathar S. et al. A novel patient recruitment strategy: patient selection directly from the community through linkage to clinical data. Appl Clin Inform 2018; 9 (01) 114-121
- 5 Mehrotra A, Ray KN, Brockmeyer DM, Barnett ML, Bender JA. . Rapidly converting to “virtual practices”: outpatient care in the era of Covid-19. NEJM Catalyst. Accessed April 1, 2023 at: https://catalyst.nejm.org/doi/full/10.1056/CAT.20.0091
- 6 Pfaff E, Lee A, Bradford R. et al. Recruiting for a pragmatic trial using the electronic health record and patient portal: successes and lessons learned. J Am Med Inform Assoc 2019; 26 (01) 44-49
- 7 Weng C, Li Y, Ryan P. et al. A distribution-based method for assessing the differences between clinical trial target populations and patient populations in electronic health records. Appl Clin Inform 2014; 5 (02) 463-479
- 8 Cahan A, Cimino JJ. Visual assessment of the similarity between a patient and trial population: is this clinical trial applicable to my patient?. Appl Clin Inform 2016; 7 (02) 477-488
- 9 Duma N, Vera Aguilera J, Paludo J. et al. Representation of minorities and women in oncology clinical trials: review of the past 14 years. J Oncol Pract 2018; 14 (01) e1-e10
- 10 Gray II DM, Nolan TS, Gregory J, Joseph JJ. Diversity in clinical trials: an opportunity and imperative for community engagement. Lancet Gastroenterol Hepatol 2021; 6 (08) 605-607
- 11 Michos ED, Van Spall HGC. Increasing representation and diversity in cardiovascular clinical trial populations. Nat Rev Cardiol 2021; 18 (08) 537-538
- 12 Oyer RA, Hurley P, Boehmer L. et al. Increasing racial and ethnic diversity in cancer clinical trials: an American Society of Clinical Oncology and Association of Community Cancer Centers joint research statement. J Clin Oncol 2022; 40 (19) 2163-2171
- 13 Alliance NDI. . Definitions. Accessed October 15, 2021 at: https://www.digitalinclusion.org/definitions/
- 14 Gehtland LM, Paquin RS, Andrews SM. et al. Using a patient portal to increase enrollment in a newborn screening research study: observational study. JMIR Pediatr Parent 2022; 5 (01) e30941
- 15 Goodson N, Wicks P, Morgan J, Hashem L, Callinan S, Reites J. Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion. NPJ Digit Med 2022; 5 (01) 58
- 16 Alcaraz KI, Vereen RN, Burnham D. Use of telephone and digital channels to engage socioeconomically disadvantaged adults in health disparities research within a social service setting: cross-sectional study. J Med Internet Res 2020; 22 (04) e16680
- 17 Clark CR, Akdas Y, Wilkins CH. et al. TechQuity is an imperative for health and technology business: let's work together to achieve it. J Am Med Inform Assoc 2021; 28 (09) 2013-2016
- 18 Rudin RS, Perez S, Rodriguez JA. et al. User-centered design of a scalable, electronic health record-integrated remote symptom monitoring intervention for patients with asthma and providers in primary care. J Am Med Inform Assoc 2021; 28 (11) 2433-2444
- 19 Rudin RS, Fanta CH, Qureshi N. et al. A clinically integrated mHealth app and practice model for collecting patient-reported outcomes between visits for asthma patients: implementation and feasibility. Appl Clin Inform 2019; 10 (05) 783-793
- 20 Greenhalgh T, Wherton J, Papoutsi C. et al. Beyond adoption: a new framework for theorizing and evaluating nonadoption, abandonment, and challenges to the scale-up, spread, and sustainability of health and care technologies. J Med Internet Res 2017; 19 (11) e367
- 21 Nwaru BI, Ekström M, Hasvold P, Wiklund F, Telg G, Janson C. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J 2020; 55 (04) 1901872
- 22 Wilson SR, Rand CS, Cabana MD. et al. Asthma outcomes: quality of life. J Allergy Clin Immunol 2012; 129 (3, suppl): S88-S123
- 23 Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J 1999; 14 (01) 32-38
- 24 Taylor DR, Bateman ED, Boulet LP. et al. A new perspective on concepts of asthma severity and control. Eur Respir J 2008; 32 (03) 545-554
- 25 Fuhlbrigge A, Peden D, Apter AJ. et al. Asthma outcomes: exacerbations. J Allergy Clin Immunol 2012; 129 (3, suppl): S34-S48
- 26 Consolidated Framework for Implementation Research. . 2022. Accessed May 23, 2023 at: https://cfirguide.org/constructs/
- 27 Strauss A, Corbin J. . Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory. 2nd ed. Thousand Oaks, CA: Sage Publications, Inc; 1998:xiii, 312-xiii, 312.
- 28 Anthony DL, Campos-Castillo C, Lim PS. Who isn't using patient portals and why? Evidence and implications from a national sample Of US adults. Health Aff (Millwood) 2018; 37 (12) 1948-1954
- 29 Goel MS, Brown TL, Williams A, Hasnain-Wynia R, Thompson JA, Baker DW. Disparities in enrollment and use of an electronic patient portal. J Gen Intern Med 2011; 26 (10) 1112-1116
- 30 El-Toukhy S, Méndez A, Collins S, Pérez-Stable EJ. Barriers to patient portal access and use: evidence from the health information national trends survey. J Am Board Fam Med 2020; 33 (06) 953-968
- 31 Eruchalu CN, Pichardo MS, Bharadwaj M. et al. The expanding digital divide: digital health access inequities during the COVID-19 pandemic in New York City. J Urban Health 2021; 98 (02) 183-186
- 32 Rodriguez JA, Betancourt JR, Sequist TD, Ganguli I. Differences in the use of telephone and video telemedicine visits during the COVID-19 pandemic. Am J Manag Care 2021; 27 (01) 21-26
- 33 Wedd J, Basu M, Curtis LM. et al. Racial, ethnic, and socioeconomic disparities in web-based patient portal usage among kidney and liver transplant recipients: cross-sectional study. J Med Internet Res 2019; 21 (04) e11864
- 34 van Deursen AJ. Digital inequality during a pandemic: quantitative study of differences in COVID-19-related internet uses and outcomes among the general population. J Med Internet Res 2020; 22 (08) e20073
- 35 Fang ML, Walker M, Wong KLY, Sixsmith J, Remend L, Sixsmith A. Future of digital health and community care: Exploring intended positive impacts and unintended negative consequences of COVID-19. Healthc Manage Forum 2022; 35 (05) 279-285
- 36 Nelson LA, Pennings JS, Sommer EC, Popescu F, Barkin SLA. A 3-item measure of digital health care literacy: development and validation study. JMIR Form Res 2022; 6 (04) e36043
- 37 Grossman LV, Masterson Creber RM, Benda NC, Wright D, Vawdrey DK, Ancker JS. Interventions to increase patient portal use in vulnerable populations: a systematic review. J Am Med Inform Assoc 2019; 26 (8–9): 855-870
- 38 Wisniewski H, Gorrindo T, Rauseo-Ricupero N, Hilty D, Torous J. The role of digital navigators in promoting clinical care and technology integration into practice. Digit Biomark 2020; 4 (suppl 1): 119-135
- 39 Rodriguez JA, Charles JP, Bates DW, Lyles C, Southworth B, Samal L. Digital healthcare equity in primary care: implementing an integrated digital health navigator. J Am Med Inform Assoc 2023; 30 (05) 965-970
- 40 Rodriguez JA, Shachar C, Bates DW. Digital inclusion as health care - supporting health care equity with digital-infrastructure initiatives. N Engl J Med 2022; 386 (12) 1101-1103