Application of Innovative Subject Recruitment System for Batch Enrollment: A Pilot Study.
Introduction: Using a digital process that leverages electronic health records (EHRs) can ease many of the challenges presented by the traditional enrollment process for clinical trials. We tested if automated batch enrollment using a technology-enabled subject recruitment system (TESRS) enhances re...
| Publicado en: | Journal of Primary Care & Community Health pp. 1 - 8 |
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| Autores principales: | , , , , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Sage Publications Inc.
8/30/2023
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=171103819&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 171103819 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21501319 AZBE jtl: Journal of Primary Care & Community Health issn: 21501319 maglogo: Y pubinfo: dt: 8/30/2023 pid: 344 pub: Sage Publications Inc. place: Thousand Oaks, California artinfo: ui: 171103819 171103819 171103819 10.1177/21501319231194967 171103819 ppf: 1 ppct: 7 formats: tig: atl: Application of Innovative Subject Recruitment System for Batch Enrollment: A Pilot Study. aug: au: Wi, Chung-Il King, Katherine S. Ryu, Euijung Natoli, Traci L. Miller, Ryan P. Spiten, Matthew J. Borah, Bijan J. Takahashi, Paul Y. Yao, Xiaoxi Noseworthy, Peter A. Pignolo, Robert J. Juhn, Young J. affil: Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, MN, USA sug: subj: Diffusion of Innovation Evaluation Research Subject Recruitment Evaluation Online Services Methods Human Male Female Randomized Controlled Trials Pilot Studies Digital Technology Electronic Health Records Research Subjects Prospective Studies Sociodemographic Factors Middle Age Decentralization Funding Source Middle Aged: 45-64 years Male Female ab: Introduction: Using a digital process that leverages electronic health records (EHRs) can ease many of the challenges presented by the traditional enrollment process for clinical trials. We tested if automated batch enrollment using a technology-enabled subject recruitment system (TESRS) enhances recruitment while preserving representation of research subjects for the study population in our study setting. Methods: An ongoing community-based prospective adult cohort study was used to randomize 600 subjects who were eligible by age and residential address to TESRS (n = 300) and standard mailing method (n = 300), respectively, for 3 months. Then, TESRS was initiated and included automatic identification of patients' preference for being contacted (online patient portal vs postal mail) from EHRs and automatic sending out of invitation letters followed by completion of a short online survey for checking eligibility and the digital consent process if eligible. We compared (1) median time to consent from invitation sent out per subject and total subjects recruited after a 3-month recruitment period, (2) the estimated study staff's time, and (3) representation of sociodemographic characteristics (e.g., age, sex, race, SES measured by HOUSES index, and rural residence) between subjects recruited via TESRS and those via traditional mailing methods. Results: Median age of randomized subjects (n = 600) was 63 years with 52.0% female and 89.2% non-Hispanic White. Over a 3-month period, results showed consent rate via TESRS was 13% (39/297) similar to 11% (31/295) via standard mailing. However, recruitment was significantly faster with the TESRS approach (median 7 vs 26 days) given the study staff's effort. Study staff's time saved by using TESRS compared to standard mailing approach was estimated at 40 min per subject (equivalent to 200 h for 300 subjects). No significant differences in characteristics of research subjects from the study population were found. Conclusion: Our study demonstrated the utility of TESRS as a subject recruitment digital technology which significantly enhanced the recruitment effort while reducing the study staff burden of recruitment while maintaining the consistency of characteristics of recruited subjects. The strategy and support for implementing and testing TESRS in other study settings should be considered. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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