{"doi":"10.17615/640g-gx18","title":"Use of comprehensive recruitment strategies in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE) multi-center clinical trial","abstract":"Background/Aims: We present and describe recruitment strategies implemented from 2013 to 2017 across 45 clinical sites in the United States, participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, an unmasked, randomized controlled trial evaluating four glucose-lowering medications added to metformin in individuals with type 2 diabetes mellitus (duration of diabetes <10 years). We examined the yield of participants recruited through Electronic Health Records systems compared to traditional recruitment methods to leverage access to type 2 diabetes patients in primary care. Methods: Site selection criteria included availability of the study population, geographic representation, the ability to recruit and retain a diverse pool of participants including traditionally underrepresented groups, and prior site research experience in diabetes clinical trials. Recruitment initiatives were employed to support and monitor recruitment, such as creation of a Recruitment and Retention Committee, development of criteria for Electronic Health Record systems queries, conduct of remote site visits, development of a public screening website, and other central and local initiatives. Notably, the study supported a dedicated recruitment coordinator at each site to manage local recruitment and facilitate screening of potential participants identified by Electronic Health Record systems. Results: The study achieved the enrollment goal of 5000 participants, meeting its target with Black/African American (20%), Hispanic/Latino (18%), and age ≧60 years (42%) subgroups but not with women (36%). Recruitment required 1 year more than the 3 years originally planned. Sites included academic hospitals, integrated health systems, and Veterans Affairs Medical Centers. Participants were enrolled through Electronic Health Record queries (68%), physician referral (13%), traditional mail outreach (7%), TV, radio, flyers, and Internet (7%), and other strategies (5%). Early implementation of targeted Electronic Health Record queries yielded a greater number of eligible participants compared to other recruitment methods. Efforts over time increasingly emphasized engagement with primary care networks. Conclusion: Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness successfully recruited a diverse study population with relatively new onset of type 2 diabetes mellitus, relying to a large extent on the use of Electronic Health Record to screen potential participants. A comprehensive approach to recruitment with frequent monitoring was critical to meet the recruitment goal.","journal":"UNC Libraries","year":2024,"id":499629,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9515,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1348330,"name":"McKee M.D","orcid":null,"position":1,"is_corresponding":false},{"id":930625,"name":"Amy Loveland","orcid":"0009-0004-7976-5256","position":2,"is_corresponding":false},{"id":1348331,"name":"Hox S.H","orcid":null,"position":3,"is_corresponding":false},{"id":1348332,"name":"Jackson A.U","orcid":null,"position":4,"is_corresponding":false},{"id":904778,"name":"Andrea Waltje","orcid":"0000-0001-5311-1925","position":5,"is_corresponding":false},{"id":483239,"name":"Heidi Krause‐Steinrauf","orcid":"0000-0001-6894-4110","position":6,"is_corresponding":false},{"id":1312341,"name":"Buse J.B","orcid":null,"position":7,"is_corresponding":false},{"id":298021,"name":"Vanita R. Aroda","orcid":"0000-0002-7706-4585","position":8,"is_corresponding":false},{"id":1348333,"name":"Phillips L.S","orcid":null,"position":9,"is_corresponding":false},{"id":1348334,"name":"Fortmann S.P","orcid":null,"position":10,"is_corresponding":false},{"id":1133848,"name":"Basma Fattaleh","orcid":null,"position":11,"is_corresponding":false},{"id":1347556,"name":"Sharon M. Hall","orcid":"0000-0002-0273-9701","position":12,"is_corresponding":false},{"id":1348335,"name":"Cherrington A.L","orcid":null,"position":13,"is_corresponding":false},{"id":1347557,"name":"Alexander Kuhn","orcid":"0000-0002-1962-4863","position":14,"is_corresponding":false},{"id":368257,"name":"Tina Killean","orcid":null,"position":0,"is_corresponding":true}],"reference_count":0,"raw_metadata":null,"created_at":"2026-07-19T02:09:53.188165Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}