{"doc_desc":{"title":"Dynamic electronic decision trees to manage sick children in Tanzania - Phase 1 cRCT data"},"study_desc":{"title_statement":{"idno":"10.16909-dataset-58","title":"Dynamic electronic decision trees to manage sick children in Tanzania - Phase 1 cRCT data","sub_title":"Master dataset from \"Phase 1\" cluster randomized trial and quality of care cluster RCT","alternate_title":"DYNAMIC TZ"},"authoring_entity":[{"name":"Valerie D'Acremont","affiliation":"Unisant\u00e9, Center for Primary Care and Public Health & University of Lausanne, Lausanne, Switzerland"},{"name":"Honorati Masanja","affiliation":"Ifakara Health Institute"},{"name":"Nyanda Ntinginya","affiliation":"Mbeya Medical Research Center - NIMR"}],"production_statement":{"producers":[{"name":"Rainer Tan","abbr":"","affiliation":"Unisant\u00e9, Center for Primary Care and Public Health & University of Lausanne, Lausanne, Switzerland","role":""},{"name":"Godfrey Kavishe","abbr":"","affiliation":"National Institute of Medical Research \u2013 Mbeya Medical Research Centre, Mbeya, United Republic of Tanzania","role":""},{"name":"Lameck B. Luwanda","abbr":"","affiliation":"Ifakara Health Institute, Dar es Salaam, United Republic of Tanzania","role":""},{"name":"Alexandra V. Kulinkina","abbr":"","affiliation":"Swiss Tropical and Public Health Institute, Allschwil, Switzerland & University of Basel, Basel, Switzerland","role":""},{"name":"Sabine Renggli","abbr":"","affiliation":"Ifakara Health Institute, Dar es Salaam, United Republic of Tanzania","role":""},{"name":"Chacha Mangu","abbr":"","affiliation":"National Institute of Medical Research \u2013 Mbeya Medical Research Centre, Mbeya, United Republic of Tanzania","role":""},{"name":"Geofrey Ashery","abbr":"","affiliation":"Ifakara Health Institute, Dar es Salaam, United Republic of Tanzania","role":""},{"name":"Margaret Jorram","abbr":"","affiliation":"Ifakara Health Institute, Dar es Salaam, United Republic of Tanzania","role":""},{"name":"Ibrahim Evans Mtebene","abbr":"","affiliation":"Ifakara Health Institute, Dar es Salaam, United Republic of Tanzania","role":""},{"name":"Peter Agrea","abbr":"","affiliation":"National Institute of Medical Research \u2013 Mbeya Medical Research Centre, Mbeya, United Republic of Tanzania","role":""},{"name":"Humphrey Mhagama","abbr":"","affiliation":"National Institute of Medical Research \u2013 Mbeya Medical Research Centre, Mbeya, United Republic of Tanzania","role":""},{"name":"Alan Vonlanthen","abbr":"","affiliation":"Unisant\u00e9, Center for Primary Care and Public Health & University of Lausanne, Lausanne, Switzerland","role":""},{"name":"Vincent Faivre","abbr":"","affiliation":"Unisant\u00e9, Center for Primary Care and Public Health & University of Lausanne, Lausanne, Switzerland","role":""},{"name":"Julien Thabard","abbr":"","affiliation":"Unisant\u00e9, Center for Primary Care and Public Health & University of Lausanne, Lausanne, Switzerland","role":""},{"name":"Gillian Levine","abbr":"","affiliation":"Swiss Tropical and Public Health Institute, Allschwil, Switzerland & University of Basel, Basel, Switzerland","role":""},{"name":"Marie-Annick Le Pogam","abbr":"","affiliation":"Unisant\u00e9, Center for Primary Care and Public Health & University of Lausanne, Lausanne, Switzerland","role":""},{"name":"Kristina Keitel","abbr":"","affiliation":"Swiss Tropical and Public Health Institute, Allschwil, Switzerland & University of Basel, Basel, Switzerland","role":""},{"name":"Patrick Taff\u00e9","abbr":"","affiliation":"Unisant\u00e9, Center for Primary Care and Public Health & University of Lausanne, Lausanne, Switzerland","role":""},{"name":"Nyanda Ntinginya","abbr":"","affiliation":"National Institute of Medical Research \u2013 Mbeya Medical Research Centre, Mbeya, United Republic of Tanzania","role":""},{"name":"Honorati Masanja","abbr":"","affiliation":"Ifakara Health Institute, Dar es Salaam, United Republic of Tanzania","role":""},{"name":"Val\u00e9rie D\u2019Acremont","abbr":"","affiliation":"Unisant\u00e9, Center for Primary Care and Public Health & University of Lausanne, Lausanne, Switzerland","role":""}],"funding_agencies":[{"name":"Fondation Botnar","abbr":"","role":"Funding"},{"name":"Swiss Development Cooperation","abbr":"SDC","role":"Funding"}],"grant_no":"6278 7F-10361.01.01"},"distribution_statement":{"contact":[{"name":"Valerie D'Acremont","affiliation":"Unisant\u00e9, Center for Primary Care and Public Health & University of Lausanne, Lausanne, Switzerland","email":"valerie.dacremont@unisante.ch","uri":""},{"name":"Rainer Tan","affiliation":"Unisant\u00e9, Center for Primary Care and Public Health & University of Lausanne, Lausanne, Switzerland","email":"rainer.tan@unisante.ch","uri":""}]},"version_statement":{"version":"version 2: Edited, de-identified dataset, for internal use only","version_date":"2025-01-01"},"study_info":{"keywords":[{"keyword":"Antibiotic stewardship","vocab":"","uri":""},{"keyword":"Digital health","vocab":"","uri":""},{"keyword":"Global Health","vocab":"","uri":""},{"keyword":"Primary Care","vocab":"","uri":""}],"abstract":"A pragmatic digital health project to improve quality of care and antibiotic stewardship in primary care level health facilities in Tanzania for the management of sick children less than 15 years of age. The data provided here are from the first open-label parellel group pragmatic cluster randomized trial in 40 health facilities in Tanzania to evaluate the impact of a digital clinical decision support algorithm compared to usual care on antibiotic prescribing and clinical outcome among children with an acute illness presenting to primary care health facilities. The second dataset is from the ancillary quality of care cluster RCT where consultations were observed in 9 intervention health facilities and 9 control health facilities, to compare the mean proportion of pre-specified symptoms and signs assessed, and appropriateness of antimicrobial treatment.","coll_dates":[{"start":"20211201","end":"20221031","cycle":""}],"nation":[{"name":"Tanzania","abbreviation":""}],"geog_coverage":"Mbeya and Morogoro region\nCouncils in Morogoro region: Ulanga DC, Mlimba DC, Ifakara TC\nCouncils in Mbeya region: Mbeya CC, Mbeya DC\nSemi-urban and rural areas","analysis_unit":"Individual consultations","data_kind":"Clinical data [cli]","notes":"Clinical data: Symptoms, signs, test results, diagnoses, treatment, clinical outcome at D7, hospitalization, referral\nDemographics: age, sex"},"method":{"data_collection":{"sampling_procedure":"Sampling, randomization and masking\nThe 40 health facilities were randomly selected from all eligible health facilities in the participating councils following a 3:2 ratio between health facilities from the Morogoro and Mbeya region (to include more health facilities in the higher malaria transmission area). In addition, to include a representative sample of health centers compared to dispensaries, four health centers per region were included.\n\nThe sampled health facilities were then randomized (1:1) to ePOCT+ (intervention) or usual care (control). Randomization was stratified by region, council, level of health facility (health center versus dispensary) and attendance rate. An independent statistician in Switzerland was provided with the list of all eligible health facilities and performed computer-generated sampling and randomization. Intervention allocation by the study team was only shared with study investigators in Tanzania once all council leaders had confirmed the participation of their selected health facilities. The nature of the intervention did not allow for masking of the intervention to health-care providers, patients or study implementers.","coll_mode":["Other [oth]"],"sources":[{"name":"","origin":"","characteristics":""}],"coll_situation":"Overall, 59,875 children were screened for inclusion between 1 December 2021 and 31 October 2022, and 44,306 (74%) consultations were enrolled (23,593 in ePOCT+ health facilities and 20,713 in usual care health facilities). The first health facilities started enrolling patients on 1 December 2021, and the last health facilities started enrolling patients on 13 April 2022. A total of 28,243 unique patients were enrolled with a mean of 1.6 consultations per patient over the duration of the study. Among those enrolled in the intervention health facilities, 17,985 (76.2%) consultations were managed using ePOCT+, and day 7 outcome was ascertained in 20,355 consultations (86.3%). In usual care health facilities, 18,937 (91.4%) consultations had final treatment documented in the electronic case report form (eCRF), and 17,292 consultations (83.5%) had day 7 outcome ascertained. Information technology (IT) problems and power outages were reported by research assistants on respectively 293 (7.3%) and 245 (6.1%) health facility days in ePOCT+ facilities, and 160 (4.1%) and 245 (6.1%) health facility days in usual care facilities. Both issues contributed to children being prevented from enrollment in the study.","cleaning_operations":"Demographic information was collected and entered in the eCRF (ePOCT+ for intervention health facilities and eCRFs for usual care facilities within the data collection system medAL-reader) by registration research assistants. Clinical data was entered by the routine clinicians in both study arms, however clinical data limited in the control arm. 7 days after the initial consult research assistants made phone calls to all participants to collect data on clinical outcome, further healthcare use, and further use of additional medications not prescribed."}},"data_access":{"dataset_availability":{"access_place":"Unisant\u00e9 Data repository","access_place_url":"https:\/\/doi.org\/10.16909\/58","status":"The access and use of this dataset is restricted to the intern team only."},"dataset_use":{"conf_dec":[{"txt":"All requests for use of data should be directed towards rainer.tan@unisante.ch or valerie.dacremont@unisante.ch","required":"yes","form_no":"","form_uri":""}],"contact":[{"name":"Valerie D'Acremont","affiliation":"Unisant\u00e9, Center for Primary Care and Public Health & University of Lausanne, Lausanne, Switzerland","email":"valerie.dacremont@unisante.ch","uri":""},{"name":"Rainer Tan","affiliation":"Unisant\u00e9, Center for Primary Care and Public Health & University of Lausanne, Lausanne, Switzerland","email":"rainer.tan@unisante.ch","uri":""}]}}},"schematype":"survey","tags":[{"tag":"Humans"}]}