title: Effect of a clinical decision support system on early action on immunological treatment failure in patients with HIV in Kenya: a cluster randomised controlled trial.
abstract: BACKGROUND
  A clinical decision support system (CDSS) is a computer program that applies a set of rules to data stored in electronic health records to offer actionable recommendations. We aimed to establish whether a CDSS that supports detection of immunological treatment failure among patients with HIV taking antiretroviral therapy (ART) would improve appropriate and timely action.
  
  
  METHODS
  We did this prospective, cluster randomised controlled trial in adults and children (aged ≥18 months) who were eligible for, and receiving, ART at HIV clinics in Siaya County, western Kenya. Health facilities were randomly assigned (1:1), via block randomisation (block size of two) with a computer-generated random number sequence, to use electronic health records either alone (control) or with CDSS (intervention). Facilities were matched by type and by number of patients enrolled in HIV care. The primary outcome measure was the difference between groups in the proportion of patients who experienced immunological treatment failure and had a documented clinical action. We used generalised linear mixed models with random effects to analyse clustered data. This trial is registered with ClinicalTrials.gov, number NCT01634802.
  
  
  RESULTS
  Between Sept 1, 2012, and Jan 31, 2014, 13 clinics, comprising 41,062 patients, were randomly assigned to the control group (n=6) or the intervention group (n=7). Data collection at each site took 12 months. Among patients eligible for ART, 10,358 (99%) of 10,478 patients were receiving ART at control sites and 10,991 (99%) of 11,028 patients were receiving ART at intervention sites. Of these patients, 1125 (11%) in the control group and 1342 (12%) in the intervention group had immunological treatment failure, of whom 332 (30%) and 727 (54%), respectively, received appropriate action. The likelihood of clinicians taking appropriate action on treatment failure was higher with CDSS alerts than with no decision support system (adjusted odds ratio 3·18, 95% CI 1·02-9·87).
  
  
  CONCLUSIONS
  CDSS significantly improved the likelihood of appropriate and timely action on immunological treatment failure. We expect our findings will be generalisable to virological monitoring of patients with HIV receiving ART once countries implement the 2015 WHO recommendation to scale up viral load monitoring.
  
  
  BACKGROUND
  US President's Emergency Plan for AIDS Relief (PEPFAR), through the US Centers for Disease Control and Prevention.
authors: Division of Global HIV/AIDS, US Centers for Disease Control and Prevention (CDC), Nairobi, Kenya. Electronic address: toluoch@cdc.gov.
authors: Tom
authors: T
authors: Oluoch
authors: Division of Global HIV/AIDS, US Centers for Disease Control and Prevention (CDC), Nairobi, Kenya.
authors: Abraham
authors: A
authors: Katana
authors: Kenya Medical Research Institute-CDC Collaborative Program, Kisumu, Kenya.
authors: Daniel
authors: D
authors: Kwaro
authors: Atlanta, GA, USA.
authors: Xenophon
authors: X
authors: Santas
authors: Kenya Medical Research Institute-CDC Collaborative Program, Kisumu, Kenya.
authors: Patrick
authors: P
authors: Langat
authors: Division of Global HIV/AIDS, US Centers for Disease Control and Prevention (CDC), Nairobi, Kenya.
authors: Samuel
authors: S
authors: Mwalili
authors: University of California, San Francisco, Nairobi, Kenya.
authors: Kimeu
authors: K
authors: Muthusi
authors: Kenya Medical Research Institute-CDC Collaborative Program, Kisumu, Kenya.
authors: Nicky
authors: N
authors: Okeyo
authors: Division of Global HIV/AIDS, US Centers for Disease Control and Prevention (CDC), Nairobi, Kenya.
authors: James K
authors: JK
authors: Ojwang
authors: Department of Medical Informatics, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands; Department of Biomedical Engineering, Linköping University, Linköping, Sweden.
authors: Ronald
authors: R
authors: Cornet
authors: Department of Medical Informatics, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
authors: Ameen
authors: A
authors: Abu-Hanna
authors: Department of Medical Informatics, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
authors: Nicolette
authors: N
authors: de Keizer
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D018791:CD4 Lymphocyte Count; D002648:Child; D002675:Child, Preschool; D020000:Decision Support Systems, Clinical; D003695:Delivery of Health Care / Q000458:organization & administration*; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology; D006801:Humans; D007223:Infant; D007630:Kenya / Q000453:epidemiology; D008297:Male; D011446:Prospective Studies; D017211:Treatment Failure; D019562:Viral Load / Q000187:drug effects
chemical_list: D019380:Anti-HIV Agents