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.

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. FINDINGS: 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). INTERPRETATION: 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. FUNDING: US President's Emergency Plan for AIDS Relief (PEPFAR), through the US Centers for Disease Control and Prevention.

A structured approach to recording AIDS-defining illnesses in Kenya: A SNOMED CT based solution.

INTRODUCTION: Several studies conducted in sub-Saharan Africa (SSA) have shown that routine clinical data in HIV clinics often have errors. Lack of structured and coded documentation of diagnosis of AIDS defining illnesses (ADIs) can compromise data quality and decisions made on clinical care. METHODS: We used a structured framework to derive a reference set of concepts and terms used to describe ADIs. The four sources used were: (i) CDC/Accenture list of opportunistic infections, (ii) SNOMED Clinical Terms (SNOMED CT), (iii) Focus Group Discussion (FGD) among clinicians and nurses attending to patients at a referral provincial hospital in western Kenya, and (iv) chart abstraction from the Maternal Child Health (MCH) and HIV clinics at the same hospital. Using the January 2014 release of SNOMED CT, concepts were retrieved that matched terms abstracted from approach iii & iv, and the content coverage assessed. Post-coordination matching was applied when needed. RESULTS: The final reference set had 1054 unique ADI concepts which were described by 1860 unique terms. Content coverage of SNOMED CT was high (99.9% with pre-coordinated concepts; 100% with post-coordination). The resulting reference set for ADIs was implemented as the interface terminology on OpenMRS data entry forms. CONCLUSION: Different sources demonstrate complementarity in the collection of concepts and terms for an interface terminology. SNOMED CT provides a high coverage in the domain of ADIs. Further work is needed to evaluate the effect of the interface terminology on data quality and quality of care.

Better adherence to pre-antiretroviral therapy guidelines after implementing an electronic medical record system in rural Kenyan HIV clinics: a multicenter pre-post study.

INTRODUCTION: The monitoring of pre-antiretroviral therapy (pre-ART) is a key indicator of HIV quality of care. This study investigated the association of an electronic medical record system (EMR) with adherence to pre-ART guidelines in rural HIV clinics in Kenya. METHODS: A retrospective study was carried out to assess the quality of pre-ART care using three indicators: (1) the performance of a baseline CD4 test, (2) time from enrollment in care to first CD4 test, and (3) time from baseline CD4 to second CD4 test. A comparison of these indicators was made pre and post the introduction of an EMR system in 17 rural HIV clinics. RESULTS: A total of 18523 patients were receiving pre-ART care, of whom 38.8% in the paper group had had at least one CD4 test compared to 53.4% in the EMR group (p<0.001). The adjusted odds of performing a CD4 test in clinics using an EMR was 1.59 (95% confidence interval 1.49-1.69). The median time from enrolment into HIV care to first CD4 test was 1.40 months (interquartile range (IQR) 0.47-4.87) for paper vs. 0.93 months (IQR 0.43-3.37) for EMR. The median time from baseline to first CD4 follow-up was 7.5 months (IQR 5.97-10.73) for paper and 6.53 months (IQR 5.57-7.87) for EMR. CONCLUSION: The use of the EMR system was associated with better compliance to HIV guidelines for pre-ART care. EMRs have a potential positive impact on quality of care for HIV patients in resource-constrained settings.

Electronic medical record systems are associated with appropriate placement of HIV patients on antiretroviral therapy in rural health facilities in Kenya: a retrospective pre-post study.

BACKGROUND AND OBJECTIVE: There is little evidence that electronic medical record (EMR) use is associated with better compliance with clinical guidelines on initiation of antiretroviral therapy (ART) among ART-eligible HIV patients. We assessed the effect of transitioning from paper-based to an EMR-based system on appropriate placement on ART among eligible patients. METHODS: We conducted a retrospective, pre-post EMR study among patients enrolled in HIV care and eligible for ART at 17 rural Kenyan clinics and compared the: (1) proportion of patients eligible for ART based on CD4 count or WHO staging who initiate therapy; (2) time from eligibility for ART to ART initiation; (3) time from ART initiation to first CD4 test. RESULTS: 7298 patients were eligible for ART; 54.8% (n=3998) were enrolled in HIV care using a paper-based system while 45.2% (n=3300) were enrolled after the implementation of the EMR. EMR was independently associated with a 22% increase in the odds of initiating ART among eligible patients (adjusted OR (aOR) 1.22, 95% CI 1.12 to 1.33). The proportion of ART-eligible patients not receiving ART was 20.3% and 15.1% for paper and EMR, respectively (χ(2)=33.5, p<0.01). Median time from ART eligibility to ART initiation was 29.1 days (IQR: 14.1-62.1) for paper compared to 27 days (IQR: 12.9-50.1) for EMR. CONCLUSIONS: EMRs can improve quality of HIV care through appropriate placement of ART-eligible patients on treatment in resource limited settings. However, other non-EMR factors influence timely initiation of ART.