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The purpose of this study is to determine whether the use of a Computerized Decision Support System (CDSS) in form of alerts to clinicians enhances early detection of immunological treatment failure in HIV patients.
We hypothesize that there is no difference in the time to detecting immunological treatment failure among HIV patients in resource poor settings whether the clinicians use an Electronic Medical Record (EMR) system with a Computerized Decision Support (CDSS) or an EMR without a CDSS. In this study, 20 clinics were assigned to the intervention (EMR+CDSS) arm and non-intervention arm (EMR only) and will be followed up for 12 months to assess whether there are any differences in time taken to detect immunological treatment failure based on CD4 cell count.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMR Only | No Intervention | Clinics in this arm of the study will have a standard Electronic Medical Record (EMR) system installed - without a computerized decision support system. |
|
| EMR+CDSS | Experimental | Clinics in this arm of the study will have an Electronic Medical Record (EMR) system with Clinical Decision Support System (CDSS) enhancement implemented as alerts to aid the clinician in decision making. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMR Only | Other | Clinics in this arm of the study will have a standard Electronic Medical Record (EMR) system installed - without a computerized decision support system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The main end-point of the study will be the proportion of patients on treatment who have experienced treatment failure and appropriate clinical action taken according to the guidelines. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Other outcome measures will be the proportion of CD4 cell counts done on time and proportion of pre-ART patient eligible for treatment that are initiated within 30 days of eligibility. The median time taken to clinical action will be measured. | 12 months |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Kwaro, MD | Contact | +254 700 858 288 | Dkwaro@kemricdc.org | |
| Nicky Okeyo, MSc | Contact | +254 721 864 474 | Nokeyo@kemricdc.org |
| Name | Affiliation | Role |
|---|---|---|
| Tom Oluoch, MSc | Centers for Disease Control and Prevention | Principal Investigator |
| Daniel Kwaro, MD | KEMRI-CDC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KEMRI/CDC Clinical Research Center | Kisumu | Nyanza | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34930228 | Derived | Oluoch T, Cornet R, Muthusi J, Katana A, Kimanga D, Kwaro D, Okeyo N, Abu-Hanna A, de Keizer N. A clinical decision support system is associated with reduced loss to follow-up among patients receiving HIV treatment in Kenya: a cluster randomized trial. BMC Med Inform Decis Mak. 2021 Dec 20;21(1):357. doi: 10.1186/s12911-021-01718-0. | |
| 26847229 |
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| ID | Term |
|---|---|
| D057286 | Electronic Health Records |
| ID | Term |
|---|---|
| D016347 | Medical Records Systems, Computerized |
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
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| EMR+CDSS | Other | Clinics in this arm of the study will have an Electronic Medical Record (EMR) system with Clinical Decision Support System (CDSS) enhancement implemented as alerts to aid the clinician in decision making. |
|
|
| Oluoch T, Katana A, Kwaro D, Santas X, Langat P, Mwalili S, Muthusi K, Okeyo N, Ojwang JK, Cornet R, Abu-Hanna A, de Keizer N. 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. Lancet HIV. 2016 Feb;3(2):e76-84. doi: 10.1016/S2352-3018(15)00242-8. Epub 2015 Dec 17. |
| D004812 |
| Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |