Evaluation of Clinical Impacts and Costs of eHealth in Rwanda

NCT04283929 | Unknown

• 1 other identifier: GH000782
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This study will estimate the impact of a suite of clinical decision-support tools on structural, process, and clinical outcomes related to HIV care. The "enhanced EMR" package under investigation will include EMR monitoring tools, data quality control procedures and support, patient reports, alerts, and reminders about patient care. This intervention will be delivered by the Ministry of Health and Rwanda Biomedical Centre and monitored by the study team led by University of Rwanda's School of Public Health and Brown University.

Conditions

HIV/AIDS and Infections; Electronic Medical Records; Clinical Decision Support System

Outcome Measures

Primary Outcomes (4)

• Rate of linkage to care among HIV-positive patients

  Denominator: All adults (18 or older) with HIV positive test results recorded in the EMR at a study facility. Patients who die in the time between receiving a positive test result and the outcome measurement at 3 months will be excluded. Numerator: Subset of these patients who are linked to care at a study facility within 3 months

  12 months

• Percentage of ART patients have viral load results in EMR (initial)

  Denominator: Adult patients on ART completing their 6th month of treatment, thus becoming eligible for viral load monitoring. Numerator: Subset of these patients with VL results in the EMR 2 months after becoming eligible for testing

  10 months

• Percentage of ART patients with treatment failure experience clinical action

  Denominator: Adult patients who have been on ART for at least 12 months and experience treatment failure: 1. Virologic (viral load ≥ 1000 copies/ml) 2. Immunological (\>50% change in CD4 from highest previous value) Numerator: Subset of these patients who have a recorded clinical action in response to treatment failure within 1 month of the detected treatment failure.

  12 months

• Percentage of patients who experience treatment failure who are fully suppressed 4 months after the point of failure

  Denominator: Adult patients who have been on ART for at least 12 months (first eligible for VL testing at 6 months, first expected result 8 months, retest after 4 months) and were found to have possible treatment failure. Numerator: Subset of these patients who are fully suppressed (viral load \< 1000 copies /ml) 4 months after the point of treatment failure.

  12 months

Secondary Outcomes (3)

• Time from HIV+ test result to linkage to care

  3 months

• Percentage of ART patients have viral load results in EMR (annual)

  12 months

• Time from detection of treatment failure to clinical action

  11 months

Study Arms (6)

Intervention 1 (Int1)

EXPERIMENTAL

Facilities assigned to the enhanced package for Int1 will receive alerts and reminders to promote linkage of HIV positives from diagnosis to care.

Other: Experimental: Intervention 1 (Int1)

Control 1 (Ctrl1)

NO INTERVENTION

Facilities assigned to the Ctrl1 will not receive any additional equipment, software tools, training or other forms of support.

Intervention 2 (Int2)

EXPERIMENTAL

Randomise the Intervention 1 group into two additional arms: Intervention 2 (Int2) and Control (Ctrl2). Facilities assigned to Int2 will also receive alerts and reminders to improve lab reporting as part of their enhanced package.

Other: Experimental: Intervention 1 (Int1); Other: Experimental: Intervention 2 (Int2)

Control 2 (Ctrl2)

NO INTERVENTION

Facilities assigned to the Ctrl2 will not receive any additional equipment, software tools, training or other forms of support to improve lab reporting as part of their enhanced EMR.

Intervention 3 (Int3)

EXPERIMENTAL

Randomise the Intervention 2 group into two additional arms: Intervention 3 (Int3) or Control (Ctrl3). Facilities assigned to Int3 will receive alerts and reminders to improve clinical response to the detection of treatment failure as part of their enhanced package.

Other: Experimental: Intervention 1 (Int1); Other: Experimental: Intervention 2 (Int2); Other: Experimental: Intervention 3 (Int3)

Control (Ctrl3)

NO INTERVENTION

Facilities assigned to Ctrl3 will not receive alerts and reminders to improve clinical response to the detection of treatment failure as part of their enhanced package.

Interventions

Experimental: Intervention 1 (Int1) OTHER

This intervention will consist of the following additions to the EMR package. A link on the clinician's homepage to enrol a new HIV+ patient in the EMR which will open a form for (1) entering patient demographics (2) adding the contact home address or description of area, phone number (if available), (3) the peer educator contacts (4) recording the HIV+ result and date. A report will be added that is run every week to identify HIV+ patients not linked to care. The patients identified will be checked with paper records to ensure they have definitely not visited, then contacted after one, 2 weeks and 4 weeks if he/she did not show up. After two attempted contacts, if the patient is not yet linked to care he/she will be visited at home by the health facility social worker using routine home visits by health care providers.

Also known as: Alerts and reminders to improve the linkage from HIV testing to care

Intervention 1 (Int1); Intervention 2 (Int2); Intervention 3 (Int3)

Experimental: Intervention 2 (Int2) OTHER

The data on availability of VL results in the EMR will come from a SQL statement to query the OpenMRS database. An alert will be fired if the patient has been enrolled for 8 months or more and does not have a viral load result in the EMR. The alert will be displayed on the patient summary and on the consult sheets, with text requesting the clinician orders a VL.

Also known as: Alerts and reminders to improve the quality and completeness of lab results in the EMR

Intervention 2 (Int2); Intervention 3 (Int3)

Experimental: Intervention 3 (Int3) OTHER

The data on VL results in the EMR showing detectable virus will come from a SQL statement to query the OpenMRS database. An alert will be fired if the patient has been enrolled for at least 12 months and the VL result in the EMR shows \> 1000 copies/mm3. The alert will be displayed on the patient summary and on the consult sheets requesting actions to address treatment failure (change first line medication, start second line medication, repeat VL, counselling on treatment adherence). A report will also be added to regularly check for patients with high viral load.

Also known as: Alerts and reminders following treatment failure detected by CD4 or viral load improve clinical action

Intervention 3 (Int3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a health center with an average (3 month) monthly volume of 50-700 patients
• Is owned and operated by the public sector or faith-based institutions
• Has a power source
• Has network connectivity
• Has at least 3 computers and 1 printer

You may not qualify if:

• District hospitals (typically with high patient volume)
• Privately owned facilities
• Facilities operated by Partners in Health (who already run a version of the intervention)
• Facilities that only offer PMTCT services
• Facilities that run OpenMRS version 1.9 (rather than 1.6)

Sponsors & Collaborators

• National University, Rwanda: lead
• Centers for Disease Control and Prevention: collaborator
• Ministry of Health, Rwanda: collaborator
• Rwanda Biomedical Centre: collaborator
• Partners in Health: collaborator
• Innovative Support to Emergencies Diseases and Disasters: collaborator
• University of Pittsburgh: collaborator
• Jembi Health Systems: collaborator
• Brown University: collaborator

Study Sites (1)

School of Public Health

Kigali, 250, Rwanda

Location

Related Publications (8)

• Allen C, Jazayeri D, Miranda J, Biondich PG, Mamlin BW, Wolfe BA, Seebregts C, Lesh N, Tierney WM, Fraser HS. Experience in implementing the OpenMRS medical record system to support HIV treatment in Rwanda. Stud Health Technol Inform. 2007;129(Pt 1):382-6.

  PMID: 17911744 BACKGROUND

• Amoroso CL, Akimana B, Wise B, Fraser HS. Using electronic medical records for HIV care in rural Rwanda. Stud Health Technol Inform. 2010;160(Pt 1):337-41.

  PMID: 20841704 BACKGROUND

• Driessen J, Cioffi M, Alide N, Landis-Lewis Z, Gamadzi G, Gadabu OJ, Douglas G. Modeling return on investment for an electronic medical record system in Lilongwe, Malawi. J Am Med Inform Assoc. 2013 Jul-Aug;20(4):743-8. doi: 10.1136/amiajnl-2012-001242. Epub 2012 Nov 9.

  PMID: 23144335 BACKGROUND

• Mamlin BW, Biondich PG, Wolfe BA, Fraser H, Jazayeri D, Allen C, Miranda J, Tierney WM. Cooking up an open source EMR for developing countries: OpenMRS - a recipe for successful collaboration. AMIA Annu Symp Proc. 2006;2006:529-33.

  PMID: 17238397 BACKGROUND

• Oluoch T, Santas X, Kwaro D, Were M, Biondich P, Bailey C, Abu-Hanna A, de Keizer N. The effect of electronic medical record-based clinical decision support on HIV care in resource-constrained settings: a systematic review. Int J Med Inform. 2012 Oct;81(10):e83-92. doi: 10.1016/j.ijmedinf.2012.07.010. Epub 2012 Aug 24.

  PMID: 22921485 BACKGROUND

• 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.

  PMID: 26847229 BACKGROUND

• Rosen S, Fox MP. Retention in HIV care between testing and treatment in sub-Saharan Africa: a systematic review. PLoS Med. 2011 Jul;8(7):e1001056. doi: 10.1371/journal.pmed.1001056. Epub 2011 Jul 19.

  PMID: 21811403 BACKGROUND

• Nsanzimana S, Kanters S, Remera E, Forrest JI, Binagwaho A, Condo J, Mills EJ. HIV care continuum in Rwanda: a cross-sectional analysis of the national programme. Lancet HIV. 2015 May;2(5):e208-15. doi: 10.1016/S2352-3018(15)00024-7. Epub 2015 Mar 27.

  PMID: 26423003 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections

Interventions

Caffeine; Fibroblast Growth Factor 3

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fibroblast Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Fraser HAMISH, MBChB

  Brown University: hamish_fraser@brown.edu

  PRINCIPAL INVESTIGATOR

• Jeanine CONDO, MD, PhD

  University of Rwanda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 25, 2020
• Study Start: September 15, 2018
• Primary Completion: July 15, 2020
• Study Completion: July 30, 2020
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: 1 month
• Access Criteria: * Interest in working on similar area * Writing a letter of request * Sign data sharing agreement

Locations

RW (1)