An Evaluation of the Effectiveness of e-IMCI Implementation in Primary Health Care Clinics in South Africa.

NCT04074083 | Completed

• 1 other identifier: BFC157/19
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

Brief Summary

The research hypothesis is that sick children attending primary health care (PHC) clinics who are managed by IMCI-trained health workers (HWs) using electronic Integrated Management of Childhood Illness guidelines (e-IMCI) receive better quality of care compared to children managed by HWs using conventional paper-based IMCI (pIMCI). The aim of the study is to evaluate the effectiveness of e-IMCI to improve care for sick children under five years attending PHC clinics in one district in KwaZulu-Natal, South Africa. Objectives:

• Proportion of sick children receiving all medications indicated among children managed by HWs using eIMCI and HWs using pIMCI.
• Proportion of sick children with risk/high risk of Tuberculosis, HIV or HIV exposed, and/or malnutrition correctly identified among children assessed using eIMCI and children assessed using pIMCI, compared to a gold standard IMCI assessment.
• Incremental cost-effectiveness of eIMCI implementation vs standard of care (pIMCI). The study will employ a prospective two-arm cluster randomized controlled trial. Sample size: a total of 30 clinics in one district will be randomly selected to participate and allocated to the intervention (eIMCI) group (n=15) and control (pIMCI) group (n=15). One IMCI trained HW will be randomly selected from each clinic to participate. Six observations will be conducted with each participating health worker Intervention HWs will receive an IMCI update and computer training based on eIMCI. Control HWs will receive a similar update using pIMCI. Both groups will receive support visits and intervention HWs will receive additional computer/IT support. Health worker knowledge will be assessed pre and post training using a self-administered questionnaire. Quality of care will be assessed in both groups using exit interviews with mothers and review of child health records. In addition, gold standard IMCI assessments will be conducted by an IMCI expert to determine correct findings. Assessment and management of the child by the IMCI expert will be compared to that of the participating HW to determine quality of care provided.

Conditions

Child Health; Clinical Practice Guidelines; Primary Health Care

Keywords

Child health; Clinical guidelines; South Africa; Africa; electronic health intervention

Outcome Measures

Primary Outcomes (3)

• Proportion of sick children receiving all medications indicated among children managed by HWs using eIMCI and HWs using pIMCI.

  Medications received by children managed by eIMCI trained HWs and pIMCI trained HWs will be determined from record reviews and compared to edications identified by an IMCI expert undertaking a gold standard IMCI assessment

  6months

• Proportion of sick children that are correctly identified among children assessed using eIMCI and children assessed using pIMCI, compared to a gold standard IMCI assessment.

  Proportion of children for whom the correct classification (diagnosis) is made using pIMCI vs eIMCI compared to gold standard IMCI assessment

  6 months

• Incremental cost-effectiveness of eIMCI implementation vs standard of care (pIMCI).

  unit cost for each additional child correctly managed

  6 months

Secondary Outcomes (8)

• Proportion of sick children who received correct assessments for each main symptom (cough, fever, diarrhoea, ear infection, HIV) among children assessed using eIMCI and children assessed using pIMCI, compared to a gold standard IMCI assessment.

  6 months

• Proportion of sick children who received correct management for each main symptom (cough, fever, diarrhoea, ear infection, HIV) among children assessed using eIMCI and children assessed using pIMCI, compared to a gold standard IMCI assessment.

  6 months

• Proportion of sick children receiving a correct assessment for nutrition among children managed using eIMCI and pIMCI compared to a gold standard IMCI assessment.

  6months

• Proportion of children who received a comprehensive IMCI assessment among children managed using eIMCI and pIMCI compared to a gold standard IMCI assessment.

  6 months

• Proportion of children requiring urgent referral or non-urgent referral correctly identified among children managed using eIMCI and pIMCI compared to a gold standard IMCI assessment.

  6 months

Study Arms (2)

Intervention electronic IMCI group

EXPERIMENTAL

15 primary health care clinics will be randomly allocated to intervention group. One IMCI trained HW will be selected in each intervention facility to be trained in electronic IMCI.

Behavioral: electronic IMCI

Control paper IMCI group

ACTIVE COMPARATOR

15 primary health care clinics will be randomly allocated to the control group. One IMCI trained HW will be selected in each control facility to receive an IMCI update (designed to mirror eIMCI training).

Behavioral: paper IMCI

Interventions

electronic IMCI BEHAVIORAL

Participants will be trained to use an electronic version of the Integrated Management of Childhood Illness (IMCI) guidelines

Intervention electronic IMCI group

paper IMCI BEHAVIORAL

Participants will be trained to use routine paper version of Integrated Management of Childhood Illness (IMCI) guidelines

Control paper IMCI group

Eligibility Criteria

• Age: 2 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• all PHC clinics in Ilembe district (N=31)
• - All IMCI trained health workers in selected clinics who routinely provide services for sick children (have provided health services for sick children in the past six months)
• All mothers of sick children aged \< 5years attending participating clinics

You may not qualify if:

• PHC clinics where there is no IMCI trained health care worker will be replaced with another clinic in the district.
• Community health Centres
• Health workers who have not attended a full IMCI training course (minimum 10days or equivalent)
• Health workers who are IMCI trained but do not regularly provide health services for sick children (eg the operational manager)
• Mothers aged \<18years
• Non-maternal caregivers
• Mothers attending for well child services (child is not sick)

Sponsors & Collaborators

• University of KwaZulu: lead
• The ELMA Foundation: collaborator
• KwaZulu Natal Department of Health: collaborator

Study Sites (1)

KZN Department of Health

Durban, KwaZulu-Natal, South Africa

Location

Related Publications (12)

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  PMID: 9529714 BACKGROUND

• Bhandari N, Mazumder S, Taneja S, Sommerfelt H, Strand TA; IMNCI Evaluation Study Group. Effect of implementation of Integrated Management of Neonatal and Childhood Illness (IMNCI) programme on neonatal and infant mortality: cluster randomised controlled trial. BMJ. 2012 Mar 21;344:e1634. doi: 10.1136/bmj.e1634.

  PMID: 22438367 BACKGROUND

• Boschi-Pinto C, Labadie G, Dilip TR, Oliphant N, Dalglish SL, Aboubaker S, Agbodjan-Prince OA, Desta T, Habimana P, Butron-Riveros B, Al-Raiby J, Siddeeg K, Kuttumuratova A, Weber M, Mehta R, Raina N, Daelmans B, Diaz T. Global implementation survey of Integrated Management of Childhood Illness (IMCI): 20 years on. BMJ Open. 2018 Jul 30;8(7):e019079. doi: 10.1136/bmjopen-2017-019079.

  PMID: 30061428 BACKGROUND

• El Arifeen S, Blum LS, Hoque DM, Chowdhury EK, Khan R, Black RE, Victora CG, Bryce J. Integrated Management of Childhood Illness (IMCI) in Bangladesh: early findings from a cluster-randomised study. Lancet. 2004 Oct 30-Nov 5;364(9445):1595-602. doi: 10.1016/S0140-6736(04)17312-1.

  PMID: 15519629 BACKGROUND

• Horwood C, Butler LM, Vermaak K, Rollins N, Haskins L, Nkosi P, Neilands TB, Qazi S. Disease profile of children under 5 years attending primary health care clinics in a high HIV prevalence setting in South Africa. Trop Med Int Health. 2011 Jan;16(1):42-52. doi: 10.1111/j.1365-3156.2010.02672.x. Epub 2010 Nov 23.

  PMID: 21091856 BACKGROUND

• Horwood C, Vermaak K, Rollins N, Haskins L, Nkosi P, Qazi S. An evaluation of the quality of IMCI assessments among IMCI trained health workers in South Africa. PLoS One. 2009 Jun 17;4(6):e5937. doi: 10.1371/journal.pone.0005937.

  PMID: 19536288 BACKGROUND

• Chopra M, Binkin NJ, Mason E, Wolfheim C. Integrated management of childhood illness: what have we learned and how can it be improved? Arch Dis Child. 2012 Apr;97(4):350-4. doi: 10.1136/archdischild-2011-301191. Epub 2012 Jan 25.

  PMID: 22278806 BACKGROUND

• Lange S, Mwisongo A, Maestad O. Why don't clinicians adhere more consistently to guidelines for the Integrated Management of Childhood Illness (IMCI)? Soc Sci Med. 2014 Mar;104:56-63. doi: 10.1016/j.socscimed.2013.12.020. Epub 2013 Dec 27.

  PMID: 24581062 BACKGROUND

• Aranda-Jan CB, Mohutsiwa-Dibe N, Loukanova S. Systematic review on what works, what does not work and why of implementation of mobile health (mHealth) projects in Africa. BMC Public Health. 2014 Feb 21;14:188. doi: 10.1186/1471-2458-14-188.

  PMID: 24555733 BACKGROUND

• Mitchell M, Hedt-Gauthier BL, Msellemu D, Nkaka M, Lesh N. Using electronic technology to improve clinical care - results from a before-after cluster trial to evaluate assessment and classification of sick children according to Integrated Management of Childhood Illness (IMCI) protocol in Tanzania. BMC Med Inform Decis Mak. 2013 Aug 27;13:95. doi: 10.1186/1472-6947-13-95.

  PMID: 23981292 BACKGROUND

• Perri-Moore S, Routen T, Shao AF, Rambaud-Althaus C, Swai N, Kahama-Maro J, D'Acremont V, Genton B, Mitchell M. Using an eIMCI-Derived Decision Support Protocol to Improve Provider-Caretaker Communication for Treatment of Children Under 5 in Tanzania. Glob Health Commun. 2015;1(1):41-47. doi: 10.1080/23762004.2016.1181486. Epub 2016 May 18.

  PMID: 27525308 BACKGROUND

• Mitchell M, Getchell M, Nkaka M, Msellemu D, Van Esch J, Hedt-Gauthier B. Perceived improvement in integrated management of childhood illness implementation through use of mobile technology: qualitative evidence from a pilot study in Tanzania. J Health Commun. 2012;17 Suppl 1:118-27. doi: 10.1080/10810730.2011.649105.

  PMID: 22548605 BACKGROUND

Study Officials

• Christiane Horwood, MB.BS., PhD

  University of KwaZulu

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: A total of 30 clinics in one district will be randomly selected to participate, with 15 clinics each randomly allocated to the intervention (eIMCI) and control (pIMCI) groups. One IMCI trained HW will be randomly selected from among all IMCI trained HWs in the clinic to participate in the study.

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 29, 2019
• Study Start: January 22, 2021
• Primary Completion: June 18, 2021
• Study Completion: November 1, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)