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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074083
Recruitment Status : Not yet recruiting
First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Collaborators:
ELMA Foundation
KwaZulu Natal Department of Health
Information provided by (Responsible Party):
Christiane Horwood, University of KwaZulu

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:

  1. To assess feasibility and acceptability of eIMCI implementation in PHC clinics
  2. To compare clinic-based management of sick children using e-IMCI with a gold standard IMCI assessment, and those managed using p-IMCI to a gold standard IMCI assessment
  3. To determine the cost effectiveness of e-IMCI compared to p-IMCI implementation in PHC clinics

Primary outcomes:

  • 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.


Condition or disease Intervention/treatment Phase
Child Health Clinical Practice Guidelines Primary Health Care Behavioral: electronic IMCI Behavioral: paper IMCI Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Effectiveness of e-IMCI Implementation Compared to Standard of Care for Sick Children Aged Under Five Years in Primary Health Care Clinics in KwaZulu-Natal, South Africa.
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention electronic IMCI group
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
Participants will be trained to use an electronic version of the Integrated Management of Childhood Illness (IMCI) guidelines

Active Comparator: Control paper IMCI group
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
Participants will be trained to use routine paper version of Integrated Management of Childhood Illness (IMCI) guidelines




Primary Outcome Measures :
  1. Proportion of sick children receiving all medications indicated among children managed by HWs using eIMCI and HWs using pIMCI. [ Time Frame: 6months ]
    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

  2. 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. [ Time Frame: 6 months ]
    Proportion of children for whom the correct classification (diagnosis) is made using pIMCI vs eIMCI compared to gold standard IMCI assessment

  3. Incremental cost-effectiveness of eIMCI implementation vs standard of care (pIMCI). [ Time Frame: 6 months ]
    unit cost for each additional child correctly managed


Secondary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]
    For each classification the proportion of children correctly identified using eIMCI vs pIMCI compared with a gold standard IMCI assessment

  2. 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. [ Time Frame: 6 months ]
    For each classification the proportion of children who received correct treatment using eIMCI vs pIMCI compared with a gold standard IMCI assessment

  3. Proportion of sick children receiving a correct assessment for nutrition among children managed using eIMCI and pIMCI compared to a gold standard IMCI assessment. [ Time Frame: 6months ]
    the proportion of children correctly classified for nutrition using eIMCI vs pIMCI compared with a gold standard IMCI assessment

  4. Proportion of children who received a comprehensive IMCI assessment among children managed using eIMCI and pIMCI compared to a gold standard IMCI assessment. [ Time Frame: 6 months ]
    The proportion of children receiving all correct classifications using eIMCI vs pIMCI compared with a gold standard IMCI assessment

  5. 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. [ Time Frame: 6 months ]
    the proportion of children correctly identified as requiring urgent referral using eIMCI vs pIMCI compared with a gold standard IMCI assessment

  6. • Proportion of mothers of sick children who receive appropriate nutrition counselling in the two groups (eIMCI and pIMCI) [ Time Frame: six months ]
    For each classification the proportion of mothers who receive age appropriate nutrition counselling using eIMCI vs pIMCI compared with a gold standard IMCI assessment

  7. Proportion of sick children attending intervention (eIMCI) clinics who were managed using eIMCI [ Time Frame: six months ]
    number of sick children seen using eIMCI as a proportion of all sick chidlren attending intervention clinics

  8. Level of IT support (phone calls, support visits) required to support implementation of eIMCI [ Time Frame: six months ]
    Numbers of support call and visits required for each intervention HW



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for clinics:

• all PHC clinics in Ilembe district (N=31)

Inclusion criteria for IMCI trained health workers:

• - 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)

Inclusion criteria for Mothers:

• All mothers of sick children aged < 5years attending participating clinics

Exclusion Criteria for clinics:

  • PHC clinics where there is no IMCI trained health care worker will be replaced with another clinic in the district.
  • Community health Centres

Exclusion criteria for Healthworkers:

  • 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)

Exclusion criteria for Mothers and children:

  • Mothers aged <18years
  • Non-maternal caregivers
  • Mothers attending for well child services (child is not sick)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074083


Contacts
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Contact: Lyn Haskins, M. Tech 0027 31 2601569 ext 4040 haskins@ukzn.ac.za
Contact: Bavashni Govender 0027 31 2601569 ext 4500 govenderB@ukzn.ac.za

Sponsors and Collaborators
University of KwaZulu
ELMA Foundation
KwaZulu Natal Department of Health
Investigators
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Principal Investigator: Christiane Horwood, MB.BS., PhD University of KwaZulu
Publications:

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Responsible Party: Christiane Horwood, Senior researcher, University of KwaZulu
ClinicalTrials.gov Identifier: NCT04074083    
Other Study ID Numbers: BFC157/19
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christiane Horwood, University of KwaZulu:
Child health
Clinical guidelines
South Africa
Africa
electronic health intervention