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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04278612
Other study ID # UNIP123
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2016
Est. completion date January 16, 2019

Study information

Verified date February 2020
Source University of KwaZulu
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This rigorous evaluation demonstrated that implementation of a time-limited quality improvement strategy effectively improved coverage of some components of an integrated maternal and child health service in a complex health environment, but we were unable to achieve the changes needed to provide a comprehensive package of care for mothers and children.


Description:

Background: Despite policies and guidelines recommending integration of health services in South Africa, provision of maternal and child health services remains fragmented. This study evaluated a rapid, scaleable, quality improvement intervention to improve integration of maternal and child health and HIV services at a primary health level, in KwaZulu-Natal, South Africa.

Methods: A three-month intervention comprised of six quality improvement mentoring visits, learning sessions with clinic staff to share learnings, and a self-administered checklist aimed to assist health workers monitor and implement an integrated package of health services for mothers and children. The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics between December 2016-February 2017. A multi-level, mixed effects logistic regression was used to account for random cluster fixed time and group effects using Stata V13.1.


Recruitment information / eligibility

Status Completed
Enrollment 1438
Est. completion date January 16, 2019
Est. primary completion date February 5, 2017
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

Women who attended the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.

Exclusion Criteria:

Women who did not attend the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Quality improvement intervention to strengthen health service provision
Quality improvement intervention comprising of regular improvement meetings based at clinics.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of KwaZulu Institute for Healthcare Improvement, UNICEF

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Maternal and Child Care Proportion of mother-baby pairs who received comprehensive care 3 months
Secondary Quality of Child Care Proportion of babies who receive growth monitoring services 3 months
Secondary Quality of Maternal Care Proportion of mothers who receive feeding advice 3 months
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