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OpenTrials
Completed

NCT Number: NCT04278612

Evaluation of the Effectiveness of a Quality Improvement Intervention

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality improvement intervention to strengthen health service provision

Other

Quality improvement intervention comprising of regular improvement meetings based at clinics.

Primary outcomes

  1. Quality of Maternal and Child Care

    Time frame: 3 months

    Proportion of mother-baby pairs who received comprehensive care

Secondary outcomes

  1. Quality of Child Care

    Time frame: 3 months

    Proportion of babies who receive growth monitoring services

  2. Quality of Maternal Care

    Time frame: 3 months

    Proportion of mothers who receive feeding advice

Sponsors and collaborators

Lead sponsor

University of KwaZulu

Other

Collaborators

  • Institute for Healthcare Improvement
  • UNICEF

Registry information

Official study title

Evaluation of the Effectiveness of a Quality Improvement Intervention to Support Integration of Maternal, and Child and HIV Care in Primary Health Care Facilities in South Africa

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Feb 20, 2020
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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