Maternal and Child HealthNCT04278612
Evaluation of the Effectiveness of a Quality Improvement Intervention
A study testing Quality improvement intervention to strengthen health service provision in people with Maternal and Child Health, run by University of KwaZulu.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Maternal and Child Health
- What is being tested?
- Quality improvement intervention to strengthen health service provision
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,438 participants
- Where
- No sites listed yet
- Study dates
- 18 Jan 2016to 16 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women who attended the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.
Who cannot join
- Women who did not attend the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- Maternal and Child Health
- Being tested
- Quality improvement intervention to strengthen health service provision
- Keywords
- Quality improvement, Integrated care, Maternal health, Child health, HIV/AIDS, South Africa, Growth Monitoring, Child Growth, Nutrition
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality improvement intervention to strengthen health service provisionOther
Quality improvement intervention comprising of regular improvement meetings based at clinics.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Provision of comprehensive care including the following:
Baby:
Measure weight and length Plot on appropriate growth charts in Road to Health Card (RTHC) Discuss with mother about the growth of the baby Identification of malnutrition and appropriate management Age-appropriate nutrition counselling Immunisation Developmental screening Vitamin A supplementation Deworming HIV Care: If mother is HIV positive -
* Polymerase chain reaction (PCR) test for the baby repeated at 10 weeks
* Nevirapine for the baby for six weeks
Mother:
Cervical cancer screening Provide family planning Screening tuberculosis (TB) and sexually transmitted infections (STIs)
HIV Care:
* HIV positive mothers - provide ART for the mother and adherence support
* HIV negative mothers- HIV test every three months while breastfeeding Receives: Other: Quality improvement intervention to strengthen health service provision |
| Control | Active comparator | Routine maternal and child care service delivery Receives: Other: Quality improvement intervention to strengthen health service provision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Maternal and Child Care
Proportion of mother-baby pairs who received comprehensive care
Measured: 3 months
Secondary outcomes (2)
Quality of Child Care
Proportion of babies who receive growth monitoring services
Measured: 3 months
Quality of Maternal Care
Proportion of mothers who receive feeding advice
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start18 Jan 2016
- Primary completion5 Feb 2017
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal and Child HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 1,438 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of KwaZulu
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF, Institute for Healthcare Improvement
- Responsible party
- Principal investigator, Christiane Horwood, University of KwaZulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278612
- Sponsor's protocol ID
- UNIP123
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will not be shared
Publications
Haskins L, Chiliza J, Barker P, Connolly C, Phakathi S, Feeley A, Horwood C. Evaluation of the effectiveness of a quality improvement intervention to support integration of maternal, child and HIV care in primary health care facilities in South Africa. BMC Public Health. 2020 Mar 12;20(1):318. doi: 10.1186/s12889-020-8397-2.
PubMed 32164597
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04278612
- Acronym / sponsor ID
- UNIP123
- Conditions
- Maternal and Child Health
- Keywords
- Quality improvement, Integrated care, Maternal health, Child health, HIV/AIDS, South Africa, Growth Monitoring, Child Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,438 participants (actual)
- Lead sponsor
- University of KwaZuluUniversity, hospital or other
- Collaborators
- UNICEF, Institute for Healthcare Improvement
- Study start
- 18 Jan 2016 (actual)
- Primary completion
- 5 Feb 2017 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Quality improvement intervention to strengthen health service provisionProvision of comprehensive care including the following: Baby: Measure weight and length Plot on appropriate growth charts in Road to Health Card (RTHC) Discuss with mother about the growth of the baby Identification of malnutrition and appropriate management Age-appropriate nutrition counselling Immunisation Developmental screening Vitamin A supplementation Deworming HIV Care: If mother is HIV positive - * Polymerase chain reaction (PCR) test for the baby repeated at 10 weeks * Nevirapine for the baby for six weeks Mother: Cervical cancer screening Provide family planning Screening tuberculosis (TB) and sexually transmitted infections (STIs) HIV Care: * HIV positive mothers - provide ART for the mother and adherence support * HIV negative mothers- HIV test every three months while breastfeeding |
| Control | Active comparator | Other: Quality improvement intervention to strengthen health service provisionRoutine maternal and child care service delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women who attended the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.
Key exclusion criteria (1 listed)
- Women who did not attend the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality improvement intervention to strengthen health service provisionQuality improvement intervention comprising of regular improvement meetings based at clinics. | Other | Control, Intervention |
Primary outcome
Quality of Maternal and Child Care
Time frame: 3 months
Proportion of mother-baby pairs who received comprehensive care
2 secondary outcomes
Quality of Child Care
Time frame: 3 months
Quality of Maternal Care
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 32164597Haskins L, Chiliza J, Barker P, Connolly C, Phakathi S, Feeley A, Horwood C. Evaluation of the effectiveness of a quality improvement intervention to support integration of maternal, child and HIV care in primary health care facilities in South Africa. BMC Public Health. 2020 Mar 12;20(1):318. doi: 10.1186/s12889-020-8397-2.
- Individual participant dataSharing planned: Yes. IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Quality improvement intervention to strengthen health service provision in people with Maternal and Child Health, run by University of KwaZulu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Maternal and Child Care (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.