- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06275867
Improved Access to Quality Care and Healthcare Use
The Impact of Access to Higher-quality Care Services on Health-seeking Patterns
Study Overview
Status
Intervention / Treatment
Detailed Description
In many low-income settings, provision of social services by the public sector is plagued by problems of quality and low accountability to users. As a result, low expected benefits or fear of neglect by service providers may delay the use of needed services, even when those are free.
In South Africa, the health system is characterised by stark inequalities, with most of the population only able to seek care in free government facilities. The low quality of the public sector, where patients wait long times to be seen by nurses, is believed to lead many to delay needed care and prevent health outcome improvement. The government of South Africa is developing proposals to introduce a national health insurance scheme that would provide free access to private providers who deliver higher care quality. However, concerns about the unequal geographical distribution of private providers raise questions about the potential benefits of the reform. This study asks several questions to inform this reform:
- Does access to higher-quality care reduce under-use of services for children but also increase overuse?
- Does access to higher-quality care lead to improved health knowledge of parents and better health outcomes for children?
- Are these effects mitigated by the distance to the contracted providers? A randomised controlled trial is used to answer these questions. The study will recruit about 1,500 individuals who are the primary caregiver of at least one child aged six or under. and randomly allocate them to a control group (CONTROL) with the default free access to government facilities or one of the two treatment groups where they will have free access to private providers located either relatively close (CONVENIENT) by or relatively far (INCONVENIENT).
The primary outcomes will be the proportion of visits that are considered unnecessary (overuse) and the number of days of illness where care-seeking is recommended by guidelines but not sought by the child's parent or guardian.
Secondary outcomes will include (1) the number of days with ill-health symptoms; (2) out-of-pocket expenditures; (3) health knowledge of parents; (4) subjective and (5) objective measures of child's health.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mylene Lagarde, PhD
- Phone Number: +447595911011
- Email: M.Lagarde@lse.ac.uk
Study Contact Backup
- Name: Duane Blaauw, MBBS
- Email: duane.blaauw@wits.ac.za
Study Locations
-
-
Gauteng
-
Soweto, Gauteng, South Africa
- Recruiting
- HDSS Soweto clusters
-
Contact:
- Nomalanga Boyce
- Email: nomalanga.boyce@wits-vida.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- parent has a child aged under 6 years old and over 2 months old
Exclusion Criteria:
- is planning to move out of the area in the next 3 months
- has private medical aid
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
In this group, participants will have free access to government facilities (usual care)
|
|
Experimental: Convenient group
In this group, for the duration of the study, participants will be given free access to a small number of private providers located relatively close by (less than 30 minutes).
|
Participants are able to take their child to receive free consultations and treatment in a network of contracted private healthcare providers.
The network of contracted providers is located close to where participants live.
|
Experimental: Inconvenient group
In this group, for the duration of the study, participants will be given free access to a small number of private providers located relatively far (about one hour).
|
Participants are able to take their child to receive free consultations and treatment in a network of contracted private healthcare providers.
The network of contracted providers is located far to where participants live.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Underuse
Time Frame: 12 weeks
|
number of days of illness where care-seeking is recommended by guidelines but not sought by the child's parent or guardian
|
12 weeks
|
Overuse
Time Frame: 12 weeks
|
proportion of primary health care visits that are considered unnecessary
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Illness duration
Time Frame: 12 weeks
|
number of days with ill-health symptoms
|
12 weeks
|
Out-of-pocket expenditures
Time Frame: 12 weeks
|
Direct (consultations, drugs) and indirect (transport) expenditures spent on health care
|
12 weeks
|
Health knowledge
Time Frame: Endline survey (i.e. 12 weeks approximately after the start of the intervention)
|
Index of knowledge of parents in relation to preventive and curative care.
Parents will answer as series of knowledge questions relative to care-seeking patterns for children (with correct and incorrect responses).
For each individual, a score will be computing by adding up all of the correct responses (1 point per correct response, 0 for incorrect), so a higher score will reflect a better knowledge.
|
Endline survey (i.e. 12 weeks approximately after the start of the intervention)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mylene Lagarde, PhD, London School of Economics and Political Science
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SOPRIMA//T023635
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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