Health Care UtilizationNCT06275867
Improved Access to Quality Care and Healthcare Use
A study testing Free high-quality care, Close distance and Far distance in people with Health Care Utilization and Health Knowledge, Attitudes, Practice, run by London School of Economics and Political Science at 1 site in South Africa.
Trial summary
This study is an individual-level randomised controlled trial which looks at the effect of providing free access to higher quality providers in urban South Africa. The study will recruit about 1,500 individuals with a child aged 5 or under. Read more about this study
- Who is it for?
- Ages 2 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization, Health Knowledge, Attitudes, Practice, Health, Subjective
- What is being tested?
- Free high-quality care, Close distance and Far distance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteSouth Africa
- Study dates
- 20 Jan 2024to 30 Aug 2024
- 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 2 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- parent has a child aged under 6 years old and over 2 months old
Who cannot join
- is planning to move out of the area in the next 3 months
- has private medical aid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Access to Higher-quality Care Services on Health-seeking Patterns
This study is an individual-level randomised controlled trial which looks at the effect of providing free access to higher quality providers in urban South Africa. The study will recruit about 1,500 individuals with a child aged 5 or under. They will be randomly allocate 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 be overuse and underuse of healthcare services for children under 5
Read the 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.
- Being tested
- Free high-quality care, Close distance, Far distance
- Medical subject headings
- Patient Acceptance of Health Care, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free high-quality careOther
Participants are able to take their child to receive free consultations and treatment in a network of contracted private healthcare providers.
Close distanceOther
The network of contracted providers is located close to where participants live.
Far distanceOther
The network of contracted providers is located far to where participants live.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | In this group, participants will have free access to government facilities (usual care) |
| Convenient group | Experimental | 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). Receives: Other: Free high-quality care; Other: Close distance |
| Inconvenient group | Experimental | 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). Receives: Other: Free high-quality care; Other: Far distance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Underuse
number of days of illness where care-seeking is recommended by guidelines but not sought by the child's parent or guardian
Measured: 12 weeks
Overuse
proportion of primary health care visits that are considered unnecessary
Measured: 12 weeks
Secondary outcomes (3)
Illness duration
number of days with ill-health symptoms
Measured: 12 weeks
Out-of-pocket expenditures
Direct (consultations, drugs) and indirect (transport) expenditures spent on health care
Measured: 12 weeks
Health knowledge
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.
Measured: Endline survey (i.e. 12 weeks approximately after the start of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start20 Jan 2024
- Primary completion10 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care UtilizationStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Economics and Political Science
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa
- Responsible party
- Sponsor
- Investigators
- Mylene Lagarde, PhD, Principal investigator, London School of Economics and Political Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275867
- Sponsor's protocol ID
- SOPRIMA//T023635
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Access to Higher-quality Care Services on Health-seeking Patterns
- ClinicalTrials.gov ID
- NCT06275867
- Acronym / sponsor ID
- SOPRIMA//T023635
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- London School of Economics and Political ScienceUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 23 Feb 2024 (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 study is an individual-level randomised controlled trial which looks at the effect of providing free access to higher quality providers in urban South Africa. The study will recruit about 1,500 individuals with a child aged 5 or under. They will be randomly allocate 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 be overuse and underuse of healthcare services for children under 5
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –In this group, participants will have free access to government facilities (usual care) |
| Convenient group | Experimental | Other: Free high-quality care, Other: Close distanceIn 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). |
| Inconvenient group | Experimental | Other: Free high-quality care, Other: Far distanceIn 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). |
Who may qualify
- Ages
- 2 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- parent has a child aged under 6 years old and over 2 months old
Key exclusion criteria (2 listed)
- is planning to move out of the area in the next 3 months
- has private medical aid
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 |
|---|---|---|
| Free high-quality careParticipants are able to take their child to receive free consultations and treatment in a network of contracted private healthcare providers. | Other | Convenient group, Inconvenient group |
| Close distanceThe network of contracted providers is located close to where participants live. | Other | Convenient group |
| Far distanceThe network of contracted providers is located far to where participants live. | Other | Inconvenient group |
Primary outcome
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
Overuse
Time frame: 12 weeks
proportion of primary health care visits that are considered unnecessary
3 secondary outcomes
Illness duration
Time frame: 12 weeks
Out-of-pocket expenditures
Time frame: 12 weeks
Health knowledge
Time frame: Endline survey (i.e. 12 weeks approximately after the start of the intervention)
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 15 Oct 2024.
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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.
Mylene Lagarde, PhD principal investigator
London School of Economics and Political Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free high-quality care, Close distance and Far distance in people with Health Care Utilization and Health Knowledge, Attitudes, Practice, run by London School of Economics and Political Science at 1 site in South Africa.
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 2 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Underuse (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.