Health Services AccessibilityNCT03131193
Primary Care Provider Supply and Patient Outcomes
A study testing Physician, Mid-level provider and Conditional Cash Transfer in people with Health Services Accessibility and Health Behavior, run by RAND at 1 site in Nigeria.
Trial summary
The evidence on how primary care provider supply and skill relates to patient outcomes is limited and inconclusive. The issue of skill is a particularly important one in low-income countries where the shortage of skilled medical professionals has led to greater use of the task-shifting model in which medical tasks are… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Services Accessibility, Health Behavior, Health Care Quality, Access, and Evaluation
- What is being tested?
- Physician, Mid-level provider and Conditional Cash Transfer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,852 participants
- Where
- 1 siteNigeria
- Study dates
- 20 Mar 2017to 30 Jun 2022
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Resident in a community served by the study PHC
- Resident in a community served by the study PHC
- Must be in 1st or 2nd trimester of pregnancy
Who cannot join
- 3rd trimester of pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimating the Returns to Provider Human Capital
The evidence on how primary care provider supply and skill relates to patient outcomes is limited and inconclusive. The issue of skill is a particularly important one in low-income countries where the shortage of skilled medical professionals has led to greater use of the task-shifting model in which medical tasks are redistributed from highly skilled health workers to mid-level providers who receive less training. In this large-scale cluster-randomized trial, the investigators randomly select primary health care facilities to receive a highly skilled provider (a doctor), a mid-level health provider, or no additional providers (the control group). The investigators study the effect of this intervention on patient outcomes. Embedded within this trial is another experimental intervention in which pregnant women residing in communities served by the primary health care facilities are assigned to receive a cash transfer conditional on using antenatal, delivery and postnatal care. The investigators study the effect of the cash transfer on health care utilization and on maternal and infant outcomes.
Read the detailed description
180 primary health care facilities in Nigeria are participating in this study. In one arm of this trial, 60 of the participating facilities are randomly assigned a physician (in addition to existing clinic staff); in a second arm, 60 facilities are randomly assigned an additional mid-level provider (of similar training to existing providers); and the third arm consists of facilities that receive no additional providers (the control group). Assigned providers will practice in those facilities for approximately one year. Stratifying by treatment arm, the investigators further randomize 10-15 enumeration areas within each facility catchment (service) area to either a Conditional Cash Transfer (CCT) arm or to a control arm. The cash transfer is intended for currently pregnant women in those enumeration areas and is conditioned upon attending four antenatal care visits, giving birth in the facility, and attending at least one postnatal visit.
To measure the effects of the interventions the investigators randomly sample 15 households in each facility catchment area and enroll all currently pregnant women within the study enumeration areas. Women at an advanced stage of pregnancy - third trimester - are excluded because such women will not be exposed to the intervention for the majority of their pregnancy. All household members are interviewed at baseline, midline (6 months later) and endline (12 months later) to collect information about health-seeking behavior and health status. Pregnant women are also interviewed at baseline and approximately 1-3 months after birth to collect information about health care utilization and birth outcomes. Additionally the investigators collect data from the participating health facilities and providers. Using a combination of provider surveys, clinical vignettes, direct clinical observation, and patient exit interviews the investigators examine the effects of the intervention on service delivery and quality.
- Conditions
- Health Services Accessibility, Health Behavior, Health Care Quality, Access, and Evaluation
- Being tested
- Physician, Mid-level provider, Conditional Cash Transfer
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysicianOther
Study primary health centers will be staffed with an additional physician
Mid-level providerOther
Study primary health centers will be staffed with an additional mid-level provider
Conditional Cash TransferBehavioural
Study participants (who are pregnant women) will receive a cash transfer conditional upon: registering for and attending antenatal care in the study clinic, giving birth in the study clinic and completing a postnatal visit with the new infant
| Study group | Role | What they receive |
|---|---|---|
| No provider - No cash transfer | No intervention | Study primary health centers (PHC) will carry out business-as-usual, with no additional staffing or changes to usual clinic operations. Study participants who live in the community served by the PHC will not receive any incentives (conditional cash transfer) to encourage them to seek care at the study clinic. |
| No Provider - Cash Transfer | Experimental | Study primary health centers (PHC) will carry out business-as-usual, with no additional staffing or changes to usual clinic operations. Study participants who live in the community served by the study PHC will receive a conditional cash transfer if they use services provided by the study PHC. Receives: Behavioral: Conditional Cash Transfer |
| Physician - No Cash Transfer | Experimental | Study PHCs will receive an additional health provider - a physician. Study participants who live in the community served by the PHC will not receive any incentives (conditional cash transfer) to encourage them to seek care at the study clinic. Receives: Other: Physician |
| Physician - Cash Transfer | Experimental | Study PHCs will receive an additional health provider - a physician. Study participants who live in the community served by the study PHC will receive a conditional cash transfer if they use services provided by the study PHC. Receives: Other: Physician; Behavioral: Conditional Cash Transfer |
| Mid-level Provider - No Cash Transfer | Experimental | Study PHCs will receive an additional health provider - a mid-level provider. Study participants who live in the community served by the PHC will not receive any incentives (conditional cash transfer) to encourage them to seek care at the study clinic. Receives: Other: Mid-level provider |
| Mid-level Provider - Cash Transfer | Experimental | Study PHCs will receive an additional health provider - a mid-level provider. Study participants who live in the community served by the study PHC will receive a conditional cash transfer if they use services provided by the study PHC. Receives: Other: Mid-level provider; Behavioral: Conditional Cash Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinic attendance
Utilization of health services will be measured using a questionnaire
Measured: 6-12 months after enrollment
Self-reported health
Self-reported health status will be measured using a questionnaire
Measured: 6-12 months after enrollment
Secondary outcomes (4)
Mortality
Child mortality will be measured using a questionnaire
Measured: 6-12 months after enrollment
Quality of care
Process quality based on adherence to clinical protocols will be measured via direct observation (observer will complete a standardized checklist)
Measured: 6-12 months after enrollment
Child weight
Child weight in kg will be measured using a weighing scale
Measured: 12 months after enrollment
Child height
Child height in cm will be measured using a measuring board or stadiometer as appropriate
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start20 Mar 2017
- Primary completion30 Dec 2018
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health Services AccessibilityStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 10,852 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Okeke, RAND
- Investigators
- Edward N Okeke, MD, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131193
- Sponsor's protocol ID
- R01HD083444
- Status last verified
- Oct 2022
- First submitted
- 10 Mar 2017
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Okeke EN, Wagner Z, Abubakar IS. Maternal Cash Transfers Led To Increases In Facility Deliveries And Improved Quality Of Delivery Care In Nigeria. Health Aff (Millwood). 2020 Jun;39(6):1051-1059. doi: 10.1377/hlthaff.2019.00893.
PubMed 32479220Okeke EN, Abubakar IS. Healthcare at the Beginning of Life and Child Survival: Evidence from a Cash Transfer Experiment in Nigeria. J Dev Econ. 2020 Mar;143:102426. doi: 10.1016/j.jdeveco.2019.102426. Epub 2019 Nov 22.
PubMed 32863533Okeke EN. Money and my mind: Maternal cash transfers and mental health. Health Econ. 2021 Nov;30(11):2879-2904. doi: 10.1002/hec.4398. Epub 2021 Aug 30.
PubMed 34462990
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating the Returns to Provider Human Capital
- ClinicalTrials.gov ID
- NCT03131193
- Acronym / sponsor ID
- R01HD083444
- Conditions
- Health Services Accessibility, Health Behavior, Health Care Quality, Access, and Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,852 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 27 Apr 2017 (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.
The evidence on how primary care provider supply and skill relates to patient outcomes is limited and inconclusive. The issue of skill is a particularly important one in low-income countries where the shortage of skilled medical professionals has led to greater use of the task-shifting model in which medical tasks are redistributed from highly skilled health workers to mid-level providers who receive less training. In this large-scale cluster-randomized trial, the investigators randomly select primary health care facilities to receive a highly skilled provider (a doctor), a mid-level health provider, or no additional providers (the control group). The investigators study the effect of this intervention on patient outcomes. Embedded within this trial is another experimental intervention in which pregnant women residing in communities served by the primary health care facilities are assigned to receive a cash transfer conditional on using antenatal, delivery and postnatal care. The investigators study the effect of the cash transfer on health care utilization and on maternal and infant outcomes.
Detailed description
180 primary health care facilities in Nigeria are participating in this study. In one arm of this trial, 60 of the participating facilities are randomly assigned a physician (in addition to existing clinic staff); in a second arm, 60 facilities are randomly assigned an additional mid-level provider (of similar training to existing providers); and the third arm consists of facilities that receive no additional providers (the control group). Assigned providers will practice in those facilities for approximately one year. Stratifying by treatment arm, the investigators further randomize 10-15 enumeration areas within each facility catchment (service) area to either a Conditional Cash Transfer (CCT) arm or to a control arm. The cash transfer is intended for currently pregnant women in those enumeration areas and is conditioned upon attending four antenatal care visits, giving birth in the facility, and attending at least one postnatal visit.
To measure the effects of the interventions the investigators randomly sample 15 households in each facility catchment area and enroll all currently pregnant women within the study enumeration areas. Women at an advanced stage of pregnancy - third trimester - are excluded because such women will not be exposed to the intervention for the majority of their pregnancy. All household members are interviewed at baseline, midline (6 months later) and endline (12 months later) to collect information about health-seeking behavior and health status. Pregnant women are also interviewed at baseline and approximately 1-3 months after birth to collect information about health care utilization and birth outcomes. Additionally the investigators collect data from the participating health facilities and providers. Using a combination of provider surveys, clinical vignettes, direct clinical observation, and patient exit interviews the investigators examine the effects of the intervention on service delivery and quality.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| No provider - No cash transfer | No intervention | –Study primary health centers (PHC) will carry out business-as-usual, with no additional staffing or changes to usual clinic operations. Study participants who live in the community served by the PHC will not receive any incentives (conditional cash transfer) to encourage them to seek care at the study clinic. |
| No Provider - Cash Transfer | Experimental | Behavioral: Conditional Cash TransferStudy primary health centers (PHC) will carry out business-as-usual, with no additional staffing or changes to usual clinic operations. Study participants who live in the community served by the study PHC will receive a conditional cash transfer if they use services provided by the study PHC. |
| Physician - No Cash Transfer | Experimental | Other: PhysicianStudy PHCs will receive an additional health provider - a physician. Study participants who live in the community served by the PHC will not receive any incentives (conditional cash transfer) to encourage them to seek care at the study clinic. |
| Physician - Cash Transfer | Experimental | Other: Physician, Behavioral: Conditional Cash TransferStudy PHCs will receive an additional health provider - a physician. Study participants who live in the community served by the study PHC will receive a conditional cash transfer if they use services provided by the study PHC. |
| Mid-level Provider - No Cash Transfer | Experimental | Other: Mid-level providerStudy PHCs will receive an additional health provider - a mid-level provider. Study participants who live in the community served by the PHC will not receive any incentives (conditional cash transfer) to encourage them to seek care at the study clinic. |
| Mid-level Provider - Cash Transfer | Experimental | Other: Mid-level provider, Behavioral: Conditional Cash TransferStudy PHCs will receive an additional health provider - a mid-level provider. Study participants who live in the community served by the study PHC will receive a conditional cash transfer if they use services provided by the study PHC. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Resident in a community served by the study PHC
- Resident in a community served by the study PHC
- Must be in 1st or 2nd trimester of pregnancy
Key exclusion criteria (1 listed)
- 3rd trimester of pregnancy
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 |
|---|---|---|
| PhysicianStudy primary health centers will be staffed with an additional physician | Other | Physician - Cash Transfer, Physician - No Cash Transfer |
| Mid-level providerStudy primary health centers will be staffed with an additional mid-level provider | Other | Mid-level Provider - Cash Transfer, Mid-level Provider - No Cash Transfer |
| Conditional Cash TransferStudy participants (who are pregnant women) will receive a cash transfer conditional upon: registering for and attending antenatal care in the study clinic, giving birth in the study clinic and completing a postnatal visit with the new infant | Behavioural | Mid-level Provider - Cash Transfer, No Provider - Cash Transfer, Physician - Cash Transfer |
Primary outcome
Clinic attendance
Time frame: 6-12 months after enrollment
Utilization of health services will be measured using a questionnaire
Self-reported health
Time frame: 6-12 months after enrollment
Self-reported health status will be measured using a questionnaire
4 secondary outcomes
Mortality
Time frame: 6-12 months after enrollment
Quality of care
Time frame: 6-12 months after enrollment
Child weight
Time frame: 12 months after enrollment
Child height
Time frame: 12 months after enrollment
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 21 Oct 2022.
- Background: PubMed 32479220Okeke EN, Wagner Z, Abubakar IS. Maternal Cash Transfers Led To Increases In Facility Deliveries And Improved Quality Of Delivery Care In Nigeria. Health Aff (Millwood). 2020 Jun;39(6):1051-1059. doi: 10.1377/hlthaff.2019.00893.
- Background: PubMed 32863533Okeke EN, Abubakar IS. Healthcare at the Beginning of Life and Child Survival: Evidence from a Cash Transfer Experiment in Nigeria. J Dev Econ. 2020 Mar;143:102426. doi: 10.1016/j.jdeveco.2019.102426. Epub 2019 Nov 22.
- Background: PubMed 34462990Okeke EN. Money and my mind: Maternal cash transfers and mental health. Health Econ. 2021 Nov;30(11):2879-2904. doi: 10.1002/hec.4398. Epub 2021 Aug 30.
- Individual participant dataSharing planned: Undecided
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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.
Edward N Okeke, MD, PhD principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician, Mid-level provider and Conditional Cash Transfer in people with Health Services Accessibility and Health Behavior, run by RAND at 1 site in Nigeria.
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 3 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 21 Oct 2022. 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 Nigeria. 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?
Clinic attendance (time frame: 6-12 months after enrollment). 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?
On the ClinicalTrials.gov record for NCT03131193, which also lists 3 linked publications.
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 21 Oct 2022.