Primary Care Provider Supply and Patient Outcomes

NCT ID: NCT03131193

Last Updated: 2022-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10852 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2022-06-30

Brief Summary

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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

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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

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Health Services Accessibility Health Behavior Health Care Quality, Access, and Evaluation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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No provider - No cash transfer

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

No Provider - Cash Transfer

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.

Group Type EXPERIMENTAL

Conditional Cash Transfer

Intervention Type BEHAVIORAL

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

Physician - No Cash Transfer

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.

Group Type EXPERIMENTAL

Physician

Intervention Type OTHER

Study primary health centers will be staffed with an additional physician

Physician - Cash Transfer

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.

Group Type EXPERIMENTAL

Physician

Intervention Type OTHER

Study primary health centers will be staffed with an additional physician

Conditional Cash Transfer

Intervention Type BEHAVIORAL

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

Mid-level Provider - No Cash Transfer

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.

Group Type EXPERIMENTAL

Mid-level provider

Intervention Type OTHER

Study primary health centers will be staffed with an additional mid-level provider

Mid-level Provider - Cash Transfer

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.

Group Type EXPERIMENTAL

Mid-level provider

Intervention Type OTHER

Study primary health centers will be staffed with an additional mid-level provider

Conditional Cash Transfer

Intervention Type BEHAVIORAL

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

Interventions

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Physician

Study primary health centers will be staffed with an additional physician

Intervention Type OTHER

Mid-level provider

Study primary health centers will be staffed with an additional mid-level provider

Intervention Type OTHER

Conditional Cash Transfer

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

• 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

Exclusion Criteria

• 3rd trimester of pregnancy
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RAND

OTHER

Sponsor Role lead

Responsible Party

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Edward Okeke

Policy Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward N Okeke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

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Aminu Kano Teaching Hospital

Kano, , Nigeria

Site Status

Countries

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Nigeria

References

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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.

Reference Type BACKGROUND
PMID: 32479220 (View on PubMed)

Okeke 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.

Reference Type BACKGROUND
PMID: 32863533 (View on PubMed)

Okeke 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.

Reference Type BACKGROUND
PMID: 34462990 (View on PubMed)

Other Identifiers

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R01HD083444

Identifier Type: NIH

Identifier Source: org_study_id

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