NCT03131193

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,852

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

1.8 years

First QC Date

March 10, 2017

Last Update Submit

October 19, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Clinic attendance

    Utilization of health services will be measured using a questionnaire

    6-12 months after enrollment

  • Self-reported health

    Self-reported health status will be measured using a questionnaire

    6-12 months after enrollment

Secondary Outcomes (4)

  • Mortality

    6-12 months after enrollment

  • Quality of care

    6-12 months after enrollment

  • Child weight

    12 months after enrollment

  • Child height

    12 months after enrollment

Study Arms (6)

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.

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.

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.

Other: PhysicianBehavioral: 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.

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.

Other: Mid-level providerBehavioral: Conditional Cash Transfer

Interventions

Study primary health centers will be staffed with an additional physician

Physician - Cash TransferPhysician - No Cash Transfer

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

Mid-level Provider - Cash TransferMid-level Provider - No 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

Mid-level Provider - Cash TransferNo Provider - Cash TransferPhysician - Cash Transfer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Resident in a community served by the study PHC

You may not qualify if:

  • Resident in a community served by the study PHC
  • Must be in 1st or 2nd trimester of pregnancy
  • 3rd trimester of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aminu Kano Teaching Hospital

Kano, Nigeria

Location

Related Publications (3)

  • 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.

    PMID: 32479220BACKGROUND
  • 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.

    PMID: 32863533BACKGROUND
  • 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.

    PMID: 34462990BACKGROUND

MeSH Terms

Conditions

Health Behavior

Interventions

Physicians

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Edward N Okeke, MD, PhD

    RAND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Policy Researcher

Study Record Dates

First Submitted

March 10, 2017

First Posted

April 27, 2017

Study Start

March 20, 2017

Primary Completion

December 30, 2018

Study Completion

June 30, 2022

Last Updated

October 21, 2022

Record last verified: 2022-10

Locations