Primary Care Provider Supply and Patient Outcomes

Health Behavior Clinical Trial

Official title:

Estimating the Returns to Provider Human Capital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131193
• Other study ID #: R01HD083444
• Status: Completed
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10852
• Est. completion date: June 30, 2022
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria for Households:

• Resident in a community served by the study PHC

Exclusion Criteria for Households: none

Inclusion Criteria for Women:

• Resident in a community served by the study PHC

• Must be in 1st or 2nd trimester of pregnancy

Exclusion Criteria for Women:

• 3rd trimester of pregnancy

Related Conditions & MeSH terms

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

Intervention

Other:
• Physician
Study primary health centers will be staffed with an additional physician
• Mid-level provider
Study primary health centers will be staffed with an additional mid-level provider

Behavioral:
• 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

Locations

Country	Name	City	State
Nigeria	Aminu Kano Teaching Hospital	Kano

Sponsors (1)

Lead Sponsor	Collaborator
RAND

Country where clinical trial is conducted

Nigeria, 

References & Publications (3)

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. pii: 102426. doi: 10.1016/j.jdeveco.2019.102426. Epub 2019 Nov 22. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinic attendance	Utilization of health services will be measured using a questionnaire	6-12 months after enrollment
Primary	Self-reported health	Self-reported health status will be measured using a questionnaire	6-12 months after enrollment
Secondary	Mortality	Child mortality will be measured using a questionnaire	6-12 months after enrollment
Secondary	Quality of care	Process quality based on adherence to clinical protocols will be measured via direct observation (observer will complete a standardized checklist)	6-12 months after enrollment
Secondary	Child weight	Child weight in kg will be measured using a weighing scale	12 months after enrollment
Secondary	Child height	Child height in cm will be measured using a measuring board or stadiometer as appropriate	12 months after enrollment