Primary Care Provider Supply and Patient Outcomes

Sponsor
RAND (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03131193
Collaborator
(none)
13,574
1
6
63.3
214.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physician
  • Other: Mid-level provider
  • Behavioral: Conditional Cash Transfer
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
13574 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Estimating the Returns to Provider Human Capital
Actual Study Start Date :
Mar 20, 2017
Actual Primary Completion Date :
Dec 30, 2018
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: 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.

Experimental: 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.

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

Experimental: 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.

Other: Physician
Study primary health centers will be staffed with an additional physician

Experimental: 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.

Other: Physician
Study primary health centers will be staffed with an additional physician

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

Experimental: 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.

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

Experimental: 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.

Other: 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

Outcome Measures

Primary Outcome Measures

  1. Clinic attendance [6-12 months after enrollment]

    Utilization of health services will be measured using a questionnaire

  2. Self-reported health [6-12 months after enrollment]

    Self-reported health status will be measured using a questionnaire

Secondary Outcome Measures

  1. Mortality [6-12 months after enrollment]

    Child mortality will be measured using a questionnaire

  2. Quality of care [6-12 months after enrollment]

    Process quality based on adherence to clinical protocols will be measured via direct observation (observer will complete a standardized checklist)

  3. Child weight [12 months after enrollment]

    Child weight in kg will be measured using a weighing scale

  4. Child height [12 months after enrollment]

    Child height in cm will be measured using a measuring board or stadiometer as appropriate

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aminu Kano Teaching Hospital Kano Nigeria

Sponsors and Collaborators

  • RAND

Investigators

  • Principal Investigator: Edward N Okeke, MD, PhD, RAND

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Edward Okeke, Policy Researcher, RAND
ClinicalTrials.gov Identifier:
NCT03131193
Other Study ID Numbers:
  • R01HD083444
First Posted:
Apr 27, 2017
Last Update Posted:
Sep 27, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 27, 2021