Maternal Care PatternsNCT03890653
Impact Evaluation of the Nigeria Result-Based Financing Project
A study testing Performance-Based Financing and Decentralized Facility Financing in people with Maternal Care Patterns, run by World Bank.
Trial summary
The World Bank and the government of Nigeria are implementing a results-based financing (RBF) project for the states of Nasarawa, Adamawa, and Ondo. This project provides incentives for improving performance at critical levels within the Nigerian health system and aims to address some of these challenges. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Maternal Care Patterns
- What is being tested?
- Performance-Based Financing and Decentralized Facility Financing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2013to 15 Dec 2019
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All health facility staff in the states of Nasarawa, Adamawa and Ondo attending to maternity patients in the study period.
- Selected mothers recently utilizing the same facilities if consent is provided.
Who cannot join
- 1. None.
About this study
Official title: Impact Evaluation of the Nigeria State Health Program Investment Credit (NSHPIC)
The World Bank and the government of Nigeria are implementing a results-based financing (RBF) project for the states of Nasarawa, Adamawa, and Ondo. This project provides incentives for improving performance at critical levels within the Nigerian health system and aims to address some of these challenges. The primary goal of the impact evaluation of this project is to determine if providing financial incentives linked directly to performance increases the quantity and quality of maternal and child health (MCH) services.
In each of the three selected States,the project finances the following interventions:
Read more
- Performance incentives to State Government and Local Government (LGA) agencies that are triggered by Disbursement Linked Indicators (DLIs) that reflect strengthened supervision and enhanced operational support for improving health systems performance. These performance incentives would be paid out on an annual basis.
- In half of the LGAs in each state, one facility per ward will receive Performance-Based Financing (PBF) wherein payments are made directly to individual health facilities based on the quantity and quality of a set of pre-defined services provided by each facility. These performance incentives would be paid out on a quarterly basis.
- In the other half of the LGAs in each state one facility per ward will receive Decentralized Facility Financing (DFF) or equivalent financing that is not be linked to any service delivery targets. These payments would be made on a quarterly basis.
The evaluation of the PBF arm, which consists of making payments to health facilities conditional on performance, but within an environment of comparable levels of overall financing, will rely on experimental assignment. The effect of the PBF intervention will be identified by comparing outcomes in the LGAs receiving PBF versus those receiving DFF in the three project states. In each of these three States, the LGAs will be randomly assigned to either the PBF package or to the DFF package.
Read the detailed description
A detailed description can be found in the attached project concept note.
- Conditions
- Maternal Care Patterns
- Being tested
- Performance-Based Financing, Decentralized Facility Financing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance-Based FinancingBehavioural
Incentive-based payments
Decentralized Facility FinancingBehavioural
Financing not linked to service delivery.
| Study group | Role | What they receive |
|---|---|---|
| Performance-Based Financing | Experimental | At least one primary healthcare centre per ward and one General Hospital per selected LGA (in 50% of LGAs in each of the 3 states) and one secondary hospital per State will be contracted by the State Primary Health Care Development Agency ) , to deliver specified services at an agreed price. Selection of which services to focus on is based on priorities identified by the Federal Government of Nigeria and the states in 2010-2015. Initial prices for each service were based on shadow prices of providing the service and have been adjusted based on implementation experience. Receives: Behavioral: Performance-Based Financing |
| Decentralized Facility Financing | Experimental | In the other half of the LGA's in each treated state, at least one facility per ward will receive Decentralized Facility Financing (DFF) or equivalent financing that is not be linked to any service delivery targets. These payments would be made on a quarterly basis. Receives: Behavioral: Decentralized Facility Financing |
| Control | No intervention | This is a pure control arm with no additional interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization of priority maternal and child health services
The utilization of priority MCH services, as defined by the quantitative checklist used by the project to measure and reward facility performance.
Measured: Each health facility assessed over a period of two days.
Secondary outcomes (3)
Utilization of priority maternal and child health services, particularly by the poor
The utilization of priority MCH services, as defined by the quantitative checklist used by the project to measure and reward facility performance, by poor households.
Measured: Each health facility assessed over a period of two days.
Aggregated Provider Performance through Direct Clinical Observation
We use data on direct clinical observations of labor and delivery to construct an aggregate measure of provider performance.
Measured: Each health provider assessed over a period of one day.
Aggregate Structural and Process Quality Index
The quantitative checklist used in the government program is replicated to a large degree in the impact evaluation survey. We construct independent observations on aggregate structural and process quality measures in the same fashion as the program has constructed and rewarded.
Measured: Each health facility assessed over a period of two days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start20 Aug 2013
- Primary completion30 Sep 2017
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal Care PatternsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- World Bank
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eeshani Kandpal, PhD, Principal investigator, World Bank
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890653
- Sponsor's protocol ID
- P128175
- Status last verified
- Mar 2019
- First submitted
- 8 May 2017
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khanna M, Loevinsohn B, Pradhan E, Fadeyibi O, McGee K, Odutolu O, Fritsche GB, Meribole E, Vermeersch CMJ, Kandpal E. Decentralized facility financing versus performance-based payments in primary health care: a large-scale randomized controlled trial in Nigeria. BMC Med. 2021 Sep 21;19(1):224. doi: 10.1186/s12916-021-02092-4.
PubMed 34544415
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of the Nigeria State Health Program Investment Credit (NSHPIC)
- ClinicalTrials.gov ID
- NCT03890653
- Acronym / sponsor ID
- P128175
- Conditions
- Maternal Care Patterns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (actual)
- Lead sponsor
- World BankUniversity, hospital or other
- Study start
- 20 Aug 2013 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 26 Mar 2019 (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 World Bank and the government of Nigeria are implementing a results-based financing (RBF) project for the states of Nasarawa, Adamawa, and Ondo. This project provides incentives for improving performance at critical levels within the Nigerian health system and aims to address some of these challenges. The primary goal of the impact evaluation of this project is to determine if providing financial incentives linked directly to performance increases the quantity and quality of maternal and child health (MCH) services.
In each of the three selected States,the project finances the following interventions:
- Performance incentives to State Government and Local Government (LGA) agencies that are triggered by Disbursement Linked Indicators (DLIs) that reflect strengthened supervision and enhanced operational support for improving health systems performance. These performance incentives would be paid out on an annual basis.
- In half of the LGAs in each state, one facility per ward will receive Performance-Based Financing (PBF) wherein payments are made directly to individual health facilities based on the quantity and quality of a set of pre-defined services provided by each facility. These performance incentives would be paid out on a quarterly basis.
- In the other half of the LGAs in each state one facility per ward will receive Decentralized Facility Financing (DFF) or equivalent financing that is not be linked to any service delivery targets. These payments would be made on a quarterly basis.
The evaluation of the PBF arm, which consists of making payments to health facilities conditional on performance, but within an environment of comparable levels of overall financing, will rely on experimental assignment. The effect of the PBF intervention will be identified by comparing outcomes in the LGAs receiving PBF versus those receiving DFF in the three project states. In each of these three States, the LGAs will be randomly assigned to either the PBF package or to the DFF package.
Detailed description
A detailed description can be found in the attached project concept note.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Performance-Based Financing | Experimental | Behavioral: Performance-Based FinancingAt least one primary healthcare centre per ward and one General Hospital per selected LGA (in 50% of LGAs in each of the 3 states) and one secondary hospital per State will be contracted by the State Primary Health Care Development Agency ) , to deliver specified services at an agreed price. Selection of which services to focus on is based on priorities identified by the Federal Government of Nigeria and the states in 2010-2015. Initial prices for each service were based on shadow prices of providing the service and have been adjusted based on implementation experience. |
| Decentralized Facility Financing | Experimental | Behavioral: Decentralized Facility FinancingIn the other half of the LGA's in each treated state, at least one facility per ward will receive Decentralized Facility Financing (DFF) or equivalent financing that is not be linked to any service delivery targets. These payments would be made on a quarterly basis. |
| Control | No intervention | –This is a pure control arm with no additional interventions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All health facility staff in the states of Nasarawa, Adamawa and Ondo attending to maternity patients in the study period.
- Selected mothers recently utilizing the same facilities if consent is provided.
Key exclusion criteria (1 listed)
- 1. None.
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 |
|---|---|---|
| Performance-Based FinancingIncentive-based payments | Behavioural | Performance-Based Financing |
| Decentralized Facility FinancingFinancing not linked to service delivery. | Behavioural | Decentralized Facility Financing |
Primary outcome
Utilization of priority maternal and child health services
Time frame: Each health facility assessed over a period of two days.
The utilization of priority MCH services, as defined by the quantitative checklist used by the project to measure and reward facility performance.
3 secondary outcomes
Utilization of priority maternal and child health services, particularly by the poor
Time frame: Each health facility assessed over a period of two days.
Aggregated Provider Performance through Direct Clinical Observation
Time frame: Each health provider assessed over a period of one day.
Aggregate Structural and Process Quality Index
Time frame: Each health facility assessed over a period of two days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Derived from this study: PubMed 34544415Khanna M, Loevinsohn B, Pradhan E, Fadeyibi O, McGee K, Odutolu O, Fritsche GB, Meribole E, Vermeersch CMJ, Kandpal E. Decentralized facility financing versus performance-based payments in primary health care: a large-scale randomized controlled trial in Nigeria. BMC Med. 2021 Sep 21;19(1):224. doi: 10.1186/s12916-021-02092-4.
- Individual participant dataSharing planned: No
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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.
Eeshani Kandpal, PhD principal investigator
World Bank
Questions about this trial
What is this clinical trial studying?
A study testing Performance-Based Financing and Decentralized Facility Financing in people with Maternal Care Patterns, run by World Bank.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Utilization of priority maternal and child health services (time frame: Each health facility assessed over a period of two days.). 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 NCT03890653, which also lists 1 linked publication.
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 26 Mar 2019.