Sustainable Financial Incentives To Improve Prescription Practices For Malaria
Primary Purpose
Malaria
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Performance based incentives
Sponsored by
About this trial
This is an interventional health services research trial for Malaria focused on measuring Malaria, Diagnostics, Health Services
Eligibility Criteria
Inclusion Criteria:
- Health facility (level 3) in Western or Rift valley province, within the Academic Model Providing Access to Healthcare (AMPATH) catchment area
- Consent from Provincial Medical Officer of Health, District Medical Officer of Health and Health facility in-charge
- Functioning laboratory including microscopic diagnosis of malaria and at least one laboratory technician.
Exclusion Criteria:
- Lack of consent from any level
- Lack of adequate laboratory infrastructure or personnel
Sites / Locations
- Moi University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Performance based incentives
Comparison
Arm Description
Performance based incentives: The Incentive arm will receive monthly visits and external quality assurance of malaria diagnostic accuracy, identical to the comparison. Incentive arm will also receive quarterly incentives linked to performance of the facility around six indicators of appropriate malaria case management
The comparison arm will receive monthly visits and monthly external quality assurance of malaria diagnostic accuracy.
Outcomes
Primary Outcome Measures
Proportion of children under 5 years of age who are treated with antimalarials following a negative malaria test
The study is designed to detect a reduction in the proportion of children under 5 years of age who are prescribed antimalarials following a negative malaria diagnostic test between the intervention and comparison arms.
Secondary Outcome Measures
Full Information
NCT ID
NCT01809873
First Posted
March 11, 2013
Last Updated
March 9, 2015
Sponsor
Duke University
Collaborators
Moi University
1. Study Identification
Unique Protocol Identification Number
NCT01809873
Brief Title
Sustainable Financial Incentives To Improve Prescription Practices For Malaria
Official Title
Sustainable Financial Incentives To Improve Prescription Practices For Malaria
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Moi University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This project aims to test an innovative, sustainable financial incentive designed to reduce the number of non-malarial fevers that are treated inappropriately with antimalarial drugs.
Detailed Description
Global investments in controlling malaria have led to some exciting reductions in the burden of malaria. In some areas, malaria-related deaths have dropped by more than 90%. As malaria transmission declines, a greater fraction of pediatric fevers are from other causes. However, these fevers continue to be treated as malaria, often despite the availability of diagnostic testing. In a typical rural health facility in Kenya, more than 90% of febrile patients are prescribed an antimalarial when no diagnostic tests are available. Even when microscopy or rapid diagnostic tests (RDTs) are available, between 50-80% of patients with a negative test are nonetheless prescribed antimalarials. Inappropriately treated fevers in children can lead to serious consequences for the patient and can accelerate the spread of drug resistance. In addition to the risk to patients, overuse of antimalarials also puts a financial strain on the government health system. Although there is considerable incentive for governments to reduce drug costs and wastage, the financial pressure is not experienced at the appropriate levels of decision-making.
This project aims to test an innovative, sustainable financial incentive designed to reduce the number of non-malarial fevers that are treated inappropriately with antimalarial drugs. The study team will test a financial incentive targeted at the health facility to determine if it improves adherence to diagnostic results and clinical protocols. Eighteen rural health facilities in Western Kenya will be enrolled and randomly allocated to one of two arms. The study team will compare the effectiveness of clinical and technical training in diagnosis of malaria alone (Arm 1) to training plus financial incentives linked to prescription practices (Arm 2) in improving diagnosis and treatment of malaria and non-malaria fevers. The practice of prescribing antimalarials to patients with a negative diagnostic will be compared between facilities with and without the incentive structure. Secondary outcomes will include sensitivity and specificity of routine microscopy at health centers, use of alternative treatments for slide negative fevers, and frequency of stock-outs of antimalarial drugs.
This project will tackle an important implementation research problem. It seeks to test solutions to the problem of poor adherence to evidence-based clinical guidelines for malaria treatment, and thereby reduce inappropriate antimalarial drug use and drug wastage. This project will be conducted in collaboration with Kenya's Division of Malaria Control and avenues to roll-out the intervention, if successful, will be actively explored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria, Diagnostics, Health Services
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
14862 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Performance based incentives
Arm Type
Experimental
Arm Description
Performance based incentives: The Incentive arm will receive monthly visits and external quality assurance of malaria diagnostic accuracy, identical to the comparison. Incentive arm will also receive quarterly incentives linked to performance of the facility around six indicators of appropriate malaria case management
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
The comparison arm will receive monthly visits and monthly external quality assurance of malaria diagnostic accuracy.
Intervention Type
Behavioral
Intervention Name(s)
Performance based incentives
Intervention Description
Facilities enrolled in the intervention arm will receive a financial incentive that is based on their diagnosis and prescription practices for malaria over that quarter. The intervention will last 12 months.
Primary Outcome Measure Information:
Title
Proportion of children under 5 years of age who are treated with antimalarials following a negative malaria test
Description
The study is designed to detect a reduction in the proportion of children under 5 years of age who are prescribed antimalarials following a negative malaria diagnostic test between the intervention and comparison arms.
Time Frame
At one year post-intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Health facility (level 3) in Western or Rift valley province, within the Academic Model Providing Access to Healthcare (AMPATH) catchment area
Consent from Provincial Medical Officer of Health, District Medical Officer of Health and Health facility in-charge
Functioning laboratory including microscopic diagnosis of malaria and at least one laboratory technician.
Exclusion Criteria:
Lack of consent from any level
Lack of adequate laboratory infrastructure or personnel
Facility Information:
Facility Name
Moi University
City
Eldoret
State/Province
Rift Valley Province
ZIP/Postal Code
30100
Country
Kenya
12. IPD Sharing Statement
Citations:
PubMed Identifier
26472130
Citation
Menya D, Platt A, Manji I, Sang E, Wafula R, Ren J, Cheruiyot O, Armstrong J, Neelon B, O'Meara WP. Using pay for performance incentives (P4P) to improve management of suspected malaria fevers in rural Kenya: a cluster randomized controlled trial. BMC Med. 2015 Oct 16;13:268. doi: 10.1186/s12916-015-0497-y.
Results Reference
derived
PubMed Identifier
23656836
Citation
Menya D, Logedi J, Manji I, Armstrong J, Neelon B, O'Meara WP. An innovative pay-for-performance (P4P) strategy for improving malaria management in rural Kenya: protocol for a cluster randomized controlled trial. Implement Sci. 2013 May 8;8:48. doi: 10.1186/1748-5908-8-48.
Results Reference
derived
Learn more about this trial
Sustainable Financial Incentives To Improve Prescription Practices For Malaria
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