Sustainable Financial Incentives To Improve Prescription Practices For Malaria

Malaria Clinical Trial

Official title:

Sustainable Financial Incentives To Improve Prescription Practices For Malaria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809873
• Other study ID #: Pro00035154
• Status: Completed
• Phase: N/A
• First received: March 11, 2013
• Last updated: March 9, 2015
• Start date: September 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14862
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Malaria

Intervention

Behavioral:
• Performance based incentives
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.

Locations

Country	Name	City	State
Kenya	Moi University	Eldoret	Rift Valley Province

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Moi University

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At one year post-intervention	No