MalariaNCT01809873
Sustainable Financial Incentives To Improve Prescription Practices For Malaria
A study testing Performance based incentives in people with Malaria, run by Duke University at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria
- What is being tested?
- Performance based incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,862 participants
- Where
- 1 siteKenya
- Study dates
- Sep 2012to Mar 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Lack of consent from any level
- Lack of adequate laboratory infrastructure or personnel
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Malaria
- Being tested
- Performance based incentives
- Keywords
- Malaria, Diagnostics, Health Services
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance based incentivesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Performance based incentives | Experimental | 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 Receives: Behavioral: Performance based incentives |
| Comparison | No intervention | The comparison arm will receive monthly visits and monthly external quality assurance of malaria diagnostic accuracy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At one year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Enrolment
- 14,862 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Moi University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809873
- Sponsor's protocol ID
- Pro00035154
- Status last verified
- Mar 2015
- First submitted
- 11 Mar 2013
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26472130Menya 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.
PubMed 23656836
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Financial Incentives To Improve Prescription Practices For Malaria
- ClinicalTrials.gov ID
- NCT01809873
- Acronym / sponsor ID
- Pro00035154
- Conditions
- Malaria
- Keywords
- Malaria, Diagnostics, Health Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,862 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Moi University
- Study start
- Sep 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Mar 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Performance based incentives | Experimental | Behavioral: Performance based incentivesPerformance 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 |
| Comparison | No intervention | –The comparison arm will receive monthly visits and monthly external quality assurance of malaria diagnostic accuracy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Lack of consent from any level
- Lack of adequate laboratory infrastructure or personnel
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 incentivesFacilities 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. | Behavioural | Performance based incentives |
Primary outcome
Proportion of children under 5 years of age who are treated with antimalarials following a negative malaria test
Time frame: At one year post-intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Derived from this study: PubMed 26472130Menya 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.
- Derived from this study: PubMed 23656836Menya 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.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performance based incentives in people with Malaria, run by Duke University at 1 site in Kenya.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of children under 5 years of age who are treated with antimalarials following a negative malaria test (time frame: At one year post-intervention). 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 NCT01809873, which also lists 2 linked publications.
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 10 Mar 2015.