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Incentives for Accurate Diagnosis: Improving Health Care Quality in Mali
Last registered on October 24, 2016

Pre-Trial

Trial Information
General Information
Title
Incentives for Accurate Diagnosis: Improving Health Care Quality in Mali
RCT ID
AEARCTR-0001707
Initial registration date
October 24, 2016
Last updated
October 24, 2016 2:09 PM EDT
Location(s)
Region
Primary Investigator
Affiliation
Dartmouth College
Other Primary Investigator(s)
PI Affiliation
Brown University
Additional Trial Information
Status
In development
Start date
2016-11-01
End date
2017-12-31
Secondary IDs
Abstract
This project’s objective is to investigate determinants of persistent overtreatment with antimalarials and to identify policies to reduce overtreatment. Overuse of medical care is often attributed to the problem of “induced demand” by an informed expert: the doctor, who is better informed than the patient, can steer demand and potentially lead patients to buy more than they would if they had the same information as the doctor. This can occur for several reasons: the doctor may have a financial interest in selling expensive treatments, but may also evaluate costs and benefits of treatment differently. For example, the doctor may not take into account the financial burden to the patient and only evaluate the medical aspects, or may even interpret the diagnostic evidence wrongly. On the other hand, it has been argued that patients in developing countries “demand” more powerful and expensive treatment than is really necessary, perhaps out of an excess confidence in “Western” drugs. We aim to understand if overprescription is driven by induced demand from doctors, or real (over)demand from patients, or both. The project will also study how doctor beliefs about the accuracy of diagnostic tests determine prescription decisions.

External Link(s)
Registration Citation
Citation
Sautmann, Anja and Simone Schaner. 2016. "Incentives for Accurate Diagnosis: Improving Health Care Quality in Mali." AEA RCT Registry. October 24. https://doi.org/10.1257/rct.1707-1.0.
Former Citation
Sautmann, Anja and Simone Schaner. 2016. "Incentives for Accurate Diagnosis: Improving Health Care Quality in Mali." AEA RCT Registry. October 24. https://www.socialscienceregistry.org/trials/1707/history/11461.
Experimental Details
Interventions
Intervention(s)
The full-scale randomized controlled trial will include three main interventions: (1) information for public-sector health care workers on the accuracy (namely the sensitivity and specificity) of rapid diagnostic tests (RDTs) for malaria, (2) information for patients on malaria signs and symptoms, malaria diagnosis, and malaria treatment, and (3) subsidies for treatment for simple malaria that are either (a) given to patients directly, or (b) handed out through doctors.

Health care workers at all public clinics (called Centre de Santé Communautaire, or CSCOM in Mali) enrolled in this study will be given a refresher training on the Government of Mali’s official guidelines on malaria diagnosis and treatment and on how to conduct RDTs. This training will be conducted by trained doctors or medical students and supervised by our Malian collaborator Dr. Seydou Doumbia (University of Bamako, Public Health).
Intervention Start Date
2016-11-15
Intervention End Date
2016-12-31
Primary Outcomes
Primary Outcomes (end points)
Our key outcomes are rates at which doctors use RDTs, the proportion of acutely ill patients who are treated for simple malaria, and the proportion of patients treated for malaria that are truly malaria positive.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Clinic-level intervention
Intervention (1): Doctor training
Half of all participating CSCOMs will be randomly selected to receive additional training on the sensitivity and specificity of RDTs. This training will be incorporated into the refresher training described above, and will include four key components:
1. First, we will organize a training on the accuracy of RDTs, with a focus on their ability to detect uncomplicated malaria. Facilitators will present data from field studies of RDT sensitivity and specificity. A Malian researcher will share information on his own research on the sensitivity and specificity of RDTs in a video testimonial.
2. We will show RDT accuracy data from the World Health Organization’s latest round of quality assurance testing for RDTs (WHO 2015). We will demonstrate in particular that the tests used in Bamako CSCOMs have only a 10% false negative rate for parasite concentrations of 200 per microliter and even lower rates for higher parasite counts.
3. We will report on studies that have tracked children who were not treated with antimalarials after a negative test and show no adverse effects (Baiden et al. 2012, d’Acremont 2010, Njama-Meya 2007).
4. A medical expert will lecture on the meaning of low parasitemia and the connection between parasite count and malarial illness.
The objective of this training is to help health care workers understand that RDT tests are reliable and very rarely miss simple malaria cases, and that patients who are not treated after a negative test are not adversely affected, especially in low-transmission regions.

Within-clinic Interventions
The remaining interventions will be randomized “within-clinic”. More specifically, this means that clinics will be randomly assigned to receive interventions 2 and 3a or 3b for different randomly-selected days during the 6-week study period. These interventions will only be administered on days at which surveyors are present. To increase salience, avoid spillovers, and make sure doctors and clinic staff understand the intervention, we will administer the same intervention type to all patients that visit the clinic on the selected day(s). Before the intervention within the same clinic is changed, doctors and clinic staff are alerted to the difference, if any, and have the chance to ask questions about e.g. the information patients receive.

Intervention (2): Patient information
In collaboration with Malian doctors, we developed a short narrative video for patients that educates patients on what malaria is and what its symptoms are for both simple and severe cases, how a malaria test works and what it looks like to do one at the clinic, and what the Malian policy is: that malaria treatment should always occur with ACTs, but only after a negative malaria test, and how simple and severe malaria treatment differ (including in price).

Intervention (3): Patient vouchers
In collaboration with the CSCOM, intervention (3) offers a subsidy for artemisinin combination therapy (ACT) for simple malaria. This subsidy is administered in the form of a paper voucher that is valid for a free dose of ACTs on the day of receipt only. We will receive pre-authorization from the head doctor of each CSCOM for this treatment. Subsidized ACTs will only be given out with a valid prescription: the voucher requires a signature from a doctor or nurse as well as a confirmation of receipt from the client (either a signature from the client, or a signature from the person leading the intervention at the clinic). Pharmacies will be reimbursed for each signed voucher that they have received. In intervention version (a), the voucher is given to the patient, either handed out in the course of intervention (2), or accompanied by a very short informational dialogue on malaria treatment. This raises patient awareness for the type of treatment they are prescribed, and reinforces the message of intervention (2). In intervention version (b), the vouchers are instead given to doctors, to be handed out to patients they diagnose.

Each CSCOM will receive the following combinations of interventions 2, 3a, and 3b: no intervention (control), 2 only, 3a only, 3b only, 2 and 3a, 2 and 3b.
Experimental Design Details
Randomization Method
Randomization was conducted in office via a Stata program.
Randomization Unit
The doctor training is randomized at the CSCOM level. CSCOMs are randomly assigned to different "schedules" that dictate when they will receive interventions 2, 3a, and 3b (as well as their combinations).
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
We plan to enroll 60 CSCOMs in the study.
Sample size: planned number of observations
3600
Sample size (or number of clusters) by treatment arms
30 of 60 CSCOMs will be randomized to receive enhanced training on the sensitivity and specificity of RDTs.

Each CSCOM will spend one day in the following voucher/patient information treatment combinations: no voucher, no information, voucher to doctors, voucher to patients, patient information, voucher to doctor + patient information, voucher to patient + patient information. Assuming 10 acutely ill patients per CSCOM, per day, this amounts to 600 patient observation per cell.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Ethics committee, Faculté de Médecine de Pharmacie et d'Odonto-Stomatologie (FMPOS), Université des Sciences, des Techniques et des Technologies de Bamako.
IRB Approval Date
2016-10-10
IRB Approval Number
2016/137/CE/FMPOS
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers