What Drives Poor Care for Child Diarrhea: A Standardized Patient Experiment

Child Diarrhea Clinical Trial

Official title:

What Drives Poor Care for Child Diarrhea: A Standardized Patient Experiment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04833790
• Other study ID #: 1R01DK126049-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diarrhea is the second leading cause of death for children around the world, although nearly all of these deaths could be prevented with an inexpensive and simple treatment: oral rehydration salts (ORS). Many children with diarrhea do not receive ORS when they seek treatment and this study uses a field experiment to examine why this occurs. We will use anonymous standardized patients combined with a randomized ORS supply intervention to isolate the causal effect of several potential reasons for why children do not receive ORS when they seek care: 1) caretakers prefer ORS alternatives, 2) providers have a financial incentives to prescribe ORS alternatives, and 3) ORS is often out of stock.

Description:

Diarrhea is the second leading cause of death for children around the world. This is true despite the fact that nearly all such deaths could be prevented with a simple and inexpensive solution: oral rehydration salts (ORS). Private health care providers, who treat the majority of childhood illness in low- and middle-income countries (LMICs), are particularly unlikely to dispense ORS to children with diarrhea. Instead, providers often dispense antibiotics inappropriately. Recognizing this significant challenge, several international organizations (including USAID) have invested heavily in trying to increase ORS dispensing in the private sector. In the absence of evidence on why ORS is so inconsistently dispensed by private providers, however, several interventions to promote private sector ORS dispensing have been ineffective. Clearly, a critical and urgent next step is to examine the key drivers of underprescription of ORS and overprescription of antibiotics in the private sector in order to inform efforts to improve diarrhea care. In this study, we examine several leading explanations for poor quality of care for child diarrhea in the private sector. First, patient preferences for ORS alternatives (e.g., an antibiotic) could be driving underprescription of ORS. We will identify the causal effect of patient preferences (Aim 1) by having anonymous standardized patients (SPs) pose as caretakers of children with diarrhea and express different (randomly assigned) preferences for treatment (ask for ORS, ask for antibiotics, or let provider decide). Second, private providers could be responding to financial incentives to sell more profitable alternatives to ORS (e.g., an antibiotic). To estimate the causal effect of financial incentives (Aim 2), we will instruct a subset of SPs to inform providers that they can get discounted treatments at a relative's drug shop. This eliminates the provider's financial incentive to recommend a given treatment and allows us to estimate the effect of such incentives. Finally, private providers might not directly distribute ORS or could have frequent stock-outs. To estimate the causal effect of stock-outs (Aim 3), we will randomly assign half of the providers to receive a three-month supply of ORS. This generates exogenous variation in stock outs and thus enables us to isolate the causal effect of stock outs on ORS and antibiotic prescribing. Combining, (a) causal estimates of the impact of each factor on prescribing, and (b) population estimates of the prevalence of each factor, will allow us to estimate the population level impact of implementing interventions that address each factor (Aim 4). This study will provide the most comprehensive evidence to date on why one of the most important health technologies in history is often not prescribed. The results will inform the design of interventions aimed at increasing ORS dispensing and reducing antibiotic dispensing. If such interventions are targeted appropriately, millions of young lives could be saved.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2451
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eligible providers will be private providers over 18 years old in our sampled villages that treat at least one case of child diarrhea per week

Exclusion Criteria:

• Providers in villages where there are no other providers will be excluded for confidentiality concerns

Related Conditions & MeSH terms

• Child Diarrhea
• Diarrhea

Intervention

Behavioral:
• Free distribution of ORS
Provides will receive 3 months supply of ORS at the beginning of the study to dispense to their patients. They will be asked to dispense the ORS at the market rate and not to give it away to other providers.
• Standardized patient with ORS preference
Providers will receive a visit from an anonymous standardize patient posing a caretaker for a child with diarrhea who requests ORS to treat their child's diarrhea.
• Standardized patient with Antibiotic preference
Providers will receive a visit from an anonymous standardize patient posing a caretaker for a child with diarrhea who requests Antibiotics to treat their child's diarrhea.
• Standardized patient with no preference
Providers will receive a visit from an anonymous standardize patient posing a caretaker for a child with diarrhea who does not request anything specific to treat their child's diarrhea.
• Standardized patient with no preference + no financial incentive
Providers will receive a visit from an anonymous standardize patient posing a caretaker for a child with diarrhea who does not request anything specific to treat their child's diarrhea. In addition they will inform the provider that they are not going to purchase anything from the provider because they have an uncle with a drug shop where they can get a discount.

Locations

Country	Name	City	State
India	Indian Institute of Management Bangalore	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
RAND

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Received or prescribed ORS	Standardized patients will record whether the provider either dispensed or prescribed ORS for their child's diarrhea .	4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
Primary	Received or prescribed antibiotic	Standardized patients will record whether the provider either dispensed or prescribed antibiotics for their child's diarrhea.	4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
Secondary	Received or prescribed zinc	Standardized patients will record whether the provider either dispensed or prescribed zinc for their child's diarrhea.	4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
Secondary	Received or prescribed zinc+ORS	Standardized patients will record whether the provider either dispensed or prescribed zinc and ORS (the gold standard treatment) for their child's diarrhea.	4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
Secondary	Received or prescribed ORS and no antibiotics	Standardized patients will record whether the provider either dispensed or prescribed ORS and no antibiotics for their child's diarrhea.	4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
Secondary	Received or prescribed ORS + zinc and no antibiotics	Standardized patients will record whether the provider either dispensed or prescribed ORS and zinc with no antibiotics for their child's diarrhea.	4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.