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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04833790
Enrollment
2451
Registered
2021-04-06
Start date
2022-05-05
Completion date
2025-05-31
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Diarrhea

Brief 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.

Detailed 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.

Interventions

BEHAVIORALFree 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.

BEHAVIORALStandardized 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.

BEHAVIORALStandardized 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.

BEHAVIORALStandardized 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.

BEHAVIORALStandardized 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.

Sponsors

RAND
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

The study participants are private health care providers in India who treat child diarrhea. Providers will be masked to which type of patient they are assigned to but not whether they receive free treatment for child diarrhea. Outcomes will assessed by anonymous standardized patients and these will be blind to whether the provider received free treatment for child diarrhea.

Intervention model description

The two interventions are patient type (4 types) and free distribution of treatment for child diarrhea (2 groups). These will be cross-randomized creating 8 study arms.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Received or Prescribed ORS4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.We will create a binary variable that indicates whether the provider either dispensed or prescribed ORS to standardized patients for their child's diarrhea. This variable will be set to 1 if the provider dispensed or prescribed ORS and to zero otherwise. The mean of this variable represents a probability.
Received or Prescribed Antibiotic4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.We will create a binary variable that indicates whether the provider either dispensed or prescribed antibiotics to standardized patients for their child's diarrhea. This variable will be set to 1 if the provider dispensed or prescribed antibiotics and to zero otherwise. The mean of this variable represents a probability.

Secondary

MeasureTime frameDescription
Received or Prescribed Zinc4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.Standardized patients will record whether the provider either dispensed or prescribed zinc for their child's diarrhea.
Received or Prescribed Zinc+ORS4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.Standardized patients will record whether the provider either dispensed or prescribed zinc and ORS (the gold standard treatment) for their child's diarrhea.
Received or Prescribed ORS and no Antibiotics4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.Standardized patients will record whether the provider either dispensed or prescribed ORS and no antibiotics for their child's diarrhea.
Received or Prescribed ORS + Zinc and no Antibiotics4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.Standardized patients will record whether the provider either dispensed or prescribed ORS and zinc with no antibiotics for their child's diarrhea.

Countries

India

Baseline characteristics

Characteristic
Age, Continuous44.4277 years
STANDARD_DEVIATION 13.48863
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2282 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Region of Enrollment
India
2282 participants
Sex: Female, Male
Female
190 Participants
Sex: Female, Male
Male
258 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
0 / 2820 / 2890 / 2850 / 2870 / 2900 / 2800 / 2750 / 294
other
Total, other adverse events
0 / 2820 / 2890 / 2850 / 2870 / 2900 / 2800 / 2750 / 294
serious
Total, serious adverse events
0 / 2820 / 2890 / 2850 / 2870 / 2900 / 2800 / 2750 / 294

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026