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Child DiarrheaNCT04833790

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

A study testing Free distribution of ORS, Standardized patient with ORS preference and Standardized patient with Antibiotic preference in people with Child Diarrhea, run by RAND at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Child Diarrhea
What is being tested?
Free distribution of ORS, Standardized patient with ORS preference and Standardized patient with Antibiotic preference
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,451 participants
Where
1 siteIndia
Study dates
5 May 2022to 31 May 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site
  • Indian Institute of Management Bangalore

    Bangalore, Karnataka

Other trials in India

About this study

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.

Read the 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.

Conditions
Child Diarrhea
Being tested
Free distribution of ORS, Standardized patient with ORS preference, Standardized patient with Antibiotic preference, Standardized patient with no preference, Standardized patient with no preference + no financial incentive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Free distribution of ORSBehavioural

    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 preferenceBehavioural

    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 preferenceBehavioural

    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 preferenceBehavioural

    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 incentiveBehavioural

    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.

Study groups in NCT04833790
Study groupRoleWhat they receive
Free distribution of ORS + standardized patient with ORS preferenceExperimentalProviders assigned to this arm will receive 3 months supply of ORS. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates a preference for ORS.
Receives: Behavioral: Free distribution of ORS; Behavioral: Standardized patient with ORS preference
Free distribution of ORS + standardized patient with Antibiotic preferenceExperimentalProviders assigned to this arm will receive 3 months supply of ORS. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates a preference for Antibiotics.
Receives: Behavioral: Free distribution of ORS; Behavioral: Standardized patient with Antibiotic preference
Free distribution of ORS + standardized patient with no preferenceExperimentalProviders assigned to this arm will receive 3 months supply of ORS. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates no preference for treatment.
Receives: Behavioral: Free distribution of ORS; Behavioral: Standardized patient with no preference
Free distribution of ORS + standardized patient with no preference + no financial incentiveExperimentalProviders assigned to this arm will receive 3 months supply of ORS. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates no preference for treatment and indicates that they will purchase whatever the provider recommends from a relative's drug shop.
Receives: Behavioral: Free distribution of ORS; Behavioral: Standardized patient with no preference + no financial incentive
Status quo ORS supply + standardized patient with ORS preferenceExperimentalProviders assigned to this arm will have status who ORS supply. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates a preference for ORS.
Receives: Behavioral: Standardized patient with ORS preference
Status quo ORS supply + standardized patient with Antibiotic preferenceExperimentalProviders assigned to this arm will have status who ORS supply. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates a preference for Antibiotics.
Receives: Behavioral: Standardized patient with Antibiotic preference
Status quo ORS supply + standardized patient with no preferenceExperimentalProviders assigned to this arm will have status who ORS supply. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates no preference for treatment.
Receives: Behavioral: Standardized patient with no preference
Status quo ORS supply + standardized patient with no preference + no financial incentiveExperimentalProviders assigned to this arm will have status who ORS supply. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates no preference for treatment and indicates that they will purchase whatever the provider recommends from a relative's drug shop.
Receives: Behavioral: Standardized patient with no preference + no financial incentive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Received or Prescribed ORS

    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.

    Measured: 4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.

  2. Received or Prescribed Antibiotic

    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.

    Measured: 4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.

Secondary outcomes (4)
  1. Received or Prescribed Zinc

    Standardized patients will record whether the provider either dispensed or prescribed zinc for their child's diarrhea.

    Measured: 4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.

  2. 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.

    Measured: 4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.

  3. 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.

    Measured: 4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.

  4. 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.

    Measured: 4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2021
  2. Study start5 May 2022
  3. Primary completion31 Dec 2022
  4. Study completion31 May 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
2,451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04833790
Sponsor's protocol ID
1R01DK126049-01A1
Status last verified
Aug 2026
First submitted
2 Apr 2021
Last updated
5 Aug 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We plan on making individual underlying data available for replication purposes but this plan needs to be finalized with our IRB

Questions about this trial

What is this clinical trial studying?

A study testing Free distribution of ORS, Standardized patient with ORS preference and Standardized patient with Antibiotic preference in people with Child Diarrhea, run by RAND at 1 site in India.

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 1 inclusion and 1 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 5 Aug 2026. 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 India. 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?

Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Received or Prescribed ORS (time frame: 4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Aug 2026.

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