CClinicalTrials.gg
CompletedNCT04833790Updated Aug 5, 2026Results posted

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

An interventional study of Free distribution of ORS and Standardized patient with ORS preference in Child Diarrhea, sponsored by RAND. Completed at 1 site in India. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by RAND · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2,451
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Child Diarrhea
03

In context

Lead sponsor

RAND is the lead sponsor of 110 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Providers in villages where there are no other providers will be excluded for confidentiality concerns
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
2,451 participants (actual)

Study arms

  • Experimental
    Free distribution of ORS + standardized patient with ORS preference

    Providers 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.

    Behavioral: Free distribution of ORS · Behavioral: Standardized patient with ORS preference

  • Experimental
    Free distribution of ORS + standardized patient with Antibiotic preference

    Providers 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.

    Behavioral: Free distribution of ORS · Behavioral: Standardized patient with Antibiotic preference

  • Experimental
    Free distribution of ORS + standardized patient with no preference

    Providers 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.

    Behavioral: Free distribution of ORS · Behavioral: Standardized patient with no preference

  • Experimental
    Free distribution of ORS + standardized patient with no preference + no financial incentive

    Providers 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.

    Behavioral: Free distribution of ORS · Behavioral: Standardized patient with no preference + no financial incentive

  • Experimental
    Status quo ORS supply + standardized patient with ORS preference

    Providers 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.

    Behavioral: Standardized patient with ORS preference

  • Experimental
    Status quo ORS supply + standardized patient with Antibiotic preference

    Providers 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.

    Behavioral: Standardized patient with Antibiotic preference

  • Experimental
    Status quo ORS supply + standardized patient with no preference

    Providers 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.

    Behavioral: Standardized patient with no preference

  • Experimental
    Status quo ORS supply + standardized patient with no preference + no financial incentive

    Providers 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.

    Behavioral: Standardized patient with no preference + no financial incentive

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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

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

Secondary outcomes

  1. Received or Prescribed Zinc

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

07

Results

Posted Aug 5, 2026

Participant flow

Participant flow — Overall Study
MilestoneFree Distribution of ORS + Standardized Patient With ORS PreferenceFree Distribution of ORS + Standardized Patient With Antibiotic PreferenceFree Distribution of ORS + Standardized Patient With no PreferenceFree Distribution of ORS + Standardized Patient With no Preference + no Financial IncentiveStatus Quo ORS Supply + Standardized Patient With ORS PreferenceStatus Quo ORS Supply + Standardized Patient With Antibiotic PreferenceStatus Quo ORS Supply + Standardized Patient With no PreferenceStatus Quo ORS Supply + Standardized Patient With no Preference + no Financial Incentive
Started282289285287290280275294
Completed282289285287290280275294
Not completed00000000

Outcome measures

PrimaryReceived 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.

Time frame:
4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
Reported as:
Mean · probability
Received or Prescribed ORS
probabilityFree Distribution of ORS + Standardized Patient With ORS PreferenceFree Distribution of ORS + Standardized Patient With Antibiotic PreferenceFree Distribution of ORS + Standardized Patient With no PreferenceFree Distribution of ORS + Standardized Patient With no Preference + no Financial IncentiveStatus Quo ORS Supply + Standardized Patient With ORS PreferenceStatus Quo ORS Supply + Standardized Patient With Antibiotic PreferenceStatus Quo ORS Supply + Standardized Patient With no PreferenceStatus Quo ORS Supply + Standardized Patient With no Preference + no Financial Incentive
Received or Prescribed ORS.5851064 ± .4935796.2456747 ± .4312333.2842105 ± .451831.3414634 ± .4750288.5172414 ± .5005664.3035714 ± .460623.2763636 ± .4480141.2857143 ± .4525242
PrimaryReceived 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.

Time frame:
4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
Reported as:
Mean · probability
Received or Prescribed Antibiotic
probabilityFree Distribution of ORS + Standardized Patient With ORS PreferenceFree Distribution of ORS + Standardized Patient With Antibiotic PreferenceFree Distribution of ORS + Standardized Patient With no PreferenceFree Distribution of ORS + Standardized Patient With no Preference + no Financial IncentiveStatus Quo ORS Supply + Standardized Patient With ORS PreferenceStatus Quo ORS Supply + Standardized Patient With Antibiotic PreferenceStatus Quo ORS Supply + Standardized Patient With no PreferenceStatus Quo ORS Supply + Standardized Patient With no Preference + no Financial Incentive
Received or Prescribed Antibiotic.6205674 ± .4861085.7543253 ± .4312333.7157895 ± .451831.6864111 ± .4647618.5862069 ± .4933637.8 ± .4007162.6909091 ± .4629612.6802721 ± .4671662
SecondaryReceived or Prescribed Zinc

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

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

Results for this outcome have not been posted.

SecondaryReceived 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.

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

Results for this outcome have not been posted.

SecondaryReceived 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.

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

Results for this outcome have not been posted.

SecondaryReceived 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.

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

Results for this outcome have not been posted.

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Free Distribution of ORS + Standardized Patient With ORS Preference0/282 (0%)0/282 (0%)0/282 (0%)
Free Distribution of ORS + Standardized Patient With Antibiotic Preference0/289 (0%)0/289 (0%)0/289 (0%)
Free Distribution of ORS + Standardized Patient With no Preference0/285 (0%)0/285 (0%)0/285 (0%)
Free Distribution of ORS + Standardized Patient With no Preference + no Financial Incentive0/287 (0%)0/287 (0%)0/287 (0%)
Status Quo ORS Supply + Standardized Patient With ORS Preference0/290 (0%)0/290 (0%)0/290 (0%)
Status Quo ORS Supply + Standardized Patient With Antibiotic Preference0/280 (0%)0/280 (0%)0/280 (0%)
Status Quo ORS Supply + Standardized Patient With no Preference0/275 (0%)0/275 (0%)0/275 (0%)
Status Quo ORS Supply + Standardized Patient With no Preference + no Financial Incentive0/294 (0%)0/294 (0%)0/294 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Free Distribution of ORS + Standardized Patient With ORS PreferenceFree Distribution of ORS + Standardized Patient With Antibiotic PreferenceFree Distribution of ORS + Standardized Patient With no PreferenceFree Distribution of ORS + Standardized Patient With no Preference + no Financial IncentiveStatus Quo ORS Supply + Standardized Patient With ORS PreferenceStatus Quo ORS Supply + Standardized Patient With Antibiotic PreferenceStatus Quo ORS Supply + Standardized Patient With no PreferenceStatus Quo ORS Supply + Standardized Patient With no Preference + no Financial IncentiveTotal
Mean44.94681 ± 13.2038844.77855 ± 14.6396344.27368 ± 13.5945644.15679 ± 12.832743.61034 ± 13.1702945.41071 ± 13.5477144.29455 ± 13.30143.9932 ± 13.6056144.4277 ± 13.48863
Sex: Female, Male
Sex: Female, Male(Participants)Free Distribution of ORS + Standardized Patient With ORS PreferenceFree Distribution of ORS + Standardized Patient With Antibiotic PreferenceFree Distribution of ORS + Standardized Patient With no PreferenceFree Distribution of ORS + Standardized Patient With no Preference + no Financial IncentiveStatus Quo ORS Supply + Standardized Patient With ORS PreferenceStatus Quo ORS Supply + Standardized Patient With Antibiotic PreferenceStatus Quo ORS Supply + Standardized Patient With no PreferenceStatus Quo ORS Supply + Standardized Patient With no Preference + no Financial IncentiveTotal
Female2426272428172123190
Male2582632582632622632542712092
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Free Distribution of ORS + Standardized Patient With ORS PreferenceFree Distribution of ORS + Standardized Patient With Antibiotic PreferenceFree Distribution of ORS + Standardized Patient With no PreferenceFree Distribution of ORS + Standardized Patient With no Preference + no Financial IncentiveStatus Quo ORS Supply + Standardized Patient With ORS PreferenceStatus Quo ORS Supply + Standardized Patient With Antibiotic PreferenceStatus Quo ORS Supply + Standardized Patient With no PreferenceStatus Quo ORS Supply + Standardized Patient With no Preference + no Financial IncentiveTotal
Hispanic or Latino000000000
Not Hispanic or Latino2822892852872902802752942282
Unknown or Not Reported000000000
Region of Enrollment
Region of Enrollment(participants)Free Distribution of ORS + Standardized Patient With ORS PreferenceFree Distribution of ORS + Standardized Patient With Antibiotic PreferenceFree Distribution of ORS + Standardized Patient With no PreferenceFree Distribution of ORS + Standardized Patient With no Preference + no Financial IncentiveStatus Quo ORS Supply + Standardized Patient With ORS PreferenceStatus Quo ORS Supply + Standardized Patient With Antibiotic PreferenceStatus Quo ORS Supply + Standardized Patient With no PreferenceStatus Quo ORS Supply + Standardized Patient With no Preference + no Financial IncentiveTotal
India2822892852872902802752942282
08

Study locations

1 site
  • Indian Institute of Management Bangalore
    Bangalore, Karnataka, India
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 22, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — We plan on making individual underlying data available for replication purposes but this plan needs to be finalized with our IRB

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04833790
Lead sponsor
RAND
Responsible party
Zachary Wagner (Professor of Policy Analysis, RAND) — Principal investigator
First posted
Apr 6, 2021
Start date
May 5, 2022
Primary completion
Dec 31, 2022
Completion
May 31, 2025
Results posted
Aug 5, 2026
Last update
Aug 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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