- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04833790
What Drives Poor Care for Child Diarrhea: A Standardized Patient Experiment
June 20, 2023 updated by: Zachary Wagner, RAND
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
2451
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Karnataka
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Bangalore, Karnataka, India
- Indian Institute of Management Bangalore
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
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.
|
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.
|
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.
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.
|
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.
|
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.
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.
|
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.
|
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.
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Received or prescribed ORS
Time Frame: 4 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 for their child's diarrhea .
|
4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
|
Received or prescribed antibiotic
Time Frame: 4 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 antibiotics for their child's diarrhea.
|
4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Received or prescribed zinc
Time Frame: 4 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.
|
4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
|
Received or prescribed zinc+ORS
Time Frame: 4 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.
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4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
|
Received or prescribed ORS and no antibiotics
Time Frame: 4 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.
|
4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
|
Received or prescribed ORS + zinc and no antibiotics
Time Frame: 4 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.
|
4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2022
Primary Completion (Actual)
December 31, 2022
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
April 2, 2021
First Submitted That Met QC Criteria
April 5, 2021
First Posted (Actual)
April 6, 2021
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 20, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DK126049-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
We plan on making individual underlying data available for replication purposes but this plan needs to be finalized with our IRB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child Diarrhea
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Tufts UniversityUniversity of California, Berkeley; University of ChicagoCompletedDiarrhea | Death | Child DevelopmentKenya
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingDiarrhea | Wasting | Malnutrition, ChildKenya
-
Stanford UniversityAmerican Refugee CommitteeCompletedDiarrhea | Cough | Fever | Malnutrition, Child
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Innovations for Poverty ActionUniversity of California, Berkeley; Tufts University; University of California... and other collaboratorsCompleted
-
International Centre for Diarrhoeal Disease Research...University of California, Berkeley; Emory University; University of California... and other collaboratorsActive, not recruiting
-
Aboca Spa Societa' AgricolaUnknownDiarrhea | Diarrhea, Infantile | Chronic Diarrhea | Acute Diarrhea
-
Napo Pharmaceuticals, Inc.Active, not recruitingAdult Solid Tumor | Cancer Therapy-Related Diarrhea | Chemotherapy-related Diarrhea | Prophylaxis of Diarrhea | Symptomatic Relief of Diarrhea | Targeted Therapy-related DiarrheaUnited States, Taiwan, Georgia, Serbia, Argentina
-
Last Mile HealthMassachusetts General Hospital; Northwestern University; Georgetown University; Heidelberg UniversityActive, not recruitingDiarrhea | Malaria | Acute Respiratory Infection | Malnutrition, ChildLiberia
-
Hospital San BartolomeInstituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo...Unknown
Clinical Trials on Free distribution of ORS
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Norwegian Institute of Public HealthStovner District, City of Oslo, NorwayCompleted
-
Mead Johnson NutritionCompletedGastroenteritis AcuteThailand
-
University of California, BerkeleyMakerere UniversityCompletedDiarrhea | Dehydration | Infantile Diarrhea
-
Mitsubishi Tanabe Pharma America Inc.Massachusetts General HospitalActive, not recruitingAmyotrophic Lateral Sclerosis | ALSUnited States, Canada
-
Seattle Children's HospitalCompletedMental Health Disorders | Suicide or Selfinflicted Injury by Firearms and ExplosivesUnited States
-
Auzone Biological Technology Pty LtdCompleted
-
Hiroshima UniversityCompleted
-
The Cleveland ClinicThe Huron FoundationCompletedMedication Adherence | Medication Compliance
-
EpicentreMédecins Sans Frontières, FranceCompleted
-
Akdeniz UniversityEnrolling by invitationHemodialysis | End-Stage Renal Disease | Interdialytic Weight GainTurkey