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

Primary Purpose

Child Diarrhea

Status
Active
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
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
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Diarrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indian Institute of Management Bangalore

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Free distribution of ORS + standardized patient with ORS preference

Free distribution of ORS + standardized patient with Antibiotic preference

Free distribution of ORS + standardized patient with no preference

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

Status quo ORS supply + standardized patient with ORS preference

Status quo ORS supply + standardized patient with Antibiotic preference

Status quo ORS supply + standardized patient with no preference

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

Arm Description

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.

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.

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.

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.

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 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 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 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.

Outcomes

Primary Outcome Measures

Received or prescribed ORS
Standardized patients will record whether the provider either dispensed or prescribed ORS for their child's diarrhea .
Received or prescribed antibiotic
Standardized patients will record whether the provider either dispensed or prescribed antibiotics for their child's diarrhea.

Secondary Outcome Measures

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

Full Information

First Posted
April 2, 2021
Last Updated
June 20, 2023
Sponsor
RAND
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1. Study Identification

Unique Protocol Identification Number
NCT04833790
Brief Title
What Drives Poor Care for Child Diarrhea: A Standardized Patient Experiment
Official Title
What Drives Poor Care for Child Diarrhea: A Standardized Patient Experiment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RAND

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
2451 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Free distribution of ORS + standardized patient with ORS preference
Arm Type
Experimental
Arm Description
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.
Arm Title
Free distribution of ORS + standardized patient with Antibiotic preference
Arm Type
Experimental
Arm Description
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.
Arm Title
Free distribution of ORS + standardized patient with no preference
Arm Type
Experimental
Arm Description
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.
Arm Title
Free distribution of ORS + standardized patient with no preference + no financial incentive
Arm Type
Experimental
Arm Description
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.
Arm Title
Status quo ORS supply + standardized patient with ORS preference
Arm Type
Experimental
Arm Description
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.
Arm Title
Status quo ORS supply + standardized patient with Antibiotic preference
Arm Type
Experimental
Arm Description
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.
Arm Title
Status quo ORS supply + standardized patient with no preference
Arm Type
Experimental
Arm Description
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.
Arm Title
Status quo ORS supply + standardized patient with no preference + no financial incentive
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Free distribution of ORS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standardized patient with ORS preference
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standardized patient with Antibiotic preference
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standardized patient with no preference
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standardized patient with no preference + no financial incentive
Intervention Description
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.
Primary Outcome Measure Information:
Title
Received or prescribed ORS
Description
Standardized patients will record whether the provider either dispensed or prescribed ORS for their child's diarrhea .
Time Frame
4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
Title
Received or prescribed antibiotic
Description
Standardized patients will record whether the provider either dispensed or prescribed antibiotics for their child's diarrhea.
Time Frame
4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur.
Secondary Outcome Measure Information:
Title
Received or prescribed zinc
Description
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.
Title
Received or prescribed zinc+ORS
Description
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.
Title
Received or prescribed ORS and no antibiotics
Description
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.
Title
Received or prescribed ORS + zinc and no antibiotics
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Indian Institute of Management Bangalore
City
Bangalore
State/Province
Karnataka
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We plan on making individual underlying data available for replication purposes but this plan needs to be finalized with our IRB

Learn more about this trial

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

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