NCT02291575

Brief Summary

The rural healthcare market in much of the developing world is composed largely of informal private providers. These private providers often have little to no certifiable medical training. Recent studies in India using medical vignettes (or hypothetical medical situations) to measure clinical competence and direct observations of doctor-patient interactions to measure clinical practice highlight the poor quality of care that most patients receive-a problem that is clearly relevant beyond India and affects most low-income countries worldwide. For instance:

  1. 1.In rural India, standardized patients presenting with chest pain and (on further questioning) radiating pain in the arm are (correctly) diagnosed with a heart attack in less than 25 percent of cases.
  2. 2.Across 8 low and middle-income countries, health care providers completed the four necessary vital statistics for new patients in less than 4 percent of interactions: health care providers in the public sectors of many developing countries routinely spend less than 1 minute per patient.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

1.6 years

First QC Date

January 24, 2014

Last Update Submit

June 27, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical Practice

    Clinical Practice will be assessed in two ways. First, we will send Standardized Patients, or trained professionals who present with a pre-developed set of symptoms (of one of the three conditions specified) to a provider without the provider's knowledge that he/she is acting. Second, the evaluating team will sit in the providers' clinics after the completion of the intervention, observing provider-patient interactions for a full day. Information will be obtained for each provider-patient interaction on (a) consultation length, (b) history taking, (c) examinations performed, (d) information given to the patient, (e) medicines dispensed/prescribed and (f) prices charged.

    Endline (3-4 months after completion of intervention)

Secondary Outcomes (2)

  • Clinical Competence

    Endline (3-4 months after completion of intervention)

  • Clinical prices and caseload

    Endline (3-4 months after completion of intervention)

Study Arms (2)

Training

EXPERIMENTAL

Of the 304 participants in the study, half will be randomized into the treatment arm in which they will receive training from the Liver Foundation.The objective of the Liver Foundation's training program will be capacity building through information in health sciences, training in referral techniques during emergencies, and maternal and child health care priorities in rural areas. The training will be in the form of two three-hour classes per week and will continue for nine months, with three mid-term exams administered every three. During this time, the evaluation team will only collect the rosters of the attendees of the training classes and conduct sporadic random visits to the sessions to gain a better sense of the training methods and attendance rates.

Other: Training

Control

ACTIVE COMPARATOR

Half of the sample will be randomized into the control group, for whom there will be no training. They will be phased into training the following year. For the current year, the control group will experience no difference in their routine, aside from some (infrequent) opportunities to participate in other public health activities as provided by the Liver Foundation to any provider involved in their various programs.

Other: Control

Interventions

(please see Arm Description)

Training
ControlOTHER

This group will not receive any training from the Liver Foundation; they will simply be evaluated at baseline and endline.

Control

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • must be a private rural healthcare practitioner in West Bengal

You may not qualify if:

  • cannot live outside of three specified districts of West Bengal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial InfarctionDiarrheaDysenteryAsthma

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisSigns and Symptoms, DigestiveSigns and SymptomsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jishnu Das, PhD

    World Bank

    PRINCIPAL INVESTIGATOR
  • Abhijit Banerjee, PhD

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MIT Professor of Economics

Study Record Dates

First Submitted

January 24, 2014

First Posted

November 14, 2014

Study Start

October 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2015

Last Updated

June 28, 2017

Record last verified: 2017-06