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Improving the Quality of Private Sector Health Care in West Bengal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291575
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : June 28, 2017
Sponsor:
Collaborators:
National Rural Health Mission, Government of West Bengal, India
Liver Foundation, West Bengal
World Bank
Information provided by (Responsible Party):
Abhijit Banerjee, Abdul Latif Jameel Poverty Action Lab

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. 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. 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.

To address these deplorably low standards in both medical knowledge and practice, the Liver Foundation in Kolkata has been working with private rural health care providers through capacity building activities to improve quality in the private sector. The program consists of multiple-week training to private rural health care providers on the basis of a well-developed curriculum in the district of Birbhum, West Bengal.

This study aims to assess the impact of this training program using a randomized evaluation, in which providers are randomly assigned to the treatment, i.e. the Liver Foundation's training program, or the control, i.e. no such training. As an independent outside evaluation team, we will run a baseline survey for all providers (through a third party data collection agency), monitor the application of and compliance in the Liver Foundation's training intervention, and conduct a final endline study. By comparing the treatment and control groups on a variety of measures developed to capture competence in provider knowledge and practice, we can rigorously assess whether such a training program for informal rural health care providers is an effective means of improving provider medical knowledge and practice in the short run. It is worth noting that this study will not be able to capture long run effects , such as price or location changes, on health care for the rural poor.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Diarrhea (Dysentery) Asthma Other: Training Other: Control Not Applicable

Detailed Description:

The evaluation of the Liver Foundation training program for rural health care providers consists of four phases. In the first phase, the Liver Foundation will comb blocks in Birbhum district and invite 300-400 rural health care providers to participate in the program. In the second phase, all recruited providers will convene at a center in Birbhum where we, the evaluation team JPAL, will conduct a baseline study. We will then randomly allocate participating providers into two groups: the Treatment group, which will receive the Liver Foundation training within the next twelve months, and the Control group, which will not. In the third phase, the program inductees will be trained according to the curriculum put forth by the Liver Foundation. Finally, in the fourth phase, we will run an extensive endline survey to evaluate how training has affected the (1) clinical practice, (2) clinical competence, and (3) prices charged and caseload of the providers who have received the training relative to their non-trained counterparts. We detail each phase in turn.

Phase I: Provider Census in Birbhum District The Liver Foundation will identify between 300 to 400 representative private rural health care providers within the Birbhum district who are interested in the training program provided by the Liver Foundation and willing to participate in the necessary randomized selection process. All providers will be told that if they attend the baseline study, they will receive the medical training; however, how soon they will receive it will be determined through a lottery.

Phase II: Baseline Study and Randomization of Providers into Training Intervention

Bringing the providers in batches to a center established for this purpose in Birbhum, the evaluation team will run a baseline study on all 300 participants over the course of three weeks. The baseline study will consist of two parts:

  1. Baseline provider survey: this survey asks basic questions about training, socioeconomic background, work practices, etc.
  2. Vignette testing: Teams of trained vignette testers will test each doctor's competence through a series of five medical vignettes.

After having completed the above two steps of the baseline survey, the evaluation team will randomly allocate these providers into two groups: the "Treatment" group, which will receive the training, and the "Control" group, which will not. Note that those individuals selected for the control group will be informed that they will receive training at a later time due to limited resources; thus we will phase them in one year later, after the evaluation of the first treatment group is complete.

Phase III: Training Intervention The primary objective of the Liver Foundation's training program will be capacity building through theoretical information in health sciences, training in proper 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 months as per the Liver Foundation curriculum. 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.

Phase IV: Endline survey After the intervention has run its course for at least nine months, we will wrap up the evaluation with an extensive endline survey. Unlike the baseline survey, which can be completed in the one central location at which the providers meet, the endline survey must be done at each providers' own place of work. We expect that the process of locating and evaluating each of the 300 providers at his or her place of work will require approximately three months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving the Quality of Private Sector Health Care in West Bengal
Study Start Date : October 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Training
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
(please see Arm Description)

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




Primary Outcome Measures :
  1. Clinical Practice [ Time Frame: Endline (3-4 months after completion of intervention) ]
    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.


Secondary Outcome Measures :
  1. Clinical Competence [ Time Frame: Endline (3-4 months after completion of intervention) ]
    Clinical competence will be assessed through the use of medical vignettes, which have been developed and used in a number of countries. In these medical vignettes, providers are presented with a series of symptoms related to a particular disease or medical condition and are evaluated on their ability to diagnose correctly and make the proper recommendations. The impact of the program in terms of clinical competence will be computed using a difference-in-difference estimator, which is the gain in the treatment group minus the gain in the control group in the completion of checklist items and diagnosis rates for the cases considered.

  2. Clinical prices and caseload [ Time Frame: Endline (3-4 months after completion of intervention) ]
    Clinical prices, or the consultation fees charged to patients, and caseload, or the number of patients a health practitioner sees per day, will be assessed using both direct observation and the standardized patients. In both cases, prices will be noted and recorded to assess the impact of the treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • must be a private rural healthcare practitioner in West Bengal

Exclusion Criteria:

  • cannot live outside of three specified districts of West Bengal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291575


Sponsors and Collaborators
Abdul Latif Jameel Poverty Action Lab
National Rural Health Mission, Government of West Bengal, India
Liver Foundation, West Bengal
World Bank
Investigators
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Principal Investigator: Jishnu Das, PhD World Bank
Principal Investigator: Abhijit Banerjee, PhD Massachusetts Institute of Technology
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Published article

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Responsible Party: Abhijit Banerjee, MIT Professor of Economics, Abdul Latif Jameel Poverty Action Lab
ClinicalTrials.gov Identifier: NCT02291575    
Other Study ID Numbers: RHCPWestBengal
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Dysentery
Myocardial Infarction
Infarction
Diarrhea
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms, Digestive
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases