Myocardial InfarctionNCT02291575
Improving the Quality of Private Sector Health Care in West Bengal
A study testing Training in people with Myocardial Infarction and Diarrhea (Dysentery), run by Abdul Latif Jameel Poverty Action Lab.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Diarrhea (Dysentery), Asthma
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- must be a private rural healthcare practitioner in West Bengal
Who cannot join
- cannot live outside of three specified districts of West Bengal
About this study
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:
- 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.
- 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.
Read more
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.
Read the 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:
- Baseline provider survey: this survey asks basic questions about training, socioeconomic background, work practices, etc.
- 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.
- Conditions
- Myocardial Infarction, Diarrhea (Dysentery), Asthma
- Being tested
- Training, Control
- Medical subject headings
- Myocardial Infarction, Diarrhea, Dysentery, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
(please see Arm Description)
ControlOther
This group will not receive any training from the Liver Foundation; they will simply be evaluated at baseline and endline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Endline (3-4 months after completion of intervention)
Secondary outcomes (2)
Clinical Competence
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.
Measured: Endline (3-4 months after completion of intervention)
Clinical prices and caseload
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.
Measured: Endline (3-4 months after completion of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdul Latif Jameel Poverty Action Lab
- Sponsor type
- University, hospital or other
- Collaborators
- National Rural Health Mission, Government of West Bengal, India, Liver Foundation, West Bengal, World Bank
- Responsible party
- Principal investigator, Abhijit Banerjee, Abdul Latif Jameel Poverty Action Lab
- Investigators
- Jishnu Das, PhD, Principal investigator, World BankAbhijit Banerjee, PhD, Principal investigator, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291575
- Sponsor's protocol ID
- RHCPWestBengal
- Status last verified
- Jun 2017
- First submitted
- 24 Jan 2014
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Private Sector Health Care in West Bengal
- ClinicalTrials.gov ID
- NCT02291575
- Acronym / sponsor ID
- RHCPWestBengal
- Conditions
- Myocardial Infarction, Diarrhea (Dysentery), Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Abdul Latif Jameel Poverty Action LabUniversity, hospital or other
- Collaborators
- National Rural Health Mission, Government of West Bengal, India, Liver Foundation, West Bengal, World Bank
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
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:
- Baseline provider survey: this survey asks basic questions about training, socioeconomic background, work practices, etc.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: TrainingOf 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. |
| Control | Active comparator | Other: ControlHalf 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. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- must be a private rural healthcare practitioner in West Bengal
Key exclusion criteria (1 listed)
- cannot live outside of three specified districts of West Bengal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training(please see Arm Description) | Other | Training |
| ControlThis group will not receive any training from the Liver Foundation; they will simply be evaluated at baseline and endline. | Other | Control |
Primary outcome
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.
2 secondary outcomes
Clinical Competence
Time frame: Endline (3-4 months after completion of intervention)
Clinical prices and caseload
Time frame: Endline (3-4 months after completion of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jishnu Das, PhD principal investigator
World Bank
Abhijit Banerjee, PhD principal investigator
Massachusetts Institute of Technology
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Myocardial Infarction and Diarrhea (Dysentery), run by Abdul Latif Jameel Poverty Action Lab.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Practice (time frame: Endline (3-4 months after completion of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.