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Trial record 1 of 2 for:    26268690 [PUBMED-IDS]
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Quality of Tuberculosis Care in Mumbai, India

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ClinicalTrials.gov Identifier: NCT02874755
Recruitment Status : Completed
First Posted : August 22, 2016
Last Update Posted : August 29, 2017
Sponsor:
Collaborators:
World Bank
Institute of Socio-Economic Research on Development and Democracy (ISERDD)
ACCESS Health International
Information provided by (Responsible Party):
Madhukar Pai, McGill University

Brief Summary:
The purpose of this study is to evaluate the impact of the Private Provider Interface Agency (PPIA) program on quality of care. The PPIA is a tuberculosis pilot program implemented in the private health sector of Mumbai city, India.

Condition or disease Intervention/treatment Phase
Tuberculosis Other: Tuberculosis Program Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: An Impact Evaluation of the Private Provider Interface Agency Program on Quality of Tuberculosis Care: A Standardized Patient Study in Mumbai, India
Study Start Date : January 2015
Actual Primary Completion Date : March 10, 2017
Actual Study Completion Date : March 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: Tuberculosis Program (PPIA)
Half of the 300 participants were randomly selected to be sensitized and engaged into the program, and subsequently to receive the benefits of the PPIA intervention. Providers in the PPIA arm if networked into the program will receive the benefits of the program, including but not limited to: ability to provide presumptive TB patients and TB cases vouchers for free and/or subsidized diagnostic testing and referrals to providers for free first line anti-TB treatment (TB cases only); reimbursements for subsidized tests; training opportunities, and access to a referral network.
Other: Tuberculosis Program
The intervention includes a variety of (1) non-financial incentives that are intended to reduce clinical and financial costs for presumptive TB patients and TB cases for diagnostic testing and treatment (free digital chest X-ray, free sputum microscopy, free or subsidized drug-susceptibility testing, free first-line anti-TB treatment) within the PPIA network, and (2) training or certified medical education (CME) sessions for the providers from the PPIA. Meanwhile, program marketing, CMEs, and other advocacy efforts are aimed to raise awareness in the communities.
Other Name: Private Provider Interface Agency Program

No Intervention: No Tuberculosis Program (Non-PPIA)
The remaining half of the sample in Mumbai selected randomly will be phased into the program at least a year after the PPIA arm. However, during the year of the study, they will not be networked into the program.



Primary Outcome Measures :
  1. Correct case management [ Time Frame: one year ]
    Correct case management is defined as the proportion of interactions (across all standardized patient (SP) cases) or proportion of providers (by SP case) in which providers managed the case according to the Standards for Tuberculosis Care in India (STCI) within the PPIA program vs. outside the PPIA. Depending on the SP case, the outcome is an index composed of actions a provider did during the interaction with the SP: correct diagnostic tests ordered, correct or harmful treatment prescribed, or referral to a qualified health care provider. These details are extracted from an exit questionnaire that is completed by the SP within 2 hours of the interaction.


Secondary Outcome Measures :
  1. Essential history checklist [ Time Frame: one year ]
    Essential history checklist is defined as the average proportion of essential history questions asked by the practitioner during an interaction for tuberculosis benchmarked against the Standards of Tuberculosis Care in India guidelines. These details are extracted from an exit questionnaire that is completed by the SP within 2 hours of the interaction.

  2. Referral for further management [ Time Frame: one year ]
    Referral for further management is defined as the proportion of interactions in which the provider refers the simulated patient to a qualified provider or another facility and the name, if specified to the SP. These details are extracted from an exit questionnaire that is completed by the SP within 2 hours of the interaction.

  3. Suspicion of tuberculosis [ Time Frame: one year ]
    Suspicion of tuberculosis is defined as the proportion of interactions in which the provider mentions tuberculosis or states that the simulated patient has tuberculosis. These details are extracted from an exit questionnaire that is completed by the SP within 2 hours of the interaction.

  4. Initiation of TB treatment [ Time Frame: one year ]
    Initiation of TB treatment is defined as the proportion of interactions in which the provider initiates the simulated patient on TB treatment. After each interaction, the SP purchases any medicines ordered by the provider. These details are collected on an exit questionnaire; active ingredients are investigated; and medicines are coded separately by two clinicians on the research team.

  5. Number of lab tests ordered [ Time Frame: one year ]
    Number of lab tests ordered is defined as the average number of lab tests ordered per interaction by providers. These details are extracted from an exit questionnaire that is completed by the SP within 2 hours of the interaction.

  6. Lab tests ordered [ Time Frame: one year ]
    Lab tests ordered is defined as the proportion of interactions in which the provider orders specific TB diagnostic tests (e.g. chest X-ray, sputum acid-fast bacillus (AFB) testing, GeneXpert) or other types of tests for the simulated patient. These details are extracted from an exit questionnaire that is completed by the SP within 2 hours of the interaction.

  7. Number of medicines [ Time Frame: one year ]
    Number of medicines is defined as the average number of medicines ordered per interaction. After each interaction, the SP purchases any medicines ordered by the provider. These details are collected on an exit questionnaire; active ingredients are investigated; and medicines are coded and categorized by two clinicians on the research team.

  8. Medicine type [ Time Frame: one year ]
    Medicine type is defined as the types of medicines ordered (e.g., antibiotics, steroids, fluoroquinolones, and others) during the simulated patient interactions. After each interaction, the SP purchases any medicines ordered by the provider. These details are collected on an exit questionnaire; active ingredients are investigated; and medicines are coded and categorized by two clinicians on the research team.

  9. Rates of case registration [ Time Frame: one year ]
    Rates of case registration is defined as the proportion of interactions in which providers who are networked in the PPIA program registers the simulated patient into the program. These details are extracted from an exit questionnaire that is completed by the SP within 2 hours of the interaction.

  10. Vouchers received [ Time Frame: one year ]
    Vouchers received is defined as the proportion of PPIA vouchers or referral coupons given to the simulated patient for any of the actions that could have resulted in a voucher or referral coupon only among providers who are in the PPIA program. These details are extracted from an exit questionnaire that is completed by the SP within 2 hours of the interaction.

  11. Patient costs [ Time Frame: one year ]
    Patient costs is defined as the average amount charged to the simulated patients by providers per interaction for the entire visit. These details are extracted from an exit questionnaire that is completed by the SP within 2 hours of the interaction.

  12. Consultation, medicine, and test costs to patients [ Time Frame: one year ]
    The outcome for consultation, medicine, and test costs to patients is defined as the average amount charged for consultation, medicines, and tests (if itemized) by providers per interaction. These details are extracted from an exit questionnaire that is completed by the SP within 2 hours of the interaction.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • AYUSH practitioners (those who are trained in the alternative medicines Ayurveda, Yoga and Naturopathy, Unani, Siddha, or Homeopathy) in two purposively selected, high slum population wards in Mumbai
  • AYUSH practitioners who are not networked in the urban PPIA program as of April 2015

Exclusion Criteria:

- AYUSH practitioners enrolled in the urban PPIA program as of April 2015


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): NCT02874755


Sponsors and Collaborators
McGill University
World Bank
Institute of Socio-Economic Research on Development and Democracy (ISERDD)
ACCESS Health International
Investigators
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Principal Investigator: Madhukar Pai, MD, PhD McGill University
Principal Investigator: Jishnu Das, PhD World Bank

Publications:
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Responsible Party: Madhukar Pai, Canada Research Chair in Epidemiology & Global Health, Director of McGill Global Health Programs, Associate Director of McGill International Tuberculosis Centre, McGill University
ClinicalTrials.gov Identifier: NCT02874755     History of Changes
Other Study ID Numbers: OPP1091843-2
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Madhukar Pai, McGill University:
Quality of Care
Standardized Patients

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections