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Trial record 2 of 2 for:    26268690 [PUBMED-IDS]

Quality of Tuberculosis Care in Urban Patna, India

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ClinicalTrials.gov Identifier: NCT02874716
Recruitment Status : Completed
First Posted : August 22, 2016
Last Update Posted : March 22, 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 health care. The PPIA is a tuberculosis pilot program implemented in the private health sector of urban Patna in the state of Bihar, India.

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 321 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 Patna, India
Actual Study Start Date : January 2015
Actual Primary Completion Date : July 31, 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: Tuberculosis Program (PPIA)
In Patna, 171 of the 321 participants were randomly selected to be sensitized and engaged into the program in Phase 1, and subsequently to receive the benefits of the PPIA intervention. Providers in the PPIA arm if engaged 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 or subsidized diagnostic testing and free first line anti-TB treatment (TB cases only); reimbursements for subsidized tests and anti-TB treatment; financial incentives to providers based on certain indicators; training opportunities, and access to a referral network.
Other: Tuberculosis Program (PPIA)
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 sputum microscopy, free digital chest X-ray, free or subsidized drug-susceptibility testing (DST), free first line anti-TB treatment), (2) training or certified medical education sessions for the providers from the PPIA, and (3) financial incentives to engaged providers for patient registration, diagnostic testing, treatment initiation, and treatment adherence. Meanwhile, health camps, advertising, 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 part of the sample in Patna selected randomly will be phased into the program at least a year after the PPIA arm in Phase 2. However, during the year of the study, they will not be engaged 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 for practitioners networked in the program [ 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.



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

Inclusion Criteria:

  • Formal providers (with Bachelor of Medicine, Bachelor of Surgery (MBBS) degree and higher) who were not enrolled in the urban PPIA program as of January 2015
  • Daily outpatients of 20 or fewer (self-reported)

Exclusion Criteria:

  • Formal providers enrolled in the urban PPIA program as of January 2015
  • Formal providers who do not see adult pulmonary patients (e.g., pediatricians, orthopedists)

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): NCT02874716


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: NCT02874716     History of Changes
Other Study ID Numbers: OPP1091843-1
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

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