An interventional study of Tuberculosis Program in Tuberculosis, sponsored by McGill University. Completed. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by McGill University · Not applicable, Interventional, and Health services research
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.
By taking advantage of a randomized roll-out design of the PPIA program in Mumbai, this evaluation aims to determine the causal effects of the program on quality of care among private sector health providers. The evaluation is embedded in an existing quality of care surveillance project that uses standardized patients to assess the quality of tuberculosis (TB) care in Mumbai, India. Below is a description of (1) the TB intervention implemented by the PPIA, (2) the quality of TB care (QuTUB) surveillance project, and (3) the randomized roll-out of the PPIA program among a subset of providers in order to isolate the impact of the program on quality of care.
The entire program and its implementation are external to the researchers. To better understand the impact of the program using an already approved surveillance study, the researchers use a stepped-wedge design that involves a sequential roll-out of the program to a subset of providers over a period of time where the order of roll-out is randomized.
Analysis:
Intention-to-treat analysis and instrumental variables will be conducted after determining (i) that the treatment assignment can serve as a good instrument by: a strong correlation to the actual enrollment statuses of the providers regardless of treatment assignment, being uncorrelated with the outcomes, and only being connected to the outcomes through actual enrollment in the program, and (ii) balance at baseline between the treatment and control groups.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →McGill University is the lead sponsor of 244 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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.
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.
Also known as: Private Provider Interface Agency Program
Correct case management
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.
Time frame: one year
Essential history checklist
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.
Time frame: one year
Referral for further management
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.
Time frame: one year
Suspicion of tuberculosis
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.
Time frame: one year
Initiation of TB treatment
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.
Time frame: one year
Number of lab tests ordered
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.
Time frame: one year
Lab tests ordered
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.
Time frame: one year
Number of medicines
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.
Time frame: one year
Medicine type
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.
Time frame: one year
Rates of case registration
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.
Time frame: one year
Vouchers received
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.
Time frame: one year
Patient costs
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.
Time frame: one year
Consultation, medicine, and test costs to patients
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.
Time frame: one year
No study locations are listed for this record.
Plan to share: Undecided
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