Quality of Tuberculosis Care in Mumbai, India

NCT02874755 | Completed

• 1 other identifier: OPP1091843-2
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis

Keywords

Quality of Care; Standardized Patients

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Secondary Outcomes (12)

• Essential history checklist

  one year

• Referral for further management

  one year

• Suspicion of tuberculosis

  one year

• Initiation of TB treatment

  one year

• Number of lab tests ordered

  one year

Study Arms (2)

Tuberculosis Program (PPIA)

EXPERIMENTAL

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

No Tuberculosis Program (Non-PPIA)

NO INTERVENTION

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.

Interventions

Tuberculosis Program OTHER

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

Tuberculosis Program (PPIA)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• McGill University: lead
• World Bank: collaborator
• Institute of Socio-Economic Research on Development and Democracy (ISERDD): collaborator
• ACCESS Health International: collaborator

Related Publications (1)

• Das J, Kwan A, Daniels B, Satyanarayana S, Subbaraman R, Bergkvist S, Das RK, Das V, Pai M. Use of standardised patients to assess quality of tuberculosis care: a pilot, cross-sectional study. Lancet Infect Dis. 2015 Nov;15(11):1305-13. doi: 10.1016/S1473-3099(15)00077-8. Epub 2015 Aug 9.

  PMID: 26268690 BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Madhukar Pai, MD, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

• Jishnu Das, PhD

  World Bank

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Canada Research Chair in Epidemiology & Global Health, Director of McGill Global Health Programs, Associate Director of McGill International Tuberculosis Centre

Study Record Dates

• First Submitted: August 7, 2016
• First Posted: August 22, 2016
• Study Start: January 1, 2015
• Primary Completion: March 10, 2017
• Study Completion: March 10, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08