Quality of Tuberculosis Care in Urban Patna, India

NCT02874716 | Completed

• 1 other identifier: OPP1091843-1
• Study Type: interventional
• Target: 321
• 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 health care. The PPIA is a tuberculosis pilot program implemented in the private health sector of urban Patna in the state of Bihar, 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

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)

No Tuberculosis Program (Non-PPIA)

NO INTERVENTION

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.

Interventions

Tuberculosis Program (PPIA) 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 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.

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:

• 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)

You may not qualify if:

• 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)

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: July 31, 2016
• Study Completion: December 1, 2016
• Last Updated: March 22, 2017

Record last verified: 2017-03