Tuberculosis Clinical Trial
Official title:
An Impact Evaluation of the Private Provider Interface Agency Program on Quality of Tuberculosis Care: A Standardized Patient Study in Patna, India
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.
By taking advantage of a randomized roll-out design of the PPIA program in urban Patna, this
evaluation aims to determine the causal effects of the program on quality of health 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 urban Patna. 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 design, 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.
1. PPIA intervention: Between January 2014 and December 2016, the pilot PPIA program was
independently implemented by the non-governmental organization World Health Partners
(WHP) in urban Patna. In its role as the PPIA in Patna, WHP's aim is to strengthen
existing efforts to control TB through engagement of the private health sector. Through
this network, the objectives are to facilitate early and accurate diagnosis with proper
notification of cases and to ensure appropriate treatment and treatment adherence to
completion among TB patients in the private sector. This is done by establishing a
network and engaging four types of private health sector actors who are of vital
importance for TB advocacy and treatment efforts: (i) formal providers, who are
qualified doctors at hospitals, nursing homes, or outpatient clinics who receive
presumptive TB cases or treat TB cases, (ii) informal providers, who are non-allopathic
providers or less than fully qualified practitioners, including practitioners of
alternative medicines Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy and
other practitioners with minimum or no qualifications, (iii) chemists/pharmacists with
a drug license, medicine stock, and anti-TB drugs for sale, and (iv) diagnostic
laboratories that conduct sputum smear microscopy and/or chest X-rays, and GeneXpert
drug susceptibility testing. The pilot will serve as a model for private health sector
involvement in national TB control and will be used to inform similar programs in other
urban Indian settings.
2. Quality of care surveillance: The QuTUB project is a part of the PPIA monitoring
efforts and runs in parallel to the program scale up and expansion. The objective of
the QuTUB project is to capture levels of quality of care through standardized patients
("mystery shoppers" or "fake patients"), who are individuals recruited locally and
trained to portray four different TB cases. Developed by a Technical Advisory Group and
benchmarked against the Standards of TB Care of India, the cases were designed to
reflect different stages of TB disease progression, some with previous interactions
with the health system upon presentation to a health care provider. Outcomes captured
by the standardized patients through an exit questionnaire given to them within 2 hours
of their interaction with providers include: history questions asked by the provider,
laboratory tests ordered, medicines dispensed or prescribed, and referrals made.
3. Randomized roll-out evaluation approach: In December 2014, WHP was interested in trying
to further understand the causal impact of their program on diagnostic processes, and
there was an opportunity to remove the selection bias and attribute differences in
quality of care solely to the program by taking advantage of a randomized roll-out
expansion plan of the PPIA program among a subset of providers. In collaboration with
the PPIA Patna team, this study takes an intention-to-treat and instrumental variables
evaluation approach through selective enrollment of a subset of providers in the second
round of program scale-up across urban Patna. The researchers note that the subset of
providers are those who were not purposively selected in the earlier round of
enrollment and therefore may be those who see fewer TB patients, or those who were
reluctant to enroll into the program during the first rounds of program expansion.
Therefore, the impact of the program on this group may be different from among those
who were enrolled previously. Under this approach, it was agreed that for the
evaluation eligible formal providers would be engaged. For this, the researchers
provided WHP with a list of 321 randomly selected providers among those who were not
already enrolled at the beginning of 2015. Providers on this list were randomly
allocated to two groups: one group (treatment) of 171 eligible formal providers would
be sensitized and engaged, and the other group (control) of 150 eligible formal
providers would not be engaged until the QuTUB study team is able to complete end-line
data collection in 2016, after a year or more. Selection into program roll-out groups
was randomized. The study group includes formal providers who would see a pulmonary TB
case and self-reported low caseloads. Standardized patients are sent to both groups
before any intervention for baseline measures of quality of care, and the standardized
patients would return again before the control group begins to receive the intervention
for an end-line measure. The entire intervention in Patna is implemented by the PPIA
and is separate from the research team implementing the quality of care surveillance
and evaluation. Care is taken to ensure that the evaluation team will be in the field
independently of the implementation.
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.
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