Primary Outcomes (explanation)
Below is a list of the main outcomes of interest for this analysis, as well as the source and the method of data collection used in each case.
• Adherence to a Checklist of quality of care and patient safety standards. This is a Checklist for Singular/Joint Inspections for Public and Private Medical Institutions, which has been developed by a technical working group (TWG) including the regulatory bodies under the Ministry of Health, the private sector, and other stakeholders. This Checklist includes indicators of infrastructure, equipment, staff characteristics, and protocols to measure quality and patient safety across all units of a health facility, and hence it allows measuring how facilities stand with respect to the standards set by the regulation. The results are mapped into a score and the measure of adherence we will use is the score as a percentage of the maximum score possible for each facility. We developed an electronic version of this Checklist. Data will be collected through surveys to the facility in-charge and staff, as well as through observation and verification during the surveys following closely the protocols that inspectors follow when they conduct inspections.
• Adherence to patient safety practices related to infection prevention, and control (IPC) in primary care, which are measured by direct observation of select practices in 3 outpatient sites. These outcomes will measure adherence to patient safety practices for five groups: (i) hand hygiene, (ii) injection and blood draw practices, (iii) use of gloves, (iv) disinfection of reusable equipment, and (v) waste segregation. This selection was based on their high-value (i.e. strong link to health-care infections), high frequency of opportunities (i.e., points in time during the care chain when a patient safety practice should be performed to avoid likely adverse events), and feasibility to develop valid, reliable, and generalizable indicators in the planned time and conditions. Adherence indicators are based on indications and actions and adapted to the specific violation.
• Adherence to case-specific checklists of essential and recommended care for 4 medical cases (subject to budget availability). This dimension of quality of care and patient safety is measured through Standardized Patients, which allows us to gauge the extent of correct treatment (both under and over-treatment) in these facilities. The method of Standardized Patients (SPs) was used in the first large-scale population study in India in 2008-2009 (See, e.g., Das et al., 2012). SPs are people from the local community who are extensively trained to present the same case to multiple providers. To assess the quality of care, SPs are trained to recall all history questions, examinations, and diagnoses. They are debriefed with a structured questionnaire within one hour of the interaction. The quality of medical advice is assessed by the time spent with patients, by providers’ adherence to case-specific checklists of essential and recommended care, the likelihood of correct diagnosis, and the appropriateness of treatment. SPs will undergo an exit survey where the data on their interaction with the doctor is recorded.
• Price of services at health facilities. The data on prices will come from a short survey that will be collected from patients from various demographic characteristics exiting the health facilities, as well as from SPs. In large health facilities, sampling of patients will be done randomly using a skip routine.
• Quantity (demand) of health care services: The data on demand corresponds to the number of patients in the last complete month at the time of the survey, collected at the health facility level through a survey from the forms reported to the MOH, or from the facility's alternative record system.