- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07416864
Enhancing Operational Efficiency in Eye Care Services
Enhancing Operational Efficiency in Eye Care Services: A Mixed-Methods Operational Research Study in a Tertiary Care Eye Hospital
Study Overview
Status
Intervention / Treatment
Detailed Description
PVRI operates close to 70-80 procedures daily. 15-20 pre-planned procedures are scheduled in the Secunderabad unit. All patients undergoing planned procedures on a daily basis spend close to 4-6 hours in the hospital. To understand the clinical workflow and time taken for the patient to undergo the procedure, a baseline assessment was conducted by the PVRI operational research team to measure the specific time taken for the patient to pass through the different sections of the hospital for undergoing any procedure.
Findings of the baseline assessment showed that waiting time was generally higher at >4 hours for all patients. The waiting time was specifically higher in the ward area before and after a procedure is done. Patients getting treated under the Cash or Third Party Administrator (TPA) category take twice as long as other categories finish billing procedures at the front office section. The individual waiting area in each section is listed on the table below.
S no Description Category Avg. Waiting time(Hr:Min)
- Total Appointment Time Non-Cataract procedure 04:24 (TAT) Cataract procedure 04:09 Credit patients 04:23 Cash/TPA patient 04:05 EHS/ARG 03:53
- Time spent at Front office/ Billing Cash-TPA 00:30 Credit/Cred + Enhanced 00:12 ARG/State Scheme 00:07 CGHS/SCCL/SCR/central 00:24
- Ward Waiting Time (Pre-op) Non-Cataract 01:03 Cataract procedure 01:04
- OR Table time Non-Cataract 00:49 Cataract procedure 00:39
- Operation Theatre time (in-out of the dept) Overall average of all cases OT time 1:24
- Average Recovery to discharge time Non-Cataract 01:33 Cataract procedure 01:51 Overall recovery average 01:44
Study Design
This study will adopt an operational research design using a mixed-methods approach, combining time-motion studies, process mapping, and intervention validation to optimize patient flow at Pushpagiri Vitreo Retina Institute (PVRI), Secunderabad unit. The design will follow three phases:
- Baseline workflow analysis (already conducted and used as reference).
- Development and implementation of interventions (checklists, billing streamlining, ward scheduling).
- Post-intervention evaluation to measure efficiency gains against defined objectives.
Study Setting and Population The study will be conducted at PVRI Secunderabad unit, a super-specialty eye hospital performing 70-80 procedures daily, of which 15-20 are pre-planned surgical cases. All patients scheduled for planned surgical procedures (cataract and non-cataract) during the study period will be eligible. Subgroup analyses will be performed for payment categories (Cash/TPA, Credit, State/EHS schemes).
Sample Size Calculation for Reduction in Overall TAT
Since the study compares mean TAT before and after intervention, the sample size has been calculated using the formula for comparison of two means, n=(Z_(α/2)+Z_β )^2×2σ^2 ┤/d^2 n=(1.96+0.84)^2×2×120^2 ┤/38^2 = 156.4
Thus, the minimum required sample size is 157 patients per phase. A 15% adjustment has been applied to the minimum calculated sample size to account for operational data loss such as cancelled procedures and incomplete records. After inflation (157 × 1.15 = 181), the value was rounded to a practical range of 180-200 patients per phase. Therefore, the final planned sample size is approximately 400 patients in total, with 200 in the baseline phase and 200 in the post-intervention phase.
Interventions
Pre-operative segregation checklist:
- Develop a standardized checklist validated by ophthalmologists and anesthetists & operational heads.
- Pilot-test on a small group of patients before scaling.
- Incorporate electronic/digital versions where feasible.
Reception and billing workflow redesign:
- Introduce a fast-track billing process for Cash/TPA patients, drawing on evidence that optimized front-office processes reduce waiting time significantly (Kern et al., 2021).
- Consider implementing token-based or electronic queue management.
Ward waiting time reduction:
- Streamline surgical slot allocation using checklist-based segregation.
- Allocate time slots and support nurses proactively based on procedure type.
Recovery and discharge process:
- Develop discharge readiness criteria checklist to shorten recovery-to-discharge time.
- Introduce counseling for patients/attendants while recovery monitoring is completed.
Data Collection Methods
- Time-motion study: Direct observation with stopwatch/timestamp recording at each stage (front office, pre-op, ward, OT, recovery, billing).
- Process mapping: Sequential workflow documentation through patient tracking sheets.
- Operational logs: Data extraction from hospital information system (where available).
Data Analysis[BM1.1]
- Descriptive statistics (mean, median, SD) to summarize time at each stage.
- Paired t-tests or Wilcoxon signed-rank tests (depending on distribution) to compare pre- and post-intervention times.
- Subgroup analyses by procedure type (cataract vs. non-cataract) and payment method.
- Simulation modeling may be applied to validate checklist scheduling efficiency Ethical Considerations
- Institutional Ethics Committee (IEC) approval will be obtained.
- Informed consent will be taken from all patients included in the study.
- Confidentiality of patient records will be maintained.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Telangana
-
Secunderabad, Telangana, India
- Recruiting
- Pushpagiri Vitreo Retina Institute
-
Contact:
- Dr. Bala Vidyadhar
- Phone Number: +91 9482395316
- Email: msbv.drrop@pvri.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients undergoing pre-planned elective procedures in the unit listed on appointment basis.
- Eligibility: Enrolment criteria: any patient undergoing any planned procedure is included on daily basis
Exclusion criteria:
- Patients undergoing emergency procedures.
- Data for patients whose procedures were cancelled/postponed
- Any other patients undergoing procedures under the free eye camps
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention arm
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient appointment time
Time Frame: 6-8 months
|
Reduction of overall Patient appointment time by 15-25%
|
6-8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Billing time
Time Frame: 6-8 months
|
Reduction in billing time at reception by 20% for patients undergoing treatment through Cash/TPA payments
|
6-8 months
|
|
Ward waiting time
Time Frame: 6-8 months
|
Reduction in Ward waiting time of all patients undergoing cataract surgery by 20%
|
6-8 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PVRI-ORCB-0001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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