Effect of Patient Information Leaflet on Working Pattern and Patient Satisfaction Level for Day Care Surgeries.
1 other identifier
interventional
449
0 countries
N/A
Brief Summary
This study aims to understand the benefits of imparting pre operative instructions through written leaflets. The influence on the number of avoidable postponements and delay is also studied.The study is restricted to patients undergoing Head \& Neck procedures under General Anaesthesia, at the minor OT complex at Tata Memorial Hospital
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2017
CompletedFirst Posted
Study publicly available on registry
January 5, 2017
CompletedStudy Start
First participant enrolled
January 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2017
CompletedResults Posted
Study results publicly available
September 16, 2019
CompletedSeptember 16, 2019
September 1, 2019
6 months
January 2, 2017
November 5, 2018
September 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Cases Postponed Due to Lack of Information to Patients in the Pre-operative Period
Cases postponed will be recorded and those caused due to lack of information of basic instruction to be followed prior to a procedure under GA will be recorded as an event.
On scheduled minor operative procedure day
Secondary Outcomes (1)
Satisfaction About Information With Respect to Instructions to be Followed
On scheduled minor operative procedure day
Study Arms (2)
Pre intervention
NO INTERVENTIONIn the first part planned over 2months (Jan - Feb), feedback forms will be collected from patients at the end of minor OT procedure. The number of postponement or rescheduling of cases will be noted. Postponement or rescheduling of case is defined as an event when the patient who is called for his turn in minor OT is deferred for any amount of time in account of starvation not adequate, investigations not brought, medications not taken as prescribed.
Post Intervention
EXPERIMENTALIn the intervention phase, the patient information leaflet (PIL) will be handed over to all patients planned for procedure in the minor OT complex. This leaflet will be handed over by the attending doctor in the Head neck OPD. The checklist pertaining to counselling at the Head neck OPD will be ticked after they are carried out. The patient will be instructed to read leaflet carefully and carry the leaflet on the day of Minor OT procedure. In the minor OT the discharge checklist in the PIL would be carried out by all concerned including the surgical, anesthesia and nursing team. The impact of use of PIL will be assessed by noting the number of postponement or rescheduling of cases.
Interventions
Patient information leaflet with instructions to be carried out before procedure under general anesthesia
Eligibility Criteria
You may qualify if:
- All adult patients (\> 18yrs), ASA I-III, undergoing elective therapeutic/diagnostic Head \& Neck surgeries under General Anaesthesiain the Minor OT complex and discharged on the same day will be included. The surgeries will include Head \& Neck surgeries like DL scopies, laser surgeries, EUA, excision biopsies etc.
You may not qualify if:
- Patients refusing to take part in study
- Patients undergoing emergency surgeries
- ASA IV patients, or high risk patients planned for admission
- Admitted patients for minor OT procedure
- Patients not getting the Information leaflet due to any reason (in 2nd half of study)
- Patient and his attendant, both illiterate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1. Disease specific information not incorporated 2. Did not assess the patient anxiety regarding the PIL
Results Point of Contact
- Title
- Dr. Sumitra Bakshi
- Organization
- Tata Memorial Hospital, Mumbai
Study Officials
- PRINCIPAL INVESTIGATOR
Sumitra G Bakshi
Professor, Department of Anesthesia, Critical Care and Pain
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Anesthetist
Study Record Dates
First Submitted
January 2, 2017
First Posted
January 5, 2017
Study Start
January 9, 2017
Primary Completion
June 23, 2017
Study Completion
December 6, 2017
Last Updated
September 16, 2019
Results First Posted
September 16, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share