NCT03011840

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
449

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

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

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

January 9, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 16, 2019

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

January 2, 2017

Results QC Date

November 5, 2018

Last Update Submit

September 12, 2019

Conditions

Keywords

Patient education handoutPatient satisfaction

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 INTERVENTION

In 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

EXPERIMENTAL

In 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.

Other: Information leaflet

Interventions

Patient information leaflet with instructions to be carried out before procedure under general anesthesia

Post Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Patient CompliancePatient Satisfaction

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

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

  • Sumitra G Bakshi

    Professor, Department of Anesthesia, Critical Care and Pain

    PRINCIPAL INVESTIGATOR

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