Trial Outcomes & Findings for Effect of Patient Information Leaflet on Working Pattern and Patient Satisfaction Level for Day Care Surgeries. (NCT NCT03011840)
NCT ID: NCT03011840
Last Updated: 2019-09-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
449 participants
Primary outcome timeframe
On scheduled minor operative procedure day
Results posted on
2019-09-16
Participant Flow
Participant milestones
| Measure |
Pre 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
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.
Information leaflet: Patient information leaflet with instructions to be carried out before procedure under general anesthesia
|
|---|---|---|
|
Overall Study
STARTED
|
232
|
217
|
|
Overall Study
COMPLETED
|
232
|
196
|
|
Overall Study
NOT COMPLETED
|
0
|
21
|
Reasons for withdrawal
| Measure |
Pre 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
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.
Information leaflet: Patient information leaflet with instructions to be carried out before procedure under general anesthesia
|
|---|---|---|
|
Overall Study
Not received PIL in post PIL phase
|
0
|
21
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pre Intervention
n=232 Participants
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
n=196 Participants
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.
Information leaflet: Patient information leaflet with instructions to be carried out before procedure under general anesthesia
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-44 years
|
57 Participants
n=232 Participants
|
37 Participants
n=196 Participants
|
94 Participants
n=428 Participants
|
|
Age, Customized
44-59 years
|
79 Participants
n=232 Participants
|
74 Participants
n=196 Participants
|
153 Participants
n=428 Participants
|
|
Age, Customized
60 years and above
|
84 Participants
n=232 Participants
|
68 Participants
n=196 Participants
|
152 Participants
n=428 Participants
|
|
Age, Customized
Data missing
|
12 Participants
n=232 Participants
|
17 Participants
n=196 Participants
|
29 Participants
n=428 Participants
|
|
Sex/Gender, Customized
Male
|
176 Participants
n=232 Participants
|
148 Participants
n=196 Participants
|
324 Participants
n=428 Participants
|
|
Sex/Gender, Customized
Female
|
36 Participants
n=232 Participants
|
34 Participants
n=196 Participants
|
70 Participants
n=428 Participants
|
|
Sex/Gender, Customized
Data missing
|
20 Participants
n=232 Participants
|
14 Participants
n=196 Participants
|
34 Participants
n=428 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Education
Illiterate
|
38 Participants
n=232 Participants
|
27 Participants
n=196 Participants
|
65 Participants
n=428 Participants
|
|
Education
School
|
71 Participants
n=232 Participants
|
74 Participants
n=196 Participants
|
145 Participants
n=428 Participants
|
|
Education
Graduate
|
46 Participants
n=232 Participants
|
31 Participants
n=196 Participants
|
77 Participants
n=428 Participants
|
|
Education
Post Graduate
|
18 Participants
n=232 Participants
|
11 Participants
n=196 Participants
|
29 Participants
n=428 Participants
|
|
Education
Data missing
|
59 Participants
n=232 Participants
|
53 Participants
n=196 Participants
|
112 Participants
n=428 Participants
|
|
Person filling form
Patient
|
53 Participants
n=232 Participants
|
43 Participants
n=196 Participants
|
96 Participants
n=428 Participants
|
|
Person filling form
Attendent
|
116 Participants
n=232 Participants
|
73 Participants
n=196 Participants
|
189 Participants
n=428 Participants
|
|
Person filling form
Data missing
|
63 Participants
n=232 Participants
|
80 Participants
n=196 Participants
|
143 Participants
n=428 Participants
|
PRIMARY outcome
Timeframe: On scheduled minor operative procedure dayPopulation: Number participants analysed depends upon the number of patients visited to the minor ot complex during assigned time 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.
Outcome measures
| Measure |
Pre Intervention
n=472 Participants
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
n=573 Participants
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.
Information leaflet: Patient information leaflet with instructions to be carried out before procedure under general anesthesia
|
|---|---|---|
|
Number of Cases Postponed Due to Lack of Information to Patients in the Pre-operative Period
|
56 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: On scheduled minor operative procedure dayPatients satisfaction with respect to instruction to be followed with administration of GA will be captured on a five point Likert scale -(5-Excellent, 4-Very good, 3-Good, 2-Poor, 1-Very poor)
Outcome measures
| Measure |
Pre Intervention
n=232 Participants
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
n=196 Participants
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.
Information leaflet: Patient information leaflet with instructions to be carried out before procedure under general anesthesia
|
|---|---|---|
|
Satisfaction About Information With Respect to Instructions to be Followed
Info about instructions to follow before surgery · Excellent
|
41 Participants
|
45 Participants
|
|
Satisfaction About Information With Respect to Instructions to be Followed
Info about instructions to follow before surgery · Very good
|
60 Participants
|
82 Participants
|
|
Satisfaction About Information With Respect to Instructions to be Followed
Info about instructions to follow before surgery · Good
|
100 Participants
|
61 Participants
|
|
Satisfaction About Information With Respect to Instructions to be Followed
Info about instructions to follow before surgery · Poor
|
4 Participants
|
1 Participants
|
|
Satisfaction About Information With Respect to Instructions to be Followed
Info about instructions to follow before surgery · Data missing
|
27 Participants
|
7 Participants
|
|
Satisfaction About Information With Respect to Instructions to be Followed
Info about instructions to follow after surgery · Excellent
|
38 Participants
|
54 Participants
|
|
Satisfaction About Information With Respect to Instructions to be Followed
Info about instructions to follow after surgery · Very good
|
62 Participants
|
65 Participants
|
|
Satisfaction About Information With Respect to Instructions to be Followed
Info about instructions to follow after surgery · Good
|
86 Participants
|
60 Participants
|
|
Satisfaction About Information With Respect to Instructions to be Followed
Info about instructions to follow after surgery · Poor
|
6 Participants
|
1 Participants
|
|
Satisfaction About Information With Respect to Instructions to be Followed
Info about instructions to follow after surgery · Data missing
|
40 Participants
|
16 Participants
|
Adverse Events
Pre Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pre Intervention
n=232 participants at risk
prior to introduction of patient information leaflet
|
Post Intervention
n=196 participants at risk
after introduction of patient information leaflet
|
|---|---|---|
|
Social circumstances
No adverse events noted
|
0.00%
0/232 • 24 hours
No adverse events noted
|
0.00%
0/196 • 24 hours
No adverse events noted
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place