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Effect of Patient Information Leaflet on Working Pattern and Patient Satisfaction Level for Day Care Surgeries.

Effect of Patient Information Leaflet on Working Pattern and Patient Satisfaction Level in a Busy Indian Day Care Operative Theatre Complex

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03011840
Enrollment
449
Registered
2017-01-05
Start date
2017-01-09
Completion date
2017-12-06
Last updated
2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Compliance

Keywords

Patient education handout, Patient satisfaction

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

Detailed description

INTRODUCTION: Patient Information is one of the key determinants of patient satisfaction. Adequate information about the disease condition, treatment plan, waiting times and 'what to do next' affects patients' overall satisfaction level. Good quality information not only reduces patient anxiety and stress, but also reduces unreasonable expectations and misconceptions. Patient satisfaction has always remained an important and commonly used indicator for measuring the quality in health care. In the recent years there is a gradual upward trend in day care surgeries all across the globe; an estimated 83% of the surgeries in the United States being performed on an ambulatory basis. In India, about 20 percent of all surgical procedures are performed on outpatients. It is estimated that by 2020, 75 percent of all surgical operations in India will be carried out in ambulatory surgery centers. The increasing trend of ambulatory surgeries has emerged from advances in anesthesia and surgical techniques. Patient information and effective communication is critical in these surgeries especially the ones that need General Anesthesia. Provision of information is one of the mainstays of effective day surgery management. This needs to cover not only what to do before and after surgery, but also what will happen on the day of surgery. There are several ways of providing information like written information, using a video, over telephone or by patient interviews before and after surgery. Verbal information alone is inadequate and must be reinforced with well-presented printed material. Tata Memorial Hospital is a premier tertiary level cancer hospital in India. Around 140-150 patients undergo minor surgical procedures (diagnostic and therapeutic) in the Minor OT complex every day. About 30-40% of surgeries belong to the Head & Neck region alone.About 40-50% of these surgeries are done under general anesthesia. At present the communication with patients in the busy outpatient department is mainly verbal. Due to time constrains, lack of a responsible attendant with the patient, important information with respect to the day care procedure is often not effectively delivered. This leads to patients not following instruction adequately with respect to starvation, medications to be taken on the day of the procedure and also not carrying all essential documents. This leads to delays, rescheduling of cases and rarely postponement of procedures. Does an information leaflet provide an effective way of communication in the peri-procedure period? Will it help in better information delivery and hence reduce the number of avoidable postponements and delay. And does this translate to better patient satisfaction is want this study aims to see. The study is restricted to patients undergoing Head & Neck procedures under general anesthesia, as they form the major bulk of patients in our minor OT complex and for logistic reasons to start with a defined group of patients. AIMS AND OBJECTIVES: 1. To reduce postponement of cases due to lack of information to patients prior to the procedure. 2. To compare satisfaction levels between patients , before and after introduction of information leaflet Primary end point: To reduce postponement of cases due to lack of information to patients prior to the procedure. Secondary end point To compare satisfaction levels between patients, before and after introduction of information leaflet. Design of the study: Intervention MATERIAL AND METHODS After Institutional Review Board approval, all adult patients meeting inclusion criteria and undergoing surgeries in the Minor operation theater 'OT' complex during a 5 month period will be enrolled in the study. The study will be done in two parts. In the First half of study- planned over 2 months (Jan - Feb), feedback forms will be collected from patients at the end of minor 'OT' procedure. All patients, meeting inclusion criteria, at the end of the procedure prior to discharge from the minor 'OT' will be explained about the study and they shall be given a feedback form to be filled and submitted. Also 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.Any postponement in view of awaiting opinion form senior consultant , special equipment or any investigations called in view of patients clinical conditions which was not anticipated in the Out Patient Department 'OPD' by the surgical colleague, or due to lack of OT time will not be included. After the initial collection of feedback over 2 months, the patient information leaflet (PIL) will be handed over to all patients planned for procedure in the minor 'OT' complex (Second half of study). 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. A period of 1 month will be allowed to streamline the use of patient information leaflet. In the subsequent 2 months,Apr- May , the impact of use of 'PIL' will be assessed. Firstly by noting the number of postponement or rescheduling of cases. In addition all patients meeting inclusion criteria will be given the feedback form. at the end of their procedure in minor 'OT'. For patients coming to minor 'OT' without a patient information leaflet- one would ascertain if the leaflet was handed in 'OPD' and not brought to minor OT or if the leaflet was not handed at all. The numbers of such misses will be recorded.Patients who did not get the leaflet in the 'OPD' will be excluded from study. Sample size calculation: From the investigator's preliminary review of postponement rate at the study center is around 20%. The investigators aim for a reduction in postponement by 50%. Group sample sizes of 199 in group 1 and 199 in group 2 achieve 80.007% power to detect a difference between the group proportions of -0.1000. The proportion in group 1 (the treatment group) is assumed to be 0.2000 under the null hypothesis and 0.1000 under the alternative hypothesis. The proportion in group 2 (the control group) is 0.2000. The test statistic used is the two-sided Z-Test with pooled variance. The significance level of the test is 0.0500.Considering a 20% loss to follow up from 'OPD' to minor 'OT', the sample size needed is 480 patients.On an average at least 250 patients of head neck patients undergo procedure under general anesthesia, per month (12-15 patients /day x 20 working days). With due consideration of our inclusion criteria, a two month recruitment period before and after the intervention should be adequate. MEASUREMENTS * No. of cases postponed before and after the introduction of the leaflet and reasons behind them * Primary data collected will be patient satisfaction levels after the procedure (both pre and post 'PIL') on a 5 point Likert scale (Ranging from very poor = 0 to Excellent = 4) * No of patients who did not receive the patient information leaflet in the' OPD' * No of patients who received the Patient information leaflet but did not get it along to the minor OT STATISTICAL ANALYSIS All Data will be analyzed using Statistical Analysis Software Package (SPSS) software. Likert scores will be treated as ordinal data. Proportions will be compared using chi square analysis. Additionally Multivariate logistic regression analysis will be used to assess the contribution of possible covariates, including age sex and patient knowledge on patient satisfaction. For all data P-value \< 0.05 will be considered as statistical significant

Interventions

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

Sponsors

Tata Memorial Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

1. Patients refusing to take part in study 2. Patients undergoing emergency surgeries 3. ASA IV patients, or high risk patients planned for admission 4. Admitted patients for minor OT procedure 5. Patients not getting the Information leaflet due to any reason (in 2nd half of study) 6. Patient and his attendant, both illiterate

Design outcomes

Primary

MeasureTime frameDescription
Number of Cases Postponed Due to Lack of Information to Patients in the Pre-operative PeriodOn scheduled minor operative procedure dayCases 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.

Secondary

MeasureTime frameDescription
Satisfaction About Information With Respect to Instructions to be FollowedOn 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)

Participant flow

Participants by arm

ArmCount
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.
232
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
196
Total428

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyNot received PIL in post PIL phase021

Baseline characteristics

CharacteristicPre InterventionPost InterventionTotal
Age, Customized
18-44 years
57 Participants37 Participants94 Participants
Age, Customized
44-59 years
79 Participants74 Participants153 Participants
Age, Customized
60 years and above
84 Participants68 Participants152 Participants
Age, Customized
Data missing
12 Participants17 Participants29 Participants
Education
Data missing
59 Participants53 Participants112 Participants
Education
Graduate
46 Participants31 Participants77 Participants
Education
Illiterate
38 Participants27 Participants65 Participants
Education
Post Graduate
18 Participants11 Participants29 Participants
Education
School
71 Participants74 Participants145 Participants
Person filling form
Attendent
116 Participants73 Participants189 Participants
Person filling form
Data missing
63 Participants80 Participants143 Participants
Person filling form
Patient
53 Participants43 Participants96 Participants
Race and Ethnicity Not Collected0 Participants
Sex/Gender, Customized
Data missing
20 Participants14 Participants34 Participants
Sex/Gender, Customized
Female
36 Participants34 Participants70 Participants
Sex/Gender, Customized
Male
176 Participants148 Participants324 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2320 / 196
other
Total, other adverse events
0 / 2320 / 196
serious
Total, serious adverse events
0 / 2320 / 196

Outcome results

Primary

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.

Time frame: On scheduled minor operative procedure day

Population: Number participants analysed depends upon the number of patients visited to the minor ot complex during assigned time period.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre InterventionNumber of Cases Postponed Due to Lack of Information to Patients in the Pre-operative Period56 Participants
Post InterventionNumber of Cases Postponed Due to Lack of Information to Patients in the Pre-operative Period44 Participants
Secondary

Satisfaction About Information With Respect to Instructions to be Followed

Patients 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)

Time frame: On scheduled minor operative procedure day

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Pre InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow before surgeryGood100 Participants
Pre InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow after surgeryExcellent38 Participants
Pre InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow before surgeryVery good60 Participants
Pre InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow after surgeryVery good62 Participants
Pre InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow before surgeryPoor4 Participants
Pre InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow after surgeryGood86 Participants
Pre InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow before surgeryExcellent41 Participants
Pre InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow before surgeryData missing27 Participants
Pre InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow after surgeryData missing40 Participants
Pre InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow after surgeryPoor6 Participants
Post InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow after surgeryData missing16 Participants
Post InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow before surgeryExcellent45 Participants
Post InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow before surgeryVery good82 Participants
Post InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow before surgeryGood61 Participants
Post InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow before surgeryPoor1 Participants
Post InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow before surgeryData missing7 Participants
Post InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow after surgeryExcellent54 Participants
Post InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow after surgeryVery good65 Participants
Post InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow after surgeryGood60 Participants
Post InterventionSatisfaction About Information With Respect to Instructions to be FollowedInfo about instructions to follow after surgeryPoor1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026