Quality Assurance Via Telephone Interviews After Cataract Surgery
Primary Purpose
Cataract
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Telephone Call
No telephone call
Sponsored by
About this trial
This is an interventional supportive care trial for Cataract focused on measuring Telephone Call
Eligibility Criteria
Inclusion Criteria:
- men and women aged 18 and older
- planned cataract surgery of both eyes
- good knowledge of the german language
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Telephone call
No telephone call
Arm Description
Patient will receive a telephone call in the evening of the day of the surgery or one day after surgery
Patient will not receive a telephone call in the evening of the day of the surgery or one day after surgery
Outcomes
Primary Outcome Measures
Number of patients
The number of patients in group 1 and group 2 seen at the outpatient clinic between surgery of the first and the second eye will be documented
Secondary Outcome Measures
Patient's Satisfaction
Patient's satisfaction with the telephone call after cataract surgery will be assessed with a question asking the patient if she/ he liked the call (5 answering options: very, a little, I don't know, no, absolutely not)
Patient's Symptoms
Patient's symptoms after cataract surgery will be assessed during the telephone interview and the questionnaire
Full Information
NCT ID
NCT05215002
First Posted
January 18, 2022
Last Updated
January 29, 2022
Sponsor
Vienna Institute for Research in Ocular Surgery
1. Study Identification
Unique Protocol Identification Number
NCT05215002
Brief Title
Quality Assurance Via Telephone Interviews After Cataract Surgery
Official Title
Quality Assurance Via Telephone Interviews After Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To analyse quality assurance after cataract surgery by assessing discomfort and other symptoms via telephone interviews either in the evening of the day of the surgery or 1 day after surgery versus no additional call after surgery.
Detailed Description
As there is a trend towards shorter hospital stays, an increasing number of patients is leaving the hospital the same day after cataract surgery. There may be questions or complaints after the patients' dismissal after cataract surgery, consequently it might be useful to call patients at the day or one day after surgery in order to ask them about their concerns.
In general, possible complications after cataract surgery are explained to patients already before surgery and patients often receive additional written information. But as patients may still be uncertain whether it would be beneficial to visit a doctor in case of problems, it might be useful to call the patients and if necessary, advise them to see a doctor. During the phone call patients have the opportunity to ask more questions if something still does not seem clear.
For patients who are scheduled for cataract surgery for both eyes, the routine procedure is as follows: if cataract surgery is scheduled for both eyes, in general the surgeries are performed one week apart. Cataract surgery is usually performed under local anaesthesia and the patient can leave the department on the same day. When patients arrive at the department of ophthalmology for the second surgery, doctors evaluate the condition of the eye, operated the week before. After each surgery of each eye patients receive a prescription of topical medication. It is recommended to see the referring ophthalmologist within a week after the procedure. In case of problems or complaints patients are always told to see a doctor immediately. A respective written information is given to the patients.
During this study we plan to call patients, who are scheduled for cataract surgery for both eyes, in the evening of the day of the surgery or one day after the surgery of the first eye and to ask questions about their current condition for quality assessment. When people return for cataract surgery of the second eye, a questionnaire will be handed out to the patients. This questionnaire includes questions concerning problems after surgery of the first eye, visits in outpatint clinics and about their satisfaction with the phone call after the surgery of the first eye.
In this study 200 patients will be included: 100 patients will receive a telephone call (50 in the evening of the day of the surgery, 50 one day after surgery) and 100 patients who will not receive a phone call.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Telephone Call
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telephone call
Arm Type
Experimental
Arm Description
Patient will receive a telephone call in the evening of the day of the surgery or one day after surgery
Arm Title
No telephone call
Arm Type
Experimental
Arm Description
Patient will not receive a telephone call in the evening of the day of the surgery or one day after surgery
Intervention Type
Other
Intervention Name(s)
Telephone Call
Intervention Description
Patient will be called in the evening of the day of the surgery or one day after surgery and asked about any complaints
Intervention Type
Other
Intervention Name(s)
No telephone call
Intervention Description
Patient will not be called in the evening of the day of the surgery or one day after surgery and asked about any complaints
Primary Outcome Measure Information:
Title
Number of patients
Description
The number of patients in group 1 and group 2 seen at the outpatient clinic between surgery of the first and the second eye will be documented
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Patient's Satisfaction
Description
Patient's satisfaction with the telephone call after cataract surgery will be assessed with a question asking the patient if she/ he liked the call (5 answering options: very, a little, I don't know, no, absolutely not)
Time Frame
24 months
Title
Patient's Symptoms
Description
Patient's symptoms after cataract surgery will be assessed during the telephone interview and the questionnaire
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
men and women aged 18 and older
planned cataract surgery of both eyes
good knowledge of the german language
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Findl, MD
Phone
+43 (1) 91021
Ext
57564
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Ruiss, MD
Phone
+43 (1) 91021
Ext
57564
Email
office@viros.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD
Phone
+43 (1) 91021
Ext
57564
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Manuel Ruiss, MSc
Phone
+43 (1) 91021
Ext
57564
Email
office@viros.at
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Quality Assurance Via Telephone Interviews After Cataract Surgery
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