- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05215002
Quality Assurance Via Telephone Interviews After Cataract Surgery
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Oliver Findl, MD
- Telefonnummer: 57564 +43 (1) 91021
- E-mail: office@viros.at
Undersøgelse Kontakt Backup
- Navn: Manuel Ruiss, MD
- Telefonnummer: 57564 +43 (1) 91021
- E-mail: office@viros.at
Studiesteder
-
-
-
Vienna, Østrig, 1140
- Rekruttering
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
-
Kontakt:
- Oliver Findl, MD
- Telefonnummer: 57564 +43 (1) 91021
- E-mail: office@viros.at
-
Kontakt:
- Manuel Ruiss, MSc
- Telefonnummer: 57564 +43 (1) 91021
- E-mail: office@viros.at
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- men and women aged 18 and older
- planned cataract surgery of both eyes
- good knowledge of the german language
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Telephone call
Patient will receive a telephone call in the evening of the day of the surgery or one day after surgery
|
Patient will be called in the evening of the day of the surgery or one day after surgery and asked about any complaints
|
|
Eksperimentel: No telephone call
Patient will not receive a telephone call in the evening of the day of the surgery or one day after surgery
|
Patient will not be called in the evening of the day of the surgery or one day after surgery and asked about any complaints
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of patients
Tidsramme: 24 months
|
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
|
24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient's Satisfaction
Tidsramme: 24 months
|
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)
|
24 months
|
|
Patient's Symptoms
Tidsramme: 24 months
|
Patient's symptoms after cataract surgery will be assessed during the telephone interview and the questionnaire
|
24 months
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Cat Tel
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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