- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07692789
Improving Uroflowmetry Interpretability: Evaluating the Impact of Patient Reminder Systems
The purpose of this study is to evaluate the impact of pre-procedure patient reminder systems on patient satisfaction, preparedness, and anxiety among patients undergoing urodynamics studies. The rate of successful procedure completion will be compared between a prospective intervention group and a historical control group to determine whether the intervention improves procedural success and healthcare delivery.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Lisa Hickman, MD
- Telefonnummer: 614-814-8205
- E-post: Lisa.Hickman@osumc.edu
Studera Kontakt Backup
- Namn: Ashka Shah
- E-post: Ashka.Shah@osumc.edu
Studieorter
-
-
Ohio
-
Columbus, Ohio, Förenta staterna, 43210
- Rekrytering
- Ohio State University Wexner Medical Center
-
Kontakt:
- Lisa Hickman, MD
- Telefonnummer: 614-814-8205
- E-post: Lisa.Hickman@osumc.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria
- Age 18 years or older
- Sex assigned at birth: Female.
- English-speaking
- Scheduled to undergo a urodynamics study at the OSU Upper Arlington Outpatient Clinic, OSU New Albany Outpatient Clinic, or OSU Eye and Ear Institute
- Ability to access a telephone
- Active MyChart account
- Ability to provide informed consent
- Documented post-residual volume of less than 150 mL
- Ability to be reached by telephone after three call attempts
- Negative point-of-care urinary tract infection on the day of the scheduled procedure (SOC)
Exclusion criteria:
- Under 18 years of age
- Patients with structural causes of urinary retention/incomplete bladder emptying (defined as a post-void residual >150ml) or a positive point-of-care urinary tract infection on the day of the procedure.
- Men are excluded as the population of interest is the female urogynecology population in both urology and obstetrics and gynecology.
- Patients without access to a telephone or an active MyChart account are excluded because the intervention relies on telephone calls and electronic messaging for delivery of pre-procedure education and reminders.
- Individuals who cannot be reached by telephone are excluded because they cannot receive the intervention.
- Non-English speaking individuals are excluded because they will not be able to receive the standardized phone call in English and will not be able to complete the informed consent.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: using patient reminder systems before scheduled urodynamics studies
The study intervention will include all participating patients receiving a phone call from a study team member reading from a script before their scheduled appointment. The phone call will involve consenting the patient for the study and a reminder to come in for the study with a comfortably full bladder, avoiding utilizing the lobby restroom before the appointment. |
Using patient reminder systems before scheduled urodynamics studies on patient satisfaction, preparedness, anxiety, and successful completion of the procedure to improve healthcare delivery by comparing a prospective intervention group with a historical control group. |
|
Inget ingripande: not using patient reminder systems before scheduled urodynamics studies
Participants for the historical control group will be identified through retrospective review of electronic medical records of patients who previously underwent scheduled urodynamics studies. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percent decrease in urodynamics procedure completion failure rate in patients who received the reminder system before scheduled urodynamics procedures vs. patients who did not receive the reminder
Tidsram: From enrollment to the end of the urodynamics study (less than 1 week)
|
Completion failure is defined as a uroflow less than 150 mL |
From enrollment to the end of the urodynamics study (less than 1 week)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluate anxiety before and after a urodynamics (UDS) procedure after delivery of a patient reminder system.
Tidsram: From enrollment to the end of the urodynamics study (less than 1 week)
|
Anxiety is measured by patient completion of ST-STAI before and after the UDS study. |
From enrollment to the end of the urodynamics study (less than 1 week)
|
|
Evaluate patient satisfaction and preparedness before and after a urodynamic study after delivery of a patient reminder system.
Tidsram: From enrollment to the end of the urodynamics study (less than 1 week)
|
Patient satisfaction and preparedness for the procedure will be assessed using Likert-style items via a survey issued to patients before and after the UDS study. |
From enrollment to the end of the urodynamics study (less than 1 week)
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Manliga urogenitala sjukdomar
- Patologiska tillstånd, anatomiska
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Urineringsstörningar
- Symtom i de nedre urinvägarna
- Urologiska manifestationer
- Framfall
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Urininkontinens
- Bäckenorgan framfall
Andra studie-ID-nummer
- STUDY20260760
Plan för individuella deltagardata (IPD)
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