The Effect of the COVID-19 on Patient Preferences and Decision Making for Obstructive Urinary Stone Interventions

Sponsor
Ankara Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04924790
Collaborator
(none)
158
1
11
14.4

Study Details

Study Description

Brief Summary

In this study, the investigators aim to evaluate the intervention preferences of patients with obstructive urinary stones who are suitable for operation during the COVID-19 pandemic. The secondary aim is to compare and evaluate the preferences compared to the pre-pandemic period and to gain a perspective on how the decision-making process has changed from the patient's point of view. Thus, by trying to understand how the COVID-19 epidemic affects the treatment choice decisions of patients, the investigators aim to determine how the state of anxiety changes these preferences.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: COVID-19 Pandemic

Detailed Description

The transformative impact of the COVID-19 pandemic on healthcare use remains an open question. At the onset of the pandemic, policies to limit transmission were adopted, including stay-at-home decisions, social distancing, and postponing elective surgery. Such policies have contributed to reduced emergency room admissions, increased concern about COVID-19, and hospital systems have had to prioritize emergency intervention.

Obstructive urolithiasis is a clinical condition that usually causes severe flank pain and causes emergency admission. It is still unclear how the epidemic impairs the treatment pathways of the obstructive urolithiasis that contributes to the emergency room visit. Treatment options range from observation and medical expulsive therapy to operative interventions such as extracorporeal shock wave lithotripsy, ureteroscopy and percutaneous nephrolithotomy. Patient preference, stone characteristics and comorbidities are of great importance in decision making. However, since obstructive ureteral stones that cannot be resolved spontaneously can cause irreversible renal parenchymal damage and obstructive pyelonephritis in a short time, the option of operation is always prioritized.

Patient perspectives on how COVID-19 is changing healthcare use and decision-making still remain unclear. In our study, the investigators plan to record patient treatment preferences by explaining in detail how and where treatment options will be applied, success and complication rates for patients diagnosed with obstructive urolithiasis and suitable for intervention in the outpatient clinic. In addition, when evaluating patient preferences, the investigators foresee to determine how the COVID-19 pandemic process has changed compared to before. It is planned that our study will have a patient-centered approach with detailed oral and written information in outpatient clinic conditions.

Study Design

Study Type:
Observational
Anticipated Enrollment :
158 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of the COVID-19 Pandemic on Patient Preferences and Decision Making for Obstructive Urinary Stone Interventions
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
COVID-19 Urinary Stone

Patients diagnosed with obstructive urinary stones in the COVID-19 period

Behavioral: COVID-19 Pandemic
Comparison of the intervention preferences of patients diagnosed with obstructive urinary stones in the urology clinic and recommended for intervention during and before COVID-19

PreCOVID-19 Urinary Stone

Patients diagnosed with obstructive urinary stones in the preCOVID-19 period

Behavioral: COVID-19 Pandemic
Comparison of the intervention preferences of patients diagnosed with obstructive urinary stones in the urology clinic and recommended for intervention during and before COVID-19

Outcome Measures

Primary Outcome Measures

  1. Rates of interventions preferred by patients [6 months]

    Rates of interventions preferred by patients for obstructive urinary stones

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Obstructive Urinary Stone
Exclusion Criteria:
  • Previous operation for urinary stone

  • Presence of bladder stone

  • Presence of stent in the ureter

  • Previous radiotherapy to the pelvic and abdominal region

  • Pregnancy

  • Neurological disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara Training and Research Hospital Ankara Altindag Turkey 06230

Sponsors and Collaborators

  • Ankara Training and Research Hospital

Investigators

  • Principal Investigator: Ali Kaan Yildiz, Ankara Training and Resarch Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ali Kaan Yildiz, Principal Investigator, Ankara Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04924790
Other Study ID Numbers:
  • COVIDUS2021
First Posted:
Jun 14, 2021
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ali Kaan Yildiz, Principal Investigator, Ankara Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022