Questionnaire for Metabolic Screening

Use of Metabolic Evaluations for Patients With Renal Calculi and the Risk of Recurrence

The purpose of this study is to determine if kidney stone patients who should have received metabolic tests (urine collection over 24-hours that determines the composition of urine) based on Canadian Urologic Association (CUA) guidelines did in fact receive them, and if these results were explained to them by their doctor.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Evaluation

Detailed Description

PURPOSE:

The purpose of the project is to determine whether metabolic workups are administered to Canadian kidney stone patients in accordance to CUA (Canadian Urologic Association) guidelines. Additionally, the study will look to evaluate whether the results of metabolic tests were sufficiently explained to patients by their doctors, and also whether or not patients would follow dietary or treatment plans to possibly prevent kidney stones based on these metabolic workups.

HYPOTHESIS:

The investigators hypothesize that the implementation of metabolic tests based on CUA guidelines is sub-optimal and that when they are prescribed, doctors do not adequately explain these results to patients. The investigators also hypothesize that patients would follow dietary and treatment plants to prevent recurrent stone formation based on these metabolic results - if they are prescribed to the patient.

JUSTIFICATION:

The investigators believe that implementation of metabolic workups is sub-optimal. The investigators would like to confirm this so that, in the future, metabolic workups can be promoted as an appropriate tool for identifying metabolic abnormalities that contribute to stone disease. If metabolic workups are administered and explained adequately to patients then further diet or treatment plans can significantly reduce recurrence of stones in stone patients.

OBJECTIVES:

1. Determine if metabolic workups were administered when they should have been according to CUA guidelines.
2. For patients who received metabolic workups, determine if the results from metabolic workups were explained to patients, and if so was it done adequately (did the patient understand the explanation)
3. Determine patient compliance regarding dietary and treatment plans based on metabolic workups

RESEARCH DESIGN:

This is a survey based study (one time completion) given to patients pre-ESWL. The surveys will be analyzed by research staff to determine the study objectives.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Nhaeem Bhojani, MD; Phone Number: 514-861-0213; Email: naeem.bhojani.chum@ssss.gouv.qc.ca
• Study Contact Backup: Name: Thomas J Grgic, BSc; Phone Number: 62421 604 875 4111; Email: thomas.grgic@alumni.ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Recruiting
      • University of British Columbia
      • Principal Investigator: Ben H Chew, MD
      • Contact: Thomas J Grgic, BSc; Phone Number: 62421 6048754111; Email: thomas.grgic@alumni.ubc.ca
      • Contact: Jonathan Lim, BSc; Phone Number: 62421 6048754111; Email: lim.jonathan@alumni.ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be screened prior to extracorporeal shockwave lithotripsy and will have had at least 1 stone episode. Participants will be recruited from Saint-Luc Hospital, VGH Hospital, Glen Hospital, Dartmouth General Hospital, St.Michael's Hospital and University of Alberta Hospital.

Description

Inclusion Criteria:

• at least 19 years of age, with at least 1 stone episode, ability to consent

Exclusion Criteria:

• inability to provide informed consent, under 19 years of age

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic Evaluation	Number of participants that did not receive metabolic evaluations based on Canadian Urologic Association (CUA) criteria	through study completion - an average of 10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Doctor Patient Communication	Number of Participants that received metabolic evaluations but did not have the results adequately explained to them	at the end of study completion - an average of 10 months
Patient Dietary/Treatment Compliance	Number of patients willing to comply with dietary/treatment advice based on the results of the metabolic evaluations	at the end of study completion - an average of 10 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: McGill University; University of Alberta; University of Toronto; Dalhousie University; Université de Montréal
• Investigators: Principal Investigator: Nhaeem Bhojani, MD, Université de Montréal; Principal Investigator: Ben H Chew, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2017
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: 24 hour urine; Metabolic Screening
• Other Study ID Numbers: H16-03324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No