Clinical trial NCT03048864: Questionnaire for Metabolic Screening
Official title: Use of Metabolic Evaluations for Patients With Renal Calculi and the Risk of Recurrence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Evaluation
Keywords: Metabolic Screening
24 hour urine
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Université de Montréal
name: McGill University
name: Dalhousie University
name: University of Toronto
name: University of Alberta
First posted: 2017-02-09
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic Evaluation
timeFrame: through study completion - an average of 10 months
Secondary outcomes:
measure: Doctor Patient Communication
timeFrame: at the end of study completion - an average of 10 months
measure: Patient Dietary/Treatment Compliance
timeFrame: at the end of study completion - an average of 10 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: Université de Montréal
name: Nhaeem Bhojani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Ben H Chew, MD
role: PRINCIPAL_INVESTIGATOR
References: