Clinical trial NCT04008680: Changes in Reliability When Assessing Multiple Patient-Reported Outcome Measures
Official title: Collection of Remotely Administered Multiple Patient-Reported Outcome Measures (CRAM-PROMs) in Orthopaedic Trauma: Assessment of the Impact of Quantity on Quality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PROM
Keywords: consistency
reliability
burden
response
methodology
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 group randomized clinical trial
Primary purpose: OTHER

Brief summary: This study investigates how reliability of patient reported outcomes can be affected with questionnaire burden and and the number of questionnaires given to study participants.

Detailed description: The primary objective of the study is to determine if the number of remotely administered questionnaires completed by fracture patients affects the psychometric properties of a questionnaire itself. We will assess the internal consistency of the EuroQuol Five Dimension - Five Level (EQ-5D-5L) Health Survey questionnaire as more questionnaires are applied.

The secondary objective is to evaluate how the number of questionnaires and the time it takes to complete them impact patient's preferences and values. We will measure the time taken by each participant to complete the EQ-5D-5L questionnaire to evaluate if it changes meaningfully as the number of questionnaires given to participants' increases. Additionally, we will assess patient preferences and values by asking how well the remotely collected PROMs reflect their health status, and how this changes relative to the number of questionnaires administered.

Our hypothesis is that there is a progressive decline in psychometric properties in the EQ-5D-5L, both in reliability and validity, as we increase the number of questionnaires given to participants. We also hypothesize that the time to complete the ED-5D-5L will increase as the number of questionnaires given to participants' increases, and that there is a threshold at which the patient feels there are no additional value to completing additional remote PROMS to adequately reflect their health status.

Eligibility criteria: Inclusion Criteria:

1. The patient presents to the in-person or virtual fracture clinic for his/her own appointment.
2. The patient has a fracture that is being managed either operatively or non-operatively.
3. Fracture occurred in the past 6 months.
4. The patient is 18 years of age or older.
5. The patient is able to read, understand, and write in English.
6. Patient provides informed, verbal or written consent.

Exclusion Criteria:

1. The patient is considered too ill or injured to participate in the study.
2. The patient is cognitively impaired, intoxicated or otherwise unable to provide consent or participate in the study.
3. The patient is co-enrolled in another study requiring completion of multiple additional PROMs.

Primary outcomes:
measure: Reliability and validity of the EQ-5D-5L
timeFrame: Day 1
Secondary outcomes:
measure: Time to completion
timeFrame: Day 1
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - General Site
state: Ontario
Study officials:
affiliation: McMaster University
name: Francesc Antoni Marcano-Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Herman Johal, MD
role: PRINCIPAL_INVESTIGATOR
References: