Changes in Reliability When Assessing Multiple Patient-Reported Outcome Measures

PROM Clinical Trial

— CRAM-PROMs  

Official title:

Collection of Remotely Administered Multiple Patient-Reported Outcome Measures (CRAM-PROMs) in Orthopaedic Trauma: Assessment of the Impact of Quantity on Quality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04008680
• Other study ID #: HiREB 7607
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Hamilton Health Sciences Corporation
• Contact: Gina Del Fabbro, BPH
• Phone: 2898080709
• Email: delfabbg[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• PROM

Intervention

Other:
• EQ-5D-5L survey internal consistency
To see how increasing the number of questionnaires affects the internal consistency of the EQ-5D-5L.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences - General Site	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability and validity of the EQ-5D-5L	The questionnaire selected to analyze reliability in our population is the EQ-5D-5L.This well-known, generic, patient-reported health questionnaire is frequently used in musculoskeletal research and has shown to have a good internal consistency. We will compute the Cronbach's alpha coefficient for the EQ-5D-5L questionnaire. We will contrast these results to analyze if there is any difference in the values obtained from the answers of the EQ-5D-5L questionnaire between the four groups.	Day 1
Secondary	Time to completion	Time to complete the questionnaire. We will collect data (through electronic software) on time to completion of the EQ-5D-5L questionnaire. We hypothesize that as patients are asked to complete more surveys, patients will fatigue as the research burden increases and take longer to complete the surveys. Data will be collected in minutes, and the mean time to completion will be compared across groups through analysis of variance tests.	Day 1