Changes in Reliability When Assessing Multiple Patient-Reported Outcome Measures (CRAM-PROMs)

Hamilton Health Sciences (HHS)

Status: Unknown

Conditions: PROM

Treatments: Other: EQ-5D-5L survey internal consistency

Study type: Interventional

Funder types: Other

Identifiers

NCT04008680

HiREB 7607

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 4 patient groups

Low response burden

Other group

Description:

Participants will be assigned to complete only the EQ-5D-5L questionnaire.

Treatment:

Other: EQ-5D-5L survey internal consistency

Low to medium response burden

Other group

Description:

Participants will be assigned to complete the General Anxiety Disorder-7 (GAD-7) questionnaire first, followed by the EQ-5D-5L questionnaire.

Treatment:

Other: EQ-5D-5L survey internal consistency

Medium to high response burden

Other group

Description:

Participants will be assigned to complete the Pain Catastrophizing Scale (PCS) questionnaire first, followed by the GAD-7, and lastly the EQ-5D-5L questionnaire.

Treatment:

Other: EQ-5D-5L survey internal consistency

High response burden

Other group

Description:

Participants will be assigned to complete the Brief Pain Inventory (BPI) questionnaire first, followed by the PCS secondly, the GAD-7 third, and lastly the EQ-5D-5L questionnaire.

Treatment:

Other: EQ-5D-5L survey internal consistency