Priming and Patient Reported Outcome Measures

Priming Subjects to Influence Responses to Patient Reported Outcome Measures

The objective of the study is to assess which health-related questionnaire is the most accurate and reliable.

The hypothesis is that some health-related questionnaires are more reliable than others.

Study Overview

• Status: Completed
• Conditions: Patient Participation; PROM
• Intervention / Treatment: Behavioral: Reflection on health-related experiences

Detailed Description

The objective of the study is to test the reliability of patient reported outcome measures, and their robustness to patient-related factors.

Patients will be randomly assigned to complete 1 of 6 patient reported outcome measures. Patients will either be asked to reflect on health-related experiences or not prior to completion of the questionnaire. Basic non-identifiable demographic information, and a brief medical questionnaire will follow completion of the patient reported outcome measure.

Results from each individual patient reported outcome measure will be compared.

• Study Type: Interventional
• Enrollment (Actual): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathan Yang, MD; Phone Number: 212-305-2500; Email: ny2325@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital- Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

18 years of age and older, living in the US, fluent written and spoken English, able to consent

Exclusion Criteria:

Any criteria that does not meet the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

18

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive health-related experiences and EQ-5D-5L; Reflecting on positive health-related experiences EQ-5D-5L questionnaire	Behavioral: Reflection on health-related experiences; This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
Experimental: Negative health-related experiences and EQ-5D-5L; Reflecting on negative health-related experiences EQ-5D-5L questionnaire	Behavioral: Reflection on health-related experiences; This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
No Intervention: Control and EQ-5D-5L; No intervention/ control group EQ-5D-5L questionnaire
Experimental: Positive health-related experiences and PROMIS; Reflecting on positive health-related experiences PROMIS Global health v1.2 questionnaire	Behavioral: Reflection on health-related experiences; This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
Experimental: Negative health-related experiences and PROMIS; Reflecting on negative health-related experiences PROMIS Global health v1.2 questionnaire	Behavioral: Reflection on health-related experiences; This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
No Intervention: Control and PROMIS; No intervention/ control group PROMIS Global health v1.2 questionnaire
Experimental: Positive health-related experiences and SF-36; Reflecting on positive health-related experiences SF-36 questionnaire	Behavioral: Reflection on health-related experiences; This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
Experimental: Negative health-related experiences and SF-36; Reflecting on negative health-related experiences SF-36 questionnaire	Behavioral: Reflection on health-related experiences; This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
No Intervention: Control and SF-36; No intervention/ control group SF-36 questionnaire
Experimental: Positive health-related experiences and SNOT-22; Reflecting on positive health-related experiences SNOT-22 questionnaire	Behavioral: Reflection on health-related experiences; This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
Experimental: Negative health-related experiences and SNOT-22; Reflecting on negative health-related experiences SNOT-22 questionnaire	Behavioral: Reflection on health-related experiences; This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
No Intervention: Control and SNOT-22; No intervention/ control group SNOT-22 questionnaire
Experimental: Positive health-related experiences and RSDI; Reflecting on positive health-related experiences RSDI questionnaire	Behavioral: Reflection on health-related experiences; This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
Experimental: Negative health-related experiences and RSDI; Reflecting on negative health-related experiences RSDI questionnaire	Behavioral: Reflection on health-related experiences; This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
No Intervention: Control and RSDI; No intervention/ control group RSDI questionnaire
Experimental: Positive health-related experiences and mini-RQLQ; Reflecting on positive health-related experiences Mini-RQLQ questionnaire	Behavioral: Reflection on health-related experiences; This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
Experimental: Negative health-related experiences and mini-RQLQ; Reflecting on negative health-related experiences Mini-RQLQ questionnaire	Behavioral: Reflection on health-related experiences; This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
No Intervention: Control and mini-RQLQ; No intervention/ control group Mini-RQLQ questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36 score	For the SF-36, a score of 0 to 100 is calculated for the domains of physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/ fatigue, emotional well-being, social functioning, pain, and general health. A higher score represents a more favorable outcome.	15 minutes
EQ-5D-5L score	For the EQ-5D-5L, a scale of 1 to 5 with descriptors is used to score the domains of mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. A higher score represents a worse outcome.	15 minutes
PROMIS Global health v1.2 score	For the PROMIS Global Health v1.2, a score of 4 to 20 is calculated for the global physical health domain, and a score of 4 to 20 is calculated for the global mental health domain. A higher score represents a worse outcome.	15 minutes
Sinonasal Outcomes Test (SNOT)-22 score	For the SNOT-22, a total score of 0 to 110 is calculated. The higher the score, the worse the outcome.	15 minutes
Rhinosinusitis Disability Index (RSDI) score	For the RSDI, a total score of 0 to 120 is calculated. The higher the score, the worse the outcome.	15 minutes
mini-RQLQ score	For the mini-RQLQ, a score 0 to 18 is calculated for the activities domain, 0 to 12 for the practical problems domain, 0 to 18 for the nose symptoms domain, 0 to 18 for the eye symptoms domain, and 0 to 18 for the other symptoms domain. A higher score represents a worse outcome.	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Present Mood Visual Analogue Scale	10 cm visual analogue scale to rate mood. The scale is between 0 and 10. A higher score represents a better outcome	15 minutes

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Medical University of South Carolina; Northwestern University
• Investigators: Principal Investigator: David Gudis, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: January 22, 2022
• First Submitted That Met QC Criteria: February 6, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AAAT8186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will potentially be shared upon reasonable request

Drug and device information, study documents

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