MIST3: Active Patient Safety Reporting

Safety Issues Clinical Trial

— MIST3  

Official title:

Mitigation Investigation for Spinal Manipulation Treatments (MIST) - Part 3: Continued Assessment & Feasibility of an Electronic Active Surveillance Reporting System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161677
• Other study ID #: Parker19_05
• Status: Completed
• Start date: November 21, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Parker University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will seek to describe and understand adverse events (AE) severity ratings.

Description:

Using an explanatory mixed methods design, three different quantitative methods 1. severity ratings based on a series of questions, 2. severity rating based on severity terms, and 3. severity based on definitions will be used to conduct a feasibility study on understanding adverse event reporting system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: December 31, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Health patients

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Safety Issues

Locations

Country	Name	City	State
United States	Parker University	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Parker University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-screening questionnaire	Severity rating based on a series of questionnaire	5-10 minute
Primary	Post-survey	Severity rating based on severity term questionnaire	Immediately after visit
Primary	follow-up questionnaire	Severity rating based on definitions questionnaire	7-10 days after visit