MIST3: Active Patient Safety Reporting (MIST3)

February 15, 2021 updated by: Parker University

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

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

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75229
        • Parker University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A convenience sample of all patients at the Parker University Wellness clinic will be invited to participate in the study.

Description

Inclusion Criteria:

  • Health patients

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-screening questionnaire
Time Frame: 5-10 minute
Severity rating based on a series of questionnaire
5-10 minute
Post-survey
Time Frame: Immediately after visit
Severity rating based on severity term questionnaire
Immediately after visit
follow-up questionnaire
Time Frame: 7-10 days after visit
Severity rating based on definitions questionnaire
7-10 days after visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parker University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2019

Primary Completion (Actual)

December 20, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

November 10, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Parker19_05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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