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CompletedNCT04161677MIST3Updated Feb 16, 2021

MIST3: Active Patient Safety Reporting

An observational study in Safety Issues, sponsored by Parker University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-16.

Sponsored by Parker University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
161
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Safety Issues

Keywords

  • Adverse event
  • Electronic reporting system
  • Chiropractic
  • Spinal manipulation
03

In context

Lead sponsor

Parker University is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  • Health patients

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
161 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Pre-screening questionnaire

    Severity rating based on a series of questionnaire

    Time frame: 5-10 minute

  2. Post-survey

    Severity rating based on severity term questionnaire

    Time frame: Immediately after visit

  3. follow-up questionnaire

    Severity rating based on definitions questionnaire

    Time frame: 7-10 days after visit

07

Study locations

1 site
  • Parker University
    Dallas, Texas 75229, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04161677
Lead sponsor
Parker University
Responsible party
Sponsor
First posted
Nov 13, 2019
Start date
Nov 21, 2019
Primary completion
Dec 20, 2020
Completion
Dec 31, 2020
Last update
Feb 16, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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