MIST3: Active Patient Safety Reporting

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04161677

Acronym

MIST3

Enrollment

161

Registered

2019-11-13

Start date

2019-11-21

Completion date

2020-12-31

Last updated

2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety Issues

Keywords

Adverse event, Electronic reporting system, Chiropractic, Spinal manipulation

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Health patients

Exclusion criteria

* None

Design outcomes

Primary

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

Countries

United States

Outcome results