(MIST2)-Part2: AEs Following DC Care at DC Teaching Clinic: Electronic (MIST2)

January 13, 2020 updated by: Parker University

Assessment & Feasibility of an Electronic Post-Symptoms Evaluation

This study aims to compare different ways to establish severity from patients reporting a new or worsening symptom (adverse event) following a chiropractic treatment at a teaching clinic using an electronic platform.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthcare systems acknowledge the importance of patient safety including the reduction of preventable adverse events (AE). For healthcare providers who perform spinal manipulation therapy (SMT), the investigation of AEs remains in its infancy for several reasons including finding a reporting system that accurately collects AEs information, varied descriptions of AE's severity and occurrence frequency and the variable natural history of musculoskeletal conditions treated by SMT. Together, these factors act together to conspire against the implementation of systematic changes in SMT application that would result in improved patient care and safety.

In addition, it is vital that patient safety training initiates at the start of a healthcare worker's career. This pilot active surveillance study was designed to assess the feasibility of collecting data with an electronic platform for patients' self-report of symptom changes as well as interns' report at a chiropractic teaching clinic.

Study Type

Observational

Enrollment (Actual)

416

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Each supervising faculty clinician in the Parker Wellness Clinic had data collected from interested patients during a pre-specified one week period of time.

Description

Inclusion Criteria:

  • Patients at the Parker University Wellness Clinic
  • Agreed to participate

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
patient - report of an adverse event
Time Frame: Up to 7 days post treatment - Day 0-7
as any unfavorable sign, symptom or disease temporarily associated with the treatment, whether or not caused by the treatment, specifically any worsened or new symptom reported by the patient up to one week after care
Up to 7 days post treatment - Day 0-7
intern - report of an adverse event
Time Frame: Immediate after treatment - Day 0
as any unfavorable sign, symptom or disease temporarily associated with the treatment, whether or not caused by the treatment, specifically any worsened or new symptom reported by the intern immediately following care
Immediate after treatment - Day 0

Collaborators and Investigators

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

Sponsor

Parker University

Collaborators

University of Alberta
Canadian Memorial Chiropractic College

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)

January 1, 2017

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (ACTUAL)

January 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Parker17_002

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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