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Completed

NCT Number: NCT03412110

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Parker University

Dallas, Texas, 75229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

active surveillance: electronic platform

Other

Provides a structure to systematically gather adverse event information from healthcare providers and sometimes directly from patients.

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Parker University

Other

Collaborators

  • Canadian Memorial Chiropractic College
  • University of Alberta

Registry information

Official study title

Assessment & Feasibility of an Electronic Post-Symptoms Evaluation

Acronym: MIST2

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2018
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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