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

Completed

• Conditions: Manipulation, Spinal; Patient Safety

• Registration Number: NCT03412110
• Lead Sponsor: Parker University

Brief Summary

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.

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 Timeline

• Study Start: 2017-01
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-01-26
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
patient - report of an adverse event	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
intern - report of an adverse event	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

Trial Locations

Locations (1)

Parker University; 🇺🇸 Dallas, Texas, United States