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

Patient Safety Clinical Trial

— MIST2  

Official title:

Assessment & Feasibility of an Electronic Post-Symptoms Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412110
• Other study ID #: Parker17_002
• Status: Completed
• Start date: January 2017
• Est. completion date: March 2017

Study information

• Verified date: January 2020
• Source: Parker University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients at the Parker University Wellness Clinic

• Agreed to participate

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Manipulation, Spinal
• Patient Safety

Intervention

Other:
• active surveillance: electronic platform
Provides a structure to systematically gather adverse event information from healthcare providers and sometimes directly from patients.

Locations

Country	Name	City	State
United States	Parker University	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Parker University	Canadian Memorial Chiropractic College, University of Alberta

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient - report of an adverse event	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
Primary	intern - report of an adverse event	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