(MIST1)-Part 1: Assessment & Feasibility of Post-Symptoms Evaluation (MIST1)

Assessing New or Worsening Symptoms (Aka Adverse Events for This Study) After Chiropractic Care at a Chiropractic Teaching Clinic: An Active Surveillance Pilot Study

To increase patient safety culture in spinal manipulation therapy (SMT) this study will assess the ability to implement an active surveillance reporting system for a chiropractic teaching clinic and determining preliminary incidence of adverse events (AE) following SMT performed by the chiropractic interns. Adverse events defined for the primary outcome of this study is any new or worsening symptom following a chiropractic encounter.

Study Overview

• Status: Completed
• Conditions: Patient Safety; Manipulation, Spinal
• Intervention / Treatment: Other: active surveillance

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 on patients' self-report of symptom changes as well as interns' report at a chiropractic teaching clinic.

• Study Type: Observational
• Enrollment (Actual): 89

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Consecutive Patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patient Encounters That Report a New or Worsening Symptom	An adverse advent is 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

Collaborators and Investigators

• Sponsor: Parker University
• Collaborators: University of Alberta; University of Texas at Tyler; Canadian Memorial Chiropractic College
• Investigators: Principal Investigator: Katherine A Pohlman, DC, MS, PhD, Parker University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

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): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: chiropractic; SMT; active surveillance reporting system
• Other Study ID Numbers: Parker16_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No