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NCT03412097 Clinical Trial

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

Patient Safety Clinical Trial

— MIST1  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03412097
Other study ID # Parker16_001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2016
Est. completion date September 2016

Study information
Verified date February 2024
Source Parker University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 89
Est. completion date September 2016
Est. primary completion date August 2016
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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Parker University Canadian Memorial Chiropractic College, University of Alberta, University of Texas at Tyler

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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