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

NCT ID: NCT03412097

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 89 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-09-30

Brief 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.

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.

Conditions

Patient Safety; Manipulation, Spinal

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

active surveillance

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas at Tyler

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

Canadian Memorial Chiropractic College

OTHER

Sponsor Role: collaborator

Parker University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine A Pohlman, DC, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Parker University

Other Identifiers

Parker16_001

Identifier Type: -

Identifier Source: org_study_id