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

Study Overview
=================
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.

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.

Official Title
-----------------
Assessing Adverse Events After Chiropractic Care at a Chiropractic Teaching Clinic: An Active Surveillance Pilot Study

Conditions
-----------------
Patient Safety, Manipulation, Spinal

Intervention / Treatment
-----------------
* Other: active surveillance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at the Parker University Wellness Clinic Agreed to participate Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: active surveillance|Provides a structure to systematically gather adverse event information from healthcare providers and sometimes directly from patients.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chiropractic, SMT, active surveillance reporting system