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

NCT03412097 | Completed Results

• 1 other identifier: Parker16_001
• Study Type: observational
• Target: 89
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patient Safety; Manipulation, Spinal

Keywords

chiropractic; SMT; active surveillance reporting system

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

active surveillance OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive Patients

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Parker University: lead
• University of Texas at Tyler: collaborator
• University of Alberta: collaborator
• Canadian Memorial Chiropractic College: collaborator

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Results Point of Contact

• Title: Dr. Katherine A Pohlman
• Organization: Parker University

kpohlman@parker.edu

972 438 6932

Study Officials

• Katherine A Pohlman, DC, MS, PhD

  Parker University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 26, 2018
• Study Start: June 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share