Active Surveillance Reporting to Identify Adverse Events Following Chiropractic Care in Older Adults

Advancing Patient Safety for Special Populations: Active Surveillance Reporting to Identify Adverse Events Following Chiropractic Care in Older Adults

In Canada, almost 19% of chiropractic patients are aged over 65 years. Although most of patients ≥65 years seek care for musculoskeletal conditions (such as back, neck and lower limb pain), there is inadequate prospective data on the safety of chiropractic care for these patients and the frequency of potential associated adverse events remains unknown. Our study will investigate changes in symptoms reported by older adults receiving chiropractic care, with a focus on safety.

Study Overview

• Status: Active, not recruiting
• Conditions: Musculoskeletal Pain; Musculoskeletal Symptoms
• Intervention / Treatment: Other: Active Surveillance Reporting System

Detailed Description

Rationale: Musculoskeletal conditions are more common and more severe in older adults than in younger adults and have a negative effect on their overall health-related quality-of-life by decreasing mobility, reducing social participation and causing substantial difficulties with activities of daily living. Canada's population is rapidly aging and the socioeconomic burden associated with these conditions will continue to escalate. Indeed, older patients (≥65 years) account for 18.8% of a chiropractor's case load. Given the high proportion of older adults as chiropractic patients, research on the safety of chiropractic care for this population is critical. Previous studies have reported adverse events (AEs) following specific chiropractic techniques or as secondary outcome measures in older adults; however, there has been no attempt to prospectively capture changes in symptoms (and specifically AEs).

Purpose: To: 1) calculate the frequency of AEs reported by older adults following chiropractic care with an active surveillance reporting system; and 2) explore patient and provider factors related to changes in symptom (e.g., new, worsening, improving) following chiropractic care.

More specifically, this study will use active surveillance reporting system to track the change in symptoms experienced by older adult patients after a chiropractic visit, in comparison to before. These symptoms can be pain, stiffness, fatigue, weakness, dizziness, nausea, etc. As active surveillances track the change in all symptoms experienced by all patients in a participating clinic, no specific condition/disease is being studied, but how the symptoms experienced by older adults seeking chiropractic care for a musculoskeletal condition (such as low back, neck, hip, should pain) change.

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Martha Funabashi, PhD; Phone Number: 714 416 482 2340; Email: mfunabashi@cmcc.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2H 3
      • Canadian Memorial Chiropractic College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Canadian community-based chiropractors and their older adult patients who come to their office for chiropractic care.

Description

Inclusion Criteria:

• older adults (≥65 years) seeking chiropractic care

Exclusion Criteria:

• diagnosed with cognitive decline (e.g. Alzheimer's Disease, dementia), acute infections, unable to read English and no access to email.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in presenting symptoms (e.g., pain, weakness, etc.) following a chiropractic visit measured by active surveillance reporting system questionnaires	An active surveillance reporting system will be used. The questionnaires have been face-validated and used in previous studies. The active surveillance system consists on 3 questionnaires to be completed by the patients regarding their symptoms (such as pain, stiffness, weakness, etc.). First questionnaire is to be completed before a chiropractic visit. Second questionnaire is to be completed immediately after chiropractic treatment is provided. Third questionnaire is to be completed 2-7 days after the chiropractic visit. Based on the answers provided in each questionnaire, the change in symptom (i.e., if the symptom improved, got worse, or if the patient is experiencing new symptoms) can be tracked and recorded.	up to 7 days after chiropractic visit

Collaborators and Investigators

• Sponsor: Canadian Memorial Chiropractic College
• Collaborators: Memorial University of Newfoundland; Macquarie University, Australia; Parker University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Patient safety; Adverse event; Older adult
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain
• Other Study ID Numbers: 202004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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