Clinical trial NCT04786015: Active Surveillance Reporting to Identify Adverse Events Following Chiropractic Care in Older Adults
Official title: Advancing Patient Safety for Special Populations: Active Surveillance Reporting to Identify Adverse Events Following Chiropractic Care in Older Adults
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Musculoskeletal Pain
Musculoskeletal Symptoms
Keywords: Older adult
Adverse event
Patient safety
Lead sponsor: Canadian Memorial Chiropractic College
Sponsor class: OTHER
Collaborators: name: Parker University
name: Macquarie University, Australia
name: Memorial University of Newfoundland
First posted: 2021-03-08
Enrollment: 900
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Canadian community-based chiropractors and their older adult patients who come to their office for chiropractic care.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in presenting symptoms (e.g., pain, weakness, etc.) following a chiropractic visit measured by active surveillance reporting system questionnaires
timeFrame: up to 7 days after chiropractic visit
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Canadian Memorial Chiropractic College
state: Ontario
Study officials:
References: