Manipulation, Spinal, Patient Safety
Conditions
Keywords
chiropractic, SMT, active surveillance reporting system
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.
Interventions
OTHERactive surveillance
Provides a structure to systematically gather adverse event information from healthcare providers and sometimes directly from patients.
Sponsors
University of Texas at Tyler
University of Alberta
Canadian Memorial Chiropractic College
Parker University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Patients at the Parker University Wellness Clinic * Agreed to participate
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patient Encounters That Report a New or Worsening Symptom | Up to 7 days post treatment - Day 0-7 | 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. |
Participant flow
Pre-assignment details
Patients who agreed to participate in the study completed a pretreatment form. After treatment, patients were asked to complete a post-treatment form. Complete information was received on 89 patients (pretreatment and post-treatment forms).
Participants by arm
| Arm | Count |
|---|---|
| Consecutive Patients Patients who agreed to participate in the study (364 encounters) completed a pretreatment form. After treatment, patients were asked to complete a post-treatment form. Complete information was received on 89 unique patients (pretreatment and post-treatment forms) totaling 119 patient encounters. | 89 |
| Total | 89 |
Baseline characteristics
| Characteristic | Consecutive Patients |
|---|---|
| Age, Continuous | 39.5 years |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 89 |
| other Total, other adverse events | 8 / 89 |
| serious Total, serious adverse events | 0 / 89 |
Outcome results
Primary
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.
Time frame: Up to 7 days post treatment - Day 0-7
Population: 89 patients completed both the pre and post-treatment forms received. These were considered complete and thus used for study analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Consecutive Patients | Number of Patient Encounters That Report a New or Worsening Symptom | 8 Participants |