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| Name | Class |
|---|---|
| University of Texas at Tyler | OTHER |
| University of Alberta | OTHER |
| Canadian Memorial Chiropractic College | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active surveillance | Other | Provides a structure to systematically gather adverse event information from healthcare providers and sometimes directly from patients. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive Patients
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| Name | Affiliation | Role |
|---|---|---|
| Katherine A Pohlman, DC, MS, PhD | Parker University | Principal Investigator |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Consecutive Patients | Data from consecutive patients who sought care at Parker University's teaching clinic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 89 patients completed both the pre and post-treatment forms received. These were considered complete and thus used for study analysis. | Posted | Count of Participants | Participants | Up to 7 days post treatment - Day 0-7 |
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0-7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Consecutive Patients | Patients who agreed to participate in the study (consecutive) 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening or new symptom | Musculoskeletal and connective tissue disorders | Systematic Assessment | Worsened and new symptoms were considered AEs (adverse events). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katherine A Pohlman | Parker University | 972 438 6932 | 7148 | kpohlman@parker.edu |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 0 |
| 89 |
| 0 |
| 89 |
| 8 |
| 89 |
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