Patient SafetyMIST1NCT03412097
(MIST1)-Part 1: Assessment & Feasibility of Post-Symptoms Evaluation
An observational study of Patient Safety and Manipulation, Spinal, run by Parker University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Safety, Manipulation, Spinal
- What is being tested?
- active surveillance
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Sep 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Consecutive Patients
Who may be able to join
- Patients at the Parker University Wellness Clinic
- Agreed to participate
Who cannot join
- none
About this study
Official title: Assessing New or Worsening Symptoms (Aka Adverse Events for This Study) After Chiropractic Care at a Chiropractic Teaching Clinic: An Active Surveillance Pilot Study
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.
Read the 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.
- Conditions
- Patient Safety, Manipulation, Spinal
- Being tested
- active surveillance
- Keywords
- chiropractic, SMT, active surveillance reporting system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active surveillanceOther
Provides a structure to systematically gather adverse event information from healthcare providers and sometimes directly from patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 days post treatment - Day 0-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study startJun 2016
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Tyler, University of Alberta, Canadian Memorial Chiropractic College
- Responsible party
- Sponsor
- Investigators
- Katherine A Pohlman, DC, MS, PhD, Principal investigator, Parker University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412097
- Sponsor's protocol ID
- Parker16_001
- Acronym
- MIST1
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2018
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing New or Worsening Symptoms (Aka Adverse Events for This Study) After Chiropractic Care at a Chiropractic Teaching Clinic: An Active Surveillance Pilot Study
- ClinicalTrials.gov ID
- NCT03412097
- Acronym / sponsor ID
- MIST1 / Parker16_001
- Conditions
- Patient Safety, Manipulation, Spinal
- Keywords
- chiropractic, SMT, active surveillance reporting system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Parker UniversityUniversity, hospital or other
- Collaborators
- University of Texas at Tyler, University of Alberta, Canadian Memorial Chiropractic College
- Study start
- Jun 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Posted 4 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive Patients
Key inclusion criteria (2 listed)
- Patients at the Parker University Wellness Clinic
- Agreed to participate
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active surveillanceProvides a structure to systematically gather adverse event information from healthcare providers and sometimes directly from patients. | Other | – |
Primary outcome
Number of Patient Encounters That Report a New or Worsening Symptom
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine A Pohlman, DC, MS, PhD principal investigator
Parker University
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Safety and Manipulation, Spinal, run by Parker University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patient Encounters That Report a New or Worsening Symptom (time frame: Up to 7 days post treatment - Day 0-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.