Patient SafetyMIST2NCT03412110
(MIST2)-Part2: AEs Following DC Care at DC Teaching Clinic: Electronic
An observational study of Patient Safety and Manipulation, Spinal, run by Parker University at 1 site in United States.
Trial summary
This study aims to compare different ways to establish severity from patients reporting a new or worsening symptom (adverse event) following a chiropractic treatment at a teaching clinic using an electronic platform. 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: electronic platform
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Each supervising faculty clinician in the Parker Wellness Clinic had data collected from interested patients during a pre-specified one week period of time.
Who may be able to join
- Patients at the Parker University Wellness Clinic
- Agreed to participate
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment & Feasibility of an Electronic Post-Symptoms Evaluation
This study aims to compare different ways to establish severity from patients reporting a new or worsening symptom (adverse event) following a chiropractic treatment at a teaching clinic using an electronic platform.
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 with an electronic platform for 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: electronic platform
- 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 surveillance: electronic platformOther
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.
patient - report of an adverse event
as 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
intern - report of an adverse event
as 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 intern immediately following care
Measured: Immediate after treatment - Day 0
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 startJan 2017
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Memorial Chiropractic College, University of Alberta
- Responsible party
- Sponsor
- Investigators
- Katherine A Pohlman, DC, MS, Principal investigator, Parker University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412110
- Sponsor's protocol ID
- Parker17_002
- Acronym
- MIST2
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2018
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment & Feasibility of an Electronic Post-Symptoms Evaluation
- ClinicalTrials.gov ID
- NCT03412110
- Acronym / sponsor ID
- MIST2 / Parker17_002
- Conditions
- Patient Safety, Manipulation, Spinal
- Keywords
- chiropractic, SMT, Active surveillance reporting system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Parker UniversityUniversity, hospital or other
- Collaborators
- Canadian Memorial Chiropractic College, University of Alberta
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare different ways to establish severity from patients reporting a new or worsening symptom (adverse event) following a chiropractic treatment at a teaching clinic using an electronic platform.
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 with an electronic platform for 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
- Each supervising faculty clinician in the Parker Wellness Clinic had data collected from interested patients during a pre-specified one week period of time.
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 surveillance: electronic platformProvides a structure to systematically gather adverse event information from healthcare providers and sometimes directly from patients. | Other | – |
Primary outcome
patient - report of an adverse event
Time frame: Up to 7 days post treatment - Day 0-7
as 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
intern - report of an adverse event
Time frame: Immediate after treatment - Day 0
as 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 intern immediately following care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Parker University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Safety and Manipulation, Spinal, run by Parker University at 1 site in United States.
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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
patient - report of an adverse event (time frame: Up to 7 days post treatment - Day 0-7). The study lists 2 primary outcomes in all. 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 14 Jan 2020.