Diagnostic ErrorsM-SafetyNCT03757884
Medical Decisions in the Hospital Setting- M-Safety
A study testing Mindfulness breathing exercise, Diagnostic Checklist and Noise cancelling headphones in people with Diagnostic Errors, run by University of Michigan at 2 sites in United States.
Trial summary
This project will introduce and evaluate an intervention designed to improve diagnostic decision making. The intervention will attempt to increase clinician mindfulness and reduce environmental distractions to promote focused thinking. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Errors
- What is being tested?
- Mindfulness breathing exercise, Diagnostic Checklist and Noise cancelling headphones
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Sep 2018to 17 Sep 2019
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hospital Medicine Physicians
Who cannot join
- Physicians other than Hopitalists
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ann Arbor VA Healthcare System
Ann Arbor, Michigan, 48105
University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Improving Medical-Decision Through Cognition, Technology and Communication, Phase 2
This project will introduce and evaluate an intervention designed to improve diagnostic decision making. The intervention will attempt to increase clinician mindfulness and reduce environmental distractions to promote focused thinking. A meta-cognitive intervention using a structured checklist will be evaluated to identify improvement in diagnostic and therapeutic decision-making and examine the role of mindfulness and architectural design in enhancing patient safety.
Read the detailed description
This project will introduce and evaluate an intervention designed to improve diagnostic decision making. The intervention will attempt to increase clinician mindfulness and reduce environmental distractions to promote system 2 thinking. A meta-cognitive intervention using a structured checklist will be evaluated to identify improvement in diagnostic and therapeutic decision-making and examine the role of mindfulness and architectural design in enhancing patient safety.
This a pretest-posttest design study that will be conducted with hospitalist physicians working at Michigan Medicine and/or the VA Ann Arbor Healthcare System. The proposed intervention will provide the participants with tools to help promote mindfulness and focus to assist with the diagnostic process. To reduce distraction, headphones to block out surrounding noise and table screens to limit distractions will be offered. To assist with diagnosis, a diagnostic checklist and use of a IPad to use an online diagnosis application will be provided.
- Conditions
- Diagnostic Errors
- Being tested
- Mindfulness breathing exercise, Diagnostic Checklist, Noise cancelling headphones, Privacy tablescreen, Diagnostic assistance application
- Keywords
- Diagnostic Errors, Hospital Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness breathing exerciseBehavioural
Spire monitor instructed mindfulness breathing
Diagnostic ChecklistBehavioural
Checklist reminder for diagnosis
Noise cancelling headphonesBehavioural
Noise cancelling headphones
Privacy tablescreenBehavioural
Privacy Tablescreen
Diagnostic assistance applicationBehavioural
Diagnostic assistance application
| Study group | Role | What they receive |
|---|---|---|
| Virtual Pod | Experimental | Mindfulness breathing, privacy screen, noise cancelling headphones, diagnostic checklist, diagnostic support on-line application Receives: Behavioral: Mindfulness breathing exercise; Behavioral: Diagnostic Checklist; Behavioral: Noise cancelling headphones; Behavioral: Privacy tablescreen; Behavioral: Diagnostic assistance application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Patient Differential Diagnosis
Differential Diagnosis
Measured: 8 months
Change in the Use of Diagnostic Checklist
Diagnostic Checklist
Measured: 8 months
Secondary outcomes (5)
Change in Mindfulness Behaviors Score
This 4 Question Survey Measures Characteristics of Mindfulness, Range- 1=Always, 6=Never
Measured: 8 months
Change in Number of Patient Diagnostic Testing
Diagnostic Testing includes Laboratory and Imaging
Measured: 8 months
Change in Time Participants are Measured as Calm
Time Measured in Minutes, Using the Spire Monitor
Measured: 8 months
Change in Time Participants are Measured as Focused
Time Measured in Minutes, Using the Spire Monitor
Measured: 8 months
Change in Time Participants are Measured as Tense
Time Measured in Minutes, Using the Spire Monitor
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start10 Sep 2018
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diagnostic ErrorsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-posttest study design
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Vineet Chopra, University of Michigan
- Investigators
- Vineet I Chopra, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757884
- Sponsor's protocol ID
- HUM00145793
- Acronym
- M-Safety
- Status last verified
- Sep 2019
- First submitted
- 27 Nov 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data security rules and regulations of the participating facilities (such as the University of Michigan and the Department of Veterans Affairs) will be followed. If data can be shared, all identifiers will be removed from the data. Data will be made available for research to those who request it once analyses has been conducted and findings have been published. Persons interested in using the data will need to submit a request in writing, stating their intended use.
Publications
Chopra V, Harrod M, Winter S, Forman J, Quinn M, Krein S, Fowler KE, Singh H, Saint S. Focused Ethnography of Diagnosis in Academic Medical Centers. J Hosp Med. 2018 Oct 1;13(10):668-672. doi: 10.12788/jhm.2966. Epub 2018 Apr 25.
PubMed 29694450
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medical-Decision Through Cognition, Technology and Communication, Phase 2
- ClinicalTrials.gov ID
- NCT03757884
- Acronym / sponsor ID
- M-Safety / HUM00145793
- Conditions
- Diagnostic Errors
- Keywords
- Diagnostic Errors, Hospital Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 29 Nov 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 project will introduce and evaluate an intervention designed to improve diagnostic decision making. The intervention will attempt to increase clinician mindfulness and reduce environmental distractions to promote focused thinking. A meta-cognitive intervention using a structured checklist will be evaluated to identify improvement in diagnostic and therapeutic decision-making and examine the role of mindfulness and architectural design in enhancing patient safety.
Detailed description
This project will introduce and evaluate an intervention designed to improve diagnostic decision making. The intervention will attempt to increase clinician mindfulness and reduce environmental distractions to promote system 2 thinking. A meta-cognitive intervention using a structured checklist will be evaluated to identify improvement in diagnostic and therapeutic decision-making and examine the role of mindfulness and architectural design in enhancing patient safety.
This a pretest-posttest design study that will be conducted with hospitalist physicians working at Michigan Medicine and/or the VA Ann Arbor Healthcare System. The proposed intervention will provide the participants with tools to help promote mindfulness and focus to assist with the diagnostic process. To reduce distraction, headphones to block out surrounding noise and table screens to limit distractions will be offered. To assist with diagnosis, a diagnostic checklist and use of a IPad to use an online diagnosis application will be provided.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-posttest study design
| Arm | Type | Receives |
|---|---|---|
| Virtual Pod | Experimental | Behavioral: Mindfulness breathing exercise, Behavioral: Diagnostic Checklist, Behavioral: Noise cancelling headphones, Behavioral: Privacy tablescreen, Behavioral: Diagnostic assistance applicationMindfulness breathing, privacy screen, noise cancelling headphones, diagnostic checklist, diagnostic support on-line application |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospital Medicine Physicians
Key exclusion criteria (1 listed)
- Physicians other than Hopitalists
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 |
|---|---|---|
| Mindfulness breathing exerciseSpire monitor instructed mindfulness breathing | Behavioural | Virtual Pod |
| Diagnostic ChecklistChecklist reminder for diagnosis | Behavioural | Virtual Pod |
| Noise cancelling headphonesNoise cancelling headphones | Behavioural | Virtual Pod |
| Privacy tablescreenPrivacy Tablescreen | Behavioural | Virtual Pod |
| Diagnostic assistance applicationDiagnostic assistance application | Behavioural | Virtual Pod |
Primary outcome
Change in Number of Patient Differential Diagnosis
Time frame: 8 months
Differential Diagnosis
Change in the Use of Diagnostic Checklist
Time frame: 8 months
Diagnostic Checklist
5 secondary outcomes
Change in Mindfulness Behaviors Score
Time frame: 8 months
Change in Number of Patient Diagnostic Testing
Time frame: 8 months
Change in Time Participants are Measured as Calm
Time frame: 8 months
Change in Time Participants are Measured as Focused
Time frame: 8 months
Change in Time Participants are Measured as Tense
Time frame: 8 months
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 20 Sep 2019.
- Background: PubMed 29694450Chopra V, Harrod M, Winter S, Forman J, Quinn M, Krein S, Fowler KE, Singh H, Saint S. Focused Ethnography of Diagnosis in Academic Medical Centers. J Hosp Med. 2018 Oct 1;13(10):668-672. doi: 10.12788/jhm.2966. Epub 2018 Apr 25.
- Individual participant dataSharing planned: Yes. Data security rules and regulations of the participating facilities (such as the University of Michigan and the Department of Veterans Affairs) will be followed. If data can be shared, all identifiers will be removed from the data. Data will be made available for research to those who request it once analyses has been conducted and findings have been published. Persons interested in using the data will need to submit a request in writing, stating their intended use.
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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.
Vineet I Chopra, MD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness breathing exercise, Diagnostic Checklist and Noise cancelling headphones in people with Diagnostic Errors, run by University of Michigan at 2 sites 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 1 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 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in Number of Patient Differential Diagnosis (time frame: 8 months). 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?
On the ClinicalTrials.gov record for NCT03757884, which also lists 1 linked publication.
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 20 Sep 2019.