MindfulnessMHCNCT03165799
Mindfulness to the Clinical Setting: The Mind Hand Connection Study
A study testing Mindfulness Education in people with Mindfulness and Education, Medical, run by University of Michigan at 1 site in United States.
Trial summary
This is a single center, randomized study that assessed the effects of mindfulness training on physician teaching teams at a VA hospital. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Education, Medical, Hand Hygiene
- What is being tested?
- Mindfulness Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2017to 1 Apr 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Internal Medicine attendings, residents, interns and medical students on inpatient patient care teams, able to provide consent
Who cannot join
- Surgical attendings, residents, interns or subspeciality teams, Internal medicine attendings rotating on non-resident teams
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48103
About this study
This is a single center, randomized study that assessed the effects of mindfulness training on physician teaching teams at a VA hospital.
Read the detailed description
The primary objective of this study was to evaluate changes in hand hygiene compliance pre- and post- intervention in Internal Medicine physician and medical student inpatient teaching teams. Half of the teaching teams received the intervention of mindfulness education. Blinded observers collected data on hand hygiene compliance and mindfulness behaviors for both teams during patient care rounds for 1-week pre and post intervention. Additionally, the intervention group participated in focus group/interview discussions.
- Conditions
- Mindfulness, Education, Medical, Hand Hygiene, Patient Safety
- Being tested
- Mindfulness Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness EducationBehavioural
Mindfulness Education
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Education | Experimental | Participants viewed an informational video titled, "All it Takes is 10 Mindful Minutes" by mindfulness expert, Andy Puddicombe. Following the video, a guided discussion was provided that focused on how the principles of mindfulness can be used to influence a physician's state of mental presence, allowing for moments of clarity, insight, and reflection, and potentially enhance provider and patient safety. Receives: Behavioral: Mindfulness Education |
| No Intervention | No intervention | Participants did not receive mindfulness education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Hygiene Compliance
Change in hand hygiene compliance observed during patient care rounds
Measured: Baseline and study completion at 2 weeks
Secondary outcomes (1)
Mindful Attention Awareness Scale
Measures core characteristics of mindfulness
Measured: Baseline and study completion at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start31 Jan 2017
- Primary completion15 Mar 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MindfulnessStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating teams were randomized with a 1:1 ratio to receive the intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), VA Ann Arbor Healthcare System
- Responsible party
- Principal investigator, Vineet Chopra, University of Michigan
- Investigators
- Vineet I Chopra, MD, Principal investigator, University of Michigan and Ann Arbor VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165799
- Sponsor's protocol ID
- 2016-020159-0004
- Other IDs
- 2016
- Acronym
- MHC
- Status last verified
- Sep 2019
- First submitted
- 19 May 2017
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gilmartin HM. Use hand cleaning to prompt mindfulness in clinic. BMJ. 2016 Jan 4;352:i13. doi: 10.1136/bmj.i13. No abstract available.
PubMed 26728590Kiyoshi-Teo H, Krein SL, Saint S. Applying mindful evidence-based practice at the bedside: using catheter-associated urinary tract infection as a model. Infect Control Hosp Epidemiol. 2013 Oct;34(10):1099-101. doi: 10.1086/673147. Epub 2013 Aug 23.
PubMed 24018928Ellingson K, Haas JP, Aiello AE, Kusek L, Maragakis LL, Olmsted RN, Perencevich E, Polgreen PM, Schweizer ML, Trexler P, VanAmringe M, Yokoe DS. Strategies to prevent healthcare-associated infections through hand hygiene. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S155-78. doi: 10.1017/s0899823x00193900. No abstract available.
PubMed 25376074King D, Vlaev I, Everett-Thomas R, Fitzpatrick M, Darzi A, Birnbach DJ. "Priming" hand hygiene compliance in clinical environments. Health Psychol. 2016 Jan;35(1):96-101. doi: 10.1037/hea0000239. Epub 2015 Jul 27.
PubMed 26214075Gilmartin H, Saint S, Rogers M, Winter S, Snyder A, Quinn M, Chopra V. Pilot randomised controlled trial to improve hand hygiene through mindful moments. BMJ Qual Saf. 2018 Oct;27(10):799-806. doi: 10.1136/bmjqs-2017-007359. Epub 2018 Feb 20.
PubMed 29463769
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness to the Clinical Setting: The Mind Hand Connection Study
- ClinicalTrials.gov ID
- NCT03165799
- Acronym / sponsor ID
- MHC / 2016-020159-0004
- Conditions
- Mindfulness, Education, Medical, Hand Hygiene, Patient Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), VA Ann Arbor Healthcare System
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 24 May 2017 (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 is a single center, randomized study that assessed the effects of mindfulness training on physician teaching teams at a VA hospital.
Detailed description
The primary objective of this study was to evaluate changes in hand hygiene compliance pre- and post- intervention in Internal Medicine physician and medical student inpatient teaching teams. Half of the teaching teams received the intervention of mindfulness education. Blinded observers collected data on hand hygiene compliance and mindfulness behaviors for both teams during patient care rounds for 1-week pre and post intervention. Additionally, the intervention group participated in focus group/interview discussions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participating teams were randomized with a 1:1 ratio to receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Education | Experimental | Behavioral: Mindfulness EducationParticipants viewed an informational video titled, "All it Takes is 10 Mindful Minutes" by mindfulness expert, Andy Puddicombe. Following the video, a guided discussion was provided that focused on how the principles of mindfulness can be used to influence a physician's state of mental presence, allowing for moments of clarity, insight, and reflection, and potentially enhance provider and patient safety. |
| No Intervention | No intervention | –Participants did not receive mindfulness education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Internal Medicine attendings, residents, interns and medical students on inpatient patient care teams, able to provide consent
Key exclusion criteria (1 listed)
- Surgical attendings, residents, interns or subspeciality teams, Internal medicine attendings rotating on non-resident teams
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 EducationMindfulness Education | Behavioural | Mindfulness Education |
Primary outcome
Hand Hygiene Compliance
Time frame: Baseline and study completion at 2 weeks
Change in hand hygiene compliance observed during patient care rounds
1 secondary outcome
Mindful Attention Awareness Scale
Time frame: Baseline and study completion at 2 weeks
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 19 Sep 2019.
- Background: PubMed 26728590Gilmartin HM. Use hand cleaning to prompt mindfulness in clinic. BMJ. 2016 Jan 4;352:i13. doi: 10.1136/bmj.i13. No abstract available.
- Background: PubMed 24018928Kiyoshi-Teo H, Krein SL, Saint S. Applying mindful evidence-based practice at the bedside: using catheter-associated urinary tract infection as a model. Infect Control Hosp Epidemiol. 2013 Oct;34(10):1099-101. doi: 10.1086/673147. Epub 2013 Aug 23.
- Background: PubMed 25376074Ellingson K, Haas JP, Aiello AE, Kusek L, Maragakis LL, Olmsted RN, Perencevich E, Polgreen PM, Schweizer ML, Trexler P, VanAmringe M, Yokoe DS. Strategies to prevent healthcare-associated infections through hand hygiene. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S155-78. doi: 10.1017/s0899823x00193900. No abstract available.
- Background: PubMed 26214075King D, Vlaev I, Everett-Thomas R, Fitzpatrick M, Darzi A, Birnbach DJ. "Priming" hand hygiene compliance in clinical environments. Health Psychol. 2016 Jan;35(1):96-101. doi: 10.1037/hea0000239. Epub 2015 Jul 27.
- Derived from this study: PubMed 29463769Gilmartin H, Saint S, Rogers M, Winter S, Snyder A, Quinn M, Chopra V. Pilot randomised controlled trial to improve hand hygiene through mindful moments. BMJ Qual Saf. 2018 Oct;27(10):799-806. doi: 10.1136/bmjqs-2017-007359. Epub 2018 Feb 20.
- 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.
Vineet I Chopra, MD principal investigator
University of Michigan and Ann Arbor VA Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Education in people with Mindfulness and Education, Medical, run by University of Michigan 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 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 19 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 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?
Hand Hygiene Compliance (time frame: Baseline and study completion at 2 weeks). 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 NCT03165799, which also lists 5 linked publications.
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 19 Sep 2019.