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Mindfulness to the Clinical Setting: The Mind Hand Connection Study (MHC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03165799
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Agency for Healthcare Research and Quality (AHRQ)
VA Ann Arbor Healthcare System
Information provided by (Responsible Party):
Vineet Chopra, University of Michigan

Brief Summary:
This is a single center, randomized study that assessed the effects of mindfulness training on physician teaching teams at a VA hospital.

Condition or disease Intervention/treatment Phase
Mindfulness Education, Medical Hand Hygiene Patient Safety Behavioral: Mindfulness Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participating teams were randomized with a 1:1 ratio to receive the intervention.
Masking: Single (Outcomes Assessor)
Masking Description: Observers collecting data were blinded to participant treatment/control randomization allocation.
Primary Purpose: Health Services Research
Official Title: Mindfulness to the Clinical Setting: The Mind Hand Connection Study
Actual Study Start Date : January 31, 2017
Actual Primary Completion Date : March 15, 2017
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness Education
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.
Behavioral: Mindfulness Education
Mindfulness Education

No Intervention: No Intervention
Participants did not receive mindfulness education.



Primary Outcome Measures :
  1. Hand Hygiene Compliance [ Time Frame: Baseline and study completion at 2 weeks ]
    Change in hand hygiene compliance observed during patient care rounds


Secondary Outcome Measures :
  1. Mindful Attention Awareness Scale [ Time Frame: Baseline and study completion at 2 weeks ]
    Measures core characteristics of mindfulness



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Internal Medicine attendings, residents, interns and medical students on inpatient patient care teams, able to provide consent

Exclusion Criteria:

Surgical attendings, residents, interns or subspeciality teams, Internal medicine attendings rotating on non-resident teams


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165799


Locations
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United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48103
Sponsors and Collaborators
University of Michigan
Agency for Healthcare Research and Quality (AHRQ)
VA Ann Arbor Healthcare System
Investigators
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Principal Investigator: Vineet I Chopra, MD University of Michigan and Ann Arbor VA Healthcare System
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vineet Chopra, Chief, Division of Hospital Medicine & Assistant Professor of Medicine & Research Scientist, University of Michigan
ClinicalTrials.gov Identifier: NCT03165799    
Other Study ID Numbers: 2016-020159-0004
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No