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Tracking Device Guided Feedback to Enhance Patient Physician Interaction

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: NCT04004806
Recruitment Status : Enrolling by invitation
First Posted : July 2, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Accreditation Council for Graduate Medical Education
Information provided by (Responsible Party):
Andrei Brateanu, MD, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date July 8, 2019
Estimated Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
Time spent at bedside [ Time Frame: through study completion, one year ]
total number of minutes spent by each participant at a patient's bedside divided by the total number of patients
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Physician burnout scores [ Time Frame: through study completion, one year ]
    correlation of time spent by residents and physicians at the patient's bedside with their burnout survey results as measured by a questionnaire provided by the Accreditation Council for Graduate Medical Education (AGME) which consists of 22 fixed response and Likert-type scale questions.
  • HCAHPS Patient satisfaction scores [ Time Frame: through study completion, one year ]
    correlation of time spent by residents and physicians at the patient's bedside with patient satisfaction scores as measured by HCAHPS v13 (based on question 5, 6 and 7 which form the 'Your Care from Doctors' section in the HCAHPS v 13.0, 2018 questionnaire)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tracking Device Guided Feedback to Enhance Patient Physician Interaction
Official Title  ICMJE Tracking Device Guided Feedback to Enhance Patient Physician Interaction
Brief Summary

A prospective cohort study aimed to determine the impact of increased physician patient interaction on physician well being and patient satisfaction. It involves recording time spent by physicians at the patient's bedside using tracking devices and providing feedback emails encouraging them to spend more time. The data will be analyzed to see if bedside time correlates with patient satisfaction scores.

The study has 3 phases - 1. Observational phase for 3 months: Only involves recording baseline physician bedside time using tracking devices. 2. Interventional phase for 6 months involves generating percentile scores for physician bedside time and providing feedback through emails and texts. 3. Post intervention phase for 3 months to evaluate the impact of intervention on daily practice of physicians.

Detailed Description

All residents and staff members who do not opt out of the study by July 1, 2019 will be included as the final study population. The planned duration of the study is 12 months starting from July 2019 - June 2020. The total time period will be further divided into three phases.

Phase 1 (Observational phase): All residents and staff physicians rotating through the inpatient medicine services during the initial 3 months who agreed to be a part of the study will be provided with Hill Rom tracking devices to quantify the time spent at the patient's bedside by each member as part of the daily practice.

Phase 2 (Intervention phase): Following the initial observational phase, the interventional phase will be 6 months in duration . During this period, the recorded time spent by the individual study participants at the patient's bedside will be compared to their respective peers (e.g. intern to intern, senior resident to senior resident and staff physician to staff physician), and percentile scores will be generated. Time spent by each member of each team at the patient's bedside will be abstracted from the tracking software daily and added on a weekly basis to generate cumulative values by the research coordinator. Patients not assigned to a particular team member will not count towards the denominator. Data will be collected individually for the staff physician, senior resident and intern in each team and compared to peer members in the other teams and converted to percentiles. Based on these percentile scores, the study participants will receive emails and text pages notifying them of the results. The participants whose scores fall in the lower 50th percentile, will be encouraged to increase patient interaction times to reach a target of at least 50th percentile. Striving to stay in the top 50th percentile will provide continuous reinforcement. The participants with scores in the top 50th percentile will receive congratulatory emails to encourage them to keep up the performance. In case of scheduling changes or absences, team members can notify the study coordinator to exclude their data for the said number of days. The percentile scores will be used solely for the purpose of this study and will neither impact trainee evaluation nor their learning objectives for the rotation. Similarly for staff physicians, the scores generated will not be a part of their annual performance reviews.

Phase 3: (Post Intervention observation phase): The final phase of the study will be 3 months. The intervention of feedback emails and text pages will be discontinued and the study participants will only be monitored to see if the past intervention made an impact on their daily clinical practice in terms of time spent with the patients.

At the end of the rotation the study participants will be assessed for their well-being and burnout by surveying them using the standard, validated, IRB-approved, anonymous questionnaires provided by the Accreditation Council for Graduate Medical Education (ACGME), during each of the above phases

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Condition  ICMJE
  • Physician Patient Relation
  • Burnout, Professional
Intervention  ICMJE Device: Hill Rom tracking device
Location tracking devices from Hill Rom company.
Other Name: Feedback emails and text pages
Study Arms  ICMJE
  • No Intervention: Pre-Intervention
    Phase 1 (Observational phase): All residents and staff physicians rotating through the inpatient medicine services during the first three (3) months, who agreed to be a part of the study, will be provided with Hill Rom tracking devices to quantify the time spent at the patient's bedside by each member as part of the daily practice.
  • Experimental: Intervention
    Phase 2 (Intervention phase): The interventional phase will be six (6) months duration. During this period, the recorded time spent by the individual study participants at the patient's bedside will be compared to their respective peers, and percentile scores will be generated. Based on these percentile scores, the study participants will receive emails notifying them of the results. Participants whose scores fall in the lower 50th percentile will be encouraged to increase patient interaction times. Participants with scores in the top 50th percentile will receive congratulatory emails to encourage them to keep up the performance.
    Intervention: Device: Hill Rom tracking device
  • No Intervention: Post-Intervention
    Phase 3: (Post Intervention observation phase): The final phase of the study will be again three (3) months. The intervention of feedback emails and text pages will be discontinued and the study participants will only be monitored to see if the past intervention made an impact on their daily clinical practice in terms of time spent with the patients.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 28, 2019)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2020
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cleveland Clinic Main Campus Internal Medicine resident or staff physician

Exclusion Criteria:

  • Below the age of 18
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004806
Other Study ID Numbers  ICMJE 18-782
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrei Brateanu, MD, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Accreditation Council for Graduate Medical Education
Investigators  ICMJE Not Provided
PRS Account The Cleveland Clinic
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP