Physician Patient RelationNCT04004806
Tracking Device Guided Feedback to Enhance Patient Physician Interaction
A study testing Hill Rom tracking device in people with Physician Patient Relation and Burnout, Professional, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physician Patient Relation, Burnout, Professional
- What is being tested?
- Hill Rom tracking device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2019to 30 Nov 2020
- 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
- Cleveland Clinic Main Campus Internal Medicine resident or staff physician
Who cannot join
- Below the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Physician Patient Relation, Burnout, Professional
- Being tested
- Hill Rom tracking device
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hill Rom tracking deviceDevice
Also called Feedback emails and text pages
Location tracking devices from Hill Rom company.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention | No 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. |
| Intervention | Experimental | 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. Receives: Device: Hill Rom tracking device |
| Post-Intervention | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent at bedside
total number of minutes spent by each participant at a patient's bedside divided by the total number of patients
Measured: through study completion, one year
Secondary outcomes (2)
Physician burnout scores
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.
Measured: through study completion, one year
HCAHPS Patient satisfaction scores
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)
Measured: through study completion, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start2 Sep 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physician Patient RelationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Accreditation Council for Graduate Medical Education
- Responsible party
- Principal investigator, Andrei Brateanu, MD, The Cleveland Clinic
- Investigators
- Andrei Brateanu, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004806
- Sponsor's protocol ID
- 18-782
- Status last verified
- Jan 2021
- First submitted
- 26 Jun 2019
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Device Guided Feedback to Enhance Patient Physician Interaction
- ClinicalTrials.gov ID
- NCT04004806
- Acronym / sponsor ID
- 18-782
- Conditions
- Physician Patient Relation, Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Accreditation Council for Graduate Medical Education
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 2 Jul 2019 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention | No 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. |
| Intervention | Experimental | Device: Hill Rom tracking devicePhase 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. |
| Post-Intervention | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cleveland Clinic Main Campus Internal Medicine resident or staff physician
Key exclusion criteria (1 listed)
- Below the age of 18
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 |
|---|---|---|
| Hill Rom tracking deviceAlso: Feedback emails and text pagesLocation tracking devices from Hill Rom company. | Device | Intervention |
Primary outcome
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
2 secondary outcomes
Physician burnout scores
Time frame: through study completion, one year
HCAHPS Patient satisfaction scores
Time frame: through study completion, one year
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 6 Jan 2021.
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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.
Andrei Brateanu, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hill Rom tracking device in people with Physician Patient Relation and Burnout, Professional, run by The Cleveland Clinic 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 6 Jan 2021. 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?
Time spent at bedside (time frame: through study completion, one year). 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 6 Jan 2021.