- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03210987
Effects of Bedside Compared to Outside the Room Case Presentation
Effect of Bedside Patient Case Presentation Compared to Outside the Room Case Presentation on Patient Perception of Quality of Care and Patient Outcomes: a Randomized-controlled, Multicenter Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Patient-centered care may be defined as "providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions". Involving patients in all steps of the healthcare process is thus important. Yet, best presentation of patients' cases during ward rounds remains unknown. During outside the room patient case presentation, the medical team discusses difficult patient or medical issues in the team, and later presents a "patient-friendly" synthesis to the patient. Bedside patient case presentation, on the other hand, allows a patient to be part of the whole team discussion. Yet, there is concern that patients may be unable to cope with the magnitude of medical information and misunderstandings may occur. Currently, there is equipoise regarding both possibilities of patient case presentation with an important lack of trial data. We thus aim to compare the effect of bedside patient case presentation with outside the room patient case presentation during ward rounds ("Chefarztvisite") on different patient- and physician-related endpoints.
Therefore, this randomized controlled trial aims to test the hypothesis that outside the room patient case presentation compared to bedside patient case presentation results in better outcomes across different dimensions including patient understanding and perception of quality of care as well as patient outcomes, physicians' preferences, perception of quality and effectiveness, and timing of the ward rounds, respectively.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Basel, Switzerland, 4056
- University Hospital Basel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Consecutive adult (>18 years) medical inpatients during their first ward round independently of their underlying disease and reason for hospital stay.
Exclusion Criteria:
- Patients with cognitive impairment, such as dementia/delirium
- Patients with paracusia.
- Patients who do not understand local language(s).
- Patients already included in this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: patient case presentation Bedside
In the bedside presentation group, patient case presentation and discussions will be at bedside with direct involvement of the patient as needed.
|
Patient case presentation in absence or presence of Patient at bedside.
Other Names:
|
|
Active Comparator: patient case presentation Outside-the-room
In the outside the room condition, case presentation and discussions will take place outside without the patient being present.
After the case presentation and discussions the team will enter the room and give the patient a short summary of the medical situation, complete the medical information and examine the patient, as needed, and discuss the next steps.
|
Patient case presentation Outside-the-room.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective understanding of disease and management
Time Frame: post ward round up to 36 h
|
average of the visual analog scale (VAS) score across the following three dimensions rated by the patient (0 "I have no knowledge at all about the situation" to 100 "I have best possible knowledge about the situation": I. Patients' subjective understanding of the disease II.
Patients' subjective understanding of the therapeutic concept III.
Patients' subjective understanding of the next steps
|
post ward round up to 36 h
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement understanding
Time Frame: post ward round up to 36 h
|
Patients' perception about how well the current ward round improved the understanding of each of these three components, i.e., current disease, therapeutic concept, and next steps (VAS, 0-100)
|
post ward round up to 36 h
|
|
Objective understanding of disease and management
Time Frame: post ward round up to 36 h
|
Comparison of patients' recall information regarding current main diagnosis, main therapeutic measures and next steps (qualitative information) with medical chart information. Answers regarding current main diagnosis will be categorized as: (1) patient correctly states both pathophysiology and localization, (2) patient correctly states either pathophysiology or localization, (3) patient states neither pathophysiology nor localization (correctly) but correctly states symptoms, (4) patient correctly states that the current diagnosis is still unclear, (5) patient states incorrect information, (6) patient correctly states a secondary diagnosis relevant for the current hospitalization Answers regarding main therapeutic measures and next steps will be categorized as: (1) correct (regarding main diagnosis), (2) incorrect (regarding main diagnosis), (3) correct (regarding secondary diagnosis), (4) incorrect (regarding secondary diagnosis) |
post ward round up to 36 h
|
|
Overall quality of care
Time Frame: post ward round up to 36 h
|
Patients' perception (each rated on a VAS 0-100) regarding: comprehensibility of information during ward round, satisfaction with care, confidence in the medical team, perceived competence of the medical team, perceived interpersonal behavior during ward round, affective response of the patients, adequacy of ward round duration (includes two additional questions asking for patients' estimations on how much time the medical team spent on their case within the ward round as well as on average per day (estimates in minutes))
|
post ward round up to 36 h
|
|
Follow up health status
Time Frame: 30 days follow up after study inclusion
|
Patients' perceived health status (EuroQol five dimensions questionnaire)
|
30 days follow up after study inclusion
|
|
Follow up understanding
Time Frame: 30 days follow up after study inclusion
|
Patients' subjective (VAS 0-100) and objective (recall as compared to objective medical chart information) understanding
|
30 days follow up after study inclusion
|
|
Follow up quality of hospital care
Time Frame: 30 days follow up after study inclusion
|
Patients' overall perspective of hospital care (Hospital Consumer Assessment of Healthcare Providers and Systems, HCAHPS)
|
30 days follow up after study inclusion
|
|
Follow up readmission
Time Frame: 30 days follow up after study inclusion
|
Patients' readmission rate since study inclusion
|
30 days follow up after study inclusion
|
|
Follow up duration of hospitalization
Time Frame: 30 days follow up after study inclusion
|
total duration of hospitalization
|
30 days follow up after study inclusion
|
|
Treating team satisfaction
Time Frame: post ward round up to 96 h
|
The treating team's satisfaction with ward round (rated on a VAS 0-100)
|
post ward round up to 96 h
|
|
Treating team performance
Time Frame: post ward round up to 96 h
|
The treating team's perceived performance in the ward round (each rated on a VAS 0-100): time management of the ward round, interaction within the medical team and with the patient during ward round, perceived time management and feasibility
|
post ward round up to 96 h
|
|
Treating team affect
Time Frame: post ward round up to 96 h
|
The treating team's affective response (rated on a VAS 0-100)
|
post ward round up to 96 h
|
|
Treating team preference
Time Frame: post ward round up to 96 h
|
The treating team's preference of bedside compared to outside the room patient case presentation (rated on a semantic differential ranging from 1 "I prefer bedside ward rounds" to 6 "I prefer ward rounds outside the room")
|
post ward round up to 96 h
|
|
Timeliness
Time Frame: during ward round which may last from 5 up to 30 minutes
|
duration of the ward round (minutes)
|
during ward round which may last from 5 up to 30 minutes
|
|
Communication-specific items during ward rounds
Time Frame: during ward round which may last from 5 up to 30 minutes
|
Rated by investigator (nominal 3-point scale (1 = yes; 2 = no; 3 = not applicable): structuring of conversation, use of patient-centered techniques, use of physician-centered techniques, dealing with emotions, conveying of complex information, negotiation of shared concepts of disease and treatment, realization of shared decision making, breaking bad news
|
during ward round which may last from 5 up to 30 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sabina Hunziker, Prof., Medical Communication, Department of Psychosomatic Medicine, University Hospital Basel, and University of Basel, Switzerland
Publications and helpful links
General Publications
- Lehmann LS, Brancati FL, Chen MC, Roter D, Dobs AS. The effect of bedside case presentations on patients' perceptions of their medical care. N Engl J Med. 1997 Apr 17;336(16):1150-5. doi: 10.1056/NEJM199704173361606.
- Chauke HL, Pattinson RC. Ward rounds -- bedside or conference room? S Afr Med J. 2006 May;96(5):398-400. No abstract available.
- O'Leary KJ, Killarney A, Hansen LO, Jones S, Malladi M, Marks K, M Shah H. Effect of patient-centred bedside rounds on hospitalised patients' decision control, activation and satisfaction with care. BMJ Qual Saf. 2016 Dec;25(12):921-928. doi: 10.1136/bmjqs-2015-004561. Epub 2015 Dec 1.
- Ramirez J, Singh J, Williams AA. Patient Satisfaction with Bedside Teaching Rounds Compared with Nonbedside Rounds. South Med J. 2016 Feb;109(2):112-5. doi: 10.14423/SMJ.0000000000000419.
- Seo M, Tamura K, Morioka E, Shijo H. Impact of medical round on patients' and residents' perceptions at a university hospital in Japan. Med Educ. 2000 May;34(5):409-11. doi: 10.1046/j.1365-2923.2000.00516.x. No abstract available.
- Becker C, Gross S, Gamp M, Beck K, Amacher SA, Mueller J, Bohren C, Blatter R, Schaefert R, Schuetz P, Leuppi J, Bassetti S, Hunziker S. Patients' Preference for Participation in Medical Decision-Making: Secondary Analysis of the BEDSIDE-OUTSIDE Trial. J Gen Intern Med. 2022 Sep 9. doi: 10.1007/s11606-022-07775-z. Online ahead of print.
- Gross S, Beck K, Becker C, Gamp M, Mueller J, Loretz N, Amacher SA, Bohren C, Gaab J, Schuetz P, Mueller B, Fux CA, Leuppi JD, Schaefert R, Langewitz W, Trendelenburg M, Breidthardt T, Eckstein J, Osthoff M, Bassetti S, Hunziker S. Perception of physicians and nursing staff members regarding outside versus bedside ward rounds: ancillary analysis of the randomised BEDSIDE-OUTSIDE trial. Swiss Med Wkly. 2022 Jan 19;152:w30112. doi: 10.4414/smw.2022.w30112. eCollection 2022 Jan 17.
- Becker C, Gamp M, Schuetz P, Beck K, Vincent A, Hochstrasser S, Metzger K, Widmer M, Thommen E, Mueller B, Fux CA, Leuppi JD, Schaefert R, Langewitz W, Trendelenburg M, Breidthardt T, Eckstein J, Osthoff M, Bassetti S, Hunziker S; BEDSIDE-OUTSIDE Study Group. Effect of Bedside Compared With Outside the Room Patient Case Presentation on Patients' Knowledge About Their Medical Care : A Randomized, Controlled, Multicenter Trial. Ann Intern Med. 2021 Sep;174(9):1282-1292. doi: 10.7326/M21-0909. Epub 2021 Jun 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Visitenstudie (2017-00991)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bedside Patient Case Presentation
-
University Hospital, GhentUniversity GhentCompletedPatient Participation | Nursing | Bedside Shift ReportBelgium
-
Reproductive Medicine Associates of New JerseyCompletedEach Patient is Both Case and Control | 1 Embryo Will be Biopsied and 1 Embryo is NotUnited States
-
Hossam Adly MohamedRecruitingPeripheral Vascular Diseases and Presentation in Patient With Autoimmune DiseasesEgypt
-
Seattle Children's HospitalCompletedCare Coordination | Medically Complex Children | Case Manager | Care Manager | Collaborative Care | Disease Management | Patient Care Team or Organization | Managed Care | Children With Chronic Conditions | Children With Special Health Care Needs | Shared Care Plan | Patient Care Plan | Health Care and Resource... and other conditionsUnited States
Clinical Trials on patient case presentation bedside
-
University of ArkansasNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHospital-based Violence Intervention | Community Firearm Violence | Firearm BehaviorsUnited States
-
Taipei Medical University WanFang HospitalCompletedAortic Dissection | Pulmonary Thromboembolism | May-Thurner Syndrome | Thrombosis in Left Atrium and Right Axillary Artery | Double IVCTaiwan
-
University of California, San FranciscoCompleted
-
Hawler Medical UniversityArab Board of Health Specializations, IraqCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedWeb Tutorial Based on Case Vignettes for Teaching Literature Critical Assessment to Nursing StudentsNew Educational TechnologiesFrance
-
Centre Hospitalier Universitaire de NīmesRecruiting
-
OridionHerzog HospitalCompleted
-
University of Colorado, DenverRobert Wood Johnson FoundationTerminatedHealthyUnited States
-
Johns Hopkins Bloomberg School of Public HealthNational Institute of Mental Health (NIMH)CompletedSuicide | Depressive Symptoms | Substance Use | Mental Health | SurveillanceUnited States
-
Indiana UniversityCompletedColorectal CancerUnited States