Bedside Patient Case PresentationNCT03210987
Effects of Bedside Compared to Outside the Room Case Presentation
A study testing patient case presentation bedside and patient case presentation Outside-the-room in people with Bedside Patient Case Presentation and Outside-the-room Patient Case Presentation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Patient case presentations during ward rounds can take place at the bedside or outside the room. The best approach to patient case presentation is yet unclear. Thus, the overall aim of this multicenter, randomized-controlled study is to test the hypothesis that outside the room patient case presentation compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bedside Patient Case Presentation, Outside-the-room Patient Case Presentation
- What is being tested?
- patient case presentation bedside and patient case presentation Outside-the-room
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,092 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Jul 2017to 20 Oct 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive adult (>18 years) medical inpatients during their first ward round independently of their underlying disease and reason for hospital stay.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Patient case presentations during ward rounds can take place at the bedside or outside the room. The best approach to patient case presentation is yet unclear. Thus, the overall aim of this multicenter, randomized-controlled study is 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.
Read the 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.
- Being tested
- patient case presentation bedside, patient case presentation Outside-the-room
- Keywords
- ward round, patient case presentation, communication, patient-centered care
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient case presentation bedsideProcedure or surgery
Also called teaching round, bedside round, ward round
Patient case presentation in absence or presence of Patient at bedside.
patient case presentation Outside-the-roomProcedure or surgery
Patient case presentation Outside-the-room.
| Study group | Role | What they receive |
|---|---|---|
| patient case presentation Bedside | Active comparator | In the bedside presentation group, patient case presentation and discussions will be at bedside with direct involvement of the patient as needed. Receives: Procedure: patient case presentation bedside |
| patient case presentation Outside-the-room | Active comparator | 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. Receives: Procedure: patient case presentation Outside-the-room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective understanding of disease and management
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
Measured: post ward round up to 36 h
Secondary outcomes (14)
Improvement understanding
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)
Measured: post ward round up to 36 h
Objective understanding of disease and management
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)
Measured: post ward round up to 36 h
Overall quality of care
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))
Measured: post ward round up to 36 h
Follow up health status
Patients' perceived health status (EuroQol five dimensions questionnaire)
Measured: 30 days follow up after study inclusion
Follow up understanding
Patients' subjective (VAS 0-100) and objective (recall as compared to objective medical chart information) understanding
Measured: 30 days follow up after study inclusion
Follow up quality of hospital care
Patients' overall perspective of hospital care (Hospital Consumer Assessment of Healthcare Providers and Systems, HCAHPS)
Measured: 30 days follow up after study inclusion
Follow up readmission
Patients' readmission rate since study inclusion
Measured: 30 days follow up after study inclusion
Follow up duration of hospitalization
total duration of hospitalization
Measured: 30 days follow up after study inclusion
Treating team satisfaction
The treating team's satisfaction with ward round (rated on a VAS 0-100)
Measured: post ward round up to 96 h
Treating team performance
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
Measured: post ward round up to 96 h
Treating team affect
The treating team's affective response (rated on a VAS 0-100)
Measured: post ward round up to 96 h
Treating team preference
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")
Measured: post ward round up to 96 h
Timeliness
duration of the ward round (minutes)
Measured: during ward round which may last from 5 up to 30 minutes
Communication-specific items during ward rounds
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
Measured: during ward round which may last from 5 up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start11 Jul 2017
- Primary completion21 Sep 2019
- Study completion20 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bedside Patient Case PresentationStudies of the same condition, open and under way.
- 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
- Model description
- On the day before the ward round, patients will be randomized 1:1 into one of both study arms. In one study arm, patient case presentation will be performed at bedside. In the other study arm, patient case presentation will be performed outside the room.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,092 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Aarau, Kantonsspital Liestal
- Responsible party
- Sponsor
- Investigators
- Sabina Hunziker, Prof., Principal investigator, Medical Communication, Department of Psychosomatic Medicine, University Hospital Basel, and University of Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210987
- Sponsor's protocol ID
- Visitenstudie (2017-00991)
- Status last verified
- Jan 2020
- First submitted
- 27 Jun 2017
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 9099660Chauke HL, Pattinson RC. Ward rounds -- bedside or conference room? S Afr Med J. 2006 May;96(5):398-400. No abstract available.
PubMed 16751910O'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.
PubMed 26628552Ramirez 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.
PubMed 26840968Seo 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.
PubMed 10760128Gross S, Becker C, Beck K, Memma V, Gaab J, Schutz P, Leuppi JD, Schaefert R, Langewitz W, Trendelenburg M, Breidthardt T, Eckstein J, Osthoff M, Bassetti S, Hunziker S. Occurrence of sensitive topics during ward round: an ancillary analysis of the BEDSIDE-OUTSIDE trial. BMJ Open. 2023 Sep 21;13(9):e073584. doi: 10.1136/bmjopen-2023-073584.
PubMed 37734895Becker 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. 2023 Apr;38(5):1180-1189. doi: 10.1007/s11606-022-07775-z. Epub 2022 Sep 9.
PubMed 36085211Gross 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.
PubMed 35072414Becker 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.
PubMed 34181449
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03210987
- Acronym / sponsor ID
- Visitenstudie (2017-00991)
- Keywords
- ward round, patient case presentation, communication, patient-centered care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,092 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Kantonsspital Aarau, Kantonsspital Liestal
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 21 Sep 2019 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 7 Jul 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.
Patient case presentations during ward rounds can take place at the bedside or outside the room. The best approach to patient case presentation is yet unclear. Thus, the overall aim of this multicenter, randomized-controlled study is 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- On the day before the ward round, patients will be randomized 1:1 into one of both study arms. In one study arm, patient case presentation will be performed at bedside. In the other study arm, patient case presentation will be performed outside the room.
| Arm | Type | Receives |
|---|---|---|
| patient case presentation Bedside | Active comparator | Procedure: patient case presentation bedsideIn the bedside presentation group, patient case presentation and discussions will be at bedside with direct involvement of the patient as needed. |
| patient case presentation Outside-the-room | Active comparator | Procedure: patient case presentation Outside-the-roomIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive adult (>18 years) medical inpatients during their first ward round independently of their underlying disease and reason for hospital stay.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| patient case presentation bedsideAlso: teaching round, bedside round, ward roundPatient case presentation in absence or presence of Patient at bedside. | Procedure or surgery | patient case presentation Bedside |
| patient case presentation Outside-the-roomPatient case presentation Outside-the-room. | Procedure or surgery | patient case presentation Outside-the-room |
Primary outcome
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
14 secondary outcomes
Improvement understanding
Time frame: post ward round up to 36 h
Objective understanding of disease and management
Time frame: post ward round up to 36 h
Overall quality of care
Time frame: post ward round up to 36 h
Follow up health status
Time frame: 30 days follow up after study inclusion
Follow up understanding
Time frame: 30 days follow up after study inclusion
Follow up quality of hospital care
Time frame: 30 days follow up after study inclusion
Follow up readmission
Time frame: 30 days follow up after study inclusion
Follow up duration of hospitalization
Time frame: 30 days follow up after study inclusion
Treating team satisfaction
Time frame: post ward round up to 96 h
Treating team performance
Time frame: post ward round up to 96 h
Treating team affect
Time frame: post ward round up to 96 h
Treating team preference
Time frame: post ward round up to 96 h
Timeliness
Time frame: 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
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 23 Jan 2020.
- Background: PubMed 9099660Lehmann 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.
- Background: PubMed 16751910Chauke HL, Pattinson RC. Ward rounds -- bedside or conference room? S Afr Med J. 2006 May;96(5):398-400. No abstract available.
- Background: PubMed 26628552O'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.
- Background: PubMed 26840968Ramirez 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.
- Background: PubMed 10760128Seo 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.
- Derived from this study: PubMed 37734895Gross S, Becker C, Beck K, Memma V, Gaab J, Schutz P, Leuppi JD, Schaefert R, Langewitz W, Trendelenburg M, Breidthardt T, Eckstein J, Osthoff M, Bassetti S, Hunziker S. Occurrence of sensitive topics during ward round: an ancillary analysis of the BEDSIDE-OUTSIDE trial. BMJ Open. 2023 Sep 21;13(9):e073584. doi: 10.1136/bmjopen-2023-073584.
- Derived from this study: PubMed 36085211Becker 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. 2023 Apr;38(5):1180-1189. doi: 10.1007/s11606-022-07775-z. Epub 2022 Sep 9.
- Derived from this study: PubMed 35072414Gross 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.
- Derived from this study: PubMed 34181449Becker 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.
- Individual participant dataSharing planned: No
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.
Sabina Hunziker, Prof. principal investigator
Medical Communication, Department of Psychosomatic Medicine, University Hospital Basel, and University of Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient case presentation bedside and patient case presentation Outside-the-room in people with Bedside Patient Case Presentation and Outside-the-room Patient Case Presentation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 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 23 Jan 2020. 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 Switzerland. 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?
Subjective understanding of disease and management (time frame: post ward round up to 36 h). 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 NCT03210987, which also lists 9 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 23 Jan 2020.