Condition category
Not Applicable
Date applied
02/04/2013
Date assigned
15/04/2013
Last edited
15/04/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Ward rounds are essential for inpatients’ medical care. During wards rounds, important decisions are made according to patient health status and results of recent investigations.
Over the last decades, rounds have moved away from the patient. Everyone agrees that there is much pressure on the time doctors spend at the bedside during rounds. Patients have shorter stays in hospitals. The patient electronic file has also become the main source of information with all its laboratory and radiological data. Nowadays, residents and medical students spend between 17% and 30% of the total round time at the bedside of patients.
The study will assess the advantages and disadvantages of spending more time at the bedside during ward rounds.

Who can participate?
Participants are the patients usually seen during attending-led ward rounds. These patients are selected by the medical team for different reasons (patient with diagnostic or therapeutic issues; patients with rare disease; etc). The patients to be seen are inpatients currently hospitalized in a 180-bed department of general internal medicine, at a University hospital.

What does the study involve?
Five pre-identified units of our department will participate; all five are comparable in terms of patient population and staffing. Every week (on Tuesdays and Thursdays), attending-led ward rounds are conducted with the whole medical team. The way in which the ward round is conducted will be randomly defined (in other words, the randomization process will allocate the round type for each round and for each unit). Patients to be seen during the ward rounds will be selected by the medical team before the allocation is communicated to the team.
The department's units taking part in the study will be randomly allocated to one of two types of attending-led ward rounds: the intervention round and the controlled traditional round.
The intervention round type involves the three steps:
(a) the resident explains the patient case to the attending, with the patient being present
(b) the attending obtained additional information from the medical team, if needed, and from the patient (interview and focused clinical exam), and
(c) the medical team’s discussion about further management in the presence of and with the patient.
The controlled round type is considered as the traditional way of performing attending-led rounds:
(a) the resident explains the case to the attending, outside the patient room (hallway or conference room)
(b) the attending and the rest of the team enter the room to interact with the patient, usually gathering additional data
(c) the medical team discusses further patient management at their convenience, either in the patient room or outside.

What are the possible benefits and risks of participating?
Possible advantages of presenting at the bedside are: to have the patients better understand their own disease, and to have them participate in the medical decision making process, which matches the current expectations of patient-centred medicine.
Possible disadvantages are: to increase patient anxiety, to discuss sensitive information during rounds, with privacy concerns for the patients.

Where is the study run from?
The Department of General Internal Medicine, University Hospital of Lausanne, Switzerland.

When is the study starting and how long is it expected to run for?
The study is expected to start in April 2013 and end in May 2014.

Who is funding the study?
The study is internally funded by the Department of General Internal Medicine. Costs are limited to payment of a research nurse to gather patient data and administrative services to data input into our patient database.

Who is the main contact?
Mr David Gachoud
david.gachoud@unil.ch

Trial website

Contact information

Type

Scientific

Primary contact

Mr David Gachoud

ORCID ID

Contact details

Educational Unit Faculty of Biology and Medicine
Department of Education and Research
Rue du Bugnon 21 BU 21/05-246
Lausanne
1011
Switzerland
+41 79 556 34 02
david.gachoud@unil.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomized controlled trial on how attending-led ward rounds fully conducted at the bedside - as compared with attending-led, traditional ward rounds - impact on patients' satisfaction, shared decision-making and disease knowledge

Acronym

Study hypothesis

During attending-led ward rounds, the attending physician is presented with a patient case. Then, the attending interacts with both the medical team on the ward and the patient to plan further management.
Our hypothesis is that fully presenting and discussing the patient case at the bedside - with the patient being present - can improve patient knowledge about the disease, satisfaction, and patient involvement in the care process.

Ethics approval

The institutional ethics board called "Commission cantonale (VD) d'éthique de la recherche sur l'être humain" approved the research protocol on February 11, 2013, Protocol Number: 47/13

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Patient outcomes in relation to specific care processes (ward rounds)

Intervention

Intervention round type (round fully conducted at the bedside) is compared with a controlled round type (round conducted on a traditional basis).

The intervention pertains to the way in which the attending-led ward round is conducted. The intervention involves having the round fully conducted at the bedside, with the patient being present from the begin to the end of the round.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patient understanding and knowledge of one’s own disease, which includes:
1. Patient self-perception of disease understanding (post-round questionnaire, with a 4-point ordinal scale: Yes = the ward round helps me understand my disease; Rather Yes; Rather No and No)
2. Knowledge gain about the disease, which means the gain allowed by the round (assessment of knowledge before and after the round, through audio-recording of disease narratives).
3. All the diseases’ narratives undergo a numeric transformation, which gives an overall score between 3 and 9. A score of 3 means minimal understanding of the diagnosis (one point), of the treatment (one point) and of the prognosis (one point). A score of 9 means full understanding of the diagnosis (three points), of the treatment (three points) and of the prognosis (three points).

Data will be gathered from the patients during two eight-week study periods. These periods can be considered as being the time intervals for outcomes measures, although full data analysis will last longer. Therefore, outcomes measures will last for two eight-week periods, starting as soon as possible in April (at the latest April 15) to the end of May/early June. The second outcome measures' period will last from Sept 2 to October 25.

Secondary outcome measures

1. Patient satisfaction (post-round questionnaire: with satisfaction assessed on an ordinal scale from 0= not satisfied at all to 10 = fully satisfied)
2. Patient involvement in the care process (post-round questionnaire, with a 4-point ordinal scale: Yes = I felt involved in the decision made during the ward rounds; Rather Yes; Rather No and No)
3. Patient anxiety (post-round questionnaire, with a 4-point ordinal scale: Yes = the ward round made me feel anxious; Rather Yes; Rather No and No)
4. Patient concerns about privacy issues (post-round questionnaire, with a 4-point ordinal scale: Yes = the medical team should be more concerned with privacy issues during ward round; Rather Yes; Rather No and No)
5. Patient overall experience of ward rounds, an assessment through three open-ended questions. Answers will be audio-recorded and semantically analyzed. Questions include: How did you experience today’s ward rounds? What went well? And What went not so well?

Overall trial start date

15/04/2013

Overall trial end date

31/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient to be seen during the attending-led ward round
2. Patients both men and women, above 16 years old, no upper age limit
3. Informed and signed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160 participants, according to sample size calculation

Participant exclusion criteria

1. Cognitive impairment (documented dementia or positive dementia screening test)
2. Delirium (documented or positive screening test)
3. Altered consciousness
4. Terminally-ill state
5. Significant communication issue (language barrier; dysarthria; dysphasia; hearing impairment)

Recruitment start date

15/04/2013

Recruitment end date

31/05/2014

Locations

Countries of recruitment

Switzerland

Trial participating centre

Educational Unit Faculty of Biology and Medicine
Lausanne
1011
Switzerland

Sponsor information

Organisation

Lausanne University Hospital (Switzerland)

Sponsor details

c/o Prof. Gérard Waeber
Department of Internal Medicine - Head
BH - 10
Rue du Bugnon 46
Lausanne
1011
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of Lausanne - Department of General Internal Medicine (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes