NursingNCT02714582

Feasibility, Appropriateness, Meaningfulness and Effectiveness of Bedside Shift Reporting

A study testing Bedside shift report in people with Nursing and Bedside Shift Report, run by University Hospital, Ghent at 8 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Nursing, Bedside Shift Report, Patient Participation
What is being tested?: Bedside shift report
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 750 participants
Where: 8 sitesBelgium
Study dates: Mar 2016to May 2018
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

Admitted on a participating hospital ward
Be conscious
Speak Dutch
Participated in at least 3 bedside shift reports
Work on a participating hospital ward
Have at least six months of experience on the ward
Have participated in 10 bedside shift reports or more

Who cannot join

Dementia or other severe cognitive/mental disorders
Nurses
No hands-on patient contact
Internship

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Belgium8 sites

AZ Sint-Jan
Bruges, 8000
AZ Alma
Eeklo, 9900
AZ Sint-Lucas
Ghent, 9000
Ghent University Hospital
Ghent, 9000
AZ Virge Jessa
Hasselt, 3500
AZ Groeninge
Kortrijk, 8500
AZ Lokeren
Lokeren, 9160
AZ Oudenaarde
Oudenaarde, 9700

Other trials in Belgium

About this study

Official title: Patient Participation at the Bedside: Feasibility, Appropriateness, Meaningfulness and Effectiveness of Bedside Shift Reporting. A Matched Controlled Trial

Hospitals face the challenge to continually improve their quality of care. In order to achieve this goal, they have to focus on both improving clinical practice and increasing the involvement of patients in the healthcare process. Both factors are equally important to quality of care. The World Health Organization highlights the role that patients and their family could play in the improvement of healthcare. Active patient participation reduces communication errors, increases patient empowerment and is associated with positive health and psychosocial outcomes. A possible strategy to improve patient participation through communication can be bedside shift report (BSR).

Bedside shift report is a process where shift-to-shift report between nurses is, if approved by the patient, executed at the patient's bedside in order to improve the patient's involvement. Bedside shift report has the potential to result in more patient satisfaction, better clinical outcomes, improvement of health education and enhanced team coherence. Preliminary research indicates that BSR decreases safety incidents and adverse events and readmissions, positively influences staff satisfaction, offers beneficial financial effects by reducing nurses' overtime, and allows direct patient care to start earlier.

Despite of these effects, rigorous and large-scale scientific research on this topic is lacking. Currently, the available evidence is scarce and mostly consists of single case or small-scale studies. Longitudinal results on effectiveness and sustainability of BSR are also unknown or inconclusive. There is a need for an increased number of controlled studies to evaluate the impact of BSR on patient, staff and economic outcomes and its longitudinal results.

The aim of this study is four-folded:

The development and fine-tuning of a BSR-intervention and implementation protocol by using diagnostic interviews, co-design, and pilot studies.
A quantitative evaluation of BSR in comparison with care as usual on patient-related, clinical, and nurse-related outcomes.
A qualitative evaluation of the feasibility, appropriateness and meaningfulness of BSR as a method to improve communication and patient participation with a particular interest in the experience of benefits and disadvantages by healthcare professionals and patients.
A process evaluation of BSR to determine the intervention fidelity and to assess the evolution of BSR over the period of the study (e.g. adaptations, consistent practice).

The study design was based on the Medical Research Council-framework for developing and evaluating complex interventions. Power calculation indicates a minimum of 5 experimental wards with 35 patients should be included in the study. The hospital, the specialization of the ward and the nurse-patient ratio will be used for the matched controlled assignment.

Conditions: Nursing, Bedside Shift Report, Patient Participation
Being tested: Bedside shift report
Keywords: Shift report, Bedside, Nursing, Matched controlled trial, Mixed method, Patient participation
Medical subject headings: Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bedside shift reportBehavioural
Also called Bedside shift handover
Bedside shift report is a process where shift-to-shift report between nurses is, if approved by the patient, executed at the patient's bedside in order to improve the patient's involvement (Anderson \& Mangino 2006).

Study groups in NCT02714582
Study group	Role	What they receive
Bedside shift report	Experimental	The experimental group (nurses and patients) will: * develop a tailored BSR-intervention by use of co-design, diagnostic interviews, and pilot testing * use the tailored BSR-intervention, with participation of the patient, instead of the regular nurse shift report Receives: Behavioral: Bedside shift report
No bedside shift report	No intervention	The control group will not use bedside shift report, but will use the regular nurse shift report without participation of the patient

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Patient Empowerment
The change in Patient Empowerment during the study will be investigated by use of repeated measures. The patterns of change between baseline, 12 months, 18 months, and 24 months will be evaluated.
The data will be collected by use of a questionnaire for patients. A validated tool, the Patient Activation Measure (PAM13), will be used.
Measured: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)

Secondary outcomes (22)

Change in Quality of Care
The change in Quality of Care during the study will be investigated by use of repeated measures. The patterns of change between baseline, 12 months, 18 months, and 24 months will be evaluated.
The data will be collected by use of a questionnaire for patients. A validated tool, the QPP (Quality of care from the Patient's Perspective), will be used.
Measured: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Individualized Care (patient)
The change in Individualized Care during the study will be investigated by use of repeated measures. For patients, the patterns of change between baseline, 12 months, 18 months, and 24 months will be evaluated.
The data will be collected by use of a questionnaire for patients. A validated tool, the ICS (Individualized Care Scale), will be used.
Measured: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Individualized Care (nurse)
The change in Individualized Care during the study will be investigated by use of repeated measures. For nurses, the patterns of change between baseline and 24 months will be evaluated.
The data will be collected by use of a questionnaire for nurses. A validated tool, the ICS (Individualized Care Scale), will be used.
Measured: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Job Satisfaction
The change in Job Satisfaction during the study will be investigated by use of repeated measures. The patterns of change between baseline and 24 months will be evaluated.
The data will be collected by use of a questionnaire for nurses. A validated tool, the MOAQ-JSS (Michigan Organizational Assessment Questionnaire - Job Satisfaction Subscale), will be used.
Measured: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Turnover Intention (1)
The change in Turnover Intention during the study will be investigated by use of repeated measures. The patterns of change between baseline and 24 months will be evaluated.
The data will be collected by use of a questionnaire for nurses. A validated tool, the MOAQ-TIS (Michigan Organizational Assessment Questionnaire - Turnover Intention Subscale), will be used.
Measured: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Turnover Intention (2)
The change in Turnover Intention during the study will be investigated by use of repeated measures. The patterns of change between baseline and 24 months will be evaluated.
The data will be collected by use of a questionnaire for nurses. Two questions from the RN4CAST (Nurse Forecasting: Human Resources Planning in Nursing) are used.
Measured: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Coordination of the Care Process
The change in Coordination of the Care Process during the study will be investigated by use of repeated measures. The patterns of change between baseline and 24 months will be evaluated.
The data will be collected by use of a questionnaire for nurses. A validated tool, the CPSET-COR (Care Process Self Evaluation Tool - Coordination subscale), will be used.
Measured: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Communication
The change in Communication during the study will be investigated by use of repeated measures. The patterns of change between baseline and 24 months will be evaluated.
The data will be collected by use of a questionnaire for nurses. A validated tool, the CPSET-COM (Care Process Self Evaluation Tool - Communication subscale), will be used.
Measured: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Work Interruptions (1)
The change in Work Interruptions during the study will be investigated by use of repeated measures. The patterns of change between baseline and 24 months will be evaluated.
The data will be collected by use of a questionnaire for nurses. A non-validated tool to measure nurses' perceptions on work interruptions, developed by the researchers, will be used.
Measured: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Work Interruptions (2)
The change in Work Interruptions during the study will be investigated by use of repeated measures. The patterns of change between baseline and 24 months will be evaluated..
The data will be collected from electronic databases from within the participating hospitals that measure the number of work interruptions ('calls for assistance').
Measured: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Patient Participation
The change in Patient Participation during the study will be investigated by use of repeated measures. The patterns of change between baseline and 24 months will be evaluated.
The data will be collected by use of a questionnaire for nurses. Five questions from a validated tool, the PaCT-HCW (Patient Participation Culture Tool for Healthcare Workers), will be used.
Measured: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Hospital Acquired Pressure Ulcers (HAPU)
The change in incidence of HAPU's during the study will be investigated by use of repeated measures. The patterns of change between baseline, 12 months, 18 months, and 24 months will be evaluated.
The data will be collected from the patient's medical file. The timeframe for registration is from the admission on the ward until discharge from the ward. Any HAPU's during the patient's stay on the ward on heel and sacrum will registered by use of the NPUAP/EPUAP classification system.
Measured: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Patient Falls
The change in incidence of Patient Falls during the study will be investigated by use of repeated measures. The patterns of change between baseline, 12 months, 18 months, and 24 months will be evaluated.
The data will be collected from the patient's medical file. The timeframe for registration is admission on the ward until discharge from the ward. Any patient falls during the patient's stay on the ward will registered.
Measured: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Unnecessary New Intravenous Drips
The change in incidence of Unnecessary New Intravenous Drips during the study will be investigated by use of repeated measures. The patterns of change between baseline, 12 months, 18 months, and 24 months will be evaluated.
The data will be collected from the patient's medical file. The timeframe for registration is from admission on the ward until discharge from the ward with a maximum of 30 days. Newly placed intravenous drips without explicit physician indication will be registered.
Measured: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Length of Stay
The change in Length of Stay during the study will be investigated by use of repeated measures. The patterns of change between baseline, 12 months, 18 months, and 24 months will be evaluated.
The data will be collected from the patient's medical file. The total length of stay on the ward will be registered.
Measured: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Unplanned Readmission
The change in incidence of Unplanned Readmissions during the study will be investigated by use of repeated measures. The patterns of change between baseline, 12 months, 18 months, and 24 months will be evaluated.
The data will be collected from the patient's medical file. Readmissions within 30 days in the same hospital will be registered.
Measured: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Pain
The change in Pain scores during the study will be investigated by use of repeated measures. The patterns of change between baseline, 12 months, 18 months, 24 months will be evaluated.
The data will be collected from the patient's medical file. The timeframe for registration is from admission on the ward until discharge from the ward. The first pain score after the nurse shift report will be registered each day.
Measured: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Duration of the shift report
The change in the Duration of the Shift Report during the study will be investigated by use of repeated measures. The patterns of change between baseline, 12 months,18 months, and 24 months will be evaluated.
Thirteen shift reports will be recorded during each data collection point. Based on the recordings, the duration of the shift report will be calculated.
Measured: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Feasibility
The data concerning the experienced Feasibility of BSR will be collected by use of individual, semi-structured interviews (patients) and semi-structured focus group interviews (nurses) using an interview guide. The data will be collected at 12 months.
Measured: 12 months: 1 data collection (12 months)
Applicability
The data concerning the experienced Applicability of BSR will be collected by use of individual, semi-structured interviews (patients) and semi-structured focus group interviews (nurses) using an interview guide. The data will be collected at 12 months.
Measured: 12 months: 1 data collection (12 months)
Meaningfulness
The data concerning the experienced Meaningfulness of BSR will be collected by use of individual, semi-structured interviews (patients) and semi-structured focus group interviews (nurses) using an interview guide. The data will be collected at 12 months.
Measured: 12 months: 1 data collection (12 months)
Change in Intervention Fidelity
The change in Intervention Fidelity during the study will be investigated by use of repeated measures. The patterns of change will be evaluated.
The data will be collected by use of non-participating observations. A checklist will be used. During each period (12 months until 18 months / 18 months until 24 months) 20 non-participating observations on each ward will be performed.
Measured: 24 months: 2 data collections during the study(between 12 months and 18 months; between 18 months and 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016May 2018

First posted21 Mar 2016 (estimated)
Study startMar 2016
Primary completionApr 2018
Study completionMay 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for NursingStudies of the same condition, open and under way.
More trials run by University Hospital, GhentThe 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 750 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02714582
Sponsor's protocol ID: HA/RP/2015/086/EC
Other IDs: B670201627044
Status last verified: Jun 2021
First submitted: 29 Feb 2016
Last updated: 16 Jun 2021
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Anderson CD, Mangino RR. Nurse shift report: who says you can't talk in front of the patient? Nurs Adm Q. 2006 Apr-Jun;30(2):112-22. doi: 10.1097/00006216-200604000-00008.
PubMed 16648723
Cairns LL, Dudjak LA, Hoffmann RL, Lorenz HL. Utilizing bedside shift report to improve the effectiveness of shift handoff. J Nurs Adm. 2013 Mar;43(3):160-5. doi: 10.1097/NNA.0b013e318283dc02.
PubMed 23425914
Evans D, Grunawalt J, McClish D, Wood W, Friese CR. Bedside shift-to-shift nursing report: implementation and outcomes. Medsurg Nurs. 2012 Sep-Oct;21(5):281-4, 292.
PubMed 23243785
Gonzalo JD, Wolpaw DR, Lehman E, Chuang CH. Patient-centered interprofessional collaborative care: factors associated with bedside interprofessional rounds. J Gen Intern Med. 2014 Jul;29(7):1040-7. doi: 10.1007/s11606-014-2817-x. Epub 2014 Mar 11.
PubMed 24615186
Gregory S, Tan D, Tilrico M, Edwardson N, Gamm L. Bedside shift reports: what does the evidence say? J Nurs Adm. 2014 Oct;44(10):541-5. doi: 10.1097/NNA.0000000000000115.
PubMed 25208269
Griffin SJ, Kinmonth AL, Veltman MW, Gillard S, Grant J, Stewart M. Effect on health-related outcomes of interventions to alter the interaction between patients and practitioners: a systematic review of trials. Ann Fam Med. 2004 Nov-Dec;2(6):595-608. doi: 10.1370/afm.142.
PubMed 15576546
Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/
PubMed 25057539
Longtin Y, Sax H, Leape LL, Sheridan SE, Donaldson L, Pittet D. Patient participation: current knowledge and applicability to patient safety. Mayo Clin Proc. 2010 Jan;85(1):53-62. doi: 10.4065/mcp.2009.0248.
PubMed 20042562
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available.
PubMed 23159157
Smeulers M, Lucas C, Vermeulen H. Effectiveness of different nursing handover styles for ensuring continuity of information in hospitalised patients. Cochrane Database Syst Rev. 2014 Jun 24;2014(6):CD009979. doi: 10.1002/14651858.CD009979.pub2.
PubMed 24957503
Wakefield DS, Ragan R, Brandt J, Tregnago M. Making the transition to nursing bedside shift reports. Jt Comm J Qual Patient Saf. 2012 Jun;38(6):243-53. doi: 10.1016/s1553-7250(12)38031-8.
PubMed 22737775
Malfait S, Eeckloo K, Van Opdorp L, Van Biesen W, Van Hecke A. The impact of bedside handovers on relevant clinical indicators: A matched-controlled multicentre longitudinal study. J Adv Nurs. 2020 Aug;76(8):2104-2112. doi: 10.1111/jan.14406. Epub 2020 May 25.
PubMed 32347554

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Participation at the Bedside: Feasibility, Appropriateness, Meaningfulness and Effectiveness of Bedside Shift Reporting. A Matched Controlled Trial
ClinicalTrials.gov ID: NCT02714582
Acronym / sponsor ID: HA/RP/2015/086/EC
Conditions: Nursing, Bedside Shift Report, Patient Participation
Keywords: Shift report, Bedside, Nursing, Matched controlled trial, Mixed method, Patient participation
Study type: Interventional
Recruitment status: Completed
Enrolment: 750 participants (actual)
Lead sponsor: University Hospital, GhentUniversity, hospital or other
Collaborators: University Ghent
Study start: Mar 2016
Primary completion: Apr 2018 (actual)
Study completion: May 2018 (actual)
First posted: 21 Mar 2016 (estimated)
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.

The aim of this study is four-folded:

The development and fine-tuning of a BSR-intervention and implementation protocol by using diagnostic interviews, co-design, and pilot studies.
A quantitative evaluation of BSR in comparison with care as usual on patient-related, clinical, and nurse-related outcomes.
A qualitative evaluation of the feasibility, appropriateness and meaningfulness of BSR as a method to improve communication and patient participation with a particular interest in the experience of benefits and disadvantages by healthcare professionals and patients.
A process evaluation of BSR to determine the intervention fidelity and to assess the evolution of BSR over the period of the study (e.g. adaptations, consistent practice).

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bedside shift report	Experimental	Behavioral: Bedside shift reportThe experimental group (nurses and patients) will: * develop a tailored BSR-intervention by use of co-design, diagnostic interviews, and pilot testing * use the tailored BSR-intervention, with participation of the patient, instead of the regular nurse shift report
No bedside shift report	No intervention	–The control group will not use bedside shift report, but will use the regular nurse shift report without participation of the patient

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Admitted on a participating hospital ward
Be conscious
Speak Dutch
Participated in at least 3 bedside shift reports
Work on a participating hospital ward

Key exclusion criteria (4 listed)

Dementia or other severe cognitive/mental disorders
Nurses
No hands-on patient contact
Internship

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
Bedside shift reportAlso: Bedside shift handoverBedside shift report is a process where shift-to-shift report between nurses is, if approved by the patient, executed at the patient's bedside in order to improve the patient's involvement (Anderson \& Mangino 2006).	Behavioural	Bedside shift report

Primary outcome

Change in Patient Empowerment
Time frame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
The change in Patient Empowerment during the study will be investigated by use of repeated measures. The patterns of change between baseline, 12 months, 18 months, and 24 months will be evaluated. The data will be collected by use of a questionnaire for patients. A validated tool, the Patient Activation Measure (PAM13), will be used.

22 secondary outcomes

Change in Quality of Care
Time frame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Individualized Care (patient)
Time frame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Individualized Care (nurse)
Time frame: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Job Satisfaction
Time frame: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Turnover Intention (1)
Time frame: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Turnover Intention (2)
Time frame: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Coordination of the Care Process
Time frame: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Communication
Time frame: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Work Interruptions (1)
Time frame: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Work Interruptions (2)
Time frame: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Patient Participation
Time frame: 24 months: 2 data collections during the study (baseline, 24 months)
Change in Hospital Acquired Pressure Ulcers (HAPU)
Time frame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Patient Falls
Time frame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Unnecessary New Intravenous Drips
Time frame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Length of Stay
Time frame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Unplanned Readmission
Time frame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Pain
Time frame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Change in Duration of the shift report
Time frame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Feasibility
Time frame: 12 months: 1 data collection (12 months)
Applicability
Time frame: 12 months: 1 data collection (12 months)
Meaningfulness
Time frame: 12 months: 1 data collection (12 months)
Change in Intervention Fidelity
Time frame: 24 months: 2 data collections during the study(between 12 months and 18 months; between 18 months and 24 months)

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 16 Jun 2021.
Background: PubMed 16648723Anderson CD, Mangino RR. Nurse shift report: who says you can't talk in front of the patient? Nurs Adm Q. 2006 Apr-Jun;30(2):112-22. doi: 10.1097/00006216-200604000-00008.
Background: PubMed 23425914Cairns LL, Dudjak LA, Hoffmann RL, Lorenz HL. Utilizing bedside shift report to improve the effectiveness of shift handoff. J Nurs Adm. 2013 Mar;43(3):160-5. doi: 10.1097/NNA.0b013e318283dc02.
Background: PubMed 23243785Evans D, Grunawalt J, McClish D, Wood W, Friese CR. Bedside shift-to-shift nursing report: implementation and outcomes. Medsurg Nurs. 2012 Sep-Oct;21(5):281-4, 292.
Background: PubMed 24615186Gonzalo JD, Wolpaw DR, Lehman E, Chuang CH. Patient-centered interprofessional collaborative care: factors associated with bedside interprofessional rounds. J Gen Intern Med. 2014 Jul;29(7):1040-7. doi: 10.1007/s11606-014-2817-x. Epub 2014 Mar 11.
Background: PubMed 25208269Gregory S, Tan D, Tilrico M, Edwardson N, Gamm L. Bedside shift reports: what does the evidence say? J Nurs Adm. 2014 Oct;44(10):541-5. doi: 10.1097/NNA.0000000000000115.
Background: PubMed 15576546Griffin SJ, Kinmonth AL, Veltman MW, Gillard S, Grant J, Stewart M. Effect on health-related outcomes of interventions to alter the interaction between patients and practitioners: a systematic review of trials. Ann Fam Med. 2004 Nov-Dec;2(6):595-608. doi: 10.1370/afm.142.
Background: PubMed 25057539Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/
Background: PubMed 20042562Longtin Y, Sax H, Leape LL, Sheridan SE, Donaldson L, Pittet D. Patient participation: current knowledge and applicability to patient safety. Mayo Clin Proc. 2010 Jan;85(1):53-62. doi: 10.4065/mcp.2009.0248.
Background: PubMed 23159157Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available.
Background: PubMed 24957503Smeulers M, Lucas C, Vermeulen H. Effectiveness of different nursing handover styles for ensuring continuity of information in hospitalised patients. Cochrane Database Syst Rev. 2014 Jun 24;2014(6):CD009979. doi: 10.1002/14651858.CD009979.pub2.
Background: PubMed 22737775Wakefield DS, Ragan R, Brandt J, Tregnago M. Making the transition to nursing bedside shift reports. Jt Comm J Qual Patient Saf. 2012 Jun;38(6):243-53. doi: 10.1016/s1553-7250(12)38031-8.
Derived from this study: PubMed 32347554Malfait S, Eeckloo K, Van Opdorp L, Van Biesen W, Van Hecke A. The impact of bedside handovers on relevant clinical indicators: A matched-controlled multicentre longitudinal study. J Adv Nurs. 2020 Aug;76(8):2104-2112. doi: 10.1111/jan.14406. Epub 2020 May 25.
Individual participant dataSharing planned: No

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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.

Ann Van Hecke, MSc, PhD principal investigator

Ghent University/Ghent University Hospital

Kristof Eeckloo, LMM, PhD principal investigator

Ghent University/Ghent University Hospital

Wim Van Biesen, MD, PhD principal investigator

Ghent University/Ghent University Hospital

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bedside shift report in people with Nursing and Bedside Shift Report, run by University Hospital, Ghent at 8 sites in Belgium.

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 7 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 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Belgium. 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?

Change in Patient Empowerment (time frame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)). 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 NCT02714582, which also lists 12 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 16 Jun 2021.