Clinical trial NCT02714582: Feasibility, Appropriateness, Meaningfulness and Effectiveness of Bedside Shift Reporting
Official title: Patient Participation at the Bedside: Feasibility, Appropriateness, Meaningfulness and Effectiveness of Bedside Shift Reporting. A Matched Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing
Bedside Shift Report
Patient Participation
Keywords: Shift report
Bedside
Nursing
Matched controlled trial
Mixed method
Patient participation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2016-03-21
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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:

1. The development and fine-tuning of a BSR-intervention and implementation protocol by using diagnostic interviews, co-design, and pilot studies.
2. A quantitative evaluation of BSR in comparison with care as usual on patient-related, clinical, and nurse-related outcomes.
3. 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.
4. 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.


Eligibility criteria: Patients

Inclusion Criteria:

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

Exclusion Criteria

* Dementia or other severe cognitive/mental disorders

Nurses

Inclusion Criteria:

* 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

Exclusion Criteria:

* No hands-on patient contact
* Internship

Primary outcomes:
measure: Change in Patient Empowerment
timeFrame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Secondary outcomes:
measure: Change in Quality of Care
timeFrame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
measure: Change in Individualized Care (patient)
timeFrame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
measure: Change in Individualized Care (nurse)
timeFrame: 24 months: 2 data collections during the study (baseline, 24 months)
measure: Change in Job Satisfaction
timeFrame: 24 months: 2 data collections during the study (baseline, 24 months)
measure: Change in Turnover Intention (1)
timeFrame: 24 months: 2 data collections during the study (baseline, 24 months)
measure: Change in Turnover Intention (2)
timeFrame: 24 months: 2 data collections during the study (baseline, 24 months)
measure: Change in Coordination of the Care Process
timeFrame: 24 months: 2 data collections during the study (baseline, 24 months)
measure: Change in Communication
timeFrame: 24 months: 2 data collections during the study (baseline, 24 months)
measure: Change in Work Interruptions (1)
timeFrame: 24 months: 2 data collections during the study (baseline, 24 months)
measure: Change in Work Interruptions (2)
timeFrame: 24 months: 2 data collections during the study (baseline, 24 months)
measure: Change in Patient Participation
timeFrame: 24 months: 2 data collections during the study (baseline, 24 months)
measure: Change in Hospital Acquired Pressure Ulcers (HAPU)
timeFrame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
measure: Change in Patient Falls
timeFrame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
measure: Change in Unnecessary New Intravenous Drips
timeFrame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
measure: Change in Length of Stay
timeFrame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
measure: Change in Unplanned Readmission
timeFrame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
measure: Change in Pain
timeFrame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
measure: Change in Duration of the shift report
timeFrame: 24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
measure: Feasibility
timeFrame: 12 months: 1 data collection (12 months)
measure: Applicability
timeFrame: 12 months: 1 data collection (12 months)
measure: Meaningfulness
timeFrame: 12 months: 1 data collection (12 months)
measure: Change in Intervention Fidelity
timeFrame: 24 months: 2 data collections during the study(between 12 months and 18 months; between 18 months and 24 months)
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Eeklo
country: Belgium
facility: AZ Alma
city: Ghent
country: Belgium
facility: AZ Sint-Lucas
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Hasselt
country: Belgium
facility: AZ Virge Jessa
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Lokeren
country: Belgium
facility: AZ Lokeren
city: Oudenaarde
country: Belgium
facility: AZ Oudenaarde
Study officials:
affiliation: Ghent University/Ghent University Hospital
name: Ann Van Hecke, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ghent University/Ghent University Hospital
name: Kristof Eeckloo, LMM, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ghent University/Ghent University Hospital
name: Wim Van Biesen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: 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/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.