Feasibility, Appropriateness, Meaningfulness and Effectiveness of Bedside Shift Reporting

Nursing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714582
• Other study ID #: HA/RP/2015/086/EC
• Secondary ID: B670201627044
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: May 2018

Study information

• Verified date: June 2021
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bedside Shift Report
• Nursing
• Patient Participation

Intervention

Behavioral:
• Bedside shift report
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).

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan	Brugge
Belgium	AZ Alma	Eeklo
Belgium	AZ Sint-Lucas	Ghent
Belgium	Ghent University Hospital	Ghent
Belgium	AZ Virge Jessa	Hasselt
Belgium	AZ Groeninge	Kortrijk
Belgium	AZ Lokeren	Lokeren
Belgium	AZ Oudenaarde	Oudenaarde

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (11)

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View 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. — View 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. Review. — View 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;(6):CD009979. doi: 10.1002/14651858.CD009979.pub2. Review. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Secondary	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.	24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Secondary	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.	24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Secondary	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.	24 months: 2 data collections during the study (baseline, 24 months)
Secondary	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.	24 months: 2 data collections during the study (baseline, 24 months)
Secondary	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.	24 months: 2 data collections during the study (baseline, 24 months)
Secondary	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.	24 months: 2 data collections during the study (baseline, 24 months)
Secondary	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.	24 months: 2 data collections during the study (baseline, 24 months)
Secondary	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.	24 months: 2 data collections during the study (baseline, 24 months)
Secondary	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.	24 months: 2 data collections during the study (baseline, 24 months)
Secondary	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').	24 months: 2 data collections during the study (baseline, 24 months)
Secondary	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.	24 months: 2 data collections during the study (baseline, 24 months)
Secondary	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.	24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Secondary	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.	24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Secondary	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.	24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Secondary	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.	24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Secondary	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.	24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Secondary	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.	24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Secondary	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.	24 months: 4 data collections during the study (baseline, 12 months, 18 months, 24 months)
Secondary	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.	12 months: 1 data collection (12 months)
Secondary	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.	12 months: 1 data collection (12 months)
Secondary	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.	12 months: 1 data collection (12 months)
Secondary	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.	24 months: 2 data collections during the study(between 12 months and 18 months; between 18 months and 24 months)