Feasibility, Appropriateness, Meaningfulness and Effectiveness of Bedside Shift Reporting

Not Applicable

Completed

• Conditions: Bedside Shift Report; Patient Participation; Nursing
• Interventions: Behavioral: Bedside shift report

• Registration Number: NCT02714582
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-29
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-21
• Primary Completion: 2018-04
• Study Completion: 2018-05
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bedside shift report	Bedside shift report	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

Primary Outcome Measures

Name	Time	Method
Change in Patient Empowerment	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.

Secondary Outcome Measures

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

Trial Locations

Locations (8)

AZ Sint-Jan; 🇧🇪 Brugge, Belgium

AZ Sint-Lucas; 🇧🇪 Ghent, Belgium

Ghent University Hospital; 🇧🇪 Ghent, Belgium

AZ Oudenaarde; 🇧🇪 Oudenaarde, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium

AZ Alma; 🇧🇪 Eeklo, Belgium

AZ Virge Jessa; 🇧🇪 Hasselt, Belgium

AZ Lokeren; 🇧🇪 Lokeren, Belgium