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Feasibility, Appropriateness, Meaningfulness and Effectiveness of Bedside Shift Reporting

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ClinicalTrials.gov Identifier: NCT02714582
Recruitment Status : Unknown
Verified October 2016 by University Hospital, Ghent.
Recruitment status was:  Active, not recruiting
First Posted : March 21, 2016
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
University Ghent
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Nursing Bedside Shift Report Patient Participation Behavioral: Bedside shift report Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Patient Participation at the Bedside: Feasibility, Appropriateness, Meaningfulness and Effectiveness of Bedside Shift Reporting. A Matched Controlled Trial
Study Start Date : March 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: 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
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).
Other Name: Bedside shift handover

No Intervention: No bedside shift report
The control group will not use bedside shift report, but will use the regular nurse shift report without participation of the patient



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Change in Quality of Care [ Time Frame: 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.


  2. Change in Individualized Care (patient) [ Time Frame: 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.


  3. Change in Individualized Care (nurse) [ Time Frame: 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.


  4. Change in Job Satisfaction [ Time Frame: 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.


  5. Change in Turnover Intention (1) [ Time Frame: 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.


  6. Change in Turnover Intention (2) [ Time Frame: 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.


  7. Change in Coordination of the Care Process [ Time Frame: 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.


  8. Change in Communication [ Time Frame: 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.


  9. Change in Work Interruptions (1) [ Time Frame: 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.


  10. Change in Work Interruptions (2) [ Time Frame: 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').


  11. Change in Patient Participation [ Time Frame: 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.


  12. Change in Hospital Acquired Pressure Ulcers (HAPU) [ Time Frame: 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.


  13. Change in Patient Falls [ Time Frame: 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.


  14. Change in Unnecessary New Intravenous Drips [ Time Frame: 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.


  15. Change in Length of Stay [ Time Frame: 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.


  16. Change in Unplanned Readmission [ Time Frame: 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.


  17. Change in Pain [ Time Frame: 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.


  18. Change in Duration of the shift report [ Time Frame: 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.


  19. Feasibility [ Time Frame: 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.

  20. Applicability [ Time Frame: 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.

  21. Meaningfulness [ Time Frame: 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.

  22. 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) ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714582


Locations
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Belgium
AZ Sint-Jan
Brugge, Belgium, 8000
AZ Alma
Eeklo, Belgium, 9900
AZ Sint-Lucas
Ghent, Belgium, 9000
Ghent University Hospital
Ghent, Belgium, 9000
AZ Virge Jessa
Hasselt, Belgium, 3500
AZ Groeninge
Kortrijk, Belgium, 8500
AZ Lokeren
Lokeren, Belgium, 9160
AZ Oudenaarde
Oudenaarde, Belgium, 9700
Sponsors and Collaborators
University Hospital, Ghent
University Ghent
Investigators
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Principal Investigator: Ann Van Hecke, MSc, PhD Ghent University/Ghent University Hospital
Principal Investigator: Kristof Eeckloo, LMM, PhD Ghent University/Ghent University Hospital
Principal Investigator: Wim Van Biesen, MD, PhD Ghent University/Ghent University Hospital
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02714582    
Other Study ID Numbers: HA/RP/2015/086/EC
B670201627044 ( Other Identifier: Ethics Committee UZ Gent )
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Ghent:
Shift report
Bedside
Nursing
Matched controlled trial
Mixed method
Patient participation