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临床试验/NCT02714582
NCT02714582已完成不适用

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

University Hospital, Ghent16 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
750
试验地点
16
主要终点
Change in Patient Empowerment

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • 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

排除标准

  • No hands-on patient contact
  • Internship

结局指标

主要结局

Change in Patient Empowerment

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (16)

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