Clinical trial NCT06962553: Nurses' Competence and Role in Survival Prediction and Prognostic Communication
Official title: Nurses' Competence and Role in Survival Prediction and Prognostic Communication: A Taboo, an Aid, or a Necessity? A Multinational Mixed- Methods Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Advanced Cancer
Terminal Malignant Tumors
Hospices
Keywords: survival analysis
projections and predictions
palliative care
hospice and palliative care nursing
nurses&amp;amp;#39;s role
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 152
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research team at each site will identify eligible patients in the palliative and hospice unit and invite their physicians and nurses to participate the study.

Brief summary: \[Background\] Nurses' roles in survival prediction and prognostic communication have historically been limited due to role delineation, lack of formal training, and cultural norms. In Taiwan and other cultural contexts, prognostic discussions have traditionally been the purview of physicians. However, evolving paradigms in health communication, practical realities in nursing practice, and the expanded responsibilities of advanced practice nurses have highlighted the importance of nurses in this domain. Nurses frequently engage in "foreseeing" prognostic indicators through daily patient care, and emerging evidence suggests their prognostic accuracy is often comparable to or exceeds that of physicians. Despite this, the exact scope of nurses' roles in prognostication remains unclear, creating gaps in understanding the contributions, benefits, and associating factors of nurses' involvement of prognostication process.

\[Aim\] This mixed-methods study aims to examine hospice nurses' competencies and roles in prognostication, with a focus on their survival prediction accuracy, confidence, influencing factors, and self-perceived responsibilities.

\[Method\] This three-year, cross-national study adopts an explanatory sequential mixed-methods design. First, the quantitative phase utilizes a prospective cohort design, recruiting palliative nurses and physicians from ten palliative care sites across three countries. Eligible clinicians include nurses and physicians who provide care for patients with advanced cancer in palliative care settings or oncologic wards. Participating clinicians will provide weekly prognostic predictions for targeted patients and rate their confidence levels. Patients' demographic and disease-related information will also be collected to estimate survival using prediction tools. Data collection will conclude upon the patient's death or discharge. Based on the results of the quantitative phase, a descriptive qualitative study will be conducted to purposefully recruit nurses with varying levels of prediction accuracy and confidence from the quantitative phase. Semi-structured interviews will be carried out to gather qualitative data on their perspectives regarding prognostication, with a particular focus on their roles. The estimated sample size for quantitative phase is 152 nurse-physician dyads (based on 152 patients), while 20-30 nurses are expected to participate in the qualitative phase.

\[Data Analysis\] Descriptive statistics, area under the receiver operating characteristic (ROC) curve (AUC), Cohen's kappa, weighted kappa, McNemar's test, and ordinal logistic regression will be used to analyze quantitative data. Qualitative data will be analyzed using conventional content analysis. Nurses' Competence and Role in Survival Prediction and Prognostic Communication.

\[Expecting Outcomes and Conclusion\] This project uniquely highlights nurses' contributions to prognostication, aiming to generate evidence that informs future research, clinical practice, and policy development. The findings will shed light on nurses' roles, functions, potential benefits, and the barriers the face in prognostication.


Eligibility criteria: Inclusion Criteria:

\[Inclusion criteria for patients\]

* 18 years old or older
* Diagnosed with advanced solid cancer, including locally extensive or metastasis cancer
* Patients admitted to palliative care units or oncology units in the participating institutions.

\[Inclusion criteria for clinicians\]

* Nurses who are the primary care nurse of the included patients
* Nurses who care for the included patients for at least one shift
* Nurses who work in palliative and hospice units or team, or oncology units for over 6 months.
* Physicians who are palliative care specialists and/or physicians with palliative care trainings
* Physicians who are the primary care physician of the included patient.

Exclusion Criteria:

* Patients with hematological malignancies are excluded.
* A participated clinicians can only participate in the study up to three times, clinicians who participate in the study for more than three times are excluded.

Primary outcomes:
measure: Palliative nurses' accuracy in making survival prediction
timeFrame: From enrollment to the end of treatment at 2.5 years
measure: Palliative nurses' levels of confidence in making prognostic predictions
timeFrame: From enrollment to the end of treatment at 2.5 years
Secondary outcomes:
measure: Relationship between palliative nurses' demographic variables, prognostic confidence, and survival prediction accuracy
timeFrame: From enrollment to the end of treatment at 2.5 years
measure: Palliative nurses' perceptions of their roles in prognostic prediction
timeFrame: From enrollment to the end of treatment at 2.5 years
measure: Themes which affect palliative nurses' prognostic prediction and level of confidence
timeFrame: From enrollment to the end of treatment at 2.5 years
Other outcomes:
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