NCT07764263

Brief Summary

When people become seriously ill, healthcare decisions are influenced not only by their medical condition, but also by their personal situation, values, wishes, and daily life circumstances. A medically appropriate treatment may not always fit what is important or realistic for an individual. Contextualised care aims to integrate relevant aspects of a patient's life into care and decision-making. This study investigates whether an interactive communication training program can help healthcare professionals provide more contextualised care for people with serious illness. The training aims to improve professionals' skills in recognising, exploring, and integrating relevant patient context into clinical decision-making and teamwork. Healthcare professionals from hospital teams in the Netherlands will participate, including physicians, nurses, nurse specialists, and physician assistants caring for patients with serious illness. The training consists of two three-hour sessions. Participants will practice communication skills using realistic clinical situations and learn how patient context can be incorporated into care planning and communication within the healthcare team. The effects of the training will be evaluated in several ways. Healthcare professionals will complete questionnaires before and after training to assess competence, communication, and job satisfaction. Responses to simulated patient situations will be analysed to examine how participants recognise and respond to patients' concerns. Medical records will also be reviewed to examine whether non-somatic aspects of care are more often documented, anticipated, and communicated after the training. Hospital-based healthcare use and associated costs will also be assessed. The study aims to provide insight into whether training hospital teams in contextualised communication can support more personalised, appropriate, and person-centred care for people living with serious illness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

2.8 years

First QC Date

August 6, 2026

Last Update Submit

August 12, 2026

Conditions

Keywords

Serious illnessContextualized carePatient-centered carePalliative careCommunication trainingHealth personnelTeam trainingMedical education

Outcome Measures

Primary Outcomes (1)

  • Change in self-assessed competence in contextualised care (measured using the Spiritual Care Competence Scale)

    Healthcare professionals' self-assessed competence will be assessed using selected domains of the Spiritual Care Competence Scale (SCCS), including communication, assessment, and referral competencies. The SCCS assesses healthcare professionals' perceived competence in addressing patients' multidimensional needs through communication, assessment, and appropriate support or referral. Higher scores indicate higher perceived competence. Changes from baseline to 4 and 16 weeks after the training will be assessed.

    Baseline (4 weeks before training) to 4 and 16 weeks after training

Secondary Outcomes (8)

  • Change in patient- and family-centred communication competence

    Baseline (4 weeks before training) to 4 and 16 weeks after training

  • Change in self-efficacy in end-of-life communication

    Baseline (4 weeks before training) to 4 and 16 weeks after training

  • Change in applied competence in contextualised communication

    Baseline (4 weeks before training) to 4 and 16 weeks after training

  • Change in documentation and integration of patient context in clinical practice

    One year before and one year after the training intervention

  • Change in healthcare professionals' job satisfaction

    Baseline (4 weeks before training) to 4 and 16 weeks after training

  • +3 more secondary outcomes

Study Arms (1)

Contextualized Care Training Intervention

EXPERIMENTAL

Participants receive an interactive communication training program on contextualized care for patients with serious illness. The training is based on the contextual care model and aims to strengthen healthcare professionals' skills in recognizing, exploring, identifying, and integrating relevant patient context into clinical communication and care planning. The intervention consists of two 3-hour training sessions. The first session focuses on individual communication skills, including recognizing contextual cues and exploring patients' personal circumstances, values, and priorities. The second session focuses on multidisciplinary collaboration, including integration of contextual information into care planning and communication within the healthcare team. The training uses interactive methods, including brief lectures, role-play with professional actors, simulated clinical situations, reflection, and feedback.

Behavioral: Contextualized Care Communication Training

Interventions

The Contextualized Care Communication Training is an interactive educational intervention designed to strengthen healthcare professionals' ability to integrate relevant patient context into care for people with serious illness. The training is based on the contextual care model and extends the original 4C-process with a fifth step focused on contextual handover within healthcare teams. The training focuses on five steps: (1) recognizing contextual cues that indicate potentially relevant patient circumstances, (2) exploring these cues through patient-centred communication, (3) identifying contextual factors that are relevant for care decisions, (4) integrating relevant contextual information into care planning, and (5) handing over contextual information within the multidisciplinary team to support continuity of care. The intervention consists of two interactive 3-hour training sessions delivered to existing hospital teams. The first session focuses on individual communication skills,

Contextualized Care Training Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare professionals working in a hospital team in the Netherlands
  • Actively involved in the care of patients with serious illness
  • Profession: physician, nurse, nurse specialist, or physician assistant
  • Age ≥18 years
  • Dutch-speaking
  • Provided informed consent

You may not qualify if:

  • Not part of a participating hospital team receiving the training intervention
  • No informed consent provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

Location

Study Officials

  • Yvonne Engels

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 13, 2026

Study Start

July 1, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Pseudonymised quantitative individual participant data underlying the results reported in the publication may be made available upon reasonable request and after review of the request by the research team. Data sharing will be subject to appropriate safeguards to protect participant confidentiality and comply with applicable regulations.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Start date: After publication of the primary study results End date: No end date
Access Criteria
Pseudonymised quantitative individual participant data underlying the results reported in the publication may be accessed by qualified researchers upon reasonable request. Requests will be reviewed by the research team to assess scientific relevance, feasibility, and compliance with ethical and data protection requirements. Approved researchers will have access to the data necessary to address the approved research question. Access to supporting information, including the study protocol and informed consent form, may also be provided upon reasonable request. Data will only be shared after approval of the request and under appropriate safeguards, including compliance with applicable data protection regulations and institutional requirements. Where applicable, data access will be governed by a data use agreement.

Locations