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Palliative CareSVPII-TRAINNCT07764263

Contextualizing Care for Patients With a Serious Illness

A study testing Contextualized Care Communication Training in people with Palliative Care, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Palliative Care
What is being tested?
Contextualized Care Communication Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteNetherlands
Study dates
1 Jul 2023to 31 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Radboudumc

    Nijmegen

Other trials in Netherlands

About this study

Official title: Contextualizing Care for Patients With a Serious Illness: Implementation of an Interactive Communication Training Program

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.

Read more

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.

Read the detailed description

Serious illness affects not only a person's physical health but also many other aspects of life, including daily functioning, relationships, social roles, personal identity, values, and future perspectives. As medical possibilities increase, healthcare professionals are increasingly confronted with complex decisions about treatments and care plans. In these situations, the most appropriate care is not necessarily the intervention that is optimal from a purely biomedical perspective, but the care that best fits the individual patient's medical condition together with their personal circumstances, goals, preferences, and possibilities.

Although multidimensional and person-centred care are widely recognised as important components of high-quality healthcare, clinical decision-making is often still predominantly focused on biomedical information. Relevant aspects of patients' lives may remain unidentified or insufficiently incorporated into care planning. This can result in care that does not adequately match patients' needs, priorities, or everyday realities.

This study focuses on contextualised care, an approach that aims to systematically integrate relevant patient context into healthcare communication, clinical reasoning, shared decision-making, and care planning. Within this approach, patient context refers to personal circumstances and characteristics that may influence the appropriateness, feasibility, or consequences of healthcare decisions. Relevant contextual factors may include, for example, patients' abilities and limitations, responsibilities, social circumstances, living situation, values, goals, coping strategies, preferences, and aspects of life that influence what patients consider meaningful or realistic.

The contextual care model is based on the principle that healthcare professionals should not only ask what treatment is medically possible, but also explore whether that treatment fits the person receiving it. Contextual information becomes clinically relevant when overlooking it may negatively influence healthcare decisions or outcomes. Integrating this information can support more personalised care, improve alignment between treatment plans and patients' lives, and contribute to appropriate healthcare utilisation.

Previous research has demonstrated that healthcare professionals can improve their contextual communication skills through training. However, existing interventions have mainly focused on individual healthcare professionals or specialist palliative care teams. In many healthcare systems, including the Netherlands, much care for people with serious illness is delivered by generalist hospital teams rather than specialist palliative care services. Therefore, it is important to understand whether contextualised care can be integrated into routine practice through training multidisciplinary hospital teams.

The aim of this study is to evaluate the effects of an interactive communication training program designed to improve healthcare professionals' competencies in providing contextualised care for patients with serious illness. The study evaluates whether training can support healthcare professionals in recognising relevant patient context, exploring this context in conversations, integrating contextual information into care planning, and communicating relevant information within multidisciplinary teams.

The training intervention is based on the contextual care model and extends the original four-step contextual communication process with an additional step focused on contextual handover. The five steps of the training approach are:

  1. Recognising: identifying verbal and non-verbal cues indicating that a patient's personal context may be relevant.
  2. Exploring: asking appropriate questions to understand the possible contextual factors influencing the patient's situation.
  3. Identifying: determining which aspects of the patient's context are relevant for healthcare decisions and planning.
  4. Integrating: incorporating relevant contextual information into care planning and decision-making.
  5. Handing over: communicating relevant contextual information within the healthcare team to support continuity and coordination of care.

The intervention is designed as an interactive team-based training program. It combines theoretical education with practical exercises, including simulated clinical situations and reflection. Attention is given both to individual communication skills and to team processes that support the integration of patient context into routine clinical practice.

The study uses a mixed-methods evaluation design to examine the impact of the intervention at multiple levels. The evaluation includes healthcare professionals' perceptions of their own competence, their ability to apply contextualised communication skills in simulated situations, changes in documentation and integration of relevant patient context in clinical practice, and healthcare utilisation and associated costs. Qualitative data are collected to explore how healthcare professionals experience contextualised care, including factors that support or hinder implementation in daily practice.

The study is conducted among multidisciplinary hospital teams in the Netherlands that provide care for patients with serious illness. By focusing on teams rather than individual professionals, the study reflects the collaborative nature of hospital care, where recognition and communication of relevant patient context require shared responsibility across healthcare professionals.

The results of this study will contribute to understanding whether contextualised care can be embedded in routine hospital practice through a scalable educational intervention. Ultimately, the study aims to support healthcare teams in providing care that is not only medically appropriate but also aligned with the lives, values, and priorities of people living with serious illness.

Conditions
Palliative Care
Being tested
Contextualized Care Communication Training
Keywords
Serious illness, Contextualized care, Patient-centered care, Palliative care, Communication training, Health personnel, Team training, Medical education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contextualized Care Communication TrainingBehavioural

    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,

Study groups in NCT07764263
Study groupRoleWhat they receive
Contextualized Care Training InterventionExperimentalParticipants 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.
Receives: Behavioral: Contextualized Care Communication Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)
  1. Change in patient- and family-centred communication competence

    Change in healthcare professionals' self-assessed competence in patient- and family-centred communication will be assessed using the 12-item Patient- and Family-Centered Communication subscale of the End-of-Life Professional Caregiver Survey (EPCS). Higher scores indicate higher perceived competence.

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

  2. Change in self-efficacy in end-of-life communication

    Change in healthcare professionals' self-efficacy in end-of-life care communication will be assessed using the Self-Efficacy in End-of-Life Care (S-EOLC) questionnaire. Higher scores indicate higher perceived self-efficacy.

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

  3. Change in applied competence in contextualised communication

    Applied competence will be assessed using participants' written responses to simulated clinical consultation videos before and after the training. Responses will be analysed to evaluate how healthcare professionals recognise, interpret, and explore patients' concerns and relevant context.

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

  4. Change in documentation and integration of patient context in clinical practice

    Implementation of contextualised care in routine clinical practice will be assessed through retrospective review of electronic medical records of deceased patients cared for by participating teams. The review will assess documentation and anticipation of relevant non-somatic and contextual dimensions, including psychological, social, and spiritual aspects, as well as handover of contextual information.

    Measured: One year before and one year after the training intervention

  5. Change in healthcare professionals' job satisfaction

    Healthcare professionals' job satisfaction will be assessed using a single-item self-report measure. Higher scores indicate higher job satisfaction.

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

  6. Hospital-based healthcare costs per patient in the final three months of life

    Hospital-based healthcare utilisation will be assessed retrospectively from electronic medical records and converted into costs using standardized unit costs. Resource use includes hospital and intensive care days, emergency department visits, and treatments including chemotherapy, radiotherapy, immunotherapy, and surgery. Costs of these healthcare utilisation components will be summed at the patient level, together with allocated intervention costs in the post-intervention period, to calculate total hospital-based healthcare costs per patient (Unit of Measure: Euros (€) per patient).

    Measured: Final 3 months of life

  7. Hospital-based healthcare costs per patient in the final month of life

    Hospital-based healthcare utilisation will be assessed retrospectively from electronic medical records and converted into costs using standardized unit costs. Resource use includes hospital and intensive care days, emergency department visits, and treatments including chemotherapy, radiotherapy, immunotherapy, and surgery. Costs of these healthcare utilisation components will be summed at the patient level, together with allocated intervention costs in the post-intervention period, to calculate total hospital-based healthcare costs per patient (Unit of Measure: Euros (€) per patient).

    Measured: Final month of life

  8. Perceived barriers and facilitators for contextualising care

    Factors influencing contextualised care will be assessed using qualitative free-text responses in which healthcare professionals report perceived barriers and facilitators to contextualising care. Responses will be analysed using directed content analysis and categorised according to predefined factors identified in previous research. This outcome does not use a numerical scale or total score.

    Measured: Baseline (4 weeks before training) and 4 and 16 weeks after training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2026
  2. Study start1 Jul 2023
  3. Primary completion31 Mar 2026
  4. Study completion31 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07764263
Sponsor's protocol ID
2023-16760
Other IDs
2023
Acronym
SVPII-TRAIN
Status last verified
Aug 2026
First submitted
6 Aug 2026
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Contextualized Care Communication Training in people with Palliative Care, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in self-assessed competence in contextualised care (measured using the Spiritual Care Competence Scale) (time frame: Baseline (4 weeks before training) to 4 and 16 weeks after training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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