End of Life, Outpatient Treatment, Palliative Patients
Conditions
Keywords
Palliative care, Telemedicine
Brief summary
This study examines the feasibility, user-friendliness, and impact of digital support in outpatient palliative care. Patients, relatives, and professional caregivers use the web-based ISPC platform (information system for Palliative Care) and an accompanying app to record symptom progression, vital signs, and care experiences. In addition, qualitative interviews, focus groups, and usability tests are conducted to analyze experiences, needs, and effects of digital innovations. The goal is to improve digital support in palliative care in a practical way, optimize patient care, and lay the foundation for sustainable integration into standard care.
Interventions
BEHAVIORALIMPULS-NRW
Participants (patients, relatives, and healthcare providers) will use the ISPC digital platform and its associated mobile application the IMPULS app to support Palliative Care. Patients can enter ePROMs and vital parameters, access medication plans, and receive relevant care information. Relatives may provide information on the patient's condition after consent. Healthcare providers access the web-based ISPC system to review patient data, plan interventions (phone calls, video visits, home visits), and document assessments and care measures. The intervention aims to improve care coordination, monitoring, and communication through digital support tools.
Sponsors
University Hospital Muenster
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults (\>18 years) receiving care from participating SAPV/PKD (Specialized Outpatient Palliative Care / Palliative Care Consultation teams) * Newly admitted patients or those already in care if study participation is deemed appropriate by the care team * Patients with a direct treatment context to the Central Palliative Care Unit (ZEP) of the University Hospital Muenster * Ability to provide written informed consent
Exclusion criteria
* Minors (\<18 years) * Individuals with language or communication barriers that cannot be reliably compensated by relatives or qualified interpreters * Impaired consciousness or reduced decision-making capacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Burden (MIDOS-2) | Baseline (at enrollment) and then weekly until the palliative condition does not allow for the patient to provide this information anymore, until a patient's death or withdrawal from the study; overall study duration from November 2025 to May 2027. | Patient-reported assessment of symptom intensity (pain, dyspnea, fatigue, and psychological distress) using the Minimal Documentation System 2 (MIDOS-2). |
| Depressive Symptoms (PHQ-8) | At baseline and after 3 months or upon clinical change; overall study duration from November 2025 to May 2027. | Self-reported depressive symptoms measured with the Patient Health Questionnaire-8. |
| Anxiety Symptoms (GAD-7) | At baseline and after 3 months or upon clinical change; overall study duration from November 2025 to May 2027. | Self-reported anxiety symptoms assessed using the Generalized Anxiety Disorder Scale-7. |
| Health-Related Quality of Life (EQ-5D-3L) | Baseline (at enrollment) and then monthly until the palliative condition does not allow for the patient to provide this information anymore, until a patient's death or withdrawal from the study; overall study duration from November 2025 to May 2027. | Health-related quality of life assessed using the EuroQol EQ-5D-3L questionnaire that comprises an index score and a visual analogue scale. |
| Patient Satisfaction (ZUF-8) | After 3 months of use or at end of participation; overall study duration from November 2025 to May 2027. | Satisfaction with care and usability of the telemedicine intervention, assessed with the ZUF-8 questionnaire. |
| Functional Status (Palliative Performance Scale, PPS) | Weekly until the palliative condition does not allow for the patient to provide this information anymore, until a patient's death or withdrawal from the study; overall study duration from November 2025 to May 2027. | Clinician-rated functional status including mobility, self-care, and intake using the Palliative Performance Scale. |
| Psychological Well-being (WHO-5) | Baseline and after 3 months or upon clinical change over the whole study duration from November 2025 to May 2027. | Subjective well-being measured using the WHO-5 Well-Being Index. |
| Functional Status (ECOG Performance Status) | Regularly throughout the observation period during the whole study duration from November 2025 to May 2027. | Clinician-rated physical functioning using the ECOG Performance Status scale. |
| Prognostic Assessment (Palliative Prognostic Index, PPI) | At baseline and upon major clinical change during the whole study duration from November 2025 to May 2027. | Prognosis estimation combining clinical parameters using the Palliative Prognostic Index (PPI). |
| Caregiver Psychosocial Distress (SCARED) | Baseline and weekly during caregiving period during the whole study duration from November 2025 to May 2027. | Caregiver emotional distress measured with the Screen for Anxiety Related Emotional Disorders (SCARED). |
| Caregiver Burden (Zarit Burden Interview, ZBI-7) | Baseline and weekly during caregiving period during the whole study duration from November 2025 to May 2027. | Subjective caregiver burden assessed with the 7-item Zarit Burden Interview short form (ZBI-7). |
| Perceived Social Support (Single-Item Measure) | Once at baseline and, if applicable, during follow-up until the palliative condition does not allow for the patient to provide this information anymore, until a patient's death or withdrawal from the study; overall study duration: Nov 2025 to May 2027. | Exploratory non-validated item assessing perceived social support among caregivers. |
| Family Satisfaction with Care (FAMCARE-2) | Approximately 2 months after patient death; overall study duration from November 2025 to May 2027. | Satisfaction of family members with care and communication using the FAMCARE-2 short form. |
| Professional Acceptance and Usability (TUQ) | After completion of the telemedicine use phase; overall study duration from November 2025 to May 2027. | Perceived usability and acceptance of telehealth among professionals, measured with the Telehealth Usability Questionnaire (TUQ). |
| System Usability (SUS) | After completion of the telemedicine use phase; overall study duration from November 2025 to May 2027. | Perceived usability and functionality of the telemedicine platform using the System Usability Scale (SUS). |
| Phase of Illness (PCOC) | At baseline and at each clinical review or when a change in the patient's clinical condition occurs. This will be proceeded until the patient's death or withdrawal from the study; overall study duration from November 2025 to May 2027. | Clinical categorization of the patient's current phase of illness according to the Palliative Care Outcomes Collaboration (PCOC) definitions: stable, unstable, deteriorating, terminal, and bereavement. The phase reflects the clinical status and care needs and is used to monitor transitions across palliative care trajectories. |
| Spiritual Well-Being (FACIT-Sp-12) | At baseline and after 3 months or at end of participation overall study duration from November 2025 to May 2027. | Spiritual well-being assessed with the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-Sp-12). The instrument measures meaning, peace, and faith as components of quality of life in patients with chronic or life-limiting illness. |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORPhilipp Lenz, Prof. Dr. med.
University Hospital Muenster
Outcome results
None listed