Primary Palliative Care - a Feasibility Cluster Trial
PrimPal
2 other identifiers
interventional
30
1 country
2
Brief Summary
This feasibility cluster-controlled randomized trial (RCT) evaluates a complex intervention for the delivery of primary palliative care in Family Health Units (FHUs). The intervention consists of training General Practitioners (GPs) in palliative care through a 30 hour e-learning program and implementing a structured consultation model (4 consultations over 12 weeks) for adult patients with advanced chronic illness. One FHU will receive the intervention and one FHU will follow usual care. The primary goal is to assess feasibility metrics (GP adherence, patient recruitment rate, and patient retention rate), which will inform the design of a subsequent full-scale cluster RCT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2026
2 active sites
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
First Submitted
Initial submission to the registry
July 27, 2026
CompletedFirst Posted
Study publicly available on registry
July 30, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
Study Completion
Last participant's last visit for all outcomes
August 31, 2027
July 30, 2026
July 1, 2026
5 months
July 27, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
GP Feasibility Rate (Implementation Rate)
Percentage of GPs in the intervention arm who successfully implement the new consultation model with their recruited patients (excluding failures due to reasons unrelated to the physician, e.g., patient death or withdrawal). Feasibility is considered demonstrated if ≥70% of GPs complete the model with at least 80% of their recruited patients.
12 weeks (from start of intervention to end of consultation cycle - Week 12 / T2)
Secondary Outcomes (4)
Patient Recruitment Rate
Baseline (T0) - during recruitment period
Patient Retention Rate
Week 12 (T2)
Perceived Barriers to Implementation
Week 12 (T2) - end of intervention
Perceived Benefits of the Intervention
Week 12 (T2) - end of intervention
Study Arms (2)
Intervention
EXPERIMENTALGeneral Practitioners in the intervention FHU complete a 30hour e-learning training programme in palliative care and apply a new structured consultation model over 12 weeks (4 consultations) with recruited patients.
Control (Usual Care)
NO INTERVENTIONGPs in the control FHU deliver usual palliative care without specific training or structured consultation model.
Interventions
Two-component complex intervention: (1) GP e-learning training programme (30 hours) covering communication, symptom management, and palliative assessment; (2) Structured consultation model based on the NCP Clinical Practice Guidelines for Quality Palliative Care (4th ed.) and WONCA GP core competencies - 4 consultations over 12 weeks.
Eligibility Criteria
You may qualify if:
- Aged 18 years or older.
- Enrolled as a patient on the list of a recruited General Practitioner in one of the participating Family Health Units.
- Diagnosed with one or more of the following advanced chronic conditions:
- Advanced-stage neoplasm (metastatic/stage IV cancer);
- Chronic Obstructive Pulmonary Disease (COPD) - GOLD classification III or IV;
- Congestive Heart Failure (CHF) - New York Heart Association (NYHA) functional classification III or IV;
- Chronic Kidney Disease (CKD) - stage IV or V.
You may not qualify if:
- Refusal to provide informed consent or to participate in the study at any point.
- Disease severity requiring urgent medical intervention (acute crisis/emergency care need at time of recruitment).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Coimbralead
- Unidade Local de Saúde de Coimbra, EPEcollaborator
Study Sites (2)
Family Health Unit 1 - ULS Coimbra (Intervention)
Coimbra, Portugal
Family Health Unit 2 - ULS Coimbra (Control)
Coimbra, Portugal
Related Publications (2)
Seica Cardoso C, Prazeres F, Oliveiros B, Nunes C, Simoes P, Aires C, Rita P, Penetra J, Lopes P, Alcobia S, Baptista S, Venancio C, Gomes B. Feasibility and effectiveness of a two-tiered intervention involving training and a new consultation model for patients with palliative care needs in primary care: A before-after study. Palliat Med. 2024 Sep;38(8):842-852. doi: 10.1177/02692163231219682. Epub 2024 Jan 16.
PMID: 38226491BACKGROUNDSeica Cardoso C, Prazeres F, Nunes C, Simoes P, Aires C, Rita P, Penetra J, Lopes P, Alcobia S, Gomes B. Impact of a complex intervention in primary care for patients with palliative care needs in their healthcare utilization: a before-after study. Prim Health Care Res Dev. 2026 Jan 30;27:e15. doi: 10.1017/S1463423625100777.
PMID: 41612825BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
July 27, 2026
First Posted
July 30, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share