Primary Palliative Care - a Feasibility Cluster Trial

Background: Demographic ageing and the rising burden of chronic disease have dramatically increased the need for palliative care. Most patients with palliative care needs are cared for in primary health care (PHC) settings, yet GPs often lack training and systematic tools to identify and manage these patients. The Principal Investigator developed a complex intervention combining GP training and a new consultation model during doctoral research, demonstrating promising results (reduction in physical and psychological symptoms) in a before-after study (published in Palliative Medicine, DOI: 10.1177/02692163231219682). The present feasibility trial is the next methodological step before undertaking a full-scale cluster RCT.

Design: Feasibility cluster-controlled RCT with an embedded qualitative component (mixed-methods). Randomisation occurs at the cluster (FHU) level. Two FHUs from ULS Coimbra (central Portugal) will be recruited: one allocated to the intervention arm and one to the control (usual care) arm.

Intervention: GPs in the intervention FHU will complete a 30hour e-learning training programme covering palliative care communication, symptom management, and patient assessment/control. After training, each GP will apply the new structured consultation model to recruited patients over 12 weeks (4 consultations). The model is grounded in the 4th edition of the National Consensus Project's Clinical Practice Guidelines for Quality Palliative Care and WONCA's core competencies for GPs in palliative care.

Control: GPs in the control FHU will follow usual care without any specific palliative care training or structured consultation model.

Participants: Adult patients (≥18 years) on the list of recruited GPs with a diagnosis of: advanced-stage neoplasm (metastatic cancer), COPD GOLD III/IV, Congestive Heart Failure NYHA III/IV, or Chronic Kidney Disease stage IV/V.

Feasibility outcomes: GP implementation rate (primary), patient recruitment rate, and patient retention rate will be assessed at baseline (T0), week 6 (T1), and week 12 (T2). Qualitative data will be collected through interviews with GPs and patients to explore perceived barriers and benefits of the intervention.

Significance: Results will be used to refine the intervention and study procedures, and to power a future definitive cluster RCT.

Inclusion criteria

• 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.

Exclusion criteria

• 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).