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.
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.
Advanced-stage neoplasm (metastatic/stage IV cancer);
Chronic Obstructive Pulmonary Disease (COPD) - GOLD classification III or IV;
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).
Parallel
Primary Palliative Care Complex Intervention (PrimPal)
Other intervention1. GPs will receive an e-learning palliative care training programme with a 30-h load, including topics such as the role of communication, the main problems and symptoms of patients with palliative care needs and how to assess and control them. Additionally, the programme covered how to apply the newly developed medical consultation model and how to use the Integrated Palliative Care Outcome Scale (IPOS) patient version 2. Primary palliative care consultation model divided into five areas (1) summarizing clinical information, (2) objective symptoms' management, (3) assessment and coding of chronic diseases and symptoms, (4) planning clinical approach and (5) addressing other problems/concerns - 4 consultations over 12 weeks.
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.
Patient Recruitment Rate
Percentage of contacted eligible patients who agree to participate in the study.
Patient Retention Rate
Percentage of enrolled patients who complete all 4 consultations and remain in the study until week 12.
Perceived Barriers to Implementation
Qualitative exploration of obstacles experienced by GPs and patients in the implementation of the intervention, assessed via semi-structured interviews
Perceived Benefits of the Intervention
Qualitative exploration of the benefits perceived by GPs and patients from the intervention, assessed via semi-structured interviews.
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University of Coimbra
Lead sponsor
Unidade Local de Saúde de Coimbra, EPE
Collaborator
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