An interventional study of Primary Palliative Care Complex Intervention (PrimPal) in Palliative Care, Primary Palliative Care and Advanced Cancer, sponsored by University of Coimbra. Not yet recruiting at 2 sites in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by University of Coimbra · Not applicable, Interventional, and Other
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.
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University of Coimbra is the lead sponsor of 84 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
General 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.
Other: Primary Palliative Care Complex Intervention (PrimPal)
GPs in the control FHU deliver usual palliative care without specific training or structured consultation model.
1. 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.
Time frame: 12 weeks (from start of intervention to end of consultation cycle - Week 12 / T2)
Patient Recruitment Rate
Percentage of contacted eligible patients who agree to participate in the study.
Time frame: Baseline (T0) - during recruitment period
Patient Retention Rate
Percentage of enrolled patients who complete all 4 consultations and remain in the study until week 12.
Time frame: Week 12 (T2)
Perceived Barriers to Implementation
Qualitative exploration of obstacles experienced by GPs and patients in the implementation of the intervention, assessed via semi-structured interviews
Time frame: Week 12 (T2) - end of intervention
Perceived Benefits of the Intervention
Qualitative exploration of the benefits perceived by GPs and patients from the intervention, assessed via semi-structured interviews.
Time frame: Week 12 (T2) - end of intervention
Plan to share: No
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
University of Coimbra