Primary Palliative Care - a Feasibility Cluster Trial

Sponsor
University of Coimbra
Study ID
NCT07737899
Status
Not Yet Recruiting

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Conditions

  • Advanced Cancer
  • Chronic Kidney Disease (Stages 4 and 5)
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Congestive Heart Failure Chronic
  • Palliative Care
  • Primary Palliative Care

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Primary Palliative Care Complex Intervention (PrimPal) — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jul 30, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Primary Palliative Care Consultation
    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.
  • No Intervention: Control (Usual Care)
    GPs in the control FHU deliver usual palliative care without specific training or structured consultation model.

Primary Outcome Measure

GP Feasibility Rate (Implementation Rate) [ Time Frame: 12 weeks (from start of intervention to end of consultation cycle - Week 12 / T2) ]

Central Contacts

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