Primary Palliative Care - a Feasibility Cluster Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Coimbra
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- GP Feasibility Rate (Implementation Rate)
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Control (Usual Care)
GPs in the control FHU deliver usual palliative care without specific training or structured consultation model.
Outcomes
Primary Outcomes
GP Feasibility Rate (Implementation Rate)
Time Frame: 12 weeks (from start of intervention to end of consultation cycle - Week 12 / T2)
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.
Secondary Outcomes
- 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)
Investigators
Carlos Seiça Cardoso
Principal Investigator
University of Coimbra