Primary Palliative Care - a Feasibility Cluster Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Primary Palliative Care Complex Intervention (PrimPal).
- Who it may be relevant to
- Registry conditions: Palliative Care, Primary Palliative Care, Advanced Cancer, Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Other Primary Palliative Care Complex Intervention (PrimPal)
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) su
Primary outcome measures
- GP Feasibility Rate (Implementation Rate) [Time frame: 12 weeks (from start of intervention to end of consultation cycle - Week 12 / T2)]
Secondary outcome measures (4)
- Patient Recruitment Rate [Time frame: Baseline (T0) - during recruitment period]
- Patient Retention Rate [Time frame: Week 12 (T2)]
- Perceived Barriers to Implementation [Time frame: Week 12 (T2) - end of intervention]
- Perceived Benefits of the Intervention [Time frame: Week 12 (T2) - end of intervention]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Portugal · 2 centers
- Family Health Unit 1 - ULS Coimbra (Intervention) — Coimbra
- Family Health Unit 2 - ULS Coimbra (Control) — Coimbra
Publications
- Seica Cardoso C, Prazeres F, Oliveiros B, Nunes C, Simoes P, Aires C, Rita P, Penetra J, Lopes P, Alcobia S, Baptista S, Venancio C, Gomes B. Feasibility and effectiveness of a two-tiered intervention involving training and a new consultation model for patients with palliative care needs in primary care: A before-after study. Palliat Med. 2024 Sep;38(8):842-852. doi: 10.1177/02692163231219682. Epu PMID 38226491
- Seica Cardoso C, Prazeres F, Nunes C, Simoes P, Aires C, Rita P, Penetra J, Lopes P, Alcobia S, Gomes B. Impact of a complex intervention in primary care for patients with palliative care needs in their healthcare utilization: a before-after study. Prim Health Care Res Dev. 2026 Jan 30;27:e15. doi: 10.1017/S1463423625100777. PMID 41612825
Identifiers
NCT: NCT07737899 · IN1590 | PrimPal Trial · 2024.18252.PEX