Primary Palliative Care - a Feasibility Cluster Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

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

Вторичные конечные точки (4)

• Patient Recruitment Rate [Срок оценки: Baseline (T0) - during recruitment period]
• Patient Retention Rate [Срок оценки: Week 12 (T2)]
• Perceived Barriers to Implementation [Срок оценки: Week 12 (T2) - end of intervention]
• Perceived Benefits of the Intervention [Срок оценки: Week 12 (T2) - end of intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Португалия · 2 центра

• Family Health Unit 1 - ULS Coimbra (Intervention) — Coimbra
• Family Health Unit 2 - ULS Coimbra (Control) — Coimbra

Публикации

• 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

Идентификаторы

NCT: NCT07737899 · IN1590 | PrimPal Trial · 2024.18252.PEX

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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