NCT07737899

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Oct 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Aug 2027

First Submitted

Initial submission to the registry

July 27, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 27, 2026

Last Update Submit

July 31, 2026

Conditions

Palliative CarePrimary Palliative CareAdvanced CancerChronic Obstructive Pulmonary Disease (COPD)Congestive Heart Failure ChronicChronic Kidney Disease (Stages 4 and 5)

Keywords

Palliative carePrimary Palliative CareGeneral practiceFamily medicineFeasibility studyCluster randomized controlled trialComplex interventionChronic disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks (from start of intervention to end of consultation cycle - Week 12 / T2)

Secondary Outcomes (4)

  • 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

Study Arms (2)

Primary Palliative Care Consultation

EXPERIMENTAL

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)

Control (Usual Care)

NO INTERVENTION

GPs in the control FHU deliver usual palliative care without specific training or structured consultation model.

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.

Primary Palliative Care Consultation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Family Health Unit 1 - ULS Coimbra (Intervention)

Coimbra, Portugal

Location

Family Health Unit 2 - ULS Coimbra (Control)

Coimbra, Portugal

Location

Related Publications (2)

  • 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. Epub 2024 Jan 16.

    PMID: 38226491BACKGROUND

  • 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: 41612825BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRenal Insufficiency, ChronicChronic Disease

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Carlos S Cardoso, PhD

CONTACT

00351 239 857 700carlosseicacardoso@uc.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 30, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

August 3, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

PT(2)