Primary Care Consultation for Patients With Palliative Care Needs

NCT05244590 | Completed

• 1 other identifier: 2007015580
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction General practitioners provide health care in the community, managing patients and families longitudinally, and there is some evidence that when they are involved in caring for people with palliative care needs alongside specialists, palliative care delivery may be more efficient. The investigators aim to determine the impact of a mix-method intervention involving training in PC and a new consultation model for patients with palliative care needs in primary care. Methods and analysis A before-after study will be conducted in the centre health care region of Portugal. The study will involve 53 patients with palliative care needs from the list of patients of the GPs who accept to collaborate with the project. The mix-method intervention will consist of: (1) training in palliative care and (2) application of a newly developed consultation model for use in the primary care setting and consisting of medical consultation every 3 weeks for a period of 12 weeks. The primary outcome is physical symptom burden, evaluated by the Integrated Palliative Outcome Scale (IPOS) patient version. Secondary outcomes include psychological symptoms, and communication/practical issues (IPOS); number of consultations for acute disease both in the health care unit and emergency department, number of hospitalizations and referrals to hospital health care services.

Conditions

Palliative Care; Primary Health Care

Outcome Measures

Primary Outcomes (1)

• Impact of the intervention in patients' physical symptom burden evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores

  GPs enrolled will evaluate physical symptoms burden before and after the 12 week intervention.

  12 week

Secondary Outcomes (3)

• Impact of the intervention in patients' psychological symptoms burden evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores

  12 week

• Impact of the intervention in patients' communication/practical issues evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores

  12 week

• Impact of the intervention on number of consultations for acute disease both in the health care unit and emergency department, number of hospitalizations and referrals to hospital health care services

  12 week

Study Arms (1)

Intervention

EXPERIMENTAL

GPs' eligibility criteria * Working in the centre health care region in Portugal. * Authorisation of the coordinator of each GP health care unit to integrate the study. Patients' eligibility criteria Inclusion criteria * Belonging to the list of patients of the recruited GPs. * 18 years or older. * Diagnosis of advanced stage neoplasm (ASN), Chronic Obstructive Pulmonary Disease (COPD) Gold III/IV, Congestive Heart Failure (CHF) NYHA III/IV, Chronic Kidney Disease (CKD) stage IV/V. Exclusion Criteria * Refusal, at any time, to participate in the study. * Level of understanding or execution that compromises taking part in the study and answering the IPOS patient version (evaluated using Mini Mental State Examination score). * Level of disease severity requiring urgent intervention (GP clinical judgement).

Other: Consultation model for patients with palliative care needs

Interventions

Consultation model for patients with palliative care needs OTHER

Training in PC for GPs The training program for GPs will meet the main training needs of GPs according to our previous study and feedback from elements of the Palliative Care Study Group of the Portuguese Association of General and Family Medicine (GESPal). The training program will have a total duration of 24 hours and will consist of two modules. Consultation model for patients Consultations will take place every 3 weeks for a total period of 12 weeks. The consultation model will be divided into five areas (Summarize clinical information, Objective symptoms' management, Assessment and coding of chronic diseases and symptoms, planning clinical approach, (other) problems/concerns) to be addressed during the assessment. The five areas were constructed to be intuitive for GPs, following the records' structure used in Portuguese primary care.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Working in the centre health care region in Portugal.
• Authorisation of the coordinator of each GP health care unit to integrate the study.
• Belonging to the list of patients of the recruited GPs.
• years or older.
• Diagnosis of advanced stage neoplasm (ASN), Chronic Obstructive Pulmonary Disease (COPD) Gold III/IV, Congestive Heart Failure (CHF) NYHA III/IV, Chronic Kidney Disease (CKD) stage IV/V.

You may not qualify if:

• Refusal, at any time, to participate in the study.
• Level of understanding or execution that compromises taking part in the study and answering the IPOS patient version (evaluated using Mini Mental State Examination score).
• Level of disease severity requiring urgent intervention (GP clinical judgement).

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

ARS Centro

Coimbra, 3000, Portugal

Location

Related Publications (2)

• 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 DERIVED

• 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: 38226491 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 17, 2022
• Study Start: April 27, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 3, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: When the data is available

Locations

PT (1)