Development and Evaluation of a Mix-method Intervention Involving Training and a New Consultation Model for Patients With Palliative Care Needs in Primary Care - Before-After Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Coimbra
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Impact of the intervention in patients' physical symptom burden evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores
Study Overview
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.
Detailed Description
Study aim:
The investigators aim to develop, apply, and evaluate a mix-method intervention involving training in PC and a new consultation model in primary care for patients with PC needs.
Primary objective:
To determine the impact of the intervention on the physical symptom burden for patients.
Secondary objectives:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •GPs' eligibility criteria Inclusion 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).
Arms & Interventions
Intervention
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).
Intervention: Consultation model for patients with palliative care needs (Other)
Outcomes
Primary Outcomes
Impact of the intervention in patients' physical symptom burden evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores
Time Frame: 12 week
GPs enrolled will evaluate physical symptoms burden before and after the 12 week intervention.
Secondary Outcomes
- 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)
Investigators
Carlos Seiça Cardoso
Primary investigator
University of Coimbra