Primary Palliative Care - a Feasibility Cluster Trial (PrimPal)
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Carlos S Cardoso, PhD
- 전화번호: 00351 239 857 700
- 이메일: carlosseicacardoso@uc.pt
연구 장소
-
-
-
Coimbra, 포르투갈
- Family Health Unit 1 - ULS Coimbra (Intervention)
-
Coimbra, 포르투갈
- Family Health Unit 2 - ULS Coimbra (Control)
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
간섭 없음: Control (Usual Care)
GPs in the control FHU deliver usual palliative care without specific training or structured consultation model.
|
|
|
실험적: Primary Palliative Care Consultation
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.
|
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
GP Feasibility Rate (Implementation Rate)
기간: 12 weeks (from start of intervention to end of consultation cycle - Week 12 / T2)
|
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)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient Recruitment Rate
기간: Baseline (T0) - during recruitment period
|
Percentage of contacted eligible patients who agree to participate in the study.
|
Baseline (T0) - during recruitment period
|
|
Patient Retention Rate
기간: Week 12 (T2)
|
Percentage of enrolled patients who complete all 4 consultations and remain in the study until week 12.
|
Week 12 (T2)
|
|
Perceived Barriers to Implementation
기간: Week 12 (T2) - end of intervention
|
Qualitative exploration of obstacles experienced by GPs and patients in the implementation of the intervention, assessed via semi-structured interviews
|
Week 12 (T2) - end of intervention
|
|
Perceived Benefits of the Intervention
기간: Week 12 (T2) - end of intervention
|
Qualitative exploration of the benefits perceived by GPs and patients from the intervention, assessed via semi-structured interviews.
|
Week 12 (T2) - end of intervention
|
공동 작업자 및 조사자
협력자
협력자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- IN1590 | PrimPal Trial
- 2024.18252.PEX (기타 보조금/기금 번호: Fundação para a Ciência e a Tecnologia (FCT))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .