Primary Palliative Care - a Feasibility Cluster Trial (PrimPal)
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Carlos S Cardoso, PhD
- 電話番号：00351 239 857 700
- メール：carlosseicacardoso@uc.pt
研究場所
-
-
-
Coimbra、ポルトガル
- Family Health Unit 1 - ULS Coimbra (Intervention)
-
Coimbra、ポルトガル
- Family Health Unit 2 - ULS Coimbra (Control)
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Control (Usual Care)
GPs in the control FHU deliver usual palliative care without specific training or structured consultation model.
|
|
|
実験的：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.
|
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
GP Feasibility Rate (Implementation Rate)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Recruitment Rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IN1590 | PrimPal Trial
- 2024.18252.PEX (その他の助成金/資金番号：Fundação para a Ciência e a Tecnologia (FCT))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。