Curtin School of Allied Health, Curtin University, Perth, Western Australia, Australia.
Department of Cardiology, Mount Hospital, Perth, Western Australia, Australia.
BMJ Open. 2023 Mar 27;13(3):e063656. doi: 10.1136/bmjopen-2022-063656.
General practitioners (GPs) routinely provide care for patients with heart failure (HF); however, adherence to management guidelines, including titrating medication to optimal dose, can be challenging in this setting. This study will evaluate the effectiveness of a multifaceted intervention to support adherence to HF management guidelines in primary care.
We will undertake a multicentre, parallel-group, randomised controlled trial of 200 participants with HF with reduced ejection fraction. Participants will be recruited during a hospital admission due to HF. Following hospital discharge, the intervention group will have follow-up with their GP scheduled at 1 week, 4 weeks and 3 months with the provision of a medication titration plan approved by a specialist HF cardiologist. The control group will receive usual care. The primary endpoint, assessed at 6 months, will be the difference between groups in the proportion of participants being prescribed five guideline-recommended treatments; (1) ACE inhibitor/angiotensin receptor blocker/angiotensin receptor neprilysin inhibitor at least 50% of target dose, (2) beta-blocker at least 50% of target dose, (3) mineralocorticoid receptor antagonist at any dose, (4) anticoagulation for patients diagnosed with atrial fibrillation, (5) referral to cardiac rehabilitation. Secondary outcomes will include functional capacity (6-minute walk test); quality of life (Kansas City Cardiomyopathy Questionnaire); depressive symptoms (Patient Health Questionnaire-2); self-care behaviour (Self-Care of Heart Failure Index). Resource utilisation will also be assessed.
Ethical approval was granted by the South Metropolitan Health Service Ethics Committee (RGS3531), with reciprocal approval at Curtin University (HRE2020-0322). Results will be disseminated via peer-reviewed publications and conferences.
ACTRN12620001069943.
全科医生（GP）通常为心力衰竭（HF）患者提供护理；然而，在这种情况下，遵循管理指南，包括将药物滴定至最佳剂量，可能具有挑战性。本研究将评估一种多方面干预措施在支持初级保健中 HF 管理指南的依从性方面的有效性。
我们将对 200 名射血分数降低的 HF 患者进行多中心、平行组、随机对照试验。参与者将在因 HF 住院期间招募。HF 出院后，干预组将按计划在 1 周、4 周和 3 个月与他们的 GP 进行随访，并提供由 HF 专家心脏病专家批准的药物滴定计划。对照组将接受常规护理。主要终点是 6 个月时评估的两组之间接受五种指南推荐治疗的参与者比例差异；（1）ACE 抑制剂/血管紧张素受体阻滞剂/血管紧张素受体脑啡肽酶抑制剂达到目标剂量的至少 50%，（2）β受体阻滞剂达到目标剂量的至少 50%，（3）任何剂量的盐皮质激素受体拮抗剂，（4）诊断为心房颤动的患者进行抗凝治疗，（5）转介至心脏康复。次要结局包括功能能力（6 分钟步行试验）；生活质量（堪萨斯城心肌病问卷）；抑郁症状（患者健康问卷-2）；自我护理行为（心力衰竭自我护理指数）。还将评估资源利用情况。
南都会健康服务伦理委员会（RGS3531）已批准伦理，科廷大学（HRE2020-0322）也有相应的批准。结果将通过同行评审的出版物和会议进行传播。
ACTRN12620001069943。
