Integrated, Multidisciplinary, Person-centered Care for Patients With Complex Comorbidities: Heart, Kidney and Diabetes - a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Patient centered outcome measures (n=131)
研究概览
简要总结
Patient with complex comorbidities present a growing challenge for health-care providers, that the current system is poorly designed to handle. Concomitant cardiovascular disease, renal dysfunction and diabetes represent almost half of all patients attending cardiac, kidney and diabetes clinics. Patients with all three of these will be randomized to standard care or to a combined, integrated, person-centered, intensified chronic disease management.
详细描述
Patients with concomitant cardiovascular disease, renal dysfunction and diabetes represent almost half of all patients attending cardiac, kidney and diabetes clinics, and about 15 % suffer all three. This proportion of patients with multiple chronic conditions increase markedly by age. These complicated diseases interact, and treatment of one affect the others. Despite this have a progressive subspecialisation caused cardiologist to treat "only" the heart, nephrologists "only" the kidneys and endocrinologists' "only" diabetes. Studies and guidelines follow the same pattern. At best this require patients to visit specialists in each field; at worst result in redundant examinations, under-diagnosis and under-treatment of comorbidities. From the patient perspective, there is a great need for coordination and improvement of the care, not only to reduce disease progression but also to optimise quality of life.
We aim to study if the treatment and outcome for patients with concomitant cardiovascular disease, renal dysfunction and diabetes can be improved through a new model to deliver healthcare. We have designed an integrated clinic to handle all three conditions at the same visit, with a person-centered team-based approach between patients, nurses and physicians, with bi-weekly therapy conferences by dedicated and educated cardiologists, nephrologists and endocrinologists. At these, optimised care-plans are developed, and at following team-visits and phone contacts, these are implemented.
The intervention will be studied in a randomised controlled trial (CareHND) at HND-centrum, a novel integrated outpatient clinic in Stockholm.
Our main hypothesis is that HND-centra results in better care, from several aspects, at lower overall burden on the health care system.
The CareHND study will randomise an estimated 260 patients to HND-centrum or standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established cardiovascular disease (such as history of myocardial infarction, angina, or heart failure requiring hospitalization, previous stroke or TIA with certain diagnosis, and peripheral vascular disease), as well as:
- •Diabetes mellitus type 1 or 2 (treated diabetes, or new onset diabetes according to WHO criteria or HbA1C > 48, and symptoms, as well as:
- •Established kidney disease (eGFR <60 mL/min/m2 calculated with the CKD-EPI formula, or an average of the CKD -EPI and Cystatin-C eGFR, or borderline GFR but concomitant microalbuminuria, or macroalbuminuria, or kidney transplant).
排除标准
- •1 - Inability to provide consent
结局指标
主要结局
Patient centered outcome measures (n=131)
时间窗: 1 year
Perceived quality of care and patient empowerment assessed by a PROMs (Patient Reported Outcome Measure) questionaire with a sum score.
Quality-of-care outcome measures (n=131)
时间窗: 1 year
Combined score of achieved target blood pressure, target HbA1C and target LDL.
Disease progression (n=260)
时间窗: 2 years
Combined death or readmission due to heart failure, myocardial infarction, PCI/CABG, end stage renal failure, acute renal failure or TIA / stroke.
次要结局
- System biology (n=131)(1 year)
- Health care structure and utilization (n=131)(1 year.)
- Patient safety (n=131)(1 year)
- Organ damage (n=131)(1 year)
- Interdisciplinary learning (n=20)(1 year)
研究者
Jonas Spaak
Professor
Danderyd Hospital