A Randomized Controlled Trial of Enhanced Caregiver Support Versus Usual Care for Managing Older Heart Failure Patients at Hospital Discharge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Patient self care
研究概览
简要总结
Close to ninety percent of older heart failure (HF) patients have some cognitive deficits at hospital discharge which may impact their ability to make effective decisions about their healthcare. However, informal care partners (CPs) may assist in managing HF when provided with appropriate education and support. The goal of this randomized clinical trial (RCT) is to evaluate an intervention which will provide 1) additional teaching on management of HF to the patient and CP following hospital discharge, 2) improved communication with the family physician, 3) a HF decision support tool for oral diuretic management, and 4) a digital talking scale. The investigators believe this intervention will improve outcomes and be cost saving.
The investigators hypothesize that enhanced education and support for the CPs to assist older HF patients following hospital discharge, combined with improved communication with family physicians, contact with a HF nurse, and simple decision support tools, will lead to earlier recognition of clinical deterioration, and improved patient outcomes. Innovative and cost-effective approaches to manage HF patients following hospital discharge are urgently needed in Canada.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Heart Failure (with preserved or impaired left ventricular systolic dysfunction) confirmed with the Boston Criteria >= 5 points
- •60 years of age or older
排除标准
- •Residence in, or planned discharge to a long-term care facility (LTC)
- •Life expectancy less than 3 months
- •Patient transferred to Geriatric Rehabilitation unit
- •No caregiver
- •Residence is more than a 30 minute rive from hospital of discharge
- •Patient refused to participate
- •Caregiver refused to participate
- •Patient referred for CV surgery prior to hospital discharge
- •Patient on IV Lasix at or bumetamide at hospital discharge
- •Not on PO Lasix at hospital discharge
- •Patient currently on dialysis
- •Caregiver unavailable during daytime hours
- •Caregiver has disability, serious mental illness or cognitive dysfunction
- •Patient discharged early
- •Patient enrolled in another randomized controlled trial
- •Patient expired
- •Patient and caregiver unable to speak and read English (Patient may be enrolled if nurse can converse minimally with patient and caregiver. S-TOFHLA will not be done for reading comprehension and questionnaires will be administered orally.)
- •Severe aortic stenosis or severe mitral stenosis
研究组 & 干预措施
Enhanced Caregiver Support with Caregiver
- Standardized Heart Failure Discharge Summary to Primary Care Physicians©
- Standardized education sessions
- Heart Failure Diuretic Decision Support Tool for Patient Self Management©
- Digital talking scale
干预措施: Standardized education sessions (Behavioral)
Enhanced Caregiver Support with Caregiver
- Standardized Heart Failure Discharge Summary to Primary Care Physicians©
- Standardized education sessions
- Heart Failure Diuretic Decision Support Tool for Patient Self Management©
- Digital talking scale
干预措施: Heart Failure Diuretic Decision Support Tool for Patient Self Management© (Other)
Enhanced Caregiver Support with Caregiver
- Standardized Heart Failure Discharge Summary to Primary Care Physicians©
- Standardized education sessions
- Heart Failure Diuretic Decision Support Tool for Patient Self Management©
- Digital talking scale
干预措施: Standardized Heart Failure Discharge Summary to Primary Care Physicians© (Other)
Enhanced Caregiver Support with Caregiver
- Standardized Heart Failure Discharge Summary to Primary Care Physicians©
- Standardized education sessions
- Heart Failure Diuretic Decision Support Tool for Patient Self Management©
- Digital talking scale
干预措施: Digital talking scale (Other)
Enhanced Caregiver Support with Caregiver
- Standardized Heart Failure Discharge Summary to Primary Care Physicians©
- Standardized education sessions
- Heart Failure Diuretic Decision Support Tool for Patient Self Management©
- Digital talking scale
干预措施: Usual care (Other)
Usual Care with Caregiver
- Usual care
干预措施: Usual care (Other)
Enhanced Support without Caregiver
- Standardized Heart Failure Discharge Summary to Primary Care Physicians©
- Standardized education sessions
- Heart Failure Diuretic Decision Support Tool for Patient Self Management©
- Digital talking scale
干预措施: Heart Failure Diuretic Decision Support Tool for Patient Self Management© (Other)
Enhanced Support without Caregiver
- Standardized Heart Failure Discharge Summary to Primary Care Physicians©
- Standardized education sessions
- Heart Failure Diuretic Decision Support Tool for Patient Self Management©
- Digital talking scale
干预措施: Standardized Heart Failure Discharge Summary to Primary Care Physicians© (Other)
Enhanced Support without Caregiver
- Standardized Heart Failure Discharge Summary to Primary Care Physicians©
- Standardized education sessions
- Heart Failure Diuretic Decision Support Tool for Patient Self Management©
- Digital talking scale
干预措施: Standardized education sessions (Behavioral)
Enhanced Support without Caregiver
- Standardized Heart Failure Discharge Summary to Primary Care Physicians©
- Standardized education sessions
- Heart Failure Diuretic Decision Support Tool for Patient Self Management©
- Digital talking scale
干预措施: Digital talking scale (Other)
Enhanced Support without Caregiver
- Standardized Heart Failure Discharge Summary to Primary Care Physicians©
- Standardized education sessions
- Heart Failure Diuretic Decision Support Tool for Patient Self Management©
- Digital talking scale
干预措施: Usual care (Other)
Usual Care without Caregiver
- Usual Care
干预措施: Usual care (Other)
结局指标
主要结局
Patient self care
时间窗: 3 months
Self-Care Heart Failure Index (SCHFI) for patients and caregivers
次要结局
- Heart failure readmission(3 months)
- Emergency room heart failure visits(3 months)
- Perceived caregiver burden(3 months)
- Heart failure knowledge acquisition(3 months)
- Medication adherence(3 months)
- Referral to heart failure clinic or to long-term care(3 months)
- Health beliefs(3 months)
- Depression(3 months)
- Death(3 months)
研究者
Catherine Demers
Associate Professor
McMaster University