A Randomized-Controlled Trial of a Health Literacy Tailored Educational Intervention for Hospitalized Congestive Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Re-hospitalization or Death
研究概览
简要总结
The primary aim of this project is to test the efficacy of an inpatient congestive heart failure (CHF) educational intervention compared with usual care among inpatients at Griffin Hospital, who are largely drawn from the population of the Naugatuck Valley in Connecticut.
The educational intervention will utilize:
- written educational materials suitable for patients with low health literacy - alternatives to written materials (e.g., video- and audiotapes) that may more effectively communicate health information to elderly patients and those with low health literacy
- a one-on-one educational session with a nurse patient educator. The educational session will use as its framework guidelines provided by the America Medical Association (AMA) to improve communication between healthcare providers and low health literacy patients. The investigators hypothesize that CHF patients who receive this educational intervention will have fewer hospital readmissions or deaths than the usual care group. The investigators further hypothesize that patients with low health literacy will derive more benefit from the intervention than patients with higher literacy.
The secondary aims of the project are to:
- assess whether patients in the education and usual care groups differ on post-discharge CHF knowledge and on satisfaction with hospital care. Compared with usual care, the investigators hypothesize that CHF patients who receive the educational intervention will have better knowledge of CHF and will be more satisfied with the care they received in the hospital.
The potential impact of the proposed project may be to increase disease knowledge and health literacy, and improve adherence to CHF treatments. This, in turn, may contribute to improved medical outcomes and reduced hospital readmissions for CHF patients. In addition, if this preliminary study provides evidence of a promising educational intervention suitable for patients with low health literacy, th investigators will endeavor to test the intervention in ethnically diverse populations throughout Connecticut.
详细描述
Variables and Measures
We will assess health literacy with the Short Test of Functional Health Literacy in Adults (STOFHLA). The STOFHLA is a brief version of the widely used instrument, the Test of Functional Health Literacy in Adults (TOFHLA) that measures patients' ability to comprehend situations often encountered in the health care setting; e.g., reading registration forms and instructions for diagnostic tests. It is a 36-item reading comprehension test written in 14-point font that requires 7 minutes to complete.
Primary Outcome The primary outcome is readmission or death from any cause within 90 days of discharge. This outcome will be ascertained by: 1) reviewing electronic and written medical records to identify patients re-admitted to Griffin Hospital; 2) monitoring obituaries; and 3) conducting three-month post-discharge follow-up phone calls to determine if the patient was admitted elsewhere since discharge from Griffin.
Secondary outcomes
- Change in knowledge of CHF from study enrollment to two weeks post-discharge will be measured by the Knowledge of CHF Questionnaire.
- Patient satisfaction with hospital care will be examined two weeks post-discharge with the 27-item Hospital Consumer Assessment of Health Plans Survey (HCAHPS) Telephone Survey Instrument.
- Feedback on educational materials will be obtained in narrative from patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible consecutive patients aged 50 years and over admitted with a primary diagnosis of CHF at Griffin Hospital will be invited to participate regardless of age, gender, race, or education level.
- •Because dietary and medication non-compliance affect patients with both systolic and diastolic heart failure, the investigators will include patients with both of these conditions, regardless of their ejection fraction.
排除标准
- •The investigators will exclude patients with clinical conditions and communication barriers that would limit their ability to participate in and/or benefit from this educational intervention.
- •The investigators will also exclude patients whose planned discharge is to another hospital or to a structured setting in which medical personnel are responsible for their care (e.g., a skilled nursing facility), thus limiting their ability to implement a largely self-directed self-care regimen upon leaving the hospital.
- •In addition, the investigators will exclude any patient who does not have a telephone and cannot, therefore, be contacted to obtain post-discharge follow-up data.
- •Specific exclusion criteria include:
- •A diagnosis of dementia or other severe mental disorder (e.g., acute delirium, psychosis)
- •Clinical instability or need for transfer to another hospital for acute intervention (e.g., experiencing cardiogenic shock, or needing valve surgery or acute coronary intervention)
- •Terminal illness or intubation
- •Moderate to severe uncorrected vision or hearing problems
- •Inability to speak English or to provide informed consent
- •Lack of access to a telephone
- •Planned discharge to a structured facility (e.g., skilled nursing facility, intermediate care facility)
结局指标
主要结局
Re-hospitalization or Death
时间窗: 90 days
Number of participants who are re-hospitalized or die within 90 days of discharge
次要结局
未报告次要终点
研究者
Dorothea Wild, MD
Principal Investigator
Griffin Hospital