Health Coaching for Patients With Cardiovascular Disease: A Mixed-Methods Evaluation of the Impact on Patient Outcomes and Provider Satisfaction and Acceptability
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Acceptability of Intervention Measure
研究概览
简要总结
For patients discharged with a diagnosis of cardiovascular disease coronary artery disease resulting in myocardial infarction and/or congestive heart failure, this study will evaluate if the addition of 12 virtual health coaching sessions over the course of 16 weeks will improve physiological, psychological, and social health outcomes, prove acceptable and satisfactory for these patients with CVD, decrease CVD-related questions and concerns sent to the provider via MyChart, and reduce hospital readmission rates over a 90-day period as compared to patients discharged with the same diagnosis who receive standard post-discharge care. The study will also evaluate the perceptions of physician and advanced practice providers related to the health coach as part of the interprofessional team and the amount of time spent addressing CVD-related patient questions and concerns via MyChart messages.
详细描述
The purpose of this mixed methods study is to evaluate the impact of 12 virtual health coaching sessions, provided post-discharge, over the course of 16 weeks on: 1) patient physiological measure of weight; 2) patient-reported perceived stress, anxiety, depression, and medication adherence, and physical, emotional, and social lifestyle behaviors; and 3) MyChart messaging to their providers related to concerns and/or questions about their cardiovascular diagnosis. The study will also assess: 4) patient acceptability and satisfaction with the health coaching intervention; 5) acceptability and satisfaction value and/or importance of the health coach intervention and feasibility of integrating the health coach into the inter-professional care team from the provider perspective; impact of the health coaching intervention on provider time spent on addressing MyChart messages; and 6) 30-, 60-, and 90-day hospital readmission rates.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •diagnosis of coronary artery disease resulting in myocardial infarction and/or congestive heart failure
- •physical condition effectively managed by routine healthcare and not requiring urgent medical attention
- •ability to communicate in English
- •access to a working phone or computer and ability to communicate via phone or computer.
排除标准
- •Patients who have had chest coronary artery bypass surgery
- •Documented cognitive and/or major psychiatric disorders, including dementia, Alzheimer's, depression or anxiety uncontrolled by anxiolytic, anti-psychotic, and/or anti-depressants and/or PHQ-9 score 15-27 and GAD-7 score >15
- •current alcohol or drug dependency
- •resident of extended care/skilled facility
- •prisoners or ward of state.
研究组 & 干预措施
Health Coaching Intervention Group
Participants will receive 12 health coaching sessions post-discharge over a 16 week period
干预措施: Health Coaching (Behavioral)
Standard Care Group
Participants will receive usual post-discharge care over the 16 week period
结局指标
主要结局
Acceptability of Intervention Measure
时间窗: Completed after the 16 week health coaching intervention for participants in the intervention group.
The Acceptability of Intervention Measure (AIM) is a 4-item self-report assessment to evaluate the acceptability of the health coaching intervention. Each statement is scored with a 5-point Likert Scale that includes 1 (completely disagree), 2 (disagree), 3 (neither agree nor disagree), 4 (agree), and 5 (completely agree). Total scores ranges from 4-20 with higher total scores indicating higher acceptability.
Body weight
时间窗: Baseline (day of hospital discharge) and at provider appointment in the ambulatory setting, 16 weeks post-hospital discharge
Patient body weight in kilograms will be obtained by clinical staff on hospital approved and calibrated electronic standing scales. The patient's body weight will be collected from the patient's electronic medical record.
Hospital readmissions
时间窗: Hospital readmissions during the 30-, 60-, and 90-days post-hospital discharge for cardiovascular disease, documented in the electronic medical record
Hospital readmissions for an inpatient stay, documented in the electronic medical record, after the hospital post-discharge for cardiovascular disease
MyChart messages
时间窗: Over the course of 16 weeks, from hospital discharge to 16 weeks post-hospital discharge
MyChart messages are questions or requests directed to the patient's provider that are related to the patient's cardiovascular disease diagnosis and hospitalization. These MyChart messages are entered into the electronic medical record by the patient and are directed to their provider, requiring an electronic or telephone response to the patient with a documented note entered by the provider relative to the follow-up provided to the patient. This outcome measure will be the number of MyChart messages entered by the patient and responded to by the provider.
Perceived Stress
时间窗: Baseline (hospital discharge), 8 weeks post-hospital discharge, and 16 weeks post-hospital discharge
Perceived Stress Scale-10 (PSS-10). A 10-item self-report measure of perceived stress. It is a measure of the degree to which situations in one's life are appraised as stressful over the past month. The 4-point Likert Scale includes responses of 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), and 4 (very often). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Medication Adherence
时间窗: Baseline, and at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge
The Hill-Bone Medication Adherence Scale (MB-MAS) is a 9-item self-assessment of medication adherence relative to a variety of chronic diseases and conditions. Likert Scale responses to each of the nine statements include 1 (all of the time), 2 (most of the time), 3 (some of the time), and 4 (none of the time). Total scores range from 4 to 36 with higher scores indicating higher medication adherence.
Lifestyle Medicine Behavior Assessment
时间窗: Completed at baseline, at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge
The Lifestyle Medicine Short Form is a 14-item self-assessment scale evaluating physical, emotional, social lifestyle behaviors. The assessment questions comprise core metrics that capture readiness to change, as well as health behaviors that are aligned with the six pillars of lifestyle medicine--physical activity, nutrition, sleep health, stress reduction, social connections, and risky substances. Questions have multiple responses based on information relating to the six pillars of lifestyle medicine. The first two questions related to Readiness to Change use a Likert Scale ranging from 0 (Not Ready) to 10 (Very Ready). Questions related to Motivation and Diet request that the participant denote different aspects of their diet. Physical exercise questions request specific days/times in minutes completed. Questions related to sleep request average hours of sleep per 24 hour period. Mood, connectedness with others, and substance use request types/amounts per week.
次要结局
- Patient Qualitative Comments(Immediately after completion of the 16 week health coaching intervention; i.e. 16 weeks post-hospital discharge)
- Provider Qualitative Comments(Will be completed within one month of their patient completing the health coach intervention.)
- Patient Qualitative Comments(Immediately after completion of the 16 week health coaching intervention; i.e. 16 weeks post-hospital discharge)
- Provider Qualitative Comments(Will be completed within one month of their patient completing the health coach intervention.)
- Patient Health Questionnaire (PHQ-9)(Baseline, 4-, 8-, and 16 weeks post-discharge for all participants)
- Generalized Anxiety Disorder-7 (GAD-7)(Baseline, 4-, 8-, and 16 weeks post-discharge for all participants)
研究者
Beth Steinberg
Associate Director of Research
Ohio State University