Patient and Family Partners in Heart Failure: Pilot Test of a Pre-visit Question Prompt List to Enhance Engagement of Heart Failure Patients and Family Members During Medical Visits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Percent of Eligible Participants Who Enroll
研究概览
简要总结
The purpose of this study is to conduct a pilot study in 30 Heart Failure (HF) patients and visit companions (i.e., a family member who accompanies the patient to medical visits), to evaluate a pre- visit question/topic prompt list, designed to enhance patient and family member engagement during visits by providing a list of questions or topics that they may want to discuss with their health care provider.
详细描述
Participants in this study will include 30 HF patients or dyads (i.e., a patient and family member who accompanies the patient into the examination room at a visit). While our study primarily will target HF dyads, if the investigators encounter recruitment difficulties, unaccompanied HF patients (i.e., HF patients who do not have a family member who can participate in the study with them) will also be enrolled.
Procedures (methods): Single group pre-post study design.
After providing informed consent, HF patients or dyads will receive the prompt list while in the waiting room prior to their visit. Completing the prompt list involves two steps. In step 1, participants will independently select from a predetermined list of questions (within topic areas) that they would like to ask their health care provider. The questions/topics were developed by other HF patients and family members in another phase of the study. Also, patients will be asked to choose behaviors they would like their family member to engage in during the visit (e.g., write down the provider's instructions, ask questions), from a structured list developed based on prior research. Family members will identify which behaviors they are willing to perform. In step 2, patients or dyads will collectively prioritize which questions/topics to discuss during the visit. Each dyad member will receive a prompt list to complete in the clinic waiting room immediately before their appointment.
All visits will be audio-taped to assess effects of the intervention on communication behaviors during the visit. All participants will complete a questionnaire at baseline, 2 days after the audio-taped clinic visit, and at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Given the nature of the intervention and it's intended purpose (i.e., to enhance communication with participants and health care providers), it is not possible to blind participants, care providers, or the investigators.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Eligibility Criteria
- •Ambulatory adult patients ≥ 30 years old
- •Receive care in the University of North Carolina at Chapel Hill Cardiology practice
- •Have a clinical diagnosis of HF
- •Currently prescribed a loop diuretic
- •Have a New York Heart Association class II-IV
- •Must speak English
- •Have a working telephone or live with the patient
- •Family Member Eligibility Criteria
- •≥ 18 years old and able to give informed consent
- •Must be willing to participate in the intervention activities and provide informed consent
- •Must speak English
- •Have a working telephone or live with the patient
- •Health Care Provider Eligibility Criteria
- •Must be an MD or advance practice provider (NP or PA) in the University of North Carolina at Chapel Hill Cardiology or General Internal Medicine practice
- •Must be willing to have an enrolled patient visit audio-taped
排除标准
- •For patients:
- •blindness,
- •terminal illness with life expectancy <1 year (based on physician estimation),
- •currently on or anticipated to start dialysis within 1 year,
- •oxygen dependent chronic obstructive pulmonary disease,
- •residency in a nursing home, or
- •psychiatric illness that would interfere with protocol completion.
结局指标
主要结局
Percent of Eligible Participants Who Enroll
时间窗: 6 months
The investigators will assess enrollment success into the study among those considered eligible. Investigators aim to have at least 50% of eligible participants enroll into the trial.
次要结局
- Mean Acceptability Checklist Score(Within 2 days after receiving checklist)
- Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale(Up to 1 month after clinic visit)
- Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale(Up to 1 month after clinic visit)
- Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale(Up to 1 month after)
- Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Confidence Subscale(Up to 1 month after.)
- Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Maintenance Subscale(Up to 1 month after)
- Mean Score on Communication With Physicians Measure(Up to 1 month after clinic visit)
- Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Management Subscale(Up to 1 month after)
- Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI)(Up to 1 month after clinic visit)