Comparing Two Acute Care Transition Programs for Older Adults and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,560
- 试验地点
- 4
- 主要终点
- Hospital-Free Days
研究概览
简要总结
This study investigates better ways to help people after they leave the hospital and how to involve their families in this process. The main goal is to see if adding family support to a patient-centered hospital-to-home intervention helps patients stay safely at home, spend fewer days back in the emergency room or going back into the hospital. The study team also wants to see if the family-centered approach helps improve the patient's ability to do everyday activities without feeling overwhelmed. Two approaches are being compared: one focuses just on the patient, and the other includes special strategies to better support families involved too. Family will be involved in assessing what the patient and family needs. The family-focused approach not only emphasizes the experience, health, and safety of the patient but also the experience of the family member caring for the older adult. The study also involves families in education and provides families skills-building experiences that can help with caregiving stress, problem-solving, and communicating with the healthcare team. The approach will help the family member prepare for their loved one's transition home and provide coaching with the goal of reducing the mental, physical and financial burden of providing care at home. To spread the intervention across many states, the study team will be using telephone calls, video calls, and other technologies as families prefer.
详细描述
For all patients, the transition from hospital to home is a vulnerable period, placing them at great risk for adverse events. In a landmark 2003 report on care transitions, investigators found that 19% of patients experience adverse events soon after discharge (many preventable or ameliorable) and 66% experience adverse drug events. Care transitions also impact those around the recently discharged patient - increasing the burden on family members who provide caregiving support. Without communication and engagement in care transitions, family members experience reduced preparedness for their post-discharge caregiving role, increased caregiver burden, social isolation, and reduced mental/physical well-being.
Patient-centered care transitions can be supported through evidence-based interventions. Recent knowledge generated through PCORI's Transitional Care Evidence to Action Network and other research programs has identified remaining evidence gaps. This Phased Large Award for Comparative Effectiveness Research entitled Comparing Two Acute Care Transition Programs for Older Adults and Their Family Caregivers will create new knowledge related to engaging and supporting family caregivers. After optimization in the feasibility phase, briefly, the Phase 2 comparative effectiveness trial will have the following characteristics:
Setting: 20 Acute Care Hospitals across 5 states selected for rural/urban diversity and patient characteristics Sample: Dyads: Older Adults (N = 1,200) discharged to home and their Family Caregivers (N = 1,200)
Comparators:
Comparator A is an active care transition program that includes effective strategies focused on the patient.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Inclusion Criteria:
- •65 and older
- •English and Spanish speaking
- •Preadmission location: community dwelling
- •Distance from Hospital: Local and Distant (rural) included
- •Cognitive impairment, dementia allowed
- •Technology Literacy: Flexible from high to low
- •EPIC readmission risk score over 12
- •Discharged home
排除标准
- •Admitted from skilled nursing facility
- •Discharged to skilled nursing facility
- •Left Against Medical Advice (AMA)
- •Planned readmission
- •Died during index admission
- •Caregiver unwilling to participate
- •Caregiver Inclusion Criteria:
- •Adults 18 and older
- •English and Spanish speaking
- •Providing tangible support to patient
- •Distance from Hospital: Local and Distant (rural) included
- •Only Mild Cognitive Impairment allowed
- •Able to be trained in Video Visit Technology
- •Available to support post-discharge
- •Caregiver Exclusion Criteria:
- •Has a greater than a mild cognitive impairment (< 12 on MCA)
研究组 & 干预措施
Patient Focused Strategies
An active care transition program that includes effective strategies focused on the patient.
干预措施: Patient-Centered Program (Other)
Patient and Family Focused Strategies
An active care transition program that includes effective strategies focused on the patient plus focused family caregiver engagement and support.
干预措施: Patient-Centered Program (Other)
Patient and Family Focused Strategies
An active care transition program that includes effective strategies focused on the patient plus focused family caregiver engagement and support.
干预措施: Family Caregiver Enhanced Program (Other)
结局指标
主要结局
Hospital-Free Days
时间窗: Day 60
The count of days alive and outside acute care hospitals from discharge to day 60. It will be calculated using EHR and Medicare claims data to objectively capture hospital free days elements (i.e.: mortality days, inpatient days, observation stays, and ED visits).
次要结局
- Number of Hospital-Free Days(Day 30, 90, and 180)
- Number of Patient Readmissions(Day 30, 60, and 90)
- Zarit Burden Interview Score(Day 60)
- Zarit Burden Interview Score(Day 30, 90, and 180)
- PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score(Day 60)
- PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score(Day 30, 90 and 180)
- Partners at Care Transitions Measure (PACT-M) - Patient Satisfaction Score(Day 7)
- Partners at Care Transitions Measure (PACT-M) - Patient Self-Efficacy Score(Day 30)
- Patient Activation Measures Score(Day 60)
- Preparedness for Caregiving Scale Score(Day 7)
- Caregiver Self-Efficacy Scale Score(Day 30)
- Caregiver Activation Measures Score(Day 60)
- Visit Completion Rate(Day 14 and 30)
- Time to First Outpatient Follow-up(Day 14 and 30)
- Rate of Access to Community Services - Patient(Day 30 and 60)
- Rate of Access to Community Services - Caregiver(Day 30 and 60)
- Partners at Care Transitions Measures - Adverse Events Score(Day 7 and 30)
- Mortality Rate(Day 60 and 180)
- Montreal Cognitive Assessment 5-minute Protocol Score(Day 0, 60, and 180)