Comparing Two Acute Care Transition Programs for Older Adults and Their Family Caregivers
調査の概要
詳細な説明
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.
Comparator B includes all Comparator A active strategies, plus focused family caregiver engagement and support.
Randomization:
1:1 Dyad-level RCT stratified by rural/urban home setting and presence of patient cognitive impairment
Patient-Centered Outcomes Include: Patient remaining safely at home (60-day hospital free days), post-discharge adverse events, patient-reported outcomes (e.g.: role functioning). Also, this study extends beyond prior effectiveness research by assessing family-caregiver-reported outcomes (e.g.: caregiver burden).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Michiyah Kimber
- 電話番号：336-716-2236
- メール：michiyah.kimber@advocatehealth.org
研究連絡先のバックアップ
- 名前：Erica Hale
- 電話番号：3367162236
- メール：erica.hale@advocatehealth.org
研究場所
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North Carolina
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Bermuda Run、North Carolina、アメリカ、27006
- 募集
- Davie Medical Center
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コンタクト：
- Houston
- 電話番号：508-688-4341
- メール：Thomas.Houston@advocatehealth.org
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High Point、North Carolina、アメリカ、27262
- 募集
- High Point Medical Center
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コンタクト：
- Houston
- 電話番号：508-688-4341
- メール：Thomas.Houston@advocatehealth.org
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North Wilkesboro、North Carolina、アメリカ、28659
- 募集
- Atrium Health Wake Forest Baptist Wilkes Medical Center
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コンタクト：
- Houston
- 電話番号：508-688-4341
- メール：Thomas.Houston@advocatehealth.org
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Winston-Salem、North Carolina、アメリカ、27157
- 募集
- Atrium Health Wake Forest Baptist Medical Center
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コンタクト：
- Houston
- 電話番号：508-688-4341
- メール：Thomas.Houston@advocatehealth.org
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
Patient Exclusion Criteria:
- 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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Patient Focused Strategies
An active care transition program that includes effective strategies focused on the patient.
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Effective strategies focused on the patient such as patient needs assessment, multi-disciplinary discharge planning, discharge instructions, follow-up education, and follow-up assessments.
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|
実験的：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.
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Effective strategies focused on the patient such as patient needs assessment, multi-disciplinary discharge planning, discharge instructions, follow-up education, and follow-up assessments.
Caregiver strategies such as a family caregiver needs assessment, structured education, and skill building.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hospital-Free Days
時間枠：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).
|
Day 60
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Hospital-Free Days
時間枠：Day 30, 90, and 180
|
The count of days alive and outside acute care hospitals from discharge to a specified day.
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).
|
Day 30, 90, and 180
|
|
Number of Patient Readmissions
時間枠：Day 30, 60, and 90
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All-cause, acute care readmissions calculated as both a count and dichotomous using EHR and Medicare claims data.
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Day 30, 60, and 90
|
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Zarit Burden Interview Score
時間枠：Day 60
|
Caregiver burden will be measured using the 12-item Zarit Burden Interview.
Scores will range from 0 to 48.
Higher scores indicate greater burden.
|
Day 60
|
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Zarit Burden Interview Score
時間枠：Day 30, 90, and 180
|
Caregiver burden will be measured using the 12-item Zarit Burden Interview.
Scores will range from 0 to 48.
Higher scores indicate greater burden.
|
Day 30, 90, and 180
|
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PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score
時間枠：Day 60
|
Social role function is one's ability to perform usual social roles and activities (e.g.: leisure, family).
It will be measured by using the APS-SF8.
Each item is scored using a 5-point Likert scale (1=Never, 5=Always).
Scores are typically converted to a standardized T-score, with a mean of 50 and a standard deviation of 10.
|
Day 60
|
|
PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score
時間枠：Day 30, 90 and 180
|
Social role function is one's ability to perform usual social roles and activities (e.g.: leisure, family).
It will be measured by using the APS-SF8.
Each item is scored using a 5-point Likert scale (1=Never, 5=Always).
Scores are typically converted to a standardized T-score, with a mean of 50 and a standard deviation of 10.
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Day 30, 90 and 180
|
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Partners at Care Transitions Measure (PACT-M) - Patient Satisfaction Score
時間枠：Day 7
|
Patient satisfaction will be measured using the 9-item PACT-M-1.
Scores will range from 9 to 45. Higher scores indicate better perception of the quality of discharge arrangements.
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Day 7
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Partners at Care Transitions Measure (PACT-M) - Patient Self-Efficacy Score
時間枠：Day 30
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Patient self-efficacy will be measured using the 8-item PACT-M-2.
Scores will range from 8 to 40.
Higher scores indicate a better experience with managing care at home.
|
Day 30
|
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Patient Activation Measures Score
時間枠：Day 60
|
Patient activation will be measured using the 13-item Patient Activation Measures.
Scores will range from 0 to 100.
Higher scores indicate greater knowledge, skills, and confidence for managing their health and health care.
|
Day 60
|
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Preparedness for Caregiving Scale Score
時間枠：Day 7
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Family caregiver preparedness will be measured using the 8-item Preparedness for Caregiving Scale.
Scores will range from 0 to 32.
Higher scores indicate better preparedness for the caregiving role.
|
Day 7
|
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Caregiver Self-Efficacy Scale Score
時間枠：Day 30
|
Family caregiver self-efficacy will be measured using the 8-item Caregiver Self-Efficacy Scale.
Scores will range from 8 to 80. Higher scores indicate higher self-efficacy.
|
Day 30
|
|
Caregiver Activation Measures Score
時間枠：Day 60
|
Patient activation will be measured using the 13-item Caregiver Activation Measures.
Scores will range from 0 to 100.
Higher scores indicate greater knowledge, skills, and confidence for managing their health and health care.
|
Day 60
|
|
Visit Completion Rate
時間枠：Day 14 and 30
|
Number of patients that completed follow-up visit
|
Day 14 and 30
|
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Time to First Outpatient Follow-up
時間枠：Day 14 and 30
|
Number of days between discharge and first outpatient follow-up visit
|
Day 14 and 30
|
|
Rate of Access to Community Services - Patient
時間枠：Day 30 and 60
|
Number of patients that had screening and intervention assessment for unmet social needs.
|
Day 30 and 60
|
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Rate of Access to Community Services - Caregiver
時間枠：Day 30 and 60
|
Number of caregivers that had screening and intervention assessment for unmet social needs
|
Day 30 and 60
|
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Partners at Care Transitions Measures - Adverse Events Score
時間枠：Day 7 and 30
|
Adverse events will be measured using the 7-item Partners at Care Transitions Measures.
Scores will range from 7 to 30.
Higher scores indicate greater care problems and more adverse events post discharge.
|
Day 7 and 30
|
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Mortality Rate
時間枠：Day 60 and 180
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Count of days to date of patient death
|
Day 60 and 180
|
|
Montreal Cognitive Assessment 5-minute Protocol Score
時間枠：Day 0, 60, and 180
|
Cognitive function (attention, orientation, language, memory, and executive function) will be measured using the Montreal Cognitive Assessment 5-min protocol.
Scores will range from 0 to 30.
Higher scores indicate better cognitive function.
|
Day 0, 60, and 180
|
協力者と研究者
捜査官
- 主任研究者：Thomas Houston, MD、Wake Forest University Health Sciences
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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