Connect-Home Clinical Trial

Study Overview
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Brief Summary
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This study will test whether transitional care targeting care needs of seriously ill, skilled nursing facility (SNF) patients and their caregivers will help to improve SNF patient outcomes (preparedness for discharge, quality of life, function and acute care use) and caregiver outcomes (preparedness for the caregiving role. caregiver burden and caregiver distress).

Detailed Description
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Prior research has not established an evidence-based model of transitional care for seriously ill SNF patients (and their caregivers) who transfer from SNF to home-based care. Connect-Home, the intervention to be tested in this study, will use existing nursing home staff and community-based nurses to deliver transitional care in SNFs and the patient's home. The feasibility, acceptability, and estimated efficacy of Connect-Home was demonstrated in a pilot test of pre-discharge elements of Connect-Home (N=133 patients and their caregivers). Compared to controls, intervention participants were significantly more prepared for discharge (higher scores on Care Transitions Measure-15) and they more frequently received individualized plans for continuing care at home. Virtually all SNF staff participants (97%) recommended the intervention for future use, demonstrating its acceptability. The objective of this study is to test the efficacy of Connect-Home for seriously ill patients discharged to home and their caregivers. In this trial, intervention participants will receive the Connect-Home intervention; the intervention has two steps. While the patient is in the SNF, nurses, social workers and rehabilitation therapists will create an individualized Transition Plan of Care and prepare the patient and caregiver to manage the patient's serious illness at home. Within 24 hours of the time that the SNF patient discharges to home, a Connect-Home Activation Nurse (Activation RN) will visit the patient at home; the Activation RN will help the patient and family caregiver implement the written Transition Plan of Care. The Connect-Home intervention will focus on six key care needs: (1) home safety and level of assistance; (2) advance care planning; (3) symptom management; (4) medication reconciliation; (5) function and activity; and (6) coordination of follow-up medical care. In this trial, the control participants will receive usual discharge planning in the SNF only. Usual discharge planning for SNF patients includes assignment to an interdisciplinary team that develops discharge instructions for the patient to follow at home with oversight by a physician. Usual care does not include a structured home visit after the patient discharges to home. Patient and caregiver outcomes will assessed in 7, 30, and 60 days after the patient discharged from the SNF to home. Outcomes assessors will be blinded to study group.

Official Title
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Connect-Home: Testing the Efficacy of Transitional Care of Patients and Caregivers During Transitions From Skilled Nursing Facilities to Home

Conditions
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Transitional Care, Caregivers, Patient Discharge, Aging, Frailty

Intervention / Treatment
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* Behavioral: Connect-Home


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for patients: English-speaking Have a Minimum Data Set 3.0 Section GG Mobility Assessment Score of 3 or less, indicating the patient requires at least 25-50% assistance for functional mobility Be diagnosed with at least 1 serious medical illness (neurodegenerative dementia, cancer, chronic kidney disease, cirrhosis, congestive heart failure, chronic obstructive or interstitial lung disease, acute infection with sepsis, acute major motor stroke, acute coronary syndrome, acute hip fracture, diabetes with end organ complications, or intensive care for >3 days while hospitalized) Having a caregiver who can be enrolled in the study For patients with cognitive impairment additional criteria include documentation in the medical record of a caregiver who is the patient's legally authorized representative; and consent of the caregiver to participate in the study as the patient's representative. Inclusion Criteria for Caregivers: English-speaking Self-reports assisting the patient at home. Exclusion Criteria for Patients: Planned hospital readmission for procedures/treatments in next 90 days. There are no exclusion criteria for Caregivers.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The Connect-Home study employs a stepped wedge cluster-randomized trial design, which is a crossover design at the cluster level where clusters of individuals (i.e., residents in a nursing home) crossover from control to intervention condition at randomly assigned timepoints or steps.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connect-Home<br>Connect-Home intervention at the skilled nursing facility and at the subject's home. | Behavioral: Connect-Home<br>* Connect-Home will introduce organizational structure to support delivery of transitional care processes. New elements of structure include:electronic health record (EHR) template, Connect-Home Toolkit, and Staff Training. After structural elements are added, SNF staff will use Connect-Home care processes to deliver the 2-step transitional care intervention.In Step 1, SNF nurses, therapists, and social workers will develop a Transition Plan of Care and prepare the patient and caregiver to manage the patient's serious illness and functional needs. In Step 2, the Connect-Home Activation RN will visit the patient's home within 24 hours of discharge; the nurse will activate the Transition Plan of Care at home. Both intervention steps focus on 6 key care needs to optimize patient and caregiver outcomes: 1) home safety and level of assistance; 2) advance care planning; 3) symptom management; 4) medication reconciliation; 5) function and activity; and 6) coordination of follow-up medical care.<br>|
| No Intervention: Control<br>Standard discharge planning at the skilled nursing facility only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge | The patient's preparedness for discharge will be measured by the Care Transitions Measure-15 (CTM-15), which includes 5 items on a 4-point scale. The CTM-15 measures self-reported knowledge and skills for continuing care at home. Summary score range 0-100, with higher scores associated with less acute care use after discharge. | 7 Days After SNF Discharge | 
| Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge | The caregiver's preparedness for caregiving will be measured by the Preparedness for Caregiving Scale (PCS), which includes 8 items on a five-point Likert scale (0-4). The PCS measures self-reported readiness for caregiving. Range = 0-32, with higher scores associated with less anxiety. | 7 Days After Patient SNF Discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge | The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means. | 30 Days After SNF Discharge | 
| McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge | The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means. | 60 Days After SNF Discharge | 
| Life Space Assessment 30 Days After Skilled Nursing Facility Discharge | Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the Life-space level (range 1-5) and the independence score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization. | 30 Days After SNF Discharge | 
| Life Space Assessment 60 Days After Skilled Nursing Facility Discharge | Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the Life-space level (range 1-5) and the independence score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization. | 60 Days After SNF Discharge | 
| Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge | Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning. Scores range 0-48; higher scores are associated with depression and social isolation. | 30 Days After Patient's SNF Discharge | 
| Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge | Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning. Scores range 0-48; higher scores are associated with depression and social isolation. | 60 Days After Patient's SNF Discharge | 
| Distress Thermometer 30 Days After Skilled Nursing Facility Discharge | Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores >4 associated with poor coping and depression. | 30 Days After Patient's SNF Discharge | 
| Distress Thermometer 60 Days After Skilled Nursing Facility Discharge | Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores >4 associated with poor coping and depression. | 60 Days After Patient's SNF Discharge | 
| Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge | Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the Emergency Department (ED) or hospital in 30 days after SNF discharge. | 30 Days After SNF Discharge | 
| Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge | Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the ED or hospital in 60 days after SNF discharge. | 60 Days After SNF Discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transitional Care, Skilled Nursing Facilities