Connect-Home Clinical Trial
Status: | Recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/23/2019 |
Start Date: | March 1, 2019 |
End Date: | August 2021 |
Contact: | Mark Toles, PhD, RN |
Email: | mtoles@email.unc.edu |
Phone: | 919-966-5684 |
Connect-Home: Testing the Efficacy of Transitional Care of Patients and Caregivers During Transitions From Skilled Nursing Facilities to Home
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).
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).
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.
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.
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.
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