- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03810534
Connect-Home Clinical Trial
Connect-Home: Testing the Efficacy of Transitional Care of Patients and Caregivers During Transitions From Skilled Nursing Facilities to Home
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC-Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Connect-Home
Connect-Home intervention at the skilled nursing facility and at the subject's home.
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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.
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No Intervention: Control
Standard discharge planning at the skilled nursing facility only.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge
Time Frame: 7 Days After SNF Discharge
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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.
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7 Days After SNF Discharge
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Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge
Time Frame: 7 Days After Patient SNF Discharge
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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.
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7 Days After Patient SNF Discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge
Time Frame: 30 Days After SNF Discharge
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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.
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30 Days After SNF Discharge
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McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge
Time Frame: 60 Days After SNF Discharge
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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.
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60 Days After SNF Discharge
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Life Space Assessment 30 Days After Skilled Nursing Facility Discharge
Time Frame: 30 Days After SNF Discharge
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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.
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30 Days After SNF Discharge
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Life Space Assessment 60 Days After Skilled Nursing Facility Discharge
Time Frame: 60 Days After SNF Discharge
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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.
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60 Days After SNF Discharge
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Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge
Time Frame: 30 Days After Patient's SNF Discharge
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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.
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30 Days After Patient's SNF Discharge
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Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge
Time Frame: 60 Days After Patient's SNF Discharge
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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.
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60 Days After Patient's SNF Discharge
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Distress Thermometer 30 Days After Skilled Nursing Facility Discharge
Time Frame: 30 Days After Patient's SNF Discharge
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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.
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30 Days After Patient's SNF Discharge
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Distress Thermometer 60 Days After Skilled Nursing Facility Discharge
Time Frame: 60 Days After Patient's SNF Discharge
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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.
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60 Days After Patient's SNF Discharge
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Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge
Time Frame: 30 Days After SNF Discharge
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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.
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30 Days After SNF Discharge
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Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge
Time Frame: 60 Days After SNF Discharge
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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.
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60 Days After SNF Discharge
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mark Toles, PhD, RN, University of North Carolina, Chapel Hill
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-1513
- R01NR017636 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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