Connect-Home Clinical Trial

Not Applicable

Completed

• Conditions: Transitional Care; Caregivers; Patient Discharge; Frailty; Aging
• Interventions: Behavioral: Connect-Home

• Registration Number: NCT03810534
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Study Start: 2019-03-01
• Primary Completion: 2021-07-24
• Study Completion: 2021-09-12
• Status Verified: 2021-12
• Results First Submitted: 2022-06-01
• Results First Submitted QC: 2022-07-29
• Last Update Submitted: 2022-07-29
• Results First Posted: 2022-08-23
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 654

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Connect-Home	Connect-Home	Connect-Home intervention at the skilled nursing facility and at the subject's home.

Primary Outcome Measures

Name	Time	Method
Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge	7 Days After SNF 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.
Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge	7 Days After Patient SNF 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.

Secondary Outcome Measures

Name	Time	Method
McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge	30 Days After SNF 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.
McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge	60 Days After SNF 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.
Life Space Assessment 30 Days After Skilled Nursing Facility Discharge	30 Days After SNF 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.
Life Space Assessment 60 Days After Skilled Nursing Facility Discharge	60 Days After SNF 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.
Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge	30 Days After Patient's SNF 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.
Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge	60 Days After Patient's SNF 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.
Distress Thermometer 30 Days After Skilled Nursing Facility Discharge	30 Days After Patient's SNF 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.
Distress Thermometer 60 Days After Skilled Nursing Facility Discharge	60 Days After Patient's SNF 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.
Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge	30 Days After SNF 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.
Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge	60 Days After SNF 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.

Trial Locations

Locations (1)

UNC-Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States