Clinical trial NCT03810534: Connect-Home Clinical Trial
Official title: Connect-Home: Testing the Efficacy of Transitional Care of Patients and Caregivers During Transitions From Skilled Nursing Facilities to Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transitional Care
Caregivers
Patient Discharge
Aging
Frailty
Keywords: Transitional Care
Skilled Nursing Facilities
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-01-18
Enrollment: 654
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge
timeFrame: 7 Days After SNF Discharge
measure: Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge
timeFrame: 7 Days After Patient SNF Discharge
Secondary outcomes:
measure: McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge
timeFrame: 30 Days After SNF Discharge
measure: McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge
timeFrame: 60 Days After SNF Discharge
measure: Life Space Assessment 30 Days After Skilled Nursing Facility Discharge
timeFrame: 30 Days After SNF Discharge
measure: Life Space Assessment 60 Days After Skilled Nursing Facility Discharge
timeFrame: 60 Days After SNF Discharge
measure: Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge
timeFrame: 30 Days After Patient's SNF Discharge
measure: Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge
timeFrame: 60 Days After Patient's SNF Discharge
measure: Distress Thermometer 30 Days After Skilled Nursing Facility Discharge
timeFrame: 30 Days After Patient's SNF Discharge
measure: Distress Thermometer 60 Days After Skilled Nursing Facility Discharge
timeFrame: 60 Days After Patient's SNF Discharge
measure: Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge
timeFrame: 30 Days After SNF Discharge
measure: Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge
timeFrame: 60 Days After SNF Discharge
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Mark Toles, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toles M, Colon-Emeric C, Hanson LC, Naylor M, Weinberger M, Covington J, Preisser JS. Transitional care from skilled nursing facilities to home: study protocol for a stepped wedge cluster randomized trial. Trials. 2021 Feb 5;22(1):120. doi: 10.1186/s13063-021-05068-0.