N/A N=324 Randomized Single-blind Supportive Care

Connect-Home Clinical Trial

Transitional Care · Caregivers · Patient Discharge · Aging · Frailty

Bottom Line

View on ClinicalTrials.gov: NCT03810534 ↗

Enrolled (actual)

324

Serious AEs

11.0%

Results posted

Aug 2022

Primary outcome: Primary: Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge — 75.80; 68.33 score on a scale — p=.62

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Connect-Home (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge	75.80; 68.33	.62
PRIMARY Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge	23.14; 19.26	.31
SECONDARY McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge	7.69; 7.69	.93
SECONDARY McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge	7.81; 7.71	.60
SECONDARY Life Space Assessment 30 Days After Skilled Nursing Facility Discharge	22.18; 22.97	.53
SECONDARY Life Space Assessment 60 Days After Skilled Nursing Facility Discharge	25.55; 28.60	.83
SECONDARY Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge	12.27; 12.33	.75
SECONDARY Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge	11.84; 11.35	.50
SECONDARY Distress Thermometer 30 Days After Skilled Nursing Facility Discharge	3.19; 3.02	.48
SECONDARY Distress Thermometer 60 Days After Skilled Nursing Facility Discharge	3.03; 2.60	.22
SECONDARY Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge	.65; 1.01	.88
SECONDARY Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge	.82; 1.24	.23

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).

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03810534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.