Connect-Home Clinical Trial

NCT03810534 | Completed Results DMC

• 2 other identifiers: 18-1513R01NR017636
• Study Type: interventional
• Target: 654
• Locations: 1 country
• Sites: 1

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).

Conditions

Transitional Care; Caregivers; Patient Discharge; Aging; Frailty

Keywords

Transitional Care; Skilled Nursing Facilities

Outcome Measures

Primary Outcomes (2)

• Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility 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.

  7 Days After SNF Discharge

• Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility 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.

  7 Days After Patient SNF Discharge

Secondary Outcomes (10)

• McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge

  30 Days After SNF Discharge

• McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge

  60 Days After SNF Discharge

• Life Space Assessment 30 Days After Skilled Nursing Facility Discharge

  30 Days After SNF Discharge

• Life Space Assessment 60 Days After Skilled Nursing Facility Discharge

  60 Days After SNF Discharge

• Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge

  30 Days After Patient's SNF Discharge

Study Arms (2)

Connect-Home

EXPERIMENTAL

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

Behavioral: Connect-Home

Control

NO INTERVENTION

Standard discharge planning at the skilled nursing facility only.

Interventions

Connect-Home BEHAVIORAL

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.

Connect-Home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• English-speaking
• Self-reports assisting the patient at home.

You may not qualify if:

• Planned hospital readmission for procedures/treatments in next 90 days.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 33546737 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mark Toles, MPH
• Organization: University of North Carolina at Chapel Hill

mtoles@email.unc.edu

919-966-5684

Study Officials

• Mark Toles, PhD, RN

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 18, 2019
• Study Start: March 1, 2019
• Primary Completion: July 24, 2021
• Study Completion: September 12, 2021
• Last Updated: August 23, 2022
• Results First Posted: August 23, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication.
• Access Criteria: Investigators who propose to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and must execute a data use/sharing agreement with UNC.

Locations

US (1)