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Connect-Home Clinical Trial

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ClinicalTrials.gov Identifier: NCT03810534
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE January 17, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date March 21, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03810534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge [ Time Frame: 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.
  • McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge [ Time Frame: 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.
  • Life Space Assessment 30 Days After Skilled Nursing Facility Discharge [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Number of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge [ Time Frame: 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 Number of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Connect-Home Clinical Trial
Official Title  ICMJE Connect-Home: Testing the Efficacy of Transitional Care of Patients and Caregivers During Transitions From Skilled Nursing Facilities to Home
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Transitional Care
  • Caregivers
  • Patient Discharge
  • Aging
  • Frailty
Intervention  ICMJE Behavioral: Connect-Home
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.
Study Arms  ICMJE
  • Experimental: Connect-Home
    Connect-Home intervention at the skilled nursing facility and at the subject's home.
    Intervention: Behavioral: Connect-Home
  • No Intervention: Control
    Standard discharge planning at the skilled nursing facility only.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
720
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark Toles, PhD, RN 919-966-5684 mtoles@email.unc.edu
Contact: Jacquelyn Covington jacquelyn_covington@med.unc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810534
Other Study ID Numbers  ICMJE 18-1513
R01NR017636 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: 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.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Mark Toles, PhD, RN University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP