Trial Outcomes & Findings for Adapting Connect-Home Transitional Care for the Unique Needs of Persons With Alzheimer's Disease and Other Dementias and Their Caregivers (NCT NCT05887388)

NCT ID: NCT05887388

Last Updated: 2023-07-21

Results Overview

Feasibility will measured using an instrument to audit skilled nursing facility medical records of the patient and the intervention log of services for the Patient and Caregiver dyad. It includes eight dichotomous (yes-no) items that indicate feasibility of the Connect-Home Plus intervention. The feasibility items include: (1) completing the Transition Plan of Care; (2) convening the care plan meeting with caregiver attending; (3) reviewing advance directives in the SNF; (4) scheduling follow-up medical appointments; (5) transmitting records to follow-up clinicians; (6) home care nurse completion of the first home visit within 24 hours after discharge; (7) completion of first caregiver support call within 72 hours of discharge; (8) completion of the second and third caregiver support call within one month of discharge. A "Yes" answer indicates that the intervention component was feasible to provide for the patient and caregiver dyad.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

30 days after SNF discharge

Results posted on

2023-07-21

Participant Flow

Participant milestones

Participant milestones
Measure
Intervention
Connect-Home Plus will be delivered in the skilled nursing facility (SNF) and via telephone after discharge. Connect-Home Plus: Connect-Home Plus will introduce organizational structure to support delivery of transitional care processes. New elements of structure include:electronic health record (EHR) template, Connect-Home Plus Toolkit, and Staff Training. After structural elements are added, SNF staff will use Connect-Home Plus 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 illness and functional needs. In Step 2, a home health care nurse will visit (one time) and a dementia caregiving specialist will call the patient's home three times within 30 days of discharge. Both intervention steps will focus on key care needs, such as 1) home safety; 2) care of symptoms of Alzheimer's disease and related dementia (ADRD); 3) symptom management; 4) medication reconciliation; 5) function and activity; and 6) coordination of follow-up medical care.
Overall Study
STARTED
38
Overall Study
Patients Started
19
Overall Study
Caregivers Started
19
Overall Study
COMPLETED
38
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data are reported separately for Patients and Caregivers.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=38 Participants
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
Age, Continuous
Patients
85.4 years
STANDARD_DEVIATION 6.8 • n=19 Participants • Data are reported separately for Patients and Caregivers.
Age, Continuous
Caregivers
61.8 years
STANDARD_DEVIATION 11.4 • n=19 Participants • Data are reported separately for Patients and Caregivers.
Sex: Female, Male
Patients · Female
15 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Sex: Female, Male
Patients · Male
4 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Sex: Female, Male
Caregivers · Female
13 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Sex: Female, Male
Caregivers · Male
6 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Ethnicity (NIH/OMB)
Patients · Hispanic or Latino
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Ethnicity (NIH/OMB)
Patients · Not Hispanic or Latino
19 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Ethnicity (NIH/OMB)
Patients · Unknown or Not Reported
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
19 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Patients · American Indian or Alaska Native
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Patients · Asian
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Patients · Native Hawaiian or Other Pacific Islander
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Patients · Black or African American
1 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Patients · White
18 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Patients · More than one race
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Patients · Unknown or Not Reported
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Caregivers · Asian
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Caregivers · Black or African American
1 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Caregivers · White
18 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Caregivers · More than one race
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
0 Participants
n=19 Participants • Data are reported separately for Patients and Caregivers.
Region of Enrollment
United States · Patients
19 Participants
n=38 Participants
Region of Enrollment
United States · Caregivers
19 Participants
n=38 Participants

PRIMARY outcome

Timeframe: 30 days after SNF discharge

Population: Data are reported only for Patients as this measure does not apply to Caregivers.

Feasibility will measured using an instrument to audit skilled nursing facility medical records of the patient and the intervention log of services for the Patient and Caregiver dyad. It includes eight dichotomous (yes-no) items that indicate feasibility of the Connect-Home Plus intervention. The feasibility items include: (1) completing the Transition Plan of Care; (2) convening the care plan meeting with caregiver attending; (3) reviewing advance directives in the SNF; (4) scheduling follow-up medical appointments; (5) transmitting records to follow-up clinicians; (6) home care nurse completion of the first home visit within 24 hours after discharge; (7) completion of first caregiver support call within 72 hours of discharge; (8) completion of the second and third caregiver support call within one month of discharge. A "Yes" answer indicates that the intervention component was feasible to provide for the patient and caregiver dyad.

Outcome measures

Outcome measures
Measure
Connect-Home Plus Patients
n=19 Participants
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
Number of Patients for Whom the Intervention Components Were Feasible
Record transmission
19 Participants
Number of Patients for Whom the Intervention Components Were Feasible
Call back #1 within 72 hours
17 Participants
Number of Patients for Whom the Intervention Components Were Feasible
Transition Plan of Care
16 Participants
Number of Patients for Whom the Intervention Components Were Feasible
Care plan meeting
19 Participants
Number of Patients for Whom the Intervention Components Were Feasible
Advance directives
15 Participants
Number of Patients for Whom the Intervention Components Were Feasible
Follow-up medical appointments
16 Participants
Number of Patients for Whom the Intervention Components Were Feasible
Home visit within 24 hours
17 Participants
Number of Patients for Whom the Intervention Components Were Feasible
Call back #2 and #3 within 30 days
16 Participants

PRIMARY outcome

Timeframe: 21 days after SNF discharge

Population: Data are reported only for Patients as this measure does not apply to Caregivers. Fifteen Patients were unable or unavailable to participate in data collection for this measure.

This interview guide will be used to assess the acceptability of Connect-Home Plus with persons with ADRD. The interview will include questions about (1) factors that made the Connect-Home Plus transitional care services easy or difficult to use, (2) specific supports that were and were not helpful, (3) the effect of Connect-Home Plus on how to manage issues related to ADRD at home, and (4) unmet needs for care of issues related to ADRD at home. Responses to the interview guide questions will be used to generate 3 4-point Likert scale acceptability scores, including (1) how helpful was Connect-Home Plus, (2) how difficult were these services to use, and (3) how well did these services prepare you for care at home. The scores will include 0 meaning not applicable, and scores 1-3 indicating acceptability, with lower scores indicating higher acceptability.

Outcome measures

Outcome measures
Measure
Connect-Home Plus Patients
n=4 Participants
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
Mean Patient Intervention Satisfaction Scores
Helpfulness
1.0 score on a scale
Standard Deviation 0
Mean Patient Intervention Satisfaction Scores
Usefulness
1.0 score on a scale
Standard Deviation 0
Mean Patient Intervention Satisfaction Scores
Appropriateness
1.0 score on a scale
Standard Deviation 0

PRIMARY outcome

Timeframe: 21 days after SNF discharge

Population: Data are reported only for Caregivers as this measure does not apply to Patients. Seven Caregivers were unavailable to participate in data collection for this measure.

This interview guide will be used to assess the acceptability of Connect-Home Plus with caregivers of persons with ADRD. This interview guide will include questions about (1) factors that made the Connect-Home Plus transitional care services easy or difficult to use, (2) specific supports that were and were not helpful, (3) the effect of Connect-Home Plus on how to manage issues related to ADRD at home, and (4) unmet needs for care of issues related to ADRD at home. Responses to the interview guide questions will be used to generate 3 4-point Likert scale acceptability scores, including (1) how helpful was Connect-Home Plus, (2) how difficult were these services to use, and (3) how well did these services prepare you for care at home. The scores will include 0 meaning not applicable, and scores 1-3 indicating acceptability, with lower scores indicating higher acceptability

Outcome measures

Outcome measures
Measure
Connect-Home Plus Patients
n=12 Participants
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
Mean Caregiver Intervention Satisfaction Scores
Helpfulness
1.3 score on a scale
Standard Deviation 0.5
Mean Caregiver Intervention Satisfaction Scores
Usefulness
1.0 score on a scale
Standard Deviation 0
Mean Caregiver Intervention Satisfaction Scores
Appropriateness
1.3 score on a scale
Standard Deviation 0.5

SECONDARY outcome

Timeframe: 7 Days After SNF Discharge

Population: Data are reported only for Patients as this measure does not apply to Caregivers and data are reported by the Patient (or the Caregiver serving as a proxy). Participants were unavailable for data collection for 3 Patients.

The patient's preparedness for discharge will be measured by the Care Transitions Measure-15 (CTM-15), which includes 15 items on a 4-point scale. The CTM-15 measures self-reported knowledge and skills for continuing care at home. Summary scores range 0-100, with higher scores indicating greater preparedness. Data collected from either the Patient or the Caregiver serving as proxy.

Outcome measures

Outcome measures
Measure
Connect-Home Plus Patients
n=16 Participants
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
Care Transitions Measure-15 (Patient)
70.3 score on a scale
Standard Deviation 12.0

SECONDARY outcome

Timeframe: 7 Days After SNF Discharge

Population: Data are reported only for Caregivers as this measure does not apply to Patients. Three Caregivers were unavailable for data collection for this measure.

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 greater preparedness.

Outcome measures

Outcome measures
Measure
Connect-Home Plus Patients
n=16 Participants
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
Preparedness for Caregiving Scale (Caregiver)
24.8 score on a scale
Standard Deviation 12.4

SECONDARY outcome

Timeframe: 30 Days After SNF Discharge

Population: Data are reported only for Patients as this measure does not apply to Caregivers and data are reported by the Patient (or the Caregiver serving as a proxy). Participants were unavailable for data collection for 5 Patients.

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 less life-space.

Outcome measures

Outcome measures
Measure
Connect-Home Plus Patients
n=14 Participants
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
Life Space Assessment
20.1 score on a scale
Standard Deviation 9.6

SECONDARY outcome

Timeframe: 30 Days After SNF Discharge

Population: Data are reported only for Patients as this measure does not apply to Caregivers. Fifteen Patients were unable or unavailable to participate in data collection for this measure.

The quality of life of the person with ADRD will be assessed with the Dementia Quality of Life Measure. It has 28 items that cover four quality of life dimensions: daily activities, memory, negative emotion and positive emotion. The score range is 28-112 with higher scores indicating better quality of life.

Outcome measures

Outcome measures
Measure
Connect-Home Plus Patients
n=4 Participants
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
Dementia Quality of Life Measure (Patient)
90.8 score on a scale
Standard Deviation 9.9

SECONDARY outcome

Timeframe: 30 Days After SNF Discharge

Population: Data are reported only for Caregivers as this measure does not apply to Patients. Four Patients reported DEMQOL themselves (and thus did not need proxy report) and 5 Caregivers were unavailable for data collection with this measure.

When the Patient was unable to answer the DEMQOL, the Caregiver was surveyed with the DEMQOL-Proxy. With this measure, the score range is 31-124 with higher scores indicating better quality of life.

Outcome measures

Outcome measures
Measure
Connect-Home Plus Patients
n=10 Participants
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
Dementia Quality of Life-Proxy Measure (Caregiver)
91.1 score on a scale
Standard Deviation 10.3

SECONDARY outcome

Timeframe: 30 Days After SNF Discharge

Population: Data are reported only for Patients as this measure does not apply to Caregivers and data are reported by the Patient (or the Caregiver serving as a proxy).

Patient's days of acute care use will be measured using the self-reported number of combined number of days the patients pends in the Emergency Department (ED) or hospital in 30 days after SNF discharge.

Outcome measures

Outcome measures
Measure
Connect-Home Plus Patients
n=19 Participants
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
Mean Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge (Patient)
0.58 days
Standard Deviation 1.7

SECONDARY outcome

Timeframe: 30 Days After SNF Discharge

Population: Data are reported only for Caregivers as this measure does not apply to Patients. Five Caregivers were unavailable for data collection for this measure.

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 greater burden.

Outcome measures

Outcome measures
Measure
Connect-Home Plus Patients
n=14 Participants
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
Zarit Caregiver Burden Scale (Caregiver)
16.6 score on a scale
Standard Deviation 6.6

SECONDARY outcome

Timeframe: 30 Days After SNF Discharge

Population: Data are reported only for Caregivers as this measure does not apply to Patients. Five Caregivers were unavailable to participate in data collection for this measure.

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 distress.

Outcome measures

Outcome measures
Measure
Connect-Home Plus Patients
n=14 Participants
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
Distress Thermometer (Caregiver)
4.1 score on a scale
Standard Deviation 3.1

Adverse Events

Patients

Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths

Caregivers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Patients
n=19 participants at risk
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge. Connect-Home Plus: Connect-Home Plus will introduce organizational structure to support delivery of transitional care processes. New elements of structure include:electronic health record (EHR) template, Connect-Home Plus Toolkit, and Staff Training. After structural elements are added, SNF staff will use Connect-Home Plus 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 illness and functional needs. In Step 2, a home health care nurse will visit (one time) and a dementia caregiving specialist will call the patient's home three times within 30 days of discharge. Both intervention steps will focus on key care needs, such as 1) home safety; 2) care of symptoms of ADRD; 3) symptom management; 4) medication reconciliation; 5) function and activity; and 6) coordination of follow-up medical care.
Caregivers
n=19 participants at risk
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge. Connect-Home Plus: Connect-Home Plus will introduce organizational structure to support delivery of transitional care processes. New elements of structure include:electronic health record (EHR) template, Connect-Home Plus Toolkit, and Staff Training. After structural elements are added, SNF staff will use Connect-Home Plus 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 illness and functional needs. In Step 2, a home health care nurse will visit (one time) and a dementia caregiving specialist will call the patient's home three times within 30 days of discharge. Both intervention steps will focus on key care needs, such as 1) home safety; 2) care of symptoms of ADRD; 3) symptom management; 4) medication reconciliation; 5) function and activity; and 6) coordination of follow-up medical care.
Infections and infestations
Acute UTI
5.3%
1/19 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 60 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
0.00%
0/19 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 60 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
Cardiac disorders
Myocardial infarction
5.3%
1/19 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 60 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
0.00%
0/19 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 60 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.

Other adverse events

Adverse event data not reported

Additional Information

Mark Toles, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-5684

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place