Trial Outcomes & Findings for Optimizing Function and Independence Through iHI-FIVES (NCT NCT03474380)
NCT ID: NCT03474380
Last Updated: 2024-06-10
Results Overview
Count of number of days not at home (e.g. days in emergency department, inpatient hospital, or post-acute facility setting) over 180 days following study determination of eligibility (e.g. referred to home based care and has a caregiver). The outcome will be assessed via administrative data (not patient report). Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1406 participants
Primary outcome timeframe
180 days
Results posted on
2024-06-10
Participant Flow
Unit of analysis: VAMC sites
Participant milestones
| Measure |
Sequence 1: Implementation Start, Month 7
VAMC site randomized to this sequence, Unique caregivers of eligible Veterans receive usual care in months 1-6 and be potentially eligible for receipt of iHI-FIVES training months 7-30
Intervention: Behavioral: iHI-FIVES
iHI-FIVES: Implementation of iHI-FIVES caregiver skills training
|
Sequence 2: Implementation Start Month 13
VAMC site randomized to this sequence, Unique caregivers of eligible Veterans receive usual care in months 1-12 and be potentially eligible for receipt of iHI-FIVES training months 13-30
Intervention: Behavioral: iHI-FIVES
iHI-FIVES: Implementation of iHI-FIVES caregiver skills training
|
Sequence 3: Implementation Start Month 19
VAMC site randomized to this sequence, Unique caregivers of eligible Veterans receive usual care in months 14-18 and be potentially eligible for receipt of iHI-FIVES training months 19-30
Intervention: Behavioral: iHI-FIVES
iHI-FIVES: Implementation of iHI-FIVES caregiver skills training
|
Sequence 4: Implementation Start Month 25
VAMC site randomized to this sequence, Unique caregivers of eligible Veterans receive usual care in months 14-24 and be potentially eligible for receipt of iHI-FIVES training months 25-30
Intervention: Behavioral: iHI-FIVES
iHI-FIVES: Implementation of iHI-FIVES caregiver skills training
|
|---|---|---|---|---|
|
Month 1-6
STARTED
|
70 2
|
111 2
|
0 0
|
0 0
|
|
Month 1-6
Veterans
|
42 2
|
77 2
|
0 0
|
0 0
|
|
Month 1-6
Caregivers Started
|
18 2
|
34 2
|
0 0
|
0 0
|
|
Month 1-6
Caregivers Completed
|
13 2
|
28 2
|
0 0
|
0 0
|
|
Month 1-6
Providers Pre-Implementation
|
10 2
|
0 0
|
0 0
|
0 0
|
|
Month 1-6
Providers Post-Implementation
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Month 1-6
COMPLETED
|
65 2
|
105 2
|
0 0
|
0 0
|
|
Month 1-6
NOT COMPLETED
|
5 0
|
6 0
|
0 0
|
0 0
|
|
Month 7-12
STARTED
|
79 2
|
102 2
|
0 0
|
0 0
|
|
Month 7-12
Veterans
|
55 2
|
61 2
|
0 0
|
0 0
|
|
Month 7-12
Caregiver Started
|
22 2
|
34 2
|
0 0
|
0 0
|
|
Month 7-12
Caregiver Completed
|
17 2
|
28 2
|
0 0
|
0 0
|
|
Month 7-12
Providers Pre-Implementation
|
0 0
|
7 2
|
0 0
|
0 0
|
|
Month 7-12
Providers Post-Implementation
|
2 2
|
0 0
|
0 0
|
0 0
|
|
Month 7-12
COMPLETED
|
74 2
|
96 2
|
0 0
|
0 0
|
|
Month 7-12
NOT COMPLETED
|
5 0
|
6 0
|
0 0
|
0 0
|
|
Month 13-18
STARTED
|
94 2
|
87 2
|
93 2
|
70 2
|
|
Month 13-18
Veterans
|
67 2
|
58 2
|
52 2
|
43 2
|
|
Month 13-18
Caregiver Started
|
27 2
|
28 2
|
31 2
|
27 2
|
|
Month 13-18
Caregiver Completed
|
19 2
|
23 2
|
21 2
|
25 2
|
|
Month 13-18
Providers Pre-Implementation
|
0 0
|
0 0
|
10 2
|
0 0
|
|
Month 13-18
Providers Post-Implementation
|
0 0
|
1 2
|
0 0
|
0 0
|
|
Month 13-18
COMPLETED
|
86 2
|
82 2
|
83 2
|
68 2
|
|
Month 13-18
NOT COMPLETED
|
8 0
|
5 0
|
10 0
|
2 0
|
|
Month 19-24
STARTED
|
85 2
|
85 2
|
92 2
|
86 2
|
|
Month 19-24
Veterans
|
59 2
|
59 2
|
61 2
|
52 2
|
|
Month 19-24
Caregiver Started
|
26 2
|
26 2
|
25 2
|
26 2
|
|
Month 19-24
Caregiver Completed
|
19 2
|
23 2
|
17 2
|
24 2
|
|
Month 19-24
Providers Pre-Implementation
|
0 0
|
0 0
|
0 0
|
8 2
|
|
Month 19-24
Providers Post-Implementation
|
0 0
|
0 0
|
6 2
|
0 0
|
|
Month 19-24
COMPLETED
|
78 2
|
82 2
|
84 2
|
84 2
|
|
Month 19-24
NOT COMPLETED
|
7 0
|
3 0
|
8 0
|
2 0
|
|
Month 25-30
STARTED
|
76 2
|
101 2
|
65 2
|
83 2
|
|
Month 25-30
Veterans
|
53 2
|
68 2
|
37 2
|
54 2
|
|
Month 25-30
Caregiver Started
|
23 2
|
33 2
|
28 2
|
27 2
|
|
Month 25-30
Caregiver Completed
|
16 2
|
25 2
|
21 2
|
21 2
|
|
Month 25-30
Providers Pre-Implementation
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Month 25-30
Providers Post-Implementation
|
0 0
|
0 0
|
0 0
|
2 2
|
|
Month 25-30
COMPLETED
|
69 2
|
93 2
|
58 2
|
77 2
|
|
Month 25-30
NOT COMPLETED
|
7 0
|
8 0
|
7 0
|
6 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care; 7 caregivers missing age in intervention and 3 in usual care
Baseline characteristics by cohort
| Measure |
Intervention
n=836 Participants
Implementation of iHI-FIVES program
Intervention: Behavioral: iHI-FIVES
iHI-FIVES: Implementation of iHI-FIVES caregiver skills training
|
Usual Care
n=497 Participants
Pre-implementation before iHI-FIVES program
|
Total
n=1333 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Veterans
|
76.0 years
STANDARD_DEVIATION 11.3 • n=571 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care; 7 caregivers missing age in intervention and 3 in usual care
|
77.4 years
STANDARD_DEVIATION 12.0 • n=327 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care; 7 caregivers missing age in intervention and 3 in usual care
|
76.5 years
STANDARD_DEVIATION 11.6 • n=898 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care; 7 caregivers missing age in intervention and 3 in usual care
|
|
Age, Continuous
Caregivers
|
63.8 years
STANDARD_DEVIATION 13 • n=258 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care; 7 caregivers missing age in intervention and 3 in usual care
|
63.1 years
STANDARD_DEVIATION 14 • n=167 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care; 7 caregivers missing age in intervention and 3 in usual care
|
63.5 years
STANDARD_DEVIATION 13 • n=425 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care; 7 caregivers missing age in intervention and 3 in usual care
|
|
Sex: Female, Male
Veterans · Female
|
32 Participants
n=571 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care 1 caregiver is missing gender in intervention arm
|
11 Participants
n=327 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care 1 caregiver is missing gender in intervention arm
|
43 Participants
n=898 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care 1 caregiver is missing gender in intervention arm
|
|
Sex: Female, Male
Veterans · Male
|
539 Participants
n=571 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care 1 caregiver is missing gender in intervention arm
|
316 Participants
n=327 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care 1 caregiver is missing gender in intervention arm
|
855 Participants
n=898 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care 1 caregiver is missing gender in intervention arm
|
|
Sex: Female, Male
Caregivers · Female
|
232 Participants
n=264 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care 1 caregiver is missing gender in intervention arm
|
156 Participants
n=170 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care 1 caregiver is missing gender in intervention arm
|
388 Participants
n=434 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care 1 caregiver is missing gender in intervention arm
|
|
Sex: Female, Male
Caregivers · Male
|
32 Participants
n=264 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care 1 caregiver is missing gender in intervention arm
|
14 Participants
n=170 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care 1 caregiver is missing gender in intervention arm
|
46 Participants
n=434 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care 1 caregiver is missing gender in intervention arm
|
|
Race (NIH/OMB)
Veterans · American Indian or Alaska Native
|
4 Participants
n=571 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
2 Participants
n=327 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
6 Participants
n=898 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Race (NIH/OMB)
Veterans · Asian
|
2 Participants
n=571 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
0 Participants
n=327 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
2 Participants
n=898 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Race (NIH/OMB)
Veterans · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=571 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
3 Participants
n=327 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
4 Participants
n=898 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Race (NIH/OMB)
Veterans · Black or African American
|
114 Participants
n=571 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
52 Participants
n=327 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
166 Participants
n=898 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Race (NIH/OMB)
Veterans · White
|
422 Participants
n=571 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
247 Participants
n=327 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
669 Participants
n=898 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Race (NIH/OMB)
Veterans · More than one race
|
19 Participants
n=571 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
14 Participants
n=327 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
33 Participants
n=898 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Race (NIH/OMB)
Veterans · Unknown or Not Reported
|
9 Participants
n=571 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
9 Participants
n=327 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
18 Participants
n=898 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
2 Participants
n=265 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
1 Participants
n=170 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
3 Participants
n=435 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Race (NIH/OMB)
Caregivers · Asian
|
5 Participants
n=265 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
2 Participants
n=170 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
7 Participants
n=435 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=265 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
0 Participants
n=170 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
0 Participants
n=435 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
56 Participants
n=265 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
29 Participants
n=170 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
85 Participants
n=435 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Race (NIH/OMB)
Caregivers · White
|
178 Participants
n=265 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
127 Participants
n=170 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
305 Participants
n=435 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
17 Participants
n=265 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
10 Participants
n=170 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
27 Participants
n=435 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
7 Participants
n=265 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
1 Participants
n=170 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
8 Participants
n=435 Participants • 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care
|
|
Region of Enrollment
United States · Veterans
|
571 Participants
n=836 Participants
|
327 Participants
n=497 Participants
|
898 Participants
n=1333 Participants
|
|
Region of Enrollment
United States · Caregivers
|
265 Participants
n=836 Participants
|
170 Participants
n=497 Participants
|
435 Participants
n=1333 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: Veterans referred to home based care and determined to have a caregiver
Count of number of days not at home (e.g. days in emergency department, inpatient hospital, or post-acute facility setting) over 180 days following study determination of eligibility (e.g. referred to home based care and has a caregiver). The outcome will be assessed via administrative data (not patient report). Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site.
Outcome measures
| Measure |
Intervention
n=571 Participants
Implementation of iHI-FIVES program
Intervention: Behavioral: iHI-FIVES
iHI-FIVES: Implementation of iHI-FIVES caregiver skills training
|
Usual Care
n=327 Participants
Pre-implementation before iHI-FIVES program
|
|---|---|---|
|
Patient Number of Days Not at Home
|
7.5 number of days not at home
Interval 4.0 to 14.1
|
13.0 number of days not at home
Interval 7.2 to 23.4
|
SECONDARY outcome
Timeframe: Baseline and 3-month follow upPopulation: Caregivers of Veterans in sample.
Analysis of satisfaction with care will be measured by the 1-item Consumer Assessment of Healthcare Providers and Systems (CAHPS) global satisfaction measure. This single-item measure asks caregivers' satisfaction with veterans' VHA care over the last 3 months. Scale ranges from 0 to 10, with 0 indicating the worst health care possible and 10 indicating the best health care possible. Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site.
Outcome measures
| Measure |
Intervention
n=265 Participants
Implementation of iHI-FIVES program
Intervention: Behavioral: iHI-FIVES
iHI-FIVES: Implementation of iHI-FIVES caregiver skills training
|
Usual Care
n=170 Participants
Pre-implementation before iHI-FIVES program
|
|---|---|---|
|
Caregiver Satisfaction With Veteran's VA Care
Baseline
|
8.3 score on a scale
Interval 7.8 to 8.7
|
8.1 score on a scale
Interval 7.5 to 8.6
|
|
Caregiver Satisfaction With Veteran's VA Care
3 month change
|
0.1 score on a scale
Interval -0.2 to 0.5
|
0.1 score on a scale
Interval -0.4 to 0.6
|
SECONDARY outcome
Timeframe: Baseline and 3-month follow upPopulation: Caregivers of Veterans in sample.
Analysis of subjective burden will be measured by the 4-item Zarit Burden Instrument. The Zarit 4-item measures subjective caregiver burden as described as the level of stress felt by a caregiver. Scores range from 0 to 16, with higher scores reflecting higher burden. Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site.
Outcome measures
| Measure |
Intervention
n=265 Participants
Implementation of iHI-FIVES program
Intervention: Behavioral: iHI-FIVES
iHI-FIVES: Implementation of iHI-FIVES caregiver skills training
|
Usual Care
n=170 Participants
Pre-implementation before iHI-FIVES program
|
|---|---|---|
|
Caregiver Subjective Burden
Baseline
|
5.1 score on a scale
Interval 4.4 to 5.9
|
5.4 score on a scale
Interval 4.6 to 6.2
|
|
Caregiver Subjective Burden
3 month change
|
0.1 score on a scale
Interval -0.3 to 0.5
|
-0.3 score on a scale
Interval -0.8 to 0.1
|
SECONDARY outcome
Timeframe: Baseline and 3-month follow upPopulation: Caregivers of Veterans in sample.
Analysis of depressive symptoms will be assessed with the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the past two weeks. Scores range from 0 to 6, with higher scores reflecting more severe depression. Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site.
Outcome measures
| Measure |
Intervention
n=265 Participants
Implementation of iHI-FIVES program
Intervention: Behavioral: iHI-FIVES
iHI-FIVES: Implementation of iHI-FIVES caregiver skills training
|
Usual Care
n=170 Participants
Pre-implementation before iHI-FIVES program
|
|---|---|---|
|
Caregiver Depressive Symptoms
Baseline
|
1.2 score on a scale
Interval 0.9 to 1.6
|
1.0 score on a scale
Interval 0.5 to 1.5
|
|
Caregiver Depressive Symptoms
3 month change
|
-0.1 score on a scale
Interval -0.4 to 0.1
|
0.3 score on a scale
Interval -0.1 to 0.7
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place