Trial Outcomes & Findings for Helping Invested Families Improve Veterans Experiences Study (NCT NCT01777490)

Last Updated: 2019-02-28

Results Overview

Days at home is defined as the total numbers of days of VA, inpatient and post-acute facility care subtracted from 365 (or number of days living in 12 month post randomization period if deceased). Mean was estimated using a generalized linear model.

Recruitment status

COMPLETED

Study phase

Target enrollment

484 participants

Primary outcome timeframe

12 months

Results posted on

2019-02-28

Participant Flow

Patient's and their informal caregiver are randomized as a dyad to a single arm assignment, either HI-FIVES or Control.

Participant milestones

Participant milestones
Measure	Arm 1: Control - Caregivers Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. Caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.	Arm 1: Control - Patients The patient of each informal caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.	Arm 2: HI FIVES - Caregivers Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.	Arm 2: HI-FIVES - Patients The patient of each informal caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - HI-FIVES: Patients randomized to the HI-FIVES arm received no direct intervention. All intervention activities focused on the patient's informal caregiver. As with Usual care, patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the HI-FIVES group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.
Overall Study STARTED	123	123	119	119
Overall Study COMPLETED	123	123	118	118
Overall Study NOT COMPLETED	0	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Control - Caregivers Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. Caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.	Arm 1: Control - Patients The patient of each informal caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.	Arm 2: HI FIVES - Caregivers Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.	Arm 2: HI-FIVES - Patients The patient of each informal caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - HI-FIVES: Patients randomized to the HI-FIVES arm received no direct intervention. All intervention activities focused on the patient's informal caregiver. As with Usual care, patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the HI-FIVES group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.
Overall Study Dyad withdrew with data use prohibition	0	0	1	1

Baseline Characteristics

One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Control - Caregivers n=123 Participants Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. Caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.	Arm 1: Control - Patients n=123 Participants The patient of each informal caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.	Arm 2: HI-FIVES - Caregivers n=119 Participants Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.	Arm 2: HI FIVES - Patients n=119 Participants The patient of each informal caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - HI-FIVES: Patients randomized to the HI-FIVES arm received no direct intervention. All intervention activities focused on the patient's informal caregiver. As with Usual care, patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the HI-FIVES group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.	Total n=484 Participants Total of all reporting groups
Age, Continuous	61.8 years STANDARD_DEVIATION 12.60 • n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	72.9 years STANDARD_DEVIATION 12.12 • n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	59.9 years STANDARD_DEVIATION 11.78 • n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	73.7 years STANDARD_DEVIATION 11.24 • n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	73.3 years STANDARD_DEVIATION 11.68 • n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Sex: Female, Male Female	111 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	5 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	103 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	4 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	223 Participants n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Sex: Female, Male Male	12 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	118 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	15 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	114 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	259 Participants n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	4 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	2 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	1 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	11 Participants n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Ethnicity (NIH/OMB) Not Hispanic or Latino	118 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	117 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	116 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	117 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	468 Participants n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	2 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	0 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	0 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	3 Participants n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	0 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	0 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	1 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	1 Participants n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Race (NIH/OMB) Asian	1 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	1 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	0 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	0 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	2 Participants n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	0 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	1 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	0 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	1 Participants n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Race (NIH/OMB) Black or African American	59 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	60 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	50 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	48 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	217 Participants n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Race (NIH/OMB) White	48 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	48 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	56 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	60 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	212 Participants n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Race (NIH/OMB) More than one race	15 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	13 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	11 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	9 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	48 Participants n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	1 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	0 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	0 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	1 Participants n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Region of Enrollment United States	123 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	123 Participants n=123 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	118 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	118 Participants n=118 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.	482 Participants n=482 Participants • One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.

PRIMARY outcome

Timeframe: 12 months

Population: All enrolled subjects were included in the analysis of the primary outcome, except for the one subject who withdrew permission to use data.

Outcome measures

Outcome measures
Measure	Arm 2: HI FIVES n=118 Participants Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. The patient of each caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.	Arm 1: Control (CAREGIVER) n=123 Participants Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source. In addition, caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.	Arm 2: HI FIVES (CAREGIVER) Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.	Arm 2: HI FIVES (PATIENT) The patient of each caregiver was also enrolled with contact limited to assessments.
Patient Days in the Community (e.g. Days Not in Emergency Department, Inpatient, or Nursing Home Setting)	353.62 days Interval 349.75 to 356.51	352.87 days Interval 348.76 to 355.94	—	—

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled patient subjects were included in the analysis of this outcome, except for the one subject who withdrew permission to use data.

VA utilization costs will be summarized across VA and non-VA contracted care and will capture all outpatient costs (laboratory, radiology, pharmacy, surgery, nursing, and treat and release ED visits) and inpatient costs (similar categories). Mean was estimated using a generalized linear model.

Outcome measures

Outcome measures
Measure	Arm 2: HI FIVES n=118 Participants Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. The patient of each caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.	Arm 1: Control (CAREGIVER) n=123 Participants Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source. In addition, caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.	Arm 2: HI FIVES (CAREGIVER) Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.	Arm 2: HI FIVES (PATIENT) The patient of each caregiver was also enrolled with contact limited to assessments.
Total Costs to the VA	41157.17 Dollars Interval 33455.72 to 50631.47	44227.55 Dollars Interval 34772.66 to 56253.3	—	—

SECONDARY outcome

Timeframe: 3 months

Population: This measure was collected from both the patient (or their proxy if not competent) and their informal caregiver. We had one dyad who withdrew from Arm 2 (HI FIVES) and asked us not to use their data.

Consumer Assessment of Healthcare Providers and Systems (CAHPS). Used by the VA Office of Performance and Quality, this outcome is considered a key measure of patient satisfaction with inpatient and outpatient care. The investigators will focus on a global satisfaction measure about the health plan: "Using any number from 0 to 10, where 0 is the worst health care possible and 10 is the best health care possible, what number would \[PATIENT: you/the patient (if not competent to answer for themselves) use to rate all of your/his/her\] \[CAREGIVER: you use to rate all the patient's\] health care in the VA in the last 3 months?" This measure was asked of both the patient and their informal caregiver. If the patient was not competent to answer for themselves, the caregiver was asked to respond on the patient's behalf. Mean was estimated using a linear mixed model.

Outcome measures

Outcome measures
Measure	Arm 2: HI FIVES n=123 Participants Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. The patient of each caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.	Arm 1: Control (CAREGIVER) n=123 Participants Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source. In addition, caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.	Arm 2: HI FIVES (CAREGIVER) n=118 Participants Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.	Arm 2: HI FIVES (PATIENT) n=118 Participants The patient of each caregiver was also enrolled with contact limited to assessments.
Satisfaction With Healthcare	8.09 units on a scale Interval 7.7 to 8.48	8.29 units on a scale Interval 7.97 to 8.61	8.58 units on a scale Interval 8.25 to 8.89	8.38 units on a scale Interval 7.99 to 8.77

SECONDARY outcome

Timeframe: 3 months

Population: All enrolled caregiver subjects were included in the analysis of this outcome, except for the one dayd who withdrew permission to use data.

The investigators selected the Center for Epidemiological Studies-Depression 10 scale (CESD-10) measure of depressive symptoms because the respondent burden is low and in order to maximize comparability with REACH I and REACH II. Range is 0-30 with a higher score indicates greater depressive symptoms. Mean was estimated using a linear mixed model.

Outcome measures

Outcome measures
Measure	Arm 2: HI FIVES n=118 Participants Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. The patient of each caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.	Arm 1: Control (CAREGIVER) n=123 Participants Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source. In addition, caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.	Arm 2: HI FIVES (CAREGIVER) Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.	Arm 2: HI FIVES (PATIENT) The patient of each caregiver was also enrolled with contact limited to assessments.
Caregiver Depressive Symptoms	8.75 units on a scale Interval 7.69 to 9.82	8.95 units on a scale Interval 7.9 to 10.0	—	—

Adverse Events

Arm 1: Control - Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 1: Control - Patients

Serious events: 71 serious events

Other events: 60 other events

Deaths: 10 deaths

Arm 2: HI-FIVES - Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: HI FIVES - Patients

Serious events: 68 serious events

Other events: 57 other events

Deaths: 14 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Arm 1: Control - Caregivers n=123 participants at risk Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. Caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.	Arm 1: Control - Patients n=123 participants at risk The patient of each informal caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.	Arm 2: HI-FIVES - Caregivers n=118 participants at risk Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.	Arm 2: HI FIVES - Patients n=118 participants at risk The patient of each informal caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - HI-FIVES: Patients randomized to the HI-FIVES arm received no direct intervention. All intervention activities focused on the patient's informal caregiver. As with Usual care, patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the HI-FIVES group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.
Gastrointestinal disorders ED Visit	0.00% 0/123 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	10.6% 13/123 • Number of events 17 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	0.00% 0/118 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	6.8% 8/118 • Number of events 13 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.
Injury, poisoning and procedural complications ED Visit	0.00% 0/123 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	13.8% 17/123 • Number of events 18 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	0.00% 0/118 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	18.6% 22/118 • Number of events 34 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.
Musculoskeletal and connective tissue disorders ED Visit	0.00% 0/123 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	17.1% 21/123 • Number of events 29 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	0.00% 0/118 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	14.4% 17/118 • Number of events 20 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.
General disorders ED Visit	0.00% 0/123 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	4.9% 6/123 • Number of events 7 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	0.00% 0/118 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	10.2% 12/118 • Number of events 12 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.
Infections and infestations ED Visit	0.00% 0/123 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	15.4% 19/123 • Number of events 24 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	0.00% 0/118 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	7.6% 9/118 • Number of events 12 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.
Nervous system disorders ED Visit	0.00% 0/123 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	4.1% 5/123 • Number of events 5 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	0.00% 0/118 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	5.1% 6/118 • Number of events 7 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.
Respiratory, thoracic and mediastinal disorders ED Visit	0.00% 0/123 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	4.9% 6/123 • Number of events 7 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	0.00% 0/118 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	1.7% 2/118 • Number of events 2 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.
Vascular disorders ED Visit	0.00% 0/123 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	9.8% 12/123 • Number of events 17 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	0.00% 0/118 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.	10.2% 12/118 • Number of events 13 • Adverse event data were collected from the date of enrollment up to 365 days post-randomization. We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.

Additional Information

Courtney Van Houtven

HSR&D/COIN, Durham VAHCS

Phone: (919)286-6936

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place