Helping Invested Families Improve Veterans Experiences Study (HI-FIVES)
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|ClinicalTrials.gov Identifier: NCT01777490|
Recruitment Status : Active, not recruiting
First Posted : January 28, 2013
Last Update Posted : August 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Caregiver Disabled Veterans Referred to Long-term Care Residing at Home Hospice Ineligible||Behavioral: Helping Invested Families Improve Veterans Experiences Study - Control Behavioral: Helping Invested Families Improve Veterans Experiences Study - HI FIVES||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Research Assistant conducting follow-up interviews is blinded as to dyad arm assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Helping Invested Families Improve Veterans Experiences Study (HI-FIVES)|
|Actual Study Start Date :||February 5, 2014|
|Actual Primary Completion Date :||January 10, 2017|
|Estimated Study Completion Date :||December 29, 2017|
Active Comparator: Arm 1: Control
Caregivers in the control arm will be referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. The patient of each caregiver will also be enrolled and contact will be limited to assessments.
Behavioral: Helping Invested Families Improve Veterans Experiences Study - Control
Usual care will be the Veteran patient care and caregiver support that are normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This process entails the patient and caregiver work with the social worker assigned to the patient to obtain home and community based care (HCBC) services. The patients in the usual care group will be free to seek medical, psychological, social support, and social services that are available through VAMCs or any other source. In addition to this, caregivers in the usual care arm will be told about the caregiver support programs in the VHA and the caregiver will receive the national VA caregiver hotline phone number (see Appendix VI for this pamphlet). The information provided mirrors efforts to support caregivers in the VA nationally and new standards of care for VA caregivers. This will be the only contact with the usual care subjects besides the scheduled data collection assessments.
Other Name: Control
Experimental: Arm 2: HI FIVES
Caregivers will take part in three phone training sessions and will attend four group training sessions at the VA. They will also be given the option of participating in 2 booster phone training sessions post-group sessions. Caregivers will be asked to provide one in-person (baseline) and three phone assessments (3, 9, and 15 months). Patients will also be enrolled and contact will be limited to assessments
Behavioral: Helping Invested Families Improve Veterans Experiences Study - HI FIVES
Caregivers in the HI-FIVES group will receive individual calls with a nurse educator to address topics he/she identified as being the highest priority learning areas. After the phone calls, caregivers will participate in evidence-based group sessions aimed to improve clinical care skills, psychological care skills, and support-seeking skills. The curriculum will be delivered by a trained nurse educator on the research team and the PI and VA Caregiver Support Staff. Three individual telephone training calls will be tailored to the individual needs of Veteran-caregiver dyad. Four group training sessions will be targeted to address common needs of Veterans and their caregivers. Given that all Veteran care recipients will have at least 2 or 3 activities of daily living (ADL) limitations. After the final group session, there will be two optional booster calls at one and three months. Four assessments in all will be collected, baseline (in person), and at 3, 9, and 15 months (by phone).
Other Name: Experimental
- Patient days in the community (e.g. days not in emergency department, inpatient, or nursing home setting) [ Time Frame: 12 months ]Days at home up to12 months post-treatment is simply 365 minus the total number of days of VA or non-VA ED, inpatient, and nursing home care, whereas days not at home is the count of days in ED, inpatient or nursing home care.
- Total costs to the VA [ Time Frame: 12 months ]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). Intervention costs will include labor and capital costs.
- Satisfaction with healthcare [ Time Frame: 3 months ]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 the patient use to rate all of his/her health care in the VA in the last 3 months?
- Caregiver depressive symptoms [ Time Frame: 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777490
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Courtney H Van Houtven, PhD||Durham VA Medical Center, Durham, NC|