Clinical trial NCT03339271: Technology-enhanced Transitional Palliative Care for Family Caregivers
Official title: Technology-enhanced Transitional Palliative Care for Family Caregivers in Rural Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-11-13
Enrollment: 384
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effect and cost of technology-enhanced transitional palliative care on family caregivers who provide care to a loved one after a hospitalization.

Detailed description: There will be two groups in this randomized control study: technology-enhanced group and usual care group. The total amount of subjects includes both the palliative care recipients and the family caregivers (both the patients and their family caregiver will sign informed consent.)

A family caregiver is broadly defined as the person self-identified as the family member or unpaid friend who is the primary informal caregiver for a patient with a terminal illness. The family caregiver may or may not be a member of the patient's nuclear family.

For the technology-enhanced group, the study nurse experienced in palliative care will have a visit with the caregiver within the first 24 hours after consent, and have daily visits with the caregiver as long as the patient is still in the hospital. During these visits, the nurse will talk to the caregiver about their own self-care needs, begin transitional care planning, and develop Readiness Plans to anticipate care giving needs the caregiver may have when they discharge from the hospital.

For the technology-enhanced group, the caregiver will take an iPad home so that the study team nurse can video chat with them. The iPad will need to be returned upon completion of the study. The study nurse will have a video chat with the caregiver at home within 24-48 hours of discharge from the hospital, and at least weekly for 8 weeks after that. The caregiver and the study nurse may also decide to have other calls on the phone during this time.

For the usual care group, doctors and nurses along with input from the Palliative Care service will help the caregiver make a plan for discharge from the hospital and for taking care of the patient upon discharge. Someone from the study team will call the caregiver once a month to check in for the 6 months after the patient discharges from the hospital.

Both groups will be asked to complete questionnaires before starting the study, and then up to seven more times over the course of 6 months.

Eligibility criteria: Inclusion Criteria:

* Adult family caregiver of adult patient hospitalized at Mayo Clinic
* Receives in-hospital palliative care consult
* Family caregiver lives in a Minnesota or Iowa county that is designated as medically under served or rural area

Exclusion Criteria:

* Family caregivers who live in Rochester, Minnesota. (Rochester, Minnesota is not considered a medically under served or rural area.)
* Patients with left ventricular assistive devices, documented chronic pain, use of home infusion pain pumps, or documented addictive behaviors.

Primary outcomes:
measure: Change in Preparedness for Caregiving Scale Score
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change in Communication With Physicians Scale Score
timeFrame: baseline, 8 weeks
measure: Mean Change in Patient Assessment of Chronic Illness Care (PACIC) Score
timeFrame: baseline, 8 weeks
measure: Change in Caregiver Quality of Life Scale - Cancer (CQOL-C) Score
timeFrame: baseline, 8 weeks
measure: Mean Change in Bakas Caregiving Outcomes Scale-Revised (BCOS-R) Score
timeFrame: baseline, 8 weeks
measure: Post Discharge Coping Difficulty Scale (PDCDS) Score
timeFrame: 2 weeks
measure: Mean Change in Center for Epidemiological Studies Depression Scale (CESD-10) Score
timeFrame: baseline, 8 weeks
measure: Mean Total Out-of-Pocket Expenditures at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Diane E Holland, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Joan M Griffin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holland DE, Vanderboom CE, Mandrekar J, Borah BJ, Dose AM, Ingram CJ, Griffin JM. A technology-enhanced model of care for transitional palliative care versus attention control for adult family caregivers in rural or medically underserved areas: study protocol for a randomized controlled trial. Trials. 2020 Oct 28;21(1):895. doi: 10.1186/s13063-020-04806-0.