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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03339271
Other study ID # 17-005188
Secondary ID R01NR016433
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2018
Est. completion date July 5, 2022

Study information

Verified date July 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 384
Est. completion date July 5, 2022
Est. primary completion date July 5, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Technology-Enhanced Support
The study nurse will meet with the caregiver daily until patient is discharged from the hospital. The caregiver will take home an iPad upon discharge, and will have an initial video chat with the study nurse within 24-48 hours of hospital discharge and weekly for 8 weeks after that.
Usual Care Support
The patient's doctor and nurses with input from the Palliative Care service will help the caregiver make a plan for discharge of the patient, and for taking care of the patient upon discharge. Someone from the study team will call the caregiver once a month for the duration of the study after the patient discharges from the hospital.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Preparedness for Caregiving Scale Score The Preparedness for Caregiving Scale captures how well family caregivers feel they are prepared for the multiple aspects of the caregiving role, using a 4-point response set ranging from 0 ("not at all") to 4 ("very well"). A mean score is calculated; higher scores indicate greater preparation for caregiving. Baseline, 8 weeks
Secondary Change in Communication With Physicians Scale Score The Communication with Physicians scale will be used to measure the communication skills of the family caregiver. Originally designed for chronic disease self-management behavior, the scale has 3 questions targeting how often the family caregiver prepares a list of questions for the doctor, asks questions, and discusses personal problems across a 6-point response set ranging from "never" to "always." Scores range from 0-5 with higher scores indicating better communication. baseline, 8 weeks
Secondary Mean Change in Patient Assessment of Chronic Illness Care (PACIC) Score The mean change in PACIC score. The PACIC was used to obtain family caregiver perceptions of the quality of chronic illness care received by the care recipient. The PACIC is a 20-item caregiver report instrument that measures caregivers' perspectives on the structure of the care for their care recipients and collects caregiver reports on the extent to which their care recipients have received specific clinical services and actions. Each question item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care. Total scores range from 0 - 100, lower scores indicate worse care, higher scores indicate better care. baseline, 8 weeks
Secondary Change in Caregiver Quality of Life Scale - Cancer (CQOL-C) Score The Caregiver Quality of Life Scale - Cancer (CQOL-C) will be used to measure the family caregiver's quality of life. The CQOL-C is a 35-item self-report measure of the impact on the caregiver's physical, emotional and spiritual well-being and on the relationship with the care recipient. Scores range from 0-140; higher scores indicate worse quality of life. baseline, 8 weeks
Secondary Mean Change in Bakas Caregiving Outcomes Scale-Revised (BCOS-R) Score The mean change in BCOS-R score. The Bakas Caregiving Outcomes Scale-Revised (BCOS-R) was used to measure the burden placed on the family caregiver in caring for their loved ones. The BCOS-R contains 16 items that measure changes as indicators of the effect of caregiving on caregivers' lives. The response set uses a 7-point Likert scale that ranges from -3 to -1 = (changed for the worst), 0 = Did not change, +1 to +3 = (changed for the best). Total scores range from -48 to 48, lower scores indicate more negative caregiver outcomes, higher scores indicate more positive caregiver outcomes. baseline, 8 weeks
Secondary Post Discharge Coping Difficulty Scale (PDCDS) Score The Post Discharge Coping Difficulty Scale (PDCDS) is a caregiver reported 11-item scale used to measure the degree of difficulty in coping with stress, recovery, self-care and management of medical needs, help and emotional support needed, confidence in self-care and medical management abilities, and adjustment after hospital discharge. The items are measured on an 11-point rating scale that ranges from 0 = Not at all to 10 = extremely, completely, or a great deal. Total scores range from 0 - 110 with lower scores indicating smaller coping difficulty and higher scores indicating greater coping difficulty. 2 weeks
Secondary Mean Change in Center for Epidemiological Studies Depression Scale (CESD-10) Score The mean change in CESD-10 score. The CESD-10 is a caregiver reported 10-item scale used to measure depression. Each question is scored on a 4-point scale, that ranges from 0 = none or rarely to 3 = all of the time. Total scores range from 0- 30, where 0 = no depression and 30 = the most depression. baseline, 8 weeks
Secondary Mean Total Out-of-Pocket Expenditures at 6 Months The Ambulatory and Home Care Record (AHCR) will be used as the healthcare cost measure. The AHCR is designed to capture costs from a societal perspective, implying that costs from all stakeholders (family care givers, care recipients, and health systems) will be collected.The AHCR captures self-reported utilization and cost information for care provided by all family caregivers and other unpaid caregivers, paid care received at home (e.g., home health care) and outside of the home (e.g., doctor/therapy appointments),as well as medications, supplies, and equipment. Out-of-pocket costs refer to all care-related expenses not paid for by the insurance. 6 months
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