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Technology-enhanced Transitional Palliative Care for Family Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339271
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Joan M. Griffin, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Palliative Care Behavioral: Technology-Enhanced Support Behavioral: Usual Care Support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 872 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Technology-enhanced Transitional Palliative Care for Family Caregivers in Rural Settings
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Technology-Enhanced Group
Family caregivers will have daily visits from the study nurse while the patient is in the hospital and will receive weekly technology-enhanced support (video chats) from the study nurse for 8 weeks after the patient is discharged from the hospital.
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.

Active Comparator: Usual Care Group
Family caregivers will have usual care support from the doctors and nurses to plan for taking care of the patient upon return home and will receive a weekly telephone call for 8 weeks after the patient is discharged from the hospital.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in Preparedness for Caregiving Scale Score [ Time Frame: Baseline, 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in Communication with Physicians Scale Score [ Time Frame: baseline, 8 weeks ]
    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.

  2. Change in Patient Assessment of Chronic Illness Care (PACIC) Score [ Time Frame: baseline, 8 weeks ]
    A modified version of the Patient Assessment of Chronic Illness Care (PACIC) will be used to obtain family caregiver perceptions of the quality of chronic illness care received by the care recipient. The PACIC was originally developed to measure patients' perspectives of the care they had received for their chronic illness, based on best practices as described in the Chronic Care Model. The PACIC consists of 20 questions with 5 subscales: (1) activation, (2) delivery system design, (3) collaborative goal setting, (4) problem-solving, and (5) follow-up/coordination. Scoring is a total mean score and a mean score for each subscale.

  3. Change in Caregiver Quality of Life Scale - Cancer (CQOL-C) Score [ Time Frame: baseline, 8 weeks ]
    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.

  4. Change in Bakas Caregiving Outcomes Scale-Revised (BCOS-R) Score [ Time Frame: baseline, 8 weeks ]
    The Bakas Caregiving Outcomes Scale-Revised (BCOS-R) will be used to measure the burden placed on the family caregiver in caring for their loved ones. The BCOS-R contains 15 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 "changed for the worst" to "changed for the best." Higher scores indicate more positive caregiver outcomes.

  5. Change Post Discharge Coping Difficulty Scale (PDCDS) Score [ Time Frame: baseline, 8 weeks ]
    The Post Discharge Coping Difficulty Scale (PDCDS) is an 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 with higher scores indicating greater coping difficulty. The family caregivers will rate the items on a scale of 0 ("not at all") to 10 ("extremely, completely, or a great deal"). The PDCDS is reliable whether self-administered or completed by interview. The instrument measures important, yet often overlooked, factors that contribute to poor post-acute recovery experiences, which are recognized as important factors likely to impact readmission and Emergency Department (ED) visits.

  6. Change in Center for Epidemiological Studies Depression Scale (CESD-10) Score [ Time Frame: baseline, 8 weeks ]
    Depression will be measured with the 10-item Center for Epidemiological Studies Depression Scale (CESD-10). The CESD-10 has been used as a screening tool for depression in studies with elderly patients as well as patients with chronic conditions. The correlation between this instrument and the original CESD, which had 20 items, is high. The CESD-10 reliability statistics are comparable to those for the original CESD. Higher scores indicate greater depressed mood. Scores of 10 or greater indicate clinically significant depression.

  7. Mean Total Third Party Expenditures at 8 weeks [ Time Frame: 8 weeks ]
    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 giver, care recipients, and health systems) will be collected.The AHCR captures self-reported utilization and cost information for care provided by all family care givers 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.

  8. Mean Total Out-of-Pocket Expenditures at 8 weeks [ Time Frame: 8 weeks ]
    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.

  9. Mean Total Time Cost for Family Caregiver at 8 weeks [ Time Frame: 8 weeks ]
    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 caregiver, care recipients, and health systems) will be collected.The AHCR captures self-reported utilization and cost information for care provided by all family care givers 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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): NCT03339271


Contacts
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Contact: Jodie A Cogswell 507-255-1036 cogswell.jodie@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Diane E Holland, PhD, RN Mayo Clinic
Principal Investigator: Joan M Griffin, Ph.D. Mayo Clinic
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Responsible Party: Joan M. Griffin, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03339271    
Other Study ID Numbers: 17-005188
R01NR016433 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No