Technology-enhanced Transitional Palliative Care for Family Caregivers

NCT ID: NCT03339271

Last Updated: 2023-08-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2022-07-05

Brief Summary

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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

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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.

Conditions

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Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Technology-Enhanced Support

Intervention Type BEHAVIORAL

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 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.

Group Type ACTIVE_COMPARATOR

Usual Care Support

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Joan M. Griffin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diane E Holland, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Joan M Griffin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Griffin JM, Holland DE, Vanderboom CE, Kaufman BG, Gustavson AM, Ransom J, Mandrekar J, Dose AM, Ingram C, Fong ZV, Wild E, Weiss ME. Assessing Family Caregiver Readiness for Hospital Discharge of Patients With Serious or Life-Limiting Illness Using Electronic Health Record (EHR) and Self-Reported Data. Health Serv Res. 2025 Jan 28;60(4):e14441. doi: 10.1111/1475-6773.14441. Online ahead of print.

Reference Type DERIVED
PMID: 39871699 (View on PubMed)

Kaufman BG, Huang RW, Holland DE, Vanderboom CE, Ingram C, Wild EM, Dose AM, Stiles C, Gustavson AM, Mandrekar J, Van Houtven CH, Griffin JM. Healthcare use and out-of-pocket costs for rural family caregivers and care recipients in a randomized controlled trial. J Am Geriatr Soc. 2024 Aug;72(8):2523-2531. doi: 10.1111/jgs.18934. Epub 2024 May 2.

Reference Type DERIVED
PMID: 38698643 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33115524 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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R01NR016433

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-005188

Identifier Type: -

Identifier Source: org_study_id

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