Technology-enhanced Transitional Palliative Care for Family Caregivers

NCT03339271 | Completed Results

• 2 other identifiers: 17-005188R01NR016433
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Palliative Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Communication With Physicians Scale Score

  baseline, 8 weeks

• Mean Change in Patient Assessment of Chronic Illness Care (PACIC) Score

  baseline, 8 weeks

• Change in Caregiver Quality of Life Scale - Cancer (CQOL-C) Score

  baseline, 8 weeks

• Mean Change in Bakas Caregiving Outcomes Scale-Revised (BCOS-R) Score

  baseline, 8 weeks

• Post Discharge Coping Difficulty Scale (PDCDS) Score

  2 weeks

Study Arms (2)

Technology-Enhanced Group

ACTIVE COMPARATOR

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

Usual Care Group

ACTIVE COMPARATOR

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

Interventions

Technology-Enhanced Support 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.

Technology-Enhanced Group

Usual Care Support 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.

Usual Care Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• 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.

  PMID: 39871699 DERIVED

• 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.

  PMID: 38698643 DERIVED

• 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.

  PMID: 33115524 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Dr. Joan Griffin
• Organization: Mayo Clinic

griffin.joan@mayo.edu

507-538-1490

Study Officials

• Diane E Holland, PhD, RN

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Joan M Griffin, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: March 20, 2018
• Primary Completion: July 5, 2022
• Study Completion: July 5, 2022
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2023-07

Locations

US (1)