CALLiNGS Protocol: Care Across Locations Longitudinally in Navigation of Goals and Symptoms

NCT03999957 | Completed DMC

• 1 other identifier: 0454-18-EP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The study intends to explore feasibility, acceptability, and quality of life outcomes from using web-conferencing technology to connect a hospital-based interdisciplinary pediatric palliative care with statewide field-based hospice teams during interdisciplinary meetings at a minimum of every 15 calendar days for a maximum of six months per enrollee.

Conditions

Palliative Care

Keywords

hospice; pediatric

Outcome Measures

Primary Outcomes (3)

• To investigate quality of life trend over time for pediatric participants and their families

  Using patient-reported \& proxy reported pediatric quality of life metrics longitudinally with pediatric quality of life scale completion by patient \& proxy every 15 days for a total of 3 months. The PedsQL™ 4.0 Generic Core Parent Report measures proxy perception on a child's quality of life. The 21-item PedsQL™ 4.0 Generic Core consists of the following dimensions: physical functioning, emotional functioning, social functioning, and school functioning. Participants are asked how much of a problem each survey item has been during the past one month. A 5-point response scale is utilized (0 = never; 4 = almost always). On the PedsQL™ 4.0 Generic Core Parent Report items are so that higher scores indicate better Health-Related Quality of Life. To reverse score, the 0-4 scale items are translated to 0-100 as follows: 0=100, 1=75, 2=50, 3=25, 4=0. To create the Total Scale Score, the mean is computed as the sum of all the items over the number of items answered on all the Scales.

  Every 15 days for a total of 3 months

• To evaluate the change in perception of adult-trained hospice providers about caring for pediatric patients on hospice

  2 qualitative interview questions asked on Day 1 with the same 2 questions asked again on Month 3. The questions are as follows: a) Please describe your experience caring for a pediatric patient. b) Please describe your experience with telepalliative use.

  Day 1 of study and at Month 3

• To monitor change in telehealth technology acceptance over two week time

  TAM-2 Scale (Technology Acceptance Model) completed on Day 1 and Day 14= two time points. The Technology Acceptance Model (TAM2) is a 15-item questionnaire that measures acceptability of a technology modality. The Technology Acceptance Model (TAM2) was developed to gauge individuals' intentions and behaviors for technology usage. TAM2 topics include perceived usefulness, ease of use and learnability, interface quality, interaction quality, reliability, satisfaction, and future use. Responses are on a five-point Likert scale (from 1= "highly disagree" to answer 5="highly agree"). Responses are tallied for a total score with a higher score correlating with a higher level of approval/acceptance of the technology modality.

  Day 1 and again on Day 14

Study Arms (1)

Interventional Arm

OTHER

Telehealth conferencing

Other: Telehealth web conferencing

Interventions

Telehealth web conferencing OTHER

Pediatric patient specific case discussions for enrolled pediatric patients at hospice staff interdisciplinary team meeting every 15 days for 60 min sessions via telehealth

Interventional Arm

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age birth to 18 years.
• Enrolling on home hospice services within the state of Nebraska at time of discharge from the hospital.

You may not qualify if:

• Age older than age 18 years
• Does not speak English
• Not enrolling in home hospice services within the state of Nebraska at time of discharge from the hospital

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (2)

Children's Hospital & Medical Center

Omaha, Nebraska, 68114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (13)

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• Dirksen SR, Belyea MJ, Epstein DR. Fatigue-based subgroups of breast cancer survivors with insomnia. Cancer Nurs. 2009 Sep-Oct;32(5):404-11. doi: 10.1097/NCC.0b013e3181a5d05e.

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• Hoffman AJ, von Eye A, Gift AG, Given BA, Given CW, Rothert M. Testing a theoretical model of perceived self-efficacy for cancer-related fatigue self-management and optimal physical functional status. Nurs Res. 2009 Jan-Feb;58(1):32-41. doi: 10.1097/NNR.0b013e3181903d7b.

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• Hsu MC, Tu CH. Improving quality-of-life outcomes for patients with cancer through mediating effects of depressive symptoms and functional status: a three-path mediation model. J Clin Nurs. 2014 Sep;23(17-18):2461-72. doi: 10.1111/jocn.12399. Epub 2013 Sep 21.

  PMID: 24112217 BACKGROUND

Study Officials

• Meaghann S Weaver, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 27, 2019
• Study Start: July 30, 2018
• Primary Completion: July 30, 2020
• Study Completion: October 30, 2020
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

US (2)