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

NCT ID: NCT03999957

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-30

Study Completion Date

2020-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Central Hypothesis is that telepalliative care has the potential to improve the quality of care delivered to pediatric palliative care patients in a rural state by connecting local care providers with palliative care interdisciplinary subspecialists at an academic health center to facilitate improved symptom burden which translates into enhanced quality of life for the pediatric patient and family members, increased confidence and comfort of local providers, and ultimately the creation of a unified and cross-setting shared care model.

Aim 1. To investigate the symptom burden for pediatric patients and the quality of life impact for pediatric patients and their families through an interdisciplinary pediatric telepalliative consultation service partnered with local hospice providers with an interface at a minimum of every 15 day intervals.

Aim 2. To evaluate the self-efficacy, knowledge, and self-perceived adequacy of local hospice providers in caring for pediatric patients before and after interdisciplinary pediatric telepalliative consultation service partnership with these local hospice providers.

Aim 3. To explore the acceptability of teleconferencing services as a form of pediatric palliative care mentorship for local hospice teams caring for children and adolescents.

Expected Outcomes Based on geography and shortage of pediatric palliative subspecialists in Nebraska, the current model of hospice services is one in which pediatric patients are managed by local adult-based hospice teams after discharge from the pediatric hospital (34 such in the past 16 months). Sixty percent of academic pediatricians in Nebraska who served as primary providers for consecutive pediatric home discharge patients self-reported feeling "very deficient" to "deficient" when asked about competence after supporting terminal patients and families in care at home (n=12).1 The knowledge gap and discomfort in managing children with complex symptom burden is magnified further for family practice or internal medicine teams serving in hospice roles for children in rural communities. Through a new telepalliative technology platform, this study fosters collaboration and communication to improve the quality of care for pediatric patients receiving hospice care in rural states. This model implements human interaction through technology to challenge the existing paradigm of silo-based care of pediatric palliative care patients. With roll-out of this intervention, we anticipate increase in pediatric hospice utilization (decreased in-hospital deaths). If feasible this model could transform the pediatric hospice care delivery in the state of Nebraska with expanded opportunity for application in settings with similar subspecialty provider shortages.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Palliative Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interventional Arm

Telehealth conferencing

Group Type OTHER

Telehealth web conferencing

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telehealth web conferencing

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Meaghann S Weaver, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital & Medical Center

Omaha, Nebraska, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Weaver MS, Reeve BB, Baker JN, Martens CE, McFatrich M, Mowbray C, Palma D, Sung L, Tomlinson D, Withycombe J, Hinds P. Concept-elicitation phase for the development of the pediatric patient-reported outcome version of the Common Terminology Criteria for Adverse Events. Cancer. 2016 Jan 1;122(1):141-8. doi: 10.1002/cncr.29702. Epub 2015 Sep 30.

Reference Type BACKGROUND
PMID: 26421973 (View on PubMed)

Rosenberg AR, Orellana L, Ullrich C, Kang T, Geyer JR, Feudtner C, Dussel V, Wolfe J. Quality of Life in Children With Advanced Cancer: A Report From the PediQUEST Study. J Pain Symptom Manage. 2016 Aug;52(2):243-53. doi: 10.1016/j.jpainsymman.2016.04.002. Epub 2016 May 21.

Reference Type BACKGROUND
PMID: 27220948 (View on PubMed)

Rodgers C, Hooke MC, Ward J, Linder LA. Symptom Clusters in Children and Adolescents with Cancer. Semin Oncol Nurs. 2016 Nov;32(4):394-404. doi: 10.1016/j.soncn.2016.08.005. Epub 2016 Oct 21.

Reference Type BACKGROUND
PMID: 27776834 (View on PubMed)

Rodgers CC, Hooke MC, Hockenberry MJ. Symptom clusters in children. Curr Opin Support Palliat Care. 2013 Mar;7(1):67-72. doi: 10.1097/SPC.0b013e32835ad551.

Reference Type BACKGROUND
PMID: 23108342 (View on PubMed)

Wang J, Jacobs S, Dewalt DA, Stern E, Gross H, Hinds PS. A Longitudinal Study of PROMIS Pediatric Symptom Clusters in Children Undergoing Chemotherapy. J Pain Symptom Manage. 2018 Feb;55(2):359-367. doi: 10.1016/j.jpainsymman.2017.08.021. Epub 2017 Sep 1.

Reference Type BACKGROUND
PMID: 28865867 (View on PubMed)

Lee SE, Vincent C, Finnegan L. An Analysis and Evaluation of the Theory of Unpleasant Symptoms. ANS Adv Nurs Sci. 2017 Jan/Mar;40(1):E16-E39. doi: 10.1097/ANS.0000000000000141.

Reference Type BACKGROUND
PMID: 27525959 (View on PubMed)

Brown SJ. Integrating and synthesizing work on middle-range theories. ANS Adv Nurs Sci. 1996 Jun;18(4):vi-vii. doi: 10.1097/00012272-199606000-00001. No abstract available.

Reference Type BACKGROUND
PMID: 8790684 (View on PubMed)

Cody WK. Middle-range theories: do they foster the development of nursing science? Nurs Sci Q. 1999 Jan;12(1):9-14. doi: 10.1177/089431849901200106. No abstract available.

Reference Type BACKGROUND
PMID: 11847659 (View on PubMed)

Lenz ER, Suppe F, Gift AG, Pugh LC, Milligan RA. Collaborative development of middle-range nursing theories: toward a theory of unpleasant symptoms. ANS Adv Nurs Sci. 1995 Mar;17(3):1-13. doi: 10.1097/00012272-199503000-00003.

Reference Type BACKGROUND
PMID: 7778887 (View on PubMed)

Pilkington FB. Development of middle-range theories. Nurs Sci Q. 2006 Jul;19(3):277-80. No abstract available.

Reference Type BACKGROUND
PMID: 16838432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19661794 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19092553 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24112217 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0454-18-EP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.