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出境医 / 临床实验 / CALLiNGS Protocol: Care Across Locations Longitudinally in Navigation of Goals and Symptoms (CALLiNGS)

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Palliative Care Other: Telehealth web conferencing Not Applicable

Detailed Description:

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: CALLiNGS Protocol: Care Across Locations Longitudinally in Navigation of Goals and Symptoms (Interdisciplinary Pediatric Telepalliative Consultations for Hospice Teams)
Actual Study Start Date : July 30, 2018
Actual Primary Completion Date : July 30, 2020
Actual Study Completion Date : October 30, 2020
Arms and Interventions
Arm Intervention/treatment
Interventional Arm
Telehealth conferencing
 Other: 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
Outcome Measures
Primary Outcome Measures :
  1. To investigate quality of life trend over time for pediatric participants and their families [ Time Frame: Every 15 days for a total of 3 months ]

    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.


  2. To evaluate the change in perception of adult-trained hospice providers about caring for pediatric patients on hospice [ Time Frame: Day 1 of study and at Month 3 ]
    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.

  3. To monitor change in telehealth technology acceptance over two week time [ Time Frame: Day 1 and again on Day 14 ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
Layout table for location information
United States, Nebraska
Children's Hospital and Medical Center
Omaha, Nebraska, United States, 68114
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Layout table for investigator information
Principal Investigator: Meaghann Weaver, MD University of Nebraska
Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE July 30, 2018
Actual Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • To investigate quality of life trend over time for pediatric participants and their families [ Time Frame: Every 15 days for a total of 3 months ]
    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.
  • To evaluate the change in perception of adult-trained hospice providers about caring for pediatric patients on hospice [ Time Frame: Day 1 of study and at Month 3 ]
    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.
  • To monitor change in telehealth technology acceptance over two week time [ Time Frame: Day 1 and again on Day 14 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • To investigate quality of life trend over time for pediatric participants and their families [ Time Frame: Every 15 days for a total of 3 months ]
    Using patient-reported and proxy reported pediatric quality of life metrics longitudinally with pediatric quality of life scale completion by patient and proxy 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 [ Time Frame: Day 1 of study and at Month 3 ]
    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.
  • To monitor change in telehealth technology acceptance over two week time [ Time Frame: Day 1 and again on Day 14 ]
    TAM-2 Scale (Technology Acceptance Model) completed on Day 1 and Day 14= two time points
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CALLiNGS Protocol: Care Across Locations Longitudinally in Navigation of Goals and Symptoms
Official Title  ICMJE CALLiNGS Protocol: Care Across Locations Longitudinally in Navigation of Goals and Symptoms (Interdisciplinary Pediatric Telepalliative Consultations for Hospice Teams)
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.
Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Palliative Care
Intervention  ICMJE Other: 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
Study Arms  ICMJE Interventional Arm
Telehealth conferencing
Intervention: Other: Telehealth web conferencing
Publications *
  • 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.
  • 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.
  • 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. Review.
  • 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. Review.
  • 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.
  • 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.
  • Brown SJ. Integrating and synthesizing work on middle-range theories. ANS Adv Nurs Sci. 1996 Jun;18(4):vi-vii.
  • Cody WK. Middle-range theories: do they foster the development of nursing science? Nurs Sci Q. 1999 Jan;12(1):9-14. Review.
  • 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.
  • Pilkington FB. Development of middle-range theories. Nurs Sci Q. 2006 Jul;19(3):277-80. Review.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 30, 2020
Actual Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03999957
Other Study ID Numbers  ICMJE 454-18-EP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meaghann Weaver, University of Nebraska
Study Sponsor  ICMJE University of Nebraska
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Meaghann Weaver, MD University of Nebraska
PRS Account University of Nebraska
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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