Palliative CareCALLiNGSNCT03999957
CALLiNGS Protocol: Care Across Locations Longitudinally in Navigation of Goals and Symptoms
A study testing Telehealth web conferencing in people with Palliative Care, run by University of Nebraska at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Palliative Care
- What is being tested?
- Telehealth web conferencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jul 2018to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age birth to 18 years.
- Enrolling on home hospice services within the state of Nebraska at time of discharge from the hospital.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital & Medical Center
Omaha, Nebraska, 68114
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: CALLiNGS Protocol: Care Across Locations Longitudinally in Navigation of Goals and Symptoms (Interdisciplinary Pediatric Telepalliative Consultations for Hospice Teams)
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.
Read the 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.
- Conditions
- Palliative Care
- Being tested
- Telehealth web conferencing
- Keywords
- hospice, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth web conferencingOther
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 group | Role | What they receive |
|---|---|---|
| Interventional Arm | Other | Telehealth conferencing Receives: Other: Telehealth web conferencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 1 and again on Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start30 Jul 2018
- Primary completion30 Jul 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meaghann S Weaver, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999957
- Sponsor's protocol ID
- 0454-18-EP
- Acronym
- CALLiNGS
- Status last verified
- Sep 2023
- First submitted
- 18 Jun 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 26421973Rosenberg 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.
PubMed 27220948Rodgers 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.
PubMed 27776834Rodgers 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.
PubMed 23108342Wang 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.
PubMed 28865867Lee 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.
PubMed 27525959Brown 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.
PubMed 8790684Cody 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.
PubMed 11847659Lenz 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.
PubMed 7778887Pilkington FB. Development of middle-range theories. Nurs Sci Q. 2006 Jul;19(3):277-80. No abstract available.
PubMed 16838432Dirksen 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.
PubMed 19661794Hoffman 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.
PubMed 19092553Hsu 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.
PubMed 24112217
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CALLiNGS Protocol: Care Across Locations Longitudinally in Navigation of Goals and Symptoms (Interdisciplinary Pediatric Telepalliative Consultations for Hospice Teams)
- ClinicalTrials.gov ID
- NCT03999957
- Acronym / sponsor ID
- CALLiNGS / 0454-18-EP
- Conditions
- Palliative Care
- Keywords
- hospice, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Other | Other: Telehealth web conferencingTelehealth conferencing |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age birth to 18 years.
- Enrolling on home hospice services within the state of Nebraska at time of discharge from the hospital.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth web conferencingPediatric patient specific case discussions for enrolled pediatric patients at hospice staff interdisciplinary team meeting every 15 days for 60 min sessions via telehealth | Other | Interventional Arm |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 26421973Weaver 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.
- Background: PubMed 27220948Rosenberg 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.
- Background: PubMed 27776834Rodgers 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.
- Background: PubMed 23108342Rodgers 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.
- Background: PubMed 28865867Wang 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.
- Background: PubMed 27525959Lee 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.
- Background: PubMed 8790684Brown 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.
- Background: PubMed 11847659Cody 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.
- Background: PubMed 7778887Lenz 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.
- Background: PubMed 16838432Pilkington FB. Development of middle-range theories. Nurs Sci Q. 2006 Jul;19(3):277-80. No abstract available.
- Background: PubMed 19661794Dirksen 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.
- Background: PubMed 19092553Hoffman 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meaghann S Weaver, MD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth web conferencing in people with Palliative Care, run by University of Nebraska at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03999957, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.