TelehealthImPAcTTNCT04969484
Improving Palliative Care Access Through Technology
A study testing Telehealth visit in people with Telehealth and Palliative Care, run by University of Utah at 2 sites in United States.
Trial summary
This project will focus on developing, optimizing and pilot-testing a multi-component Improving Access Through Technology (ImPAcTT) intervention that leverages existing telehealth technologies to provide staff education; family outreach, engagement and support; care coordination; and resident symptom management and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telehealth, Palliative Care
- What is being tested?
- Telehealth visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Feb 2018to 30 Jun 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary participant
- Age >= 18 years
- English language fluency
- Palliative Care Consult Screening Tool (PCCS) scoring 9 or above
- If participant does not demonstrate capacity to consent, he/she must be able to assent to study procedures, be told of plan to approach surrogate and have a legally authorized representative available to provide consent
- Family/friend caregivers:
- Closest relative/next of kin/friend who is involved in the care of his/her loved one before and during the study period
- English fluency
Who cannot join
- Primary participant:
- Enrolled in hospice
- Unable to assent to study procedures
- Expresses resistance or dissent to participation or the use of surrogate consent
- Family/friend caregiver:
- Life expectancy < 1 year (e.g., metastatic cancer)
- Evidence of cognitive impairment or inability to consent to study procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Utah
Salt Lake City, Utah, 84112
University of California San Francisco - UCSF
San Francisco, California, 94143
About this study
Official title: Improving Palliative Care Access Through Technology (ImPAcTT): A Multi- Component Pilot Study
This project will focus on developing, optimizing and pilot-testing a multi-component Improving Access Through Technology (ImPAcTT) intervention that leverages existing telehealth technologies to provide staff education; family outreach, engagement and support; care coordination; and resident symptom management and facilitation of goals-of-care discussion.
Read the detailed description
Almost 1.8 million older Americans live in nursing homes (NH), with estimates that this number will grow to more than 3 million by 2050. NHs are increasingly becoming the place of care and site of death for frail older adults dying from multiple chronic illnesses. Unfortunately, most residents die without the benefit of palliative care (PC) or with palliation delayed until the last days of life.
Unfortunately, hospice services are often the only formal end of life care service available in NHs, and access to hospice enrollment is complicated by financial implications for both NHs and residents.
Telehealth, or remote monitoring of patients through information and communication technologies, is an effective mechanism for addressing the increased demand on health services and has much to offer to people living with and dying from advanced illness. Moreover, numerous studies have demonstrated positive benefits of using telehealth in the NH to improve access to consultants (e.g., neurology, dermatology, psychiatry).
Little is known, however, about the effect of using Telehealth on improving access to PC specialists in the NH setting.
The proposed ImPAcTT intervention employs a secure communications platform that permits multi-person live video, audio, and text message consultations; real-time document sharing and documentation for advanced care planning discussions; and remote virtual assessment capabilities.
The investigator will conduct a pilot implementation trial of ImPAcTT in 3 study nursing homes to evaluate our ability to safely recruit and retain study participants, collect appropriate and accurate data, and determine preliminary estimates of an effect size of the intervention.
- Conditions
- Telehealth, Palliative Care
- Being tested
- Telehealth visit
- Keywords
- End of life, Care transition, Nursing Home
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth visitOther
ImPACTT Telehealth visit with the PC provider
| Study group | Role | What they receive |
|---|---|---|
| ImPAcTT intervention | Experimental | Within 48-72 hours of enrollment in the study, the primary participant and family will receive an ImPAcTT Telehealth visit with the PC provider. The provider will conduct a comprehensive PC assessment aligned with the National Consensus Project for Quality Palliative Care guidelines. Visits, which may include remote physical assessment using a digital stethoscope, dermatoscope, etc., will be documented and transmitted to the NH. Advanced Care Planning (ACP) and goals of care discussions will be facilitated by the ability to virtually share and edit documents, such as the Physician Orders for Life Sustaining Treatment (POLST), in real time with primary participants and/or family. The PC provider will conduct follow-up visits 1 week following the initial visit, then on a case-by-case basis. Receives: Other: Telehealth visit |
| Usual care | No intervention | Participants will receive the standard of care established at the NH. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptom distress (composite measure)
Symptom distress as measured by the Edmonton Symptom Assessment Scale - ESAS
- ESAS physical score (total of physical 6 symptoms, score range 0-60)
- ESAS emotional score (total of 2 emotional symptoms, score range 0-60)
- ESAS total symptom distress score (physical score + emotional score + well being)
For all symptom distress scores:
High score means: worst outcome Low score means: better outcome
Measured: Baseline and Last visit -12 weeks
Change in Symptom impact
Symptom impact as measured by the "Quality of Life at the End of Life" - QUAL-E
Symptom impact subscale:
Minimum value: 3 Maximum value: 15
High score means: worst outcome Low score means: better outcome
Measured: Baseline and Last visit -12 weeks
Secondary outcomes (10)
Change in number of completed POLST forms
Number of Physician's Orders for Life-Sustaining Treatment - POLST forms completed
Measured: Baseline and Last visit -12 weeks
Type of changes in POLST forms
Type of changes in Physician's Orders for Life-Sustaining Treatment -POLST forms
Measured: Baseline and Last visit -12 weeks
Number of In-hospital death
Number of In-hospital death
Measured: Baseline and Last visit -12 weeks
Change in Family Satisfaction
Family Satisfaction as measured by the "Quality of Life at the End of Life - Family" - QUAL-E Fam
Subscale: Relationship with Healthcare Provider [Questions #5-8 with 5 item Likert scales, average of 4 scores] Minimum value: 1 Maximum value: 5
High score means: worst outcome Low score means: better outcome
Measured: Baseline and Last visit -12 weeks
Number of residents transitioned to hospice
Number of residents transitioned to hospice
Measured: Last visit - week 12
Change in acute care utilization (composite measure)
Number of ED Visits and number of Hospitalizations
Measured: Baseline and Last visit -12 weeks
Change in Functional Status
Functional Status as measured by the PalliativePerformance Scale (PPSv2)
Minimum value: 0% Maximum value: 100%
High score means: better outcome Low score means: worst outcome
Measured: Baseline and Last visit -12 weeks
Change in Depression Status
Depression as measured by the Patient Health Questionnaire-9 (PHQ-9)
Subscales:
- Question 1: Minimum value: 0 Maximum value: 27
High score means: worst outcome Low score means: better outcome
- Question 2: Minimum value: 1 Maximum value: 4
High score means: worst outcome Low score means: better outcome
Measured: Baseline and Last visit -12 weeks
Change in Cognitive Status
Cognition as measured by the Montreal - Cognitive Assessment (MoCA)
Minimum value: 0 Maximum value: 30
High score means: better outcome Low score means: worst outcome
Measured: Baseline and Last visit -12 weeks
Change in Mortality
Risk for dying within one year as measured by the Flacker Mortality Score
Minimum value: 0 Maximum value: 15.21
High score means: worst outcome Low score means: better outcome
Measured: Baseline and Last visit -12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start19 Feb 2018
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Why it stopped: K76 grant transferred to new institution (NOA 3/2020). COVID-19 significantly impacted study team personnel \& study setting; human subjects restrictions at both the University and CMS levels prevented any human subjects research for more than a year.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (64)Papers the sponsor has linked to this study.
- Other trials for TelehealthStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The trial will be implemented in 3 nursing homes to evaluate the feasibility and acceptability of the multi-component ImPAcTT intervention.
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Caroline Stephens, University of Utah
- Investigators
- Caroline E Stephens, PhD, RN, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969484
- Sponsor's protocol ID
- IRB_00129094
- Other IDs
- 5K76AG054862-05
- Acronym
- ImPAcTT
- Status last verified
- Jul 2021
- First submitted
- 4 May 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data (complete dataset with full documentation including metadata, protocols, etc) will be made available by the online publication date unless the NIH policy specifies an earlier date. The PI will work the primary mentor to ensure that the study data are submitted to the PCRC De-identified Data Repository. (https://palliativecareresearch.org/corescenters/data-informatics-statistics-core-disc/pcrc-de-identified-data-repository-didr). This would allow for secondary data analyses of the data to be conducted and support those who need access to these datasets for preliminary data and/or grant proposal preparation. Human subject data will be shared with other investigators within the limits of HIPAA and other patient confidentiality requirements, including the removal of all participant identifiers from all source documents and the use of unique participant identification numbers, and in accordance with PCRC protocols.
Publications
Mitchell SL, Teno JM, Miller SC, Mor V. A national study of the location of death for older persons with dementia. J Am Geriatr Soc. 2005 Feb;53(2):299-305. doi: 10.1111/j.1532-5415.2005.53118.x.
PubMed 15673356National Center for Health Statistics (US). Health, United States, 2010: With Special Feature on Death and Dying. Hyattsville (MD): National Center for Health Statistics (US); 2011 Feb. Report No.: 2011-1232. Available from http://www.ncbi.nlm.nih.gov/books/NBK54381/
PubMed 21634072Brock DB, Foley DJ. Demography and epidemiology of dying in the U.S. with emphasis on deaths of older persons. Hosp J. 1998;13(1-2):49-60. doi: 10.1080/0742-969x.1998.11882887.
PubMed 9644392Bercovitz A, Decker FH, Jones A, Remsburg RE. End-of-life care in nursing homes: 2004 National Nursing Home Survey. Natl Health Stat Report. 2008 Oct 8;(9):1-23.
PubMed 19013934Kaye HS, Harrington C, LaPlante MP. Long-term care: who gets it, who provides it, who pays, and how much? Health Aff (Millwood). 2010 Jan-Feb;29(1):11-21. doi: 10.1377/hlthaff.2009.0535.
PubMed 20048355Stephens C, Halifax E, Bui N, Lee SJ, Harrington C, Shim J, Ritchie C. Provider Perspectives on the Influence of Family on Nursing Home Resident Transfers to the Emergency Department: Crises at the End of Life. Curr Gerontol Geriatr Res. 2015;2015:893062. doi: 10.1155/2015/893062. Epub 2015 Aug 24.
PubMed 26379704Stephens CE, Halifax E, David D, Bui N, Lee SJ, Shim J, Ritchie CS. "They Don't Trust Us": The Influence of Perceptions of Inadequate Nursing Home Care on Emergency Department Transfers and the Potential Role for Telehealth. Clin Nurs Res. 2020 Mar;29(3):157-168. doi: 10.1177/1054773819835015. Epub 2019 Apr 21.
PubMed 31007055Gozalo P, Teno JM, Mitchell SL, Skinner J, Bynum J, Tyler D, Mor V. End-of-life transitions among nursing home residents with cognitive issues. N Engl J Med. 2011 Sep 29;365(13):1212-21. doi: 10.1056/NEJMsa1100347.
PubMed 21991894Miller SC, Lima JC, Looze J, Mitchell SL. Dying in U.S. nursing homes with advanced dementia: how does health care use differ for residents with, versus without, end-of-life Medicare skilled nursing facility care? J Palliat Med. 2012 Jan;15(1):43-50. doi: 10.1089/jpm.2011.0210. Epub 2011 Dec 16.
PubMed 22175816Cohen A, Bulanda JR. Social Supports as Enabling Factors in Nursing Home Admissions: Rural, Suburban, and Urban Differences. J Appl Gerontol. 2016 Jul;35(7):721-43. doi: 10.1177/0733464814566677. Epub 2015 Jan 11.
PubMed 25582118Bolin JN, Phillips CD, Hawes C. Urban and rural differences in end-of-life pain and treatment status on admission to a nursing facility. Am J Hosp Palliat Care. 2006 Jan-Feb;23(1):51-7. doi: 10.1177/104990910602300109.
PubMed 16450663Douthit N, Kiv S, Dwolatzky T, Biswas S. Exposing some important barriers to health care access in the rural USA. Public Health. 2015 Jun;129(6):611-20. doi: 10.1016/j.puhe.2015.04.001. Epub 2015 May 27.
PubMed 26025176Matthews KA, Croft JB, Liu Y, Lu H, Kanny D, Wheaton AG, Cunningham TJ, Khan LK, Caraballo RS, Holt JB, Eke PI, Giles WH. Health-Related Behaviors by Urban-Rural County Classification - United States, 2013. MMWR Surveill Summ. 2017 Feb 3;66(5):1-8. doi: 10.15585/mmwr.ss6605a1.
PubMed 28151923Aragon K, Covinsky K, Miao Y, Boscardin WJ, Flint L, Smith AK. Use of the Medicare posthospitalization skilled nursing benefit in the last 6 months of life. Arch Intern Med. 2012 Nov 12;172(20):1573-9. doi: 10.1001/archinternmed.2012.4451.
PubMed 23026981Ersek M, Carpenter JG. Geriatric palliative care in long-term care settings with a focus on nursing homes. J Palliat Med. 2013 Oct;16(10):1180-7. doi: 10.1089/jpm.2013.9474. Epub 2013 Aug 28.
PubMed 23984636
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Palliative Care Access Through Technology (ImPAcTT): A Multi- Component Pilot Study
- ClinicalTrials.gov ID
- NCT04969484
- Acronym / sponsor ID
- ImPAcTT / IRB_00129094
- Conditions
- Telehealth, Palliative Care
- Keywords
- End of life, Care transition, Nursing Home
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: K76 grant transferred to new institution (NOA 3/2020). COVID-19 significantly impacted study team personnel \& study setting; human subjects restrictions at both the University and CMS levels prevented any human subjects research for more than a year.
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 20 Jul 2021 (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.
This project will focus on developing, optimizing and pilot-testing a multi-component Improving Access Through Technology (ImPAcTT) intervention that leverages existing telehealth technologies to provide staff education; family outreach, engagement and support; care coordination; and resident symptom management and facilitation of goals-of-care discussion.
Detailed description
Almost 1.8 million older Americans live in nursing homes (NH), with estimates that this number will grow to more than 3 million by 2050. NHs are increasingly becoming the place of care and site of death for frail older adults dying from multiple chronic illnesses. Unfortunately, most residents die without the benefit of palliative care (PC) or with palliation delayed until the last days of life.
Unfortunately, hospice services are often the only formal end of life care service available in NHs, and access to hospice enrollment is complicated by financial implications for both NHs and residents.
Telehealth, or remote monitoring of patients through information and communication technologies, is an effective mechanism for addressing the increased demand on health services and has much to offer to people living with and dying from advanced illness. Moreover, numerous studies have demonstrated positive benefits of using telehealth in the NH to improve access to consultants (e.g., neurology, dermatology, psychiatry).
Little is known, however, about the effect of using Telehealth on improving access to PC specialists in the NH setting.
The proposed ImPAcTT intervention employs a secure communications platform that permits multi-person live video, audio, and text message consultations; real-time document sharing and documentation for advanced care planning discussions; and remote virtual assessment capabilities.
The investigator will conduct a pilot implementation trial of ImPAcTT in 3 study nursing homes to evaluate our ability to safely recruit and retain study participants, collect appropriate and accurate data, and determine preliminary estimates of an effect size of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial will be implemented in 3 nursing homes to evaluate the feasibility and acceptability of the multi-component ImPAcTT intervention.
| Arm | Type | Receives |
|---|---|---|
| ImPAcTT intervention | Experimental | Other: Telehealth visitWithin 48-72 hours of enrollment in the study, the primary participant and family will receive an ImPAcTT Telehealth visit with the PC provider. The provider will conduct a comprehensive PC assessment aligned with the National Consensus Project for Quality Palliative Care guidelines. Visits, which may include remote physical assessment using a digital stethoscope, dermatoscope, etc., will be documented and transmitted to the NH. Advanced Care Planning (ACP) and goals of care discussions will be facilitated by the ability to virtually share and edit documents, such as the Physician Orders for Life Sustaining Treatment (POLST), in real time with primary participants and/or family. The PC provider will conduct follow-up visits 1 week following the initial visit, then on a case-by-case basis. |
| Usual care | No intervention | –Participants will receive the standard of care established at the NH. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary participant
- Age >= 18 years
- English language fluency
- Palliative Care Consult Screening Tool (PCCS) scoring 9 or above
- If participant does not demonstrate capacity to consent, he/she must be able to assent to study procedures, be told of plan to approach surrogate and have a legally authorized representative available to provide consent
Key exclusion criteria (7 listed)
- Enrolled in hospice
- Unable to assent to study procedures
- Expresses resistance or dissent to participation or the use of surrogate consent
- Life expectancy < 1 year (e.g., metastatic cancer)
- Evidence of cognitive impairment or inability to consent to study procedures
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 visitImPACTT Telehealth visit with the PC provider | Other | ImPAcTT intervention |
Primary outcome
Change in Symptom distress (composite measure)
Time frame: Baseline and Last visit -12 weeks
Symptom distress as measured by the Edmonton Symptom Assessment Scale - ESAS * ESAS physical score (total of physical 6 symptoms, score range 0-60) * ESAS emotional score (total of 2 emotional symptoms, score range 0-60) * ESAS total symptom distress score (physical score + emotional score + well being) For all symptom distress scores: High score means: worst outcome Low score means: better outcome
Change in Symptom impact
Time frame: Baseline and Last visit -12 weeks
Symptom impact as measured by the "Quality of Life at the End of Life" - QUAL-E Symptom impact subscale: Minimum value: 3 Maximum value: 15 High score means: worst outcome Low score means: better outcome
10 secondary outcomes
Change in number of completed POLST forms
Time frame: Baseline and Last visit -12 weeks
Type of changes in POLST forms
Time frame: Baseline and Last visit -12 weeks
Number of In-hospital death
Time frame: Baseline and Last visit -12 weeks
Change in Family Satisfaction
Time frame: Baseline and Last visit -12 weeks
Number of residents transitioned to hospice
Time frame: Last visit - week 12
Change in acute care utilization (composite measure)
Time frame: Baseline and Last visit -12 weeks
Change in Functional Status
Time frame: Baseline and Last visit -12 weeks
Change in Depression Status
Time frame: Baseline and Last visit -12 weeks
Change in Cognitive Status
Time frame: Baseline and Last visit -12 weeks
Change in Mortality
Time frame: Baseline and Last visit -12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Results publication: PubMed 15673356Mitchell SL, Teno JM, Miller SC, Mor V. A national study of the location of death for older persons with dementia. J Am Geriatr Soc. 2005 Feb;53(2):299-305. doi: 10.1111/j.1532-5415.2005.53118.x.
- Results publication: PubMed 21634072National Center for Health Statistics (US). Health, United States, 2010: With Special Feature on Death and Dying. Hyattsville (MD): National Center for Health Statistics (US); 2011 Feb. Report No.: 2011-1232. Available from http://www.ncbi.nlm.nih.gov/books/NBK54381/
- Results publication: PubMed 9644392Brock DB, Foley DJ. Demography and epidemiology of dying in the U.S. with emphasis on deaths of older persons. Hosp J. 1998;13(1-2):49-60. doi: 10.1080/0742-969x.1998.11882887.
- Results publication: PubMed 19013934Bercovitz A, Decker FH, Jones A, Remsburg RE. End-of-life care in nursing homes: 2004 National Nursing Home Survey. Natl Health Stat Report. 2008 Oct 8;(9):1-23.
- Results publication: PubMed 20048355Kaye HS, Harrington C, LaPlante MP. Long-term care: who gets it, who provides it, who pays, and how much? Health Aff (Millwood). 2010 Jan-Feb;29(1):11-21. doi: 10.1377/hlthaff.2009.0535.
- Results publication: PubMed 26379704Stephens C, Halifax E, Bui N, Lee SJ, Harrington C, Shim J, Ritchie C. Provider Perspectives on the Influence of Family on Nursing Home Resident Transfers to the Emergency Department: Crises at the End of Life. Curr Gerontol Geriatr Res. 2015;2015:893062. doi: 10.1155/2015/893062. Epub 2015 Aug 24.
- Results publication: PubMed 31007055Stephens CE, Halifax E, David D, Bui N, Lee SJ, Shim J, Ritchie CS. "They Don't Trust Us": The Influence of Perceptions of Inadequate Nursing Home Care on Emergency Department Transfers and the Potential Role for Telehealth. Clin Nurs Res. 2020 Mar;29(3):157-168. doi: 10.1177/1054773819835015. Epub 2019 Apr 21.
- Results publication: PubMed 21991894Gozalo P, Teno JM, Mitchell SL, Skinner J, Bynum J, Tyler D, Mor V. End-of-life transitions among nursing home residents with cognitive issues. N Engl J Med. 2011 Sep 29;365(13):1212-21. doi: 10.1056/NEJMsa1100347.
- Results publication: PubMed 22175816Miller SC, Lima JC, Looze J, Mitchell SL. Dying in U.S. nursing homes with advanced dementia: how does health care use differ for residents with, versus without, end-of-life Medicare skilled nursing facility care? J Palliat Med. 2012 Jan;15(1):43-50. doi: 10.1089/jpm.2011.0210. Epub 2011 Dec 16.
- Results publication: PubMed 25582118Cohen A, Bulanda JR. Social Supports as Enabling Factors in Nursing Home Admissions: Rural, Suburban, and Urban Differences. J Appl Gerontol. 2016 Jul;35(7):721-43. doi: 10.1177/0733464814566677. Epub 2015 Jan 11.
- Results publication: PubMed 16450663Bolin JN, Phillips CD, Hawes C. Urban and rural differences in end-of-life pain and treatment status on admission to a nursing facility. Am J Hosp Palliat Care. 2006 Jan-Feb;23(1):51-7. doi: 10.1177/104990910602300109.
- Results publication: PubMed 26025176Douthit N, Kiv S, Dwolatzky T, Biswas S. Exposing some important barriers to health care access in the rural USA. Public Health. 2015 Jun;129(6):611-20. doi: 10.1016/j.puhe.2015.04.001. Epub 2015 May 27.
- Improving palliative care in nursing homes \[online report\]. New York: Center to Advance Palliative Care. 2008.Link provided by the sponsor.
- Corbin J, Strauss A, Strauss AL. Basics of qualitative research. Sage; 2014.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data (complete dataset with full documentation including metadata, protocols, etc) will be made available by the online publication date unless the NIH policy specifies an earlier date. The PI will work the primary mentor to ensure that the study data are submitted to the PCRC De-identified Data Repository. (https://palliativecareresearch.org/corescenters/data-informatics-statistics-core-disc/pcrc-de-identified-data-repository-didr). This would allow for secondary data analyses of the data to be conducted and support those who need access to these datasets for preliminary data and/or grant proposal preparation. Human subject data will be shared with other investigators within the limits of HIPAA and other patient confidentiality requirements, including the removal of all participant identifiers from all source documents and the use of unique participant identification numbers, and in accordance with PCRC protocols.
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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.
Caroline E Stephens, PhD, RN principal investigator
University of Utah
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 visit in people with Telehealth and Palliative Care, run by University of Utah 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 8 inclusion and 7 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: paused, as of the sponsor's last update on 20 Jul 2021. 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?
Results are not available in the source record.
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?
Change in Symptom distress (composite measure) (time frame: Baseline and Last visit -12 weeks). The study lists 2 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 NCT04969484, which also lists 64 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 20 Jul 2021; AzTrials last refreshed its copy on 27 Oct 2026.