Improving Palliative Care Access Through Technology (ImPAcTT)
2021. július 7. frissítette: Caroline Stephens, University of Utah
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.
A tanulmány áttekintése
Állapot
Felfüggesztett
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Várható)
81
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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California
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San Francisco, California, Egyesült Államok, 94143
- University of California San Francisco - UCSF
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Utah
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Salt Lake City, Utah, Egyesült Államok, 84112
- University of Utah
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
Purposeful sampling will take place in an attempt to collect data from a range of ethnically and racially diverse participants.
INCLUSION CRITERIA:
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
EXCLUSION CRITERIA:
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: ImPAcTT intervention
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.
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ImPACTT Telehealth visit with the PC provider
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Nincs beavatkozás: Usual care
Participants will receive the standard of care established at the NH.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Change in Symptom distress (composite measure)
Időkeret: Baseline and Last visit -12 weeks
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Symptom distress as measured by the Edmonton Symptom Assessment Scale - ESAS
For all symptom distress scores: High score means: worst outcome Low score means: better outcome |
Baseline and Last visit -12 weeks
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Change in Symptom impact
Időkeret: Baseline and Last visit -12 weeks
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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 |
Baseline and Last visit -12 weeks
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in number of completed POLST forms
Időkeret: Baseline and Last visit -12 weeks
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Number of Physician's Orders for Life-Sustaining Treatment - POLST forms completed
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Baseline and Last visit -12 weeks
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Type of changes in POLST forms
Időkeret: Baseline and Last visit -12 weeks
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Type of changes in Physician's Orders for Life-Sustaining Treatment -POLST forms
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Baseline and Last visit -12 weeks
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Number of In-hospital death
Időkeret: Baseline and Last visit -12 weeks
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Number of In-hospital death
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Baseline and Last visit -12 weeks
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Change in Family Satisfaction
Időkeret: Baseline and Last visit -12 weeks
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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 |
Baseline and Last visit -12 weeks
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Number of residents transitioned to hospice
Időkeret: Last visit - week 12
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Number of residents transitioned to hospice
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Last visit - week 12
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Change in acute care utilization (composite measure)
Időkeret: Baseline and Last visit -12 weeks
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Number of ED Visits and number of Hospitalizations
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Baseline and Last visit -12 weeks
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Change in Functional Status
Időkeret: Baseline and Last visit -12 weeks
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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 |
Baseline and Last visit -12 weeks
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Change in Depression Status
Időkeret: Baseline and Last visit -12 weeks
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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 |
Baseline and Last visit -12 weeks
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Change in Cognitive Status
Időkeret: Baseline and Last visit -12 weeks
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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 |
Baseline and Last visit -12 weeks
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Change in Mortality
Időkeret: Baseline and Last visit -12 weeks
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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 |
Baseline and Last visit -12 weeks
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Caroline E Stephens, PhD, RN, University of Utah
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- Stephens 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.
- Levy C, Morris M, Kramer A. Improving end-of-life outcomes in nursing homes by targeting residents at high-risk of mortality for palliative care: program description and evaluation. J Palliat Med. 2008 Mar;11(2):217-25. doi: 10.1089/jpm.2007.0147.
- Casarett D, Karlawish J, Morales K, Crowley R, Mirsch T, Asch DA. Improving the use of hospice services in nursing homes: a randomized controlled trial. JAMA. 2005 Jul 13;294(2):211-7. doi: 10.1001/jama.294.2.211.
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- National 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/
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- Bercovitz 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.
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- Stephens 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.
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- Miller 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.
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- Miller SC, Dahal R, Lima JC, Intrator O, Martin E, Bull J, Hanson LC. Palliative Care Consultations in Nursing Homes and End-of-Life Hospitalizations. J Pain Symptom Manage. 2016 Dec;52(6):878-883. doi: 10.1016/j.jpainsymman.2016.05.017. Epub 2016 Sep 17.
- Miller SC, Lima JC, Intrator O, Martin E, Bull J, Hanson LC. Palliative Care Consultations in Nursing Homes and Reductions in Acute Care Use and Potentially Burdensome End-of-Life Transitions. J Am Geriatr Soc. 2016 Nov;64(11):2280-2287. doi: 10.1111/jgs.14469. Epub 2016 Sep 19.
- Stephens CE, Hunt LJ, Bui N, Halifax E, Ritchie CS, Lee SJ. Palliative Care Eligibility, Symptom Burden, and Quality-of-Life Ratings in Nursing Home Residents. JAMA Intern Med. 2018 Jan 1;178(1):141-142. doi: 10.1001/jamainternmed.2017.6299.
- Zerzan J, Stearns S, Hanson L. Access to palliative care and hospice in nursing homes. JAMA. 2000 Nov 15;284(19):2489-94. doi: 10.1001/jama.284.19.2489.
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- Johnston B, Kidd L, Wengstrom Y, Kearney N. An evaluation of the use of Telehealth within palliative care settings across Scotland. Palliat Med. 2012 Mar;26(2):152-61. doi: 10.1177/0269216311398698. Epub 2011 Mar 4.
- Low JA, Beins G, Lee KK, Koh E. Last moments of life: can telemedicine play a role? Palliat Support Care. 2013 Aug;11(4):353-5. doi: 10.1017/S1478951512000995. Epub 2013 Feb 7.
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- Teno JM, Clarridge BR, Casey V, Welch LC, Wetle T, Shield R, Mor V. Family perspectives on end-of-life care at the last place of care. JAMA. 2004 Jan 7;291(1):88-93. doi: 10.1001/jama.291.1.88.
- Miller SC, Teno JM, Mor V. Hospice and palliative care in nursing homes. Clin Geriatr Med. 2004 Nov;20(4):717-34, vii. doi: 10.1016/j.cger.2004.07.005.
- Huskamp HA, Stevenson DG, Chernew ME, Newhouse JP. A new medicare end-of-life benefit for nursing home residents. Health Aff (Millwood). 2010 Jan-Feb;29(1):130-5. doi: 10.1377/hlthaff.2009.0523.
- Stevenson DG, Bramson JS. Hospice care in the nursing home setting: a review of the literature. J Pain Symptom Manage. 2009 Sep;38(3):440-51. doi: 10.1016/j.jpainsymman.2009.05.006.
- Ding J, Saunders C, Cook A, Johnson CE. End-of-life care in rural general practice: how best to support commitment and meet challenges? BMC Palliat Care. 2019 Jun 25;18(1):51. doi: 10.1186/s12904-019-0435-4.
- Carlson MD, Lim B, Meier DE. Strategies and innovative models for delivering palliative care in nursing homes. J Am Med Dir Assoc. 2011 Feb;12(2):91-8. doi: 10.1016/j.jamda.2010.07.016. Epub 2010 Nov 10.
- Lupu D; American Academy of Hospice and Palliative Medicine Workforce Task Force. Estimate of current hospice and palliative medicine physician workforce shortage. J Pain Symptom Manage. 2010 Dec;40(6):899-911. doi: 10.1016/j.jpainsymman.2010.07.004.
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Hasznos linkek
- National Consensus Project for Quality Palliative Care. Clinical practice guidelines for quality palliative care, 3rd ed., Pittsburgh, PA. 2013.
- Improving palliative care in nursing homes [online report]. New York: Center to Advance Palliative Care. 2008.
- Corbin J, Strauss A, Strauss AL. Basics of qualitative research. Sage; 2014.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2018. február 19.
Elsődleges befejezés (Várható)
2022. június 30.
A tanulmány befejezése (Várható)
2022. június 30.
Tanulmányi regisztráció dátumai
Először benyújtva
2021. május 4.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2021. július 7.
Első közzététel (Tényleges)
2021. július 20.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2021. július 20.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2021. július 7.
Utolsó ellenőrzés
2021. július 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- IRB_00129094
- 5K76AG054862-05 (Az Egyesült Államok NIH támogatása/szerződése)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
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.
IPD megosztási időkeret
Data will be made available by the online publication date unless the NIH policy specifies an earlier date.
IPD-megosztási hozzáférési feltételek
This study has specific data and resource sharing plans to make data available both to the community of scientists interested in palliative care and nursing home research to avoid unintentional duplication of research.
Moreover, the investigator would welcome collaboration with others who could make use of the Telehealth visit protocols developed in this ImPAcTT project.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
- ANALYTIC_CODE
- CSR
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
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