Improving Palliative Care Access Through Technology (ImPAcTT)
keskiviikko 7. heinäkuuta 2021 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Odotettu)
81
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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California
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San Francisco, California, Yhdysvallat, 94143
- University of California San Francisco - UCSF
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Utah
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Salt Lake City, Utah, Yhdysvallat, 84112
- University of Utah
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Ei väliintuloa: Usual care
Participants will receive the standard of care established at the NH.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Symptom distress (composite measure)
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in number of completed POLST forms
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Caroline E Stephens, PhD, RN, University of Utah
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- 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.
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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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- 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.
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Hyödyllisiä linkkejä
- 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.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
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Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- IRB_00129094
- 5K76AG054862-05 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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-jaon aikakehys
Data will be made available by the online publication date unless the NIH policy specifies an earlier date.
IPD-jaon käyttöoikeuskriteerit
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.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
- ANALYTIC_CODE
- CSR
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
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