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Improving Palliative Care Access Through Technology (ImPAcTT)

7. juli 2021 opdateret af: 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.

Studieoversigt

Status

Suspenderet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

81

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94143
        • University of California San Francisco - UCSF
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • University of Utah

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Telehealth visit
ImPACTT Telehealth visit with the PC provider
Ingen indgriben: Usual care
Participants will receive the standard of care established at the NH.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Symptom distress (composite measure)
Tidsramme: 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
Baseline and Last visit -12 weeks
Change in Symptom impact
Tidsramme: 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
Baseline and Last visit -12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in number of completed POLST forms
Tidsramme: Baseline and Last visit -12 weeks
Number of Physician's Orders for Life-Sustaining Treatment - POLST forms completed
Baseline and Last visit -12 weeks
Type of changes in POLST forms
Tidsramme: Baseline and Last visit -12 weeks
Type of changes in Physician's Orders for Life-Sustaining Treatment -POLST forms
Baseline and Last visit -12 weeks
Number of In-hospital death
Tidsramme: Baseline and Last visit -12 weeks
Number of In-hospital death
Baseline and Last visit -12 weeks
Change in Family Satisfaction
Tidsramme: Baseline and Last visit -12 weeks

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
Number of residents transitioned to hospice
Tidsramme: Last visit - week 12
Number of residents transitioned to hospice
Last visit - week 12
Change in acute care utilization (composite measure)
Tidsramme: Baseline and Last visit -12 weeks
Number of ED Visits and number of Hospitalizations
Baseline and Last visit -12 weeks
Change in Functional Status
Tidsramme: Baseline and Last visit -12 weeks

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
Change in Depression Status
Tidsramme: Baseline and Last visit -12 weeks

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
Change in Cognitive Status
Tidsramme: Baseline and Last visit -12 weeks

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
Change in Mortality
Tidsramme: Baseline and Last visit -12 weeks

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Utah

Samarbejdspartnere

National Institute on Aging (NIA)

Efterforskere

  • Ledende efterforsker: Caroline E Stephens, PhD, RN, University of Utah

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. februar 2018

Primær færdiggørelse (Forventet)

30. juni 2022

Studieafslutning (Forventet)

30. juni 2022

Datoer for studieregistrering

Først indsendt

4. maj 2021

Først indsendt, der opfyldte QC-kriterier

7. juli 2021

Først opslået (Faktiske)

20. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • IRB_00129094
  • 5K76AG054862-05 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Data will be made available by the online publication date unless the NIH policy specifies an earlier date.

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Palliativ pleje

Kliniske forsøg med Telehealth visit

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Singapore

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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