Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Improving Palliative Care Access Through Technology (ImPAcTT)

7 juli 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Geschorst

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

81

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • San Francisco, California, Verenigde Staten, 94143
        • University of California San Francisco - UCSF
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84112
        • University of Utah

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Telehealth visit
ImPACTT Telehealth visit with the PC provider
Geen tussenkomst: Usual care
Participants will receive the standard of care established at the NH.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Symptom distress (composite measure)
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in number of completed POLST forms
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and Last visit -12 weeks
Number of In-hospital death
Baseline and Last visit -12 weeks
Change in Family Satisfaction
Tijdsspanne: 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
Tijdsspanne: Last visit - week 12
Number of residents transitioned to hospice
Last visit - week 12
Change in acute care utilization (composite measure)
Tijdsspanne: Baseline and Last visit -12 weeks
Number of ED Visits and number of Hospitalizations
Baseline and Last visit -12 weeks
Change in Functional Status
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Utah

Medewerkers

National Institute on Aging (NIA)

Onderzoekers

  • Hoofdonderzoeker: Caroline E Stephens, PhD, RN, University of Utah

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 februari 2018

Primaire voltooiing (Verwacht)

30 juni 2022

Studie voltooiing (Verwacht)

30 juni 2022

Studieregistratiedata

Eerst ingediend

4 mei 2021

Eerst ingediend dat voldeed aan de QC-criteria

7 juli 2021

Eerst geplaatst (Werkelijk)

20 juli 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 juli 2021

Laatste update ingediend die voldeed aan QC-criteria

7 juli 2021

Laatst geverifieerd

1 juli 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • IRB_00129094
  • 5K76AG054862-05 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren