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Improving Palliative Care Access Through Technology (ImPAcTT)

7 luglio 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Sospeso

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

81

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • San Francisco, California, Stati Uniti, 94143
        • University of California San Francisco - UCSF
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84112
        • University of Utah

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Telehealth visit
ImPACTT Telehealth visit with the PC provider
Nessun intervento: Usual care
Participants will receive the standard of care established at the NH.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Symptom distress (composite measure)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in number of completed POLST forms
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline and Last visit -12 weeks
Number of In-hospital death
Baseline and Last visit -12 weeks
Change in Family Satisfaction
Lasso di tempo: 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
Lasso di tempo: Last visit - week 12
Number of residents transitioned to hospice
Last visit - week 12
Change in acute care utilization (composite measure)
Lasso di tempo: Baseline and Last visit -12 weeks
Number of ED Visits and number of Hospitalizations
Baseline and Last visit -12 weeks
Change in Functional Status
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Utah

Collaboratori

National Institute on Aging (NIA)

Investigatori

  • Investigatore principale: Caroline E Stephens, PhD, RN, University of Utah

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 febbraio 2018

Completamento primario (Anticipato)

30 giugno 2022

Completamento dello studio (Anticipato)

30 giugno 2022

Date di iscrizione allo studio

Primo inviato

4 maggio 2021

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2021

Primo Inserito (Effettivo)

20 luglio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 luglio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2021

Ultimo verificato

1 luglio 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • IRB_00129094
  • 5K76AG054862-05 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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