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Improving Palliative Care Access Through Technology (ImPAcTT)

7 juillet 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Suspendu

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

81

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • California
      • San Francisco, California, États-Unis, 94143
        • University of California San Francisco - UCSF
    • Utah
      • Salt Lake City, Utah, États-Unis, 84112
        • University of Utah

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
ImPACTT Telehealth visit with the PC provider
Aucune intervention: Usual care
Participants will receive the standard of care established at the NH.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Symptom distress (composite measure)
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in number of completed POLST forms
Délai: 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
Délai: 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
Délai: Baseline and Last visit -12 weeks
Number of In-hospital death
Baseline and Last visit -12 weeks
Change in Family Satisfaction
Délai: 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
Délai: Last visit - week 12
Number of residents transitioned to hospice
Last visit - week 12
Change in acute care utilization (composite measure)
Délai: Baseline and Last visit -12 weeks
Number of ED Visits and number of Hospitalizations
Baseline and Last visit -12 weeks
Change in Functional Status
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Caroline E Stephens, PhD, RN, University of Utah

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 février 2018

Achèvement primaire (Anticipé)

30 juin 2022

Achèvement de l'étude (Anticipé)

30 juin 2022

Dates d'inscription aux études

Première soumission

4 mai 2021

Première soumission répondant aux critères de contrôle qualité

7 juillet 2021

Première publication (Réel)

20 juillet 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 juillet 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juillet 2021

Dernière vérification

1 juillet 2021

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • IRB_00129094
  • 5K76AG054862-05 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

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

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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