NCT04969484

Brief Summary

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

4.4 years

First QC Date

May 4, 2021

Last Update Submit

July 7, 2021

Conditions

TelehealthPalliative Care

Keywords

End of lifeCare transitionNursing Home

Outcome Measures

Primary Outcomes (2)

  • Change in Symptom distress (composite measure)

    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

    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

Secondary Outcomes (10)

  • Change in number of completed POLST forms

    Baseline and Last visit -12 weeks

  • Type of changes in POLST forms

    Baseline and Last visit -12 weeks

  • Number of In-hospital death

    Baseline and Last visit -12 weeks

  • Change in Family Satisfaction

    Baseline and Last visit -12 weeks

  • Number of residents transitioned to hospice

    Last visit - week 12

  • +5 more secondary outcomes

Study Arms (2)

ImPAcTT intervention

EXPERIMENTAL

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.

Other: Telehealth visit

Usual care

NO INTERVENTION

Participants will receive the standard of care established at the NH.

Interventions

Telehealth visitOTHER

ImPACTT Telehealth visit with the PC provider

ImPAcTT intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California San Francisco - UCSF

San Francisco, California, 94143, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

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Related Links

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Caroline E Stephens, PhD, RN

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The trial will be implemented in 3 nursing homes to evaluate the feasibility and acceptability of the multi-component ImPAcTT intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, RN, GNP-BC, FAAN, Helen Lowe Bamberger Colby Presidential Endowed Chair in Gerontological Nursing, Associate Professor

Study Record Dates

First Submitted

May 4, 2021

First Posted

July 20, 2021

Study Start

February 19, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be made available by the online publication date unless the NIH policy specifies an earlier date.
Access Criteria
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.
More information

Locations

US(2)