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Improving Palliative Care Access Through Technology (ImPAcTT)

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ClinicalTrials.gov Identifier: NCT04969484
Recruitment Status : Suspended (K76 grant transferred to new institution (NOA 3/2020). COVID-19 significantly impacted study team personnel & study setting; human subjects restrictions at both the University and CMS levels prevented any human subjects research for more than a year.)
First Posted : July 20, 2021
Last Update Posted : July 20, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Caroline Stephens, University of Utah

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.

Condition or disease Intervention/treatment Phase
Telehealth Palliative Care Other: Telehealth visit Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The trial will be implemented in 3 nursing homes to evaluate the feasibility and acceptability of the multi-component ImPAcTT intervention.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Palliative Care Access Through Technology (ImPAcTT): A Multi- Component Pilot Study
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: 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.
Other: Telehealth visit
ImPACTT Telehealth visit with the PC provider

No Intervention: Usual care
Participants will receive the standard of care established at the NH.



Primary Outcome Measures :
  1. Change in Symptom distress (composite measure) [ Time Frame: 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


  2. Change in Symptom impact [ Time Frame: 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



Secondary Outcome Measures :
  1. Change in number of completed POLST forms [ Time Frame: Baseline and Last visit -12 weeks ]
    Number of Physician's Orders for Life-Sustaining Treatment - POLST forms completed

  2. Type of changes in POLST forms [ Time Frame: Baseline and Last visit -12 weeks ]
    Type of changes in Physician's Orders for Life-Sustaining Treatment -POLST forms

  3. Number of In-hospital death [ Time Frame: Baseline and Last visit -12 weeks ]
    Number of In-hospital death

  4. Change in Family Satisfaction [ Time Frame: 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


  5. Number of residents transitioned to hospice [ Time Frame: Last visit - week 12 ]
    Number of residents transitioned to hospice

  6. Change in acute care utilization (composite measure) [ Time Frame: Baseline and Last visit -12 weeks ]
    Number of ED Visits and number of Hospitalizations

  7. Change in Functional Status [ Time Frame: 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


  8. Change in Depression Status [ Time Frame: 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


  9. Change in Cognitive Status [ Time Frame: 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


  10. Change in Mortality [ Time Frame: 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04969484


Locations
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United States, California
University of California San Francisco - UCSF
San Francisco, California, United States, 94143
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Caroline E Stephens, PhD, RN University of Utah
Additional Information:
Publications of Results:

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Responsible Party: Caroline Stephens, PhD, RN, GNP-BC, FAAN, Helen Lowe Bamberger Colby Presidential Endowed Chair in Gerontological Nursing, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT04969484    
Other Study ID Numbers: IRB_00129094
5K76AG054862-05 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://palliativecareresearch.org/corescenters/data-informatics-statistics-core-disc/pcrc-de-identified-data-repository-didr

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caroline Stephens, University of Utah:
End of life
Care transition
Nursing Home