Improving Palliative Care Access Through Technology

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Palliative Care Access Through Technology (ImPAcTT): A Multi- Component Pilot Study

Conditions
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Telehealth, Palliative Care

Intervention / Treatment
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* Other: Telehealth visit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ImPAcTT intervention<br>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<br>* ImPACTT Telehealth visit with the PC provider<br>|
| No Intervention: Usual care<br>Participants will receive the standard of care established at the NH. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of completed POLST forms | Number of Physician's Orders for Life-Sustaining Treatment - POLST forms completed | Baseline and Last visit -12 weeks | 
| Type of changes in POLST forms | Type of changes in Physician's Orders for Life-Sustaining Treatment -POLST forms | Baseline and Last visit -12 weeks | 
| Number of In-hospital death | Number of In-hospital death | Baseline and Last visit -12 weeks | 
| Change in Family Satisfaction | 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 | Number of residents transitioned to hospice | Last visit - week 12 | 
| Change in acute care utilization (composite measure) | Number of ED Visits and number of Hospitalizations | Baseline and Last visit -12 weeks | 
| Change in Functional Status | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End of life, Care transition, Nursing Home