Improving Palliative Care Access Through Technology

Not Applicable

Suspended

• Conditions: Palliative Care; Telehealth

• Registration Number: NCT04969484
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2018-02-19
• Study First Submitted: 2021-05-04
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-07
• Study First Posted: 2021-07-20
• Last Update Posted: 2021-07-20
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Symptom distress (composite measure)	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
Change in Symptom impact	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

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

Trial Locations

Locations (2)

University of California San Francisco - UCSF; 🇺🇸 San Francisco, California, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States