Improving Palliative Care Access Through Technology

Palliative Care Clinical Trial

— ImPAcTT  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04969484
• Other study ID #: IRB_00129094
• Secondary ID: 5K76AG054862-05
• Status: Suspended
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2021
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 81
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Palliative Care
• Telehealth

Intervention

Other:
• Telehealth visit
ImPACTT Telehealth visit with the PC provider

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah
United States	University of California San Francisco - UCSF	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (64)

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* Note: There are 64 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Number of In-hospital death	Number of In-hospital death	Baseline and Last visit -12 weeks
Secondary	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
Secondary	Number of residents transitioned to hospice	Number of residents transitioned to hospice	Last visit - week 12
Secondary	Change in acute care utilization (composite measure)	Number of ED Visits and number of Hospitalizations	Baseline and Last visit -12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Corbin J, Strauss A, Strauss AL. Basics of qualitative research. Sage; 2014.
•   Improving palliative care in nursing homes [online report]. New York: Center to Advance Palliative Care. 2008.
•   National Consensus Project for Quality Palliative Care. Clinical practice guidelines for quality palliative care, 3rd ed., Pittsburgh, PA. 2013.
•   Strumpf NE, Tuch H, Stillman D, Parrish P, Morrison N. Implementing palliative care in the nursing home Ann Longterm Care, 2004;12, 35-41