Clinical trial NCT04969484: Improving Palliative Care Access Through Technology
Official title: Improving Palliative Care Access Through Technology (ImPAcTT): A Multi- Component Pilot Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Telehealth
Palliative Care
Keywords: End of life
Care transition
Nursing Home
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-07-20
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial will be implemented in 3 nursing homes to evaluate the feasibility and acceptability of the multi-component ImPAcTT intervention.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in Symptom distress (composite measure)
timeFrame: Baseline and Last visit -12 weeks
measure: Change in Symptom impact
timeFrame: Baseline and Last visit -12 weeks
Secondary outcomes:
measure: Change in number of completed POLST forms
timeFrame: Baseline and Last visit -12 weeks
measure: Type of changes in POLST forms
timeFrame: Baseline and Last visit -12 weeks
measure: Number of In-hospital death
timeFrame: Baseline and Last visit -12 weeks
measure: Change in Family Satisfaction
timeFrame: Baseline and Last visit -12 weeks
measure: Number of residents transitioned to hospice
timeFrame: Last visit - week 12
measure: Change in acute care utilization (composite measure)
timeFrame: Baseline and Last visit -12 weeks
measure: Change in Functional Status
timeFrame: Baseline and Last visit -12 weeks
measure: Change in Depression Status
timeFrame: Baseline and Last visit -12 weeks
measure: Change in Cognitive Status
timeFrame: Baseline and Last visit -12 weeks
measure: Change in Mortality
timeFrame: Baseline and Last visit -12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco - UCSF
state: California
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Caroline E Stephens, PhD, RN
role: PRINCIPAL_INVESTIGATOR
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