Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome in Survivors of Critical Illness: a Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Completion of Post-ICU follow-up
Study Overview
Brief Summary
The goal of this pilot randomized controlled trial is to determine if a randomized controlled trial of a collaborative pharmacist-intensivist telehealth follow-up after intensive care unit discharge can feasibly be performed in patients who have survived a critical illness.
The study intervention will be telehealth follow-up appointments provided by clinical pharmacists at approximately one and three months post-hospital discharge. The purpose of the follow-up appointments will be to assess for post-intensive care syndrome and provide recommend interventions aimed at improving recovery
Participants will randomized to receive the study intervention or standard of care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults 18-89 years of age
- •Required admission to either medical or surgical ICU
- •Respiratory failure requiring invasive mechanical ventilation of at least 24 hours during ICU stay; or ICU stay of at least 7 days
- •Anticipated discharge to home after hospitalization
- •Consent from patients themselves or a legally authorized representative if necessary
Exclusion Criteria
- •Pregnancy
- •Incarceration/Imprisonment
- •Life expectancy less than 6 months or enrolled in hospice/palliative care
- •Anticipated discharge to skilled nursing facility, medical rehabilitation facility, or other long terms care facility
- •Unable to participate in telehealth
Arms & Interventions
Telehealth Intervention Group
This group will receive the study intervention (i.e. telehealth follow-up appointments at approximately one and three months post-hospital discharge).
Intervention: Post-ICU Telehealth Follow-up (Behavioral)
Standard of Care Group
This group will receive standard post-ICU care following hospital discharge.
Outcomes
Primary Outcomes
Completion of Post-ICU follow-up
Time Frame: From enrollment to end of follow-up period at seven months
Percentage of patients completing post-ICU follow-up
Secondary Outcomes
- Hospital or ICU re-admissions(Enrollment up to 7 months)
- Quality of life at 6 months using the Short Form Survey (SF-36)(From enrollment to 7 months)
- Emergency department visits(Enrollment up to 7 months)
- Mortality(within 6 months post-hospital discharge)
Investigators
Andrew Franck
Clinical Pharmacy Specialist
Malcom Randall VA Medical Center