Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome

NCT06983496 | Recruiting

• 1 other identifier: IRB202401793
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Intensive Care Syndrome (PICS)

Outcome Measures

Primary Outcomes (1)

• Completion of Post-ICU follow-up

  Percentage of patients completing post-ICU follow-up

  From enrollment to end of follow-up period at seven months

Secondary Outcomes (4)

• Quality of life at 6 months using the Short Form Survey (SF-36)

  From enrollment to 7 months

• Hospital or ICU re-admissions

  Enrollment up to 7 months

• Emergency department visits

  Enrollment up to 7 months

• Mortality

  within 6 months post-hospital discharge

Study Arms (2)

Telehealth Intervention Group

EXPERIMENTAL

This group will receive the study intervention (i.e. telehealth follow-up appointments at approximately one and three months post-hospital discharge).

Behavioral: Post-ICU Telehealth Follow-up

Standard of Care Group

NO INTERVENTION

This group will receive standard post-ICU care following hospital discharge.

Interventions

Post-ICU Telehealth Follow-up BEHAVIORAL

The post-ICU clinic follow-up will be conducted by a pharmacist via a telehealth visit. A collaborating physician (i.e. intensivist) will provide clinical support and oversight as needed. The appointments will be 30-60 minute telephone/video calls. Participants be assessed for PICS and recommended interventions to improve their care.

Telehealth Intervention Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Malcom Randall VA Medical Center: lead

Study Sites (1)

Malcom Randall Veterans Affairs Medical Center

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Conditions

postintensive care syndrome

Central Study Contacts

Andrew J Franck, Pharm.D.

CONTACT

3523761611; Andrew.Franck@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Specialist

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 21, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (1)