Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome

Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome in Survivors of Critical Illness: a Pilot Randomized Controlled Trial

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 Overview

• Status: Recruiting
• Conditions: Post Intensive Care Syndrome (PICS)
• Intervention / Treatment: Behavioral: Post-ICU Telehealth Follow-up

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew J Franck, Pharm.D.; Phone Number: 105771 3523761611; Email: Andrew.Franck@va.gov

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Recruiting
      • Malcom Randall Veterans Affairs Medical Center
      • Contact: Andrew J Franck, Pharm.D.; Phone Number: 352-376-1611; Email: Andrew.Franck@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: Post-ICU Telehealth Follow-up; 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.
No Intervention: Standard of Care Group; This group will receive standard post-ICU care following hospital discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life at 6 months using the Short Form Survey (SF-36)	Medical Outcomes Study (MOS) 36-Item Short Form Health Survey (SF-36). Scores 0-100, higher scores indicating more favorable health state.	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

Collaborators and Investigators

• Sponsor: Malcom Randall VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 28, 2025
• First Submitted That Met QC Criteria: May 20, 2025
• First Posted (Actual): May 21, 2025

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; postintensive care syndrome
• Other Study ID Numbers: IRB202401793

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No