Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome

Not Applicable

Not yet recruiting

• Conditions: Post Intensive Care Syndrome (PICS)

• Registration Number: NCT06983496
• Lead Sponsor: Malcom Randall VA Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-28
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-06
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Completion of Post-ICU follow-up	From enrollment to end of follow-up period at seven months	Percentage of patients completing post-ICU follow-up

Secondary Outcome Measures

Name	Time	Method
Quality of life at 6 months using the Short Form Survey (SF-36)	From enrollment to 7 months	Medical Outcomes Study (MOS) 36-Item Short Form Health Survey (SF-36). Scores 0-100, higher scores indicating more favorable health state.
Emergency department visits	Enrollment up to 7 months
Mortality	within 6 months post-hospital discharge
Hospital or ICU re-admissions	Enrollment up to 7 months