Recruiting

Telehealth Follow-Up

Sponsor:

Malcom Randall VA Medical Center

Code:

NCT06983496

Conditions

Post Intensive Care Syndrome (PICS)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Post-ICU Telehealth Follow-up

Study Details

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)

Study ID

NCT06983496

Start date

Jun 1, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

no intervention: Standard of Care Group

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

Interventions

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.

Primary outcome measure

  • Completion of Post-ICU follow-up [ Time Frame: From enrollment to end of follow-up period at seven months ]

Central Contacts and Locations

Central contacts

Andrew J Franck, Pharm.D.

3523761611Andrew.Franck@va.gov

Locations

Malcom Randall Veterans Affairs Medical Center

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Andrew J Franck, Pharm.D.

352-376-1611Andrew.Franck@va.gov

More Information

Sponsor

Malcom Randall VA Medical Center

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Malcom Randall VA Medical Center on 2025-09-23.