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NCT Number: NCT06983496

Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome

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.

Recruiting

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Key information

Conditions

Post Intensive Care Syndrome (PICS) postintensive care syndrome

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malcom Randall Veterans Affairs Medical Center

Gainesville, Florida, 32608, United States

Location status: Recruiting

Location contact

Andrew J Franck, Pharm.D.

CONTACT

[email protected]

352-376-1611

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

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

    Time frame: 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.

  2. Hospital or ICU re-admissions

    Time frame: Enrollment up to 7 months

  3. Emergency department visits

    Time frame: Enrollment up to 7 months

  4. Mortality

    Time frame: within 6 months post-hospital discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew J Franck, Pharm.D.

CONTACT

[email protected]

3523761611 ext. 105771

Sponsors and collaborators

Lead sponsor

Malcom Randall VA Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 21, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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