Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome

NCT ID: NCT06983496

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Post Intensive Care Syndrome (PICS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Post-ICU Telehealth Follow-up

Intervention Type 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.

Standard of Care Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Malcom Randall VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Andrew Franck

Clinical Pharmacy Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Malcom Randall Veterans Affairs Medical Center

Gainesville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrew J Franck, Pharm.D.

Role: CONTACT

3523761611 ext. 105771

Facility Contacts

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Andrew J Franck, Pharm.D.

Role: primary

352-376-1611

Other Identifiers

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IRB202401793

Identifier Type: -

Identifier Source: org_study_id

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