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Recruiting NCT06983496

Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome

No phase Interventional Post Intensive Care Syndrome (PICS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Post-ICU Telehealth Follow-up.
Who it may be relevant to
Registry conditions: Post Intensive Care Syndrome (PICS). Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Completion of Post-ICU follow-up [Time frame: From enrollment to end of follow-up period at seven months]
Secondary outcome measures (4)
  • Quality of life at 6 months using the Short Form Survey (SF-36) [Time frame: From enrollment to 7 months]
  • Hospital or ICU re-admissions [Time frame: Enrollment up to 7 months]
  • Emergency department visits [Time frame: Enrollment up to 7 months]
  • Mortality [Time frame: within 6 months post-hospital discharge]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Malcom Randall Veterans Affairs Medical Center — Gainesville

Identifiers

NCT: NCT06983496 · IRB202401793

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗