Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorMalcom Randall VA Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Telehealth Intervention GroupExperimental treatment 1 intervention
Group B: Standard of Care GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Completion of Post-ICU follow-up

Percentage of patients completing post-ICU follow-up

Time frame
From enrollment to end of follow-up period at seven months

Secondary outcomes

1

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

Medical Outcomes Study (MOS) 36-Item Short Form Health Survey (SF-36). Scores 0-100, higher scores indicating more favorable health state.

Time frame
From enrollment to 7 months
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

Other outcomes

Sponsors and contacts

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