Post Intensive Care Syndrome (PICS)NCT06983496
Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome
A study testing Post-ICU Telehealth Follow-up in people with Post Intensive Care Syndrome (PICS), run by Malcom Randall VA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Post Intensive Care Syndrome (PICS)
- What is being tested?
- Post-ICU Telehealth Follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Malcom Randall Veterans Affairs Medical Center
Gainesville, Florida, 32608
Andrew J Franck, Pharm.D., 352-376-1611, Andrew.Franck@va.gov
About this study
Official title: Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome in Survivors of Critical Illness: a Pilot Randomized Controlled 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.
- Conditions
- Post Intensive Care Syndrome (PICS)
- Being tested
- Post-ICU Telehealth Follow-up
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-ICU Telehealth Follow-upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Intervention Group | Experimental | This group will receive the study intervention (i.e. telehealth follow-up appointments at approximately one and three months post-hospital discharge). Receives: Behavioral: Post-ICU Telehealth Follow-up |
| Standard of Care Group | No intervention | This group will receive standard post-ICU care following hospital discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Post-ICU follow-up
Percentage of patients completing post-ICU follow-up
Measured: From enrollment to end of follow-up period at seven months
Secondary outcomes (4)
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.
Measured: From enrollment to 7 months
Hospital or ICU re-admissions
Measured: Enrollment up to 7 months
Emergency department visits
Measured: Enrollment up to 7 months
Mortality
Measured: within 6 months post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jun 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care Syndrome (PICS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malcom Randall VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Andrew Franck, Malcom Randall VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983496
- Sponsor's protocol ID
- IRB202401793
- Status last verified
- Sep 2025
- First submitted
- 28 Apr 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome in Survivors of Critical Illness: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06983496
- Acronym / sponsor ID
- IRB202401793
- Conditions
- Post Intensive Care Syndrome (PICS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Malcom Randall VA Medical CenterUS federal agency
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth Intervention Group | Experimental | Behavioral: Post-ICU Telehealth Follow-upThis group will receive the study intervention (i.e. telehealth follow-up appointments at approximately one and three months post-hospital discharge). |
| Standard of Care Group | No intervention | –This group will receive standard post-ICU care following hospital discharge. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-ICU Telehealth Follow-upThe 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. | Behavioural | Telehealth Intervention Group |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-ICU Telehealth Follow-up in people with Post Intensive Care Syndrome (PICS), run by Malcom Randall VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew J Franck, Pharm.D. (3523761611 ext. 105771, Andrew.Franck@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Post-ICU follow-up (time frame: From enrollment to end of follow-up period at seven months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.