NCT03738774

Addressing Post-Intensive Care Syndrome Among Survivors of COVID (APICS-COVID)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the relationship between early unmet needs after hospital discharge and subsequent clinical outcomes among survivors of acute respiratory failure. The investigators hypothesize that early unmet needs are associated with poor outcomes at three months.

Detailed description

Despite the accumulation of data documenting the reality of extensive functional impairments following ICU stay, the specific treatment needs of individuals experiencing Post-Intensive Care Syndrome (PICS) are not well known largely because of a relative lack of knowledge about the specific unmet needs of patients at risk for PICS at the time of hospital discharge. These possible needs include oxygen prescriptions, equipment for noninvasive ventilation, durable medical equipment prescriptions, coordination with government assistance and community health programs, physical or occupational therapy in the home or at an outpatient clinic, medications restarted or discontinued as appropriate. This study will enrol individuals who were diagnosed with acute respiratory failure during an ICU admission and were discharged from the ICU alive. Once enrolled, participants' medical records will be reviewed for demographic and medical information. Questionnaires will be used to assess the participant's status prior to ICU admittance, including comorbidities, medications, physical functioning, quality of life, alcohol/smoking/substance use, social support and healthcare utilization. While in the ICU, participants will receive usual clinical care in this observational study. Data on mechanical ventilation, arterial blood gas values, acute respiratory distress syndrome (ARDS) diagnosis, delirium, and medical status will be collected. Information regarding the patients' postdischarge needs including medical equipment, medication, home care services, dialysis, appointments, counselling and referral will also be collected by reviewing the discharge note. Follow-up evaluations by phone call will occur at 1-4 weeks, 3 and 6 months following the ICU discharge. At 1-4 weeks, the investigators will evaluate, via phone call whether the patient's post-discharge needs are met. At 3 months and 6 months phone calls, standardized surveys will be used to assess mortality status, readmission, healthcare utilization, functional outcomes, quality of life, mental health status, coping and social support and return to work.

Conditions

• Post Intensive Care Syndrome

Timeline

• Start date: 2019-01-02
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2018-11-13
• Last updated: 2025-08-19

Locations

5 sites across 1 country: United States