Post-Hospital Case Management to Improve Clinical Outcomes in Individuals Requiring Mechanical Ventilation
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Interventional

Summary: 
      King County Lung Injury Project: Survivor Outcome Study (KCLIP:SOS) is a randomized trial for
      individuals who have survived prolonged mechanical ventilation (5 days or more). The
      objective is to enroll individuals who are likely to have impaired health status resulting
      from prolonged critical illness but whose long term prognosis is good. Such individuals are
      most likely to benefit from the study intervention of case management targeted at post
      intensive care complications.

      KCLIP:SOS will test whether an outpatient intervention based on a nurse using a targeted case
      management tool can reduce patient morbidity and improve quality of life in the 6 months
      following hospital discharge. This intervention will be compared to usual post-hospital care.
    

Detailed description: 
      BACKGROUND:

      The purpose of this study is to understand individuals' physical and emotional conditions and
      concerns after being ventilated in the hospital. Modern hospital care helps many people
      survive even if they are on ventilators for long periods of time. Some individuals who leave
      the hospital after this kind of intensive care suffer from depression, post-traumatic stress
      disorder, muscle weakness, tiredness or breathing difficulties that may decrease their
      quality of life. Doctors know little about finding and treating these problems in survivors
      of mechanical ventilation.

      DESIGN NARRATIVE:

      Participants will be randomly assigned in blocks of 10 (5 participants to usual care and 5
      participants to case management) for home or skilled nursing facility discharges. The Outcome
      Assessors (the interviewers collecting outcomes data) will be blinded to group assignment.

      Primary outcome: All participants will have a baseline interview soon after hospital
      discharge and a final interview at the end of the 6-month intervention period (outcome
      assessments). All subjects will be asked to keep a diary/journal of their medical
      appointments, health services, and medications. Participants will be called once a month to
      collect this information.

      Key secondary outcomes: Case management participants will be contacted by the nurse case
      manager who will provide follow-up care for 6 months. At the end of the study, interview
      results will be sent to the personal physician of the usual care participants so that
      appropriate care can follow.
    

Intervention name(s): Targeted Case Management; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A nurse case manager will assess and follow intervention arm subjects for six months. Nurse case manager will help subjects acquire needed community health services.; Participants will receive usual care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment