Clinical trial NCT00149513: Post-Hospital Case Management to Improve Clinical Outcomes in Individuals Requiring Mechanical Ventilation
Official title: King County Lung Injury Project: Survivor Outcome Study (KCLIP:SOS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* On a ventilator for 5 or more days
* Expected to survive the 6 months post-hospital discharge period
* Lives in the SOS zip code area (King, Pierce and Snohomish counties)

Exclusion Criteria:

* Severe pre-hospital health conditions
* Lack of availability for follow-up (e.g. homeless, chronic substance abuse)
* Non-English speakers
* Severe psychiatric issues
* Need for special rehabilitation services not available in the intervention
* Predicted survival of less than 6 months

Primary outcomes:
measure: Scores for quality of life measures
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Gordon Rubenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: