Post-Hospital Case Management to Improve Clinical Outcomes in Individuals Requiring Mechanical Ventilation

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Behavioral: Targeted Case Management; Behavioral: Usual care

• Registration Number: NCT00149513
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-21
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Targeted Case Management	Targeted nurse case management
2	Usual care	Usual Care

Primary Outcome Measures

Name	Time	Method
Scores for quality of life measures	6 months

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States