Post-Hospital Case Management to Improve Clinical Outcomes in Individuals Requiring Mechanical Ventilation
NCT ID: NCT00149513
Last Updated: 2017-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
600 participants
INTERVENTIONAL
2003-09-30
2009-02-28
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Targeted nurse case management
Targeted Case Management
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.
2
Usual Care
Usual care
Participants will receive usual care.
Interventions
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Targeted Case Management
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.
Usual care
Participants will receive usual care.
Eligibility Criteria
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Inclusion Criteria
* Expected to survive the 6 months post-hospital discharge period
* Lives in the SOS zip code area (King, Pierce and Snohomish counties)
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Washington
OTHER
Responsible Party
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Elizabeth Parsons
Assistant Professor, SOM: Department of Medicine: Pulmonary, Critical Care and Sleep Medicine
Principal Investigators
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Gordon Rubenfeld, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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25934
Identifier Type: -
Identifier Source: org_study_id