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

NCT00149513 | Completed

• 2 other identifiers: 25934P50HL073996
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Scores for quality of life measures

  6 months

Study Arms (2)

1

EXPERIMENTAL

Targeted nurse case management

Behavioral: Targeted Case Management

2

ACTIVE COMPARATOR

Usual Care

Behavioral: Usual care

Interventions

Targeted Case Management BEHAVIORAL

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.

1

Usual care BEHAVIORAL

Participants will receive usual care.

2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Gordon Rubenfeld, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, SOM: Department of Medicine: Pulmonary, Critical Care and Sleep Medicine

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: September 1, 2003
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 26, 2017

Record last verified: 2017-12

Locations

US (1)