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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00149513
First received: September 6, 2005
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Acute Respiratory Distress Syndrome
Behavioral: Targeted Case Management
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: King County Lung Injury Project: Survivor Outcome Study (KCLIP:SOS)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Scores for quality of life measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: September 2003
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Targeted nurse case management
Behavioral: 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.
Active Comparator: 2
Usual Care
Behavioral: Usual care
Participants will receive usual 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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149513

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Gordon Rubenfeld, MD University of Washington
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00149513     History of Changes
Other Study ID Numbers: 263, P50HL073996
Study First Received: September 6, 2005
Last Updated: December 18, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014