Post-Hospital Case Management to Improve Clinical Outcomes in Individuals Requiring Mechanical Ventilation
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 12/27/2017 |
| Start Date: | September 2003 |
| End Date: | February 2009 |
King County Lung Injury Project: Survivor Outcome Study (KCLIP:SOS)
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.
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.
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.
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.
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
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