Acute Respiratory Distress SyndromeNCT00149513
Post-Hospital Case Management to Improve Clinical Outcomes in Individuals Requiring Mechanical Ventilation
A study testing Targeted Case Management in people with Acute Respiratory Distress Syndrome, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Targeted Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Targeted Case Management, Usual care
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Case ManagementBehavioural
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 careBehavioural
Participants will receive usual care.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Targeted nurse case management Receives: Behavioral: Targeted Case Management |
| 2 | Active comparator | Usual Care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores for quality of life measures
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Elizabeth Parsons, University of Washington
- Investigators
- Gordon Rubenfeld, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149513
- Sponsor's protocol ID
- 25934
- Other IDs
- P50HL073996
- Status last verified
- Dec 2017
- First submitted
- 6 Sep 2005
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- King County Lung Injury Project: Survivor Outcome Study (KCLIP:SOS)
- ClinicalTrials.gov ID
- NCT00149513
- Acronym / sponsor ID
- 25934
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2003
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Targeted Case ManagementTargeted nurse case management |
| 2 | Active comparator | Behavioral: Usual careUsual Care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Case ManagementA nurse case manager will assess and follow intervention arm subjects for six months. Nurse case manager will help subjects acquire needed community health services. | Behavioural | 1 |
| Usual careParticipants will receive usual care. | Behavioural | 2 |
Primary outcome
Scores for quality of life measures
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon Rubenfeld, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Case Management in people with Acute Respiratory Distress Syndrome, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores for quality of life measures (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.