Mechanical VentilationPhase 2NCT00214344
Family Preparation Study For Withdrawal of Mechanical Ventilation From Their Family Member
A Phase 2 study testing family preparation for withdrawing life support in people with Mechanical Ventilation and Critically Ill, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Using the self-regulation theory, an intervention to prepare families for that experience was developed. This study will assess the impact of the intervention on a family's evaluation of their preparation and their short-term coping. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mechanical Ventilation, Critically Ill
- What is being tested?
- family preparation for withdrawing life support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Feb 2007
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Next of kin of a patient who will have withdrawal of life support
- Participant must be 18 years of age or older and read, write, and speak English
Who cannot join
- Family is unusually highly emotional
- Patient will be a living donor
- Patient is conscious
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Usefulness of Preparing Families For Withdrawal of Mechanical Ventilation From Their Family Member: A Pilot Study
Using the self-regulation theory, an intervention to prepare families for that experience was developed. This study will assess the impact of the intervention on a family's evaluation of their preparation and their short-term coping. The site used for this study will be the Trauma and Life Support Center (TLC), University of Wisconsin (UW) Hospital. After a decision has been made to withdraw life support, a member of the TLC staff will approach the next of kin of the patient to inform him/her about the study and inquire about his/her interest to participate. Using an experimental design, 10 family members will be assigned to the control group and 10 to the intervention group. Upon agreement, a research nurse will use a "coin toss method" for group assignment of the subjects until there are ten in each group. Experimental group subjects will receive the intervention after the family meeting. Demographics of the next of kin will be collected at this time. Patient information such as demographics, diagnosis, and time of withdrawal and death will be collected too. Two to four weeks after death, a telephone interview will be conducted with the next of kin using the "Evaluation of the Experience of Withdrawal" questionnaire and the Profile of Mood State - shortened version.
Potential benefits are that the families will be prepared for the experience of the dying patient, which will help them cope better during withdrawal and after their loss. There are no major risks to the subjects but there might be an increase in psychological distress.
- Conditions
- Mechanical Ventilation, Critically Ill
- Being tested
- family preparation for withdrawing life support
- Keywords
- dying
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family preparation for withdrawing life supportBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Are the families who received education/counseling better prepared for the experience of the dying patient
Secondary outcomes (1)
This is a feasibility Pilot Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2003
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin T Kirchhoff, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214344
- Sponsor's protocol ID
- M-2003-0040
- Status last verified
- Sep 2005
- First submitted
- 15 Sep 2005
- Last updated
- 5 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Usefulness of Preparing Families For Withdrawal of Mechanical Ventilation From Their Family Member: A Pilot Study
- ClinicalTrials.gov ID
- NCT00214344
- Acronym / sponsor ID
- M-2003-0040
- Conditions
- Mechanical Ventilation, Critically Ill
- Keywords
- dying
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2003
- Study completion
- Feb 2007 (actual)
- First posted
- 21 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.
Using the self-regulation theory, an intervention to prepare families for that experience was developed. This study will assess the impact of the intervention on a family's evaluation of their preparation and their short-term coping. The site used for this study will be the Trauma and Life Support Center (TLC), University of Wisconsin (UW) Hospital. After a decision has been made to withdraw life support, a member of the TLC staff will approach the next of kin of the patient to inform him/her about the study and inquire about his/her interest to participate. Using an experimental design, 10 family members will be assigned to the control group and 10 to the intervention group. Upon agreement, a research nurse will use a "coin toss method" for group assignment of the subjects until there are ten in each group. Experimental group subjects will receive the intervention after the family meeting. Demographics of the next of kin will be collected at this time. Patient information such as demographics, diagnosis, and time of withdrawal and death will be collected too. Two to four weeks after death, a telephone interview will be conducted with the next of kin using the "Evaluation of the Experience of Withdrawal" questionnaire and the Profile of Mood State - shortened version.
Potential benefits are that the families will be prepared for the experience of the dying patient, which will help them cope better during withdrawal and after their loss. There are no major risks to the subjects but there might be an increase in psychological distress.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Next of kin of a patient who will have withdrawal of life support
- Participant must be 18 years of age or older and read, write, and speak English
Key exclusion criteria (3 listed)
- Family is unusually highly emotional
- Patient will be a living donor
- Patient is conscious
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 |
|---|---|---|
| family preparation for withdrawing life support | Behavioural | – |
Primary outcome
Are the families who received education/counseling better prepared for the experience of the dying patient
1 secondary outcome
This is a feasibility Pilot Study
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 5 Oct 2015.
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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.
Karin T Kirchhoff principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing family preparation for withdrawing life support in people with Mechanical Ventilation and Critically Ill, run by University of Wisconsin, Madison 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 2 inclusion and 3 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 5 Oct 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Are the families who received education/counseling better prepared for the experience of the dying patient. 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 5 Oct 2015.