ICU PatientNCT00305981
The ICU Care Knowledge Study
An observational study of ICU Patient, run by University of California, San Francisco at 1 site in United States.
Trial summary
Family members have poor overall understanding of ICU patients' prognosis, resuscitation status and care, defined a priori as less than 75% correct responses to the yes/no ICU care questions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ICU Patient
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to not given
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- family member of ICU patient
Who cannot join
- incarceration, unable to participate in interview
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital ICU
San Francisco, California, 94110
About this study
Official title: The ICU Care Knowledge Study: A Prospective Study of Family Members' Knowledge of ICU Care and Prognosis
Family members have poor overall understanding of ICU patients' prognosis, resuscitation status and care, defined a priori as less than 75% correct responses to the yes/no ICU care questions.
Family members of all adult patients admitted to an intensive care of San Francisco General Hospital will be screened for enrollment and recruited sequentially over a period of nine months (August 1, 2005-March 31, 2006). We will determine the frequency of family members' correct responses to the survey questions about ICU care. Family member responses will be compared to the chart and real-time patient observation reality (gold standard).
Read more
Hypothesis # 2 Poor English language comprehension and low education level (defined as not having completed high school) are risk factors for poor ICU care understanding and knowledge.
During their surveys family members will be asked questions regarding their English language comprehension and education level. Association of these possible risk factors with low level of ICU care knowledge will be tested primarily using analysis of variance. Should our hypothesis #2 prove to be correct, our future goal will be to develop recommendations for interventions to increase understanding specific for these high risk groups. One of these interventions is described in Hypothesis #3 below.
Hypothesis # 3 Provision of the results of family members' knowledge assessment to health care providers will result in improved ICU care knowledge on subsequent testing.
Subjects will be randomized to two groups-one group's health care providers will be shown the results of family members' initial ICU knowledge assessment; the other group's providers will not be given these results. One to two days after providing this summary to providers, all randomized subjects will undergo a second interview assessing their ICU care knowledge. Changes in the frequency of correct responses between the two groups will be compared using mean differences in proportions with 95% confidence intervals.
- Conditions
- ICU Patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU PatientStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 154 participants
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Robert M Rodriguez, MD, Principal investigator, San Francisco General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305981
- Sponsor's protocol ID
- H1665-26922
- Status last verified
- Oct 2005
- First submitted
- 17 Mar 2006
- Last updated
- 19 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ICU Care Knowledge Study: A Prospective Study of Family Members' Knowledge of ICU Care and Prognosis
- ClinicalTrials.gov ID
- NCT00305981
- Acronym / sponsor ID
- H1665-26922
- Conditions
- ICU Patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2005
- First posted
- 22 Mar 2006 (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.
Family members have poor overall understanding of ICU patients' prognosis, resuscitation status and care, defined a priori as less than 75% correct responses to the yes/no ICU care questions.
Family members of all adult patients admitted to an intensive care of San Francisco General Hospital will be screened for enrollment and recruited sequentially over a period of nine months (August 1, 2005-March 31, 2006). We will determine the frequency of family members' correct responses to the survey questions about ICU care. Family member responses will be compared to the chart and real-time patient observation reality (gold standard).
Hypothesis # 2 Poor English language comprehension and low education level (defined as not having completed high school) are risk factors for poor ICU care understanding and knowledge.
During their surveys family members will be asked questions regarding their English language comprehension and education level. Association of these possible risk factors with low level of ICU care knowledge will be tested primarily using analysis of variance. Should our hypothesis #2 prove to be correct, our future goal will be to develop recommendations for interventions to increase understanding specific for these high risk groups. One of these interventions is described in Hypothesis #3 below.
Hypothesis # 3 Provision of the results of family members' knowledge assessment to health care providers will result in improved ICU care knowledge on subsequent testing.
Subjects will be randomized to two groups-one group's health care providers will be shown the results of family members' initial ICU knowledge assessment; the other group's providers will not be given these results. One to two days after providing this summary to providers, all randomized subjects will undergo a second interview assessing their ICU care knowledge. Changes in the frequency of correct responses between the two groups will be compared using mean differences in proportions with 95% confidence intervals.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- family member of ICU patient
Key exclusion criteria (1 listed)
- incarceration, unable to participate in interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 19 Apr 2007.
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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.
Robert M Rodriguez, MD principal investigator
San Francisco General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU Patient, run by University of California, San Francisco 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 1 inclusion and 1 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 19 Apr 2007. 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.
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 19 Apr 2007.