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The ICU Care Knowledge Study

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ClinicalTrials.gov Identifier: NCT00305981
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : April 19, 2007
Information provided by:

Study Description
Brief 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.

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.

Condition or disease
ICU Patient

Study Design

Study Type : Observational
Estimated Enrollment : 154 participants
Observational Model: Defined Population
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: The ICU Care Knowledge Study: A Prospective Study of Family Members' Knowledge of ICU Care and Prognosis
Study Start Date : October 2005
Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • family member of ICU patient

Exclusion Criteria:

  • incarceration, unable to participate in interview
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305981

United States, California
San Francisco General Hospital ICU
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Robert M Rodriguez, MD San Francisco General Hospital
More Information

ClinicalTrials.gov Identifier: NCT00305981     History of Changes
Other Study ID Numbers: H1665-26922
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: April 19, 2007
Last Verified: October 2005