Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305981
Status:
COMPLETED
Last Update Posted:
2007-04-19
First Post:
2006-03-17
Brief Title:
The ICU Care Knowledge Study
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
The ICU Care Knowledge Study A Prospective Study of Family Members Knowledge of ICU Care and Prognosis
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 yesno 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 groups health care providers will be shown the results of family members initial ICU knowledge assessment the other groups 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
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 groups health care providers will be shown the results of family members initial ICU knowledge assessment the other groups 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None