The ICU Care Knowledge Study - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 17, 2006

Last Updated Date

April 17, 2007

Start Date ^†

October 2005

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00305981 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

The ICU Care Knowledge Study

Official Title ^†

The ICU Care Knowledge Study: A Prospective Study of Family Members' Knowledge of ICU Care and Prognosis

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.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Psychosocial, Cross-Sectional, Defined Population, Prospective Study

Condition ^†

ICU Patient

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

154

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

family member of ICU patient

Exclusion Criteria:

incarceration, unable to participate in interview

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00305981

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University of California, San Francisco

Collaborators ^††

Investigators ^†

Principal Investigator:

Robert M Rodriguez, MD

San Francisco General Hospital

Information Provided By

University of California, San Francisco

Verification Date

October 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.