The ICU Care Knowledge Study

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00305981
First received: March 17, 2006
Last updated: April 17, 2007
Last verified: October 2005
  Purpose

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
ICU Patient

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: The ICU Care Knowledge Study: A Prospective Study of Family Members' Knowledge of ICU Care and Prognosis

Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 154
Study Start Date: October 2005
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • family member of ICU patient

Exclusion Criteria:

  • incarceration, unable to participate in interview
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305981

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

No publications provided

ClinicalTrials.gov Identifier: NCT00305981     History of Changes
Other Study ID Numbers: H1665-26922
Study First Received: March 17, 2006
Last Updated: April 17, 2007
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 19, 2014