Critical IllnessNCT00226291
The Clinical Informationist: Does the Model Work
A study testing Synthesized evidence report in people with Critical Illness, run by Vanderbilt University at 1 site in United States.
Trial summary
This study is investigating the effects of an established clinical informationist program (evidence-based practice support service in which information professionals with significant clinical knowledge bases and advanced information seeking and appraisal skills) on clinical decision making at selected critical care… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness
- What is being tested?
- Synthesized evidence report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to May 2007
- Phase
- Interventional
- 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
- Evidence-based questions requested by clinician on current service as an attending, resident, fellow, or nurse practitioner on one of the units included in the study
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
This study is investigating the effects of an established clinical informationist program (evidence-based practice support service in which information professionals with significant clinical knowledge bases and advanced information seeking and appraisal skills) on clinical decision making at selected critical care units at Vanderbilt University Medical Center
Read the detailed description
Background To evaluate the role of the Clinical Informatics Consult Service(CICS), an informationist service at the Eskind Biomedical Library (EBL) at Vanderbilt University Medical Center (VUMC, in clinical decision-making, the EBL has been awarded a 3-year grant from the National Library of Medicine (5 R01 LM07849-02). The CICS is a well-established program that facilitates evidence-based practice by delivering targeted information in answer to complex, patient-specific questions. The CICS places librarians with specialized training in medical subject areas and in information retrieval ("clinical informationists") on clinical teams in intensive care settings. Acting as expert consultants, they analyze the biomedical literature to identify, filter, and present the best examples of each clinical viewpoint expressed about key problems.
Evaluation Project Working in cooperation with the Center for Evaluation and Program Improvement (CEPI) at Peabody College of Vanderbilt, the investigators will evaluate formally the role of CICS in clinical decision-making and evidence-seeking behavior. While past studies have evaluated clinical medical librarians' roles, few if any studies have examined the effectiveness and utility of the new clinical informationist approach in sites where informationists are well-established.
The project will also create reusable evaluation tools transferable across environments. Through a combination of observation and interviews, investigators will examine librarian involvement in three existing Vanderbilt CICS intensive care units. The project will collect detailed information about the ways in which clinicians incorporate CICS-provided information into their workflows. Next, investigators will conduct a randomized trial to evaluate the effect of CICS on decision-making. Investigators will compare clinicians' intended course of care vs. actual care when CICS results are provided and when clinicians seek information themselves.
Finally, "virtual cases" developed from actual patient CICS-related scenarios in each clinical unit will be incorporated into training tools that can be used to export elements of the CICS model to other locations. Demonstration of the utility of the clinical informationist approach can foster widespread adoption nationally, and increase the degree to which clinical practice becomes evidence-based.
- Conditions
- Critical Illness
- Being tested
- Synthesized evidence report
- Keywords
- EBM, evidence based medicine, informationist, clinical medical librarian
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthesized evidence reportOther
Also called Literature summary, Evidence report
Each consultation response included a documented bibliographic search strategy with corresponding references, a targeted list of full-text articles, and a written synthesis and critique of the relevant research materials.
| Study group | Role | What they receive |
|---|---|---|
| Synthesized evidence report | Experimental | Each consultation response included a documented bibliographic search strategy with corresponding references, a targeted list of full-text articles, and a written synthesis and critique of the relevant research materials. Receives: Other: Synthesized evidence report |
| No evidence report | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate and potential future clinical decisions
Measured: 3 days post-consult
Secondary outcomes (5)
Clinical action index
Measured: 3 days post-consult
Number of research articles read
Measured: 3 days post-consult
Satisfaction
Measured: 3 days post-consult
Colleague consults
Measured: 3 days post-consult
Time spent searching the literature
Measured: 3 days post-consult
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionFeb 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nunzia Giuse, Vanderbilt University
- Investigators
- Nunzia B Giuse, MD, MLS, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226291
- Sponsor's protocol ID
- 040624
- Other IDs
- 5R01LM007849
- Status last verified
- May 2014
- First submitted
- 22 Sep 2005
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Giuse NB, Koonce TY, Jerome RN, Cahall M, Sathe NA, Williams A. Evolution of a mature clinical informationist model. J Am Med Inform Assoc. 2005 May-Jun;12(3):249-55. doi: 10.1197/jamia.M1726. Epub 2005 Jan 31.
PubMed 15684125Rosenbloom ST, Giuse NB, Jerome RN, Blackford JU. Providing evidence-based answers to complex clinical questions: evaluating the consistency of article selection. Acad Med. 2005 Jan;80(1):109-14. doi: 10.1097/00001888-200501000-00025.
PubMed 15618105Jerome RN, Giuse NB, Gish KW, Sathe NA, Dietrich MS. Information needs of clinical teams: analysis of questions received by the Clinical Informatics Consult Service. Bull Med Libr Assoc. 2001 Apr;89(2):177-84.
PubMed 11337949Florance V, Giuse NB, Ketchell DS. Information in context: integrating information specialists into practice settings. J Med Libr Assoc. 2002 Jan;90(1):49-58.
PubMed 11838460Giuse NB, Kafantaris SR, Miller MD, Wilder KS, Martin SL, Sathe NA, Campbell JD. Clinical medical librarianship: the Vanderbilt experience. Bull Med Libr Assoc. 1998 Jul;86(3):412-6. No abstract available.
PubMed 9681179Giuse NB. Advancing the practice of clinical medical librarianship. Bull Med Libr Assoc. 1997 Oct;85(4):437-8. No abstract available.
PubMed 9431437Sathe NA, Todd P, Gregg W, Clark J, Giuse NB. Virtual cases as a tool to promote the incorporation of EBM techniques into housestaff training . Medical Library Association Annual Meeting, Phoenix, AZ, May 2006. (Poster)
Mulvaney SA, Bickman L, Giuse NB, Lambert EW, Sathe NA, Jerome RN. A randomized effectiveness trial of a clinical informatics consult service: impact on evidence-based decision-making and knowledge implementation. J Am Med Inform Assoc. 2008 Mar-Apr;15(2):203-11. doi: 10.1197/jamia.M2461. Epub 2007 Dec 20.
PubMed 18096918Mulvaney S, Bickman L, Lambert W, Sathe N, Jerome R, Guise NB. Barriers to and facilitators of evidence based practices in physicians. Society for Behavioral Medicine 28th Annual Meeting. Washington, DC. March 2007. (Poster)
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Informationist: Does the Model Work
- ClinicalTrials.gov ID
- NCT00226291
- Acronym / sponsor ID
- 040624
- Conditions
- Critical Illness
- Keywords
- EBM, evidence based medicine, informationist, clinical medical librarian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 26 Sep 2005 (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.
This study is investigating the effects of an established clinical informationist program (evidence-based practice support service in which information professionals with significant clinical knowledge bases and advanced information seeking and appraisal skills) on clinical decision making at selected critical care units at Vanderbilt University Medical Center
Detailed description
Background To evaluate the role of the Clinical Informatics Consult Service(CICS), an informationist service at the Eskind Biomedical Library (EBL) at Vanderbilt University Medical Center (VUMC, in clinical decision-making, the EBL has been awarded a 3-year grant from the National Library of Medicine (5 R01 LM07849-02). The CICS is a well-established program that facilitates evidence-based practice by delivering targeted information in answer to complex, patient-specific questions. The CICS places librarians with specialized training in medical subject areas and in information retrieval ("clinical informationists") on clinical teams in intensive care settings. Acting as expert consultants, they analyze the biomedical literature to identify, filter, and present the best examples of each clinical viewpoint expressed about key problems.
Evaluation Project Working in cooperation with the Center for Evaluation and Program Improvement (CEPI) at Peabody College of Vanderbilt, the investigators will evaluate formally the role of CICS in clinical decision-making and evidence-seeking behavior. While past studies have evaluated clinical medical librarians' roles, few if any studies have examined the effectiveness and utility of the new clinical informationist approach in sites where informationists are well-established.
The project will also create reusable evaluation tools transferable across environments. Through a combination of observation and interviews, investigators will examine librarian involvement in three existing Vanderbilt CICS intensive care units. The project will collect detailed information about the ways in which clinicians incorporate CICS-provided information into their workflows. Next, investigators will conduct a randomized trial to evaluate the effect of CICS on decision-making. Investigators will compare clinicians' intended course of care vs. actual care when CICS results are provided and when clinicians seek information themselves.
Finally, "virtual cases" developed from actual patient CICS-related scenarios in each clinical unit will be incorporated into training tools that can be used to export elements of the CICS model to other locations. Demonstration of the utility of the clinical informationist approach can foster widespread adoption nationally, and increase the degree to which clinical practice becomes evidence-based.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synthesized evidence report | Experimental | Other: Synthesized evidence reportEach consultation response included a documented bibliographic search strategy with corresponding references, a targeted list of full-text articles, and a written synthesis and critique of the relevant research materials. |
| No evidence report | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Evidence-based questions requested by clinician on current service as an attending, resident, fellow, or nurse practitioner on one of the units included in the study
Key exclusion criteria (1 listed)
- All others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synthesized evidence reportAlso: Literature summary, Evidence reportEach consultation response included a documented bibliographic search strategy with corresponding references, a targeted list of full-text articles, and a written synthesis and critique of the relevant research materials. | Other | Synthesized evidence report |
Primary outcome
Immediate and potential future clinical decisions
Time frame: 3 days post-consult
5 secondary outcomes
Clinical action index
Time frame: 3 days post-consult
Number of research articles read
Time frame: 3 days post-consult
Satisfaction
Time frame: 3 days post-consult
Colleague consults
Time frame: 3 days post-consult
Time spent searching the literature
Time frame: 3 days post-consult
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 28 May 2014.
- Background: PubMed 15684125Giuse NB, Koonce TY, Jerome RN, Cahall M, Sathe NA, Williams A. Evolution of a mature clinical informationist model. J Am Med Inform Assoc. 2005 May-Jun;12(3):249-55. doi: 10.1197/jamia.M1726. Epub 2005 Jan 31.
- Background: PubMed 15618105Rosenbloom ST, Giuse NB, Jerome RN, Blackford JU. Providing evidence-based answers to complex clinical questions: evaluating the consistency of article selection. Acad Med. 2005 Jan;80(1):109-14. doi: 10.1097/00001888-200501000-00025.
- Background: PubMed 11337949Jerome RN, Giuse NB, Gish KW, Sathe NA, Dietrich MS. Information needs of clinical teams: analysis of questions received by the Clinical Informatics Consult Service. Bull Med Libr Assoc. 2001 Apr;89(2):177-84.
- Background: PubMed 11838460Florance V, Giuse NB, Ketchell DS. Information in context: integrating information specialists into practice settings. J Med Libr Assoc. 2002 Jan;90(1):49-58.
- Background: PubMed 9681179Giuse NB, Kafantaris SR, Miller MD, Wilder KS, Martin SL, Sathe NA, Campbell JD. Clinical medical librarianship: the Vanderbilt experience. Bull Med Libr Assoc. 1998 Jul;86(3):412-6. No abstract available.
- Background: PubMed 9431437Giuse NB. Advancing the practice of clinical medical librarianship. Bull Med Libr Assoc. 1997 Oct;85(4):437-8. No abstract available.
- BackgroundSathe NA, Todd P, Gregg W, Clark J, Giuse NB. Virtual cases as a tool to promote the incorporation of EBM techniques into housestaff training . Medical Library Association Annual Meeting, Phoenix, AZ, May 2006. (Poster)
- Results publication: PubMed 18096918Mulvaney SA, Bickman L, Giuse NB, Lambert EW, Sathe NA, Jerome RN. A randomized effectiveness trial of a clinical informatics consult service: impact on evidence-based decision-making and knowledge implementation. J Am Med Inform Assoc. 2008 Mar-Apr;15(2):203-11. doi: 10.1197/jamia.M2461. Epub 2007 Dec 20.
- Results publicationMulvaney S, Bickman L, Lambert W, Sathe N, Jerome R, Guise NB. Barriers to and facilitators of evidence based practices in physicians. Society for Behavioral Medicine 28th Annual Meeting. Washington, DC. March 2007. (Poster)
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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.
Nunzia B Giuse, MD, MLS principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synthesized evidence report in people with Critical Illness, run by Vanderbilt University 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 28 May 2014. 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.
What does the primary outcome measure?
Immediate and potential future clinical decisions (time frame: 3 days post-consult). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00226291, which also lists 9 linked publications.
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 28 May 2014.