Clinical Decision-makingNCT01255488
Research Abstract Usefulness in Clinical Decision-making
A study testing Access to EBN-Search (without full-text manuscripts) in people with Clinical Decision-making, run by Uniformed Services University of the Health Sciences at 1 site in United States.
Trial summary
To better understand the extent to which family nurse practitioners (FNPs) might use research abstracts in shaping their clinical decision-making under simulated conditions. A secondary point is to examine if and how FNPs might use full-text manuscripts (associated with the abstracts) if made available to them. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Decision-making
- What is being tested?
- Access to EBN-Search (without full-text manuscripts)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jun 2011
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Matriculated family nurse practitioner graduate students of USUHS 2010/2011 academic year
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Uniformed Services University
Bethesda, Maryland, 20814
About this study
Official title: Family Nurse Practitioner Perception of Journal Abstract Usefulness in Clinical Decision-making: a Randomized Controlled Trial
To better understand the extent to which family nurse practitioners (FNPs) might use research abstracts in shaping their clinical decision-making under simulated conditions. A secondary point is to examine if and how FNPs might use full-text manuscripts (associated with the abstracts) if made available to them.
Read the detailed description
The study will recruit the approximate 25 - 1st year and 25 - 2nd year family nurse practitioner students of the Graduate School of Nursing. After being presented an overview of the study and informed consent document, those electing to participate will draw a sealed envelope indicating whether they are assigned to group A (intervention group) or group B (control group). The participant will proceed to the associated room, be provided a brief clinical case (appropriate to their training), an iPad device with pre-loaded EBN-Search engine, and a questionnaire. The EBN-Search engine for the intervention group will include 9 research abstracts associated to the case. The EBN-Search for the control group will include both the research abstracts and full-text versions of the manuscripts. The participants will be provided 20 minutes to complete the questionnaire using the information available to them. The questionnaire will require the participant to indicate treatment plan, respond to questions regarding the usefulness of research abstracts, questions regarding the usefulness of full-text (control group only) and recommendations on improving EBN-Search.
- Conditions
- Clinical Decision-making
- Being tested
- Access to EBN-Search (without full-text manuscripts)
- Keywords
- Search engine, Clinical decision-making, Research abstracts, Full-text manuscripts, Family Nurse Practitioners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to EBN-Search (without full-text manuscripts)Behavioural
Also called Research abstracts, Full-text manuscripts
Family nurse practitioner access to EBN-Search without availability of full-text manuscripts.
| Study group | Role | What they receive |
|---|---|---|
| EBN-Search (without full-text manuscripts) | Experimental | In the intervention arm research subjects will be provided access to EBN-Search (a fictitious search engine) with nine abstracts relating to the clinical case but no full-text manuscripts. Receives: Behavioral: Access to EBN-Search (without full-text manuscripts) |
| EBN-Search (with full text manuscripts) | Active comparator | Research subjects will be exposed to 9 abstracts and corresponding full-text manuscripts related to the simulated clinical encounter. Receives: Behavioral: Access to EBN-Search (without full-text manuscripts) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of perception of abstract usefulness in clinical decision-making
At conclusion of the simulated exercise subjects will complete a data collection instrument indicating their perception of abstract usefulness in their clinical decision-making.
Measured: Immediate post-experiment
Secondary outcomes (1)
Use of full-text manuscripts when available in simulated clinical encounter
For those subjects with ready access to full-text manuscripts (n=25) during the simulated clinical encounter, we will measure how often they are accessed by the subjects.
Measured: During experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Decision-makingStudies 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Investigators
- Ronald W. Gimbel, PhD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255488
- Sponsor's protocol ID
- R02930-S2
- Status last verified
- Nov 2010
- First submitted
- 6 Dec 2010
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Nurse Practitioner Perception of Journal Abstract Usefulness in Clinical Decision-making: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01255488
- Acronym / sponsor ID
- R02930-S2
- Conditions
- Clinical Decision-making
- Keywords
- Search engine, Clinical decision-making, Research abstracts, Full-text manuscripts, Family Nurse Practitioners
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 7 Dec 2010 (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.
To better understand the extent to which family nurse practitioners (FNPs) might use research abstracts in shaping their clinical decision-making under simulated conditions. A secondary point is to examine if and how FNPs might use full-text manuscripts (associated with the abstracts) if made available to them.
Detailed description
The study will recruit the approximate 25 - 1st year and 25 - 2nd year family nurse practitioner students of the Graduate School of Nursing. After being presented an overview of the study and informed consent document, those electing to participate will draw a sealed envelope indicating whether they are assigned to group A (intervention group) or group B (control group). The participant will proceed to the associated room, be provided a brief clinical case (appropriate to their training), an iPad device with pre-loaded EBN-Search engine, and a questionnaire. The EBN-Search engine for the intervention group will include 9 research abstracts associated to the case. The EBN-Search for the control group will include both the research abstracts and full-text versions of the manuscripts. The participants will be provided 20 minutes to complete the questionnaire using the information available to them. The questionnaire will require the participant to indicate treatment plan, respond to questions regarding the usefulness of research abstracts, questions regarding the usefulness of full-text (control group only) and recommendations on improving EBN-Search.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBN-Search (without full-text manuscripts) | Experimental | Behavioral: Access to EBN-Search (without full-text manuscripts)In the intervention arm research subjects will be provided access to EBN-Search (a fictitious search engine) with nine abstracts relating to the clinical case but no full-text manuscripts. |
| EBN-Search (with full text manuscripts) | Active comparator | Behavioral: Access to EBN-Search (without full-text manuscripts)Research subjects will be exposed to 9 abstracts and corresponding full-text manuscripts related to the simulated clinical encounter. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Matriculated family nurse practitioner graduate students of USUHS 2010/2011 academic year
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Access to EBN-Search (without full-text manuscripts)Also: Research abstracts, Full-text manuscriptsFamily nurse practitioner access to EBN-Search without availability of full-text manuscripts. | Behavioural | EBN-Search (with full text manuscripts), EBN-Search (without full-text manuscripts) |
Primary outcome
Measure of perception of abstract usefulness in clinical decision-making
Time frame: Immediate post-experiment
At conclusion of the simulated exercise subjects will complete a data collection instrument indicating their perception of abstract usefulness in their clinical decision-making.
1 secondary outcome
Use of full-text manuscripts when available in simulated clinical encounter
Time frame: During experiment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2010.
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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.
Ronald W. Gimbel, PhD principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to EBN-Search (without full-text manuscripts) in people with Clinical Decision-making, run by Uniformed Services University of the Health Sciences 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: status not confirmed, as of the sponsor's last update on 7 Dec 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronald W Gimbel, PhD (301-295-3077, rgimbel@usuhs.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of perception of abstract usefulness in clinical decision-making (time frame: Immediate post-experiment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2010.