Respiratory Tract InfectionsNCT00235040
Evaluating the Effectiveness of the Acute Respiratory Infection Smart Form
A study testing Smart Form in people with Respiratory Tract Infections, run by Agency for Healthcare Research and Quality (AHRQ).
Trial summary
To evaluate the effectiveness of the Acute Respiratory Infection Smart Form Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Smart Form
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,257 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Respiratory Infection visit
Who cannot join
- Any patients who are not part of a panel of a participating physician
About this study
Official title: Evaluating Smart Forms and Quality Dashboards in an EHR: Effectiveness of the Acute Respiratory Infection Smart Form
To evaluate the effectiveness of the Acute Respiratory Infection Smart Form
Read the detailed description
Specific Aim 1: To design and implement an integrated documentation-based clinical decision support and physician feedback system, provided in an electronic health record (EHR), to improve the management of patients with acute medical conditions.
Hypothesis 1: A documentation-based clinical decision support tool (CDSS) "smart form" physician feedback system, can be designed and implemented to facilitate documentation and physician order-entry, provide individualized, evidence-based recommendations for the management of patients acute respiratory infections (ARIs), and are usable by primary care physicians.
Specific Aim 2: To determine the effectiveness of documentation-based CDSS and physician feedback on documentation and the clinical management of patients respiratory tract infections.
Hypothesis 2A: A documentation-based CDSS "smart form" will increase the documentation of important clinical data in patients with ARI when compared to usual practice.
Hypothesis 2B: A documentation-based CDSS "smart form" will increase adherence with guidelines for the management of patients with ARI when compared to usual practice.
- Conditions
- Respiratory Tract Infections
- Being tested
- Smart Form
- Keywords
- Upper Respiratory Infections, Respiratory Tract Infections, Tree Number C01.539.739, Tree Number C08.730, Unique ID D012141
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart FormBehavioural
Computer Decision Support System
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Intervention Receives: Behavioral: Smart Form |
| 2 | No intervention | Control Receives: Behavioral: Smart Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic prescribing rates
Measured: 9 months
Secondary outcomes (1)
Appropriateness of antibiotic prescribing, re-visit rates, antibiotic costs, use of antibiotics, all-cause antibiotic use, quality of documentation
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionMay 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18,257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Investigators
- Blackford Middleton, MD, MPH, MSc, Principal investigator, Partners Healthcare Systems Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235040
- Sponsor's protocol ID
- R01HS015169-1
- Other IDs
- R01HS015169
- Status last verified
- Jan 2012
- First submitted
- 6 Oct 2005
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Linder JA, Schnipper JL, Middleton B. Method of electronic health record documentation and quality of primary care. J Am Med Inform Assoc. 2012 Nov-Dec;19(6):1019-24. doi: 10.1136/amiajnl-2011-000788. Epub 2012 May 19.
PubMed 22610494
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Smart Forms and Quality Dashboards in an EHR: Effectiveness of the Acute Respiratory Infection Smart Form
- ClinicalTrials.gov ID
- NCT00235040
- Acronym / sponsor ID
- R01HS015169-1
- Conditions
- Respiratory Tract Infections
- Keywords
- Upper Respiratory Infections, Respiratory Tract Infections, Tree Number C01.539.739, Tree Number C08.730, Unique ID D012141
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,257 participants (actual)
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Study start
- Nov 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 10 Oct 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.
To evaluate the effectiveness of the Acute Respiratory Infection Smart Form
Detailed description
Specific Aim 1: To design and implement an integrated documentation-based clinical decision support and physician feedback system, provided in an electronic health record (EHR), to improve the management of patients with acute medical conditions.
Hypothesis 1: A documentation-based clinical decision support tool (CDSS) "smart form" physician feedback system, can be designed and implemented to facilitate documentation and physician order-entry, provide individualized, evidence-based recommendations for the management of patients acute respiratory infections (ARIs), and are usable by primary care physicians.
Specific Aim 2: To determine the effectiveness of documentation-based CDSS and physician feedback on documentation and the clinical management of patients respiratory tract infections.
Hypothesis 2A: A documentation-based CDSS "smart form" will increase the documentation of important clinical data in patients with ARI when compared to usual practice.
Hypothesis 2B: A documentation-based CDSS "smart form" will increase adherence with guidelines for the management of patients with ARI when compared to usual practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: Smart FormIntervention |
| 2 | No intervention | Behavioral: Smart FormControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute Respiratory Infection visit
Key exclusion criteria (1 listed)
- Any patients who are not part of a panel of a participating physician
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 |
|---|---|---|
| Smart FormComputer Decision Support System | Behavioural | 1, 2 |
Primary outcome
Antibiotic prescribing rates
Time frame: 9 months
1 secondary outcome
Appropriateness of antibiotic prescribing, re-visit rates, antibiotic costs, use of antibiotics, all-cause antibiotic use, quality of documentation
Time frame: 9 months
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 26 Jan 2012.
- Derived from this study: PubMed 22610494Linder JA, Schnipper JL, Middleton B. Method of electronic health record documentation and quality of primary care. J Am Med Inform Assoc. 2012 Nov-Dec;19(6):1019-24. doi: 10.1136/amiajnl-2011-000788. Epub 2012 May 19.
Related trials for Respiratory Tract Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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.
Blackford Middleton, MD, MPH, MSc principal investigator
Partners Healthcare Systems Inc
Questions about this trial
What is this clinical trial studying?
A study testing Smart Form in people with Respiratory Tract Infections, run by Agency for Healthcare Research and Quality (AHRQ).
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 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Antibiotic prescribing rates (time frame: 9 months). 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 NCT00235040, which also lists 1 linked publication.
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 26 Jan 2012.