Evaluating the Effectiveness of the Acute Respiratory Inf... | NCT00235040

Studies
Evaluating the Effectiveness of the Acute Respiratory Infection Smart Form

NCT00235040

Sponsor

Agency for Healthcare Research and Quality (AHRQ)

Status

Completed

Last Update Posted

Jan 26, 2012Estimated

Enrollment

18,257Actual

Phase

Not Applicable

Conditions

Respiratory Tract Infections

Interventions

Smart Form

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01HS015169	U.S. AHRQ Grant/Contract		View source

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

May 2006Actual

Completion Date

Aug 2007Actual

First Submitted Date

Oct 6, 2005

First Submission Date that Met QC Criteria

Oct 7, 2005

First Posted Date

Oct 10, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2012

Last Update Posted Date

Jan 26, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Agency for Healthcare Research and Quality (AHRQ)FED

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18,257Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Intervention	Behavioral: Smart Form
2	No Intervention	Control	Behavioral: Smart Form

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Smart Form	Behavioral	Computer Decision Support System	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Antibiotic prescribing rates		9 months

Secondary Outcomes

Measure	Description	Time Frame
Appropriateness of antibiotic prescribing, re-visit rates, antibiotic costs, use of antibiotics, all-cause antibiotic use, quality of documentation		9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute Respiratory Infection visit

Exclusion Criteria:

Any patients who are not part of a panel of a participating physician

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Blackford Middleton, MD, MPH, MSc	Partners Healthcare Systems Inc	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22610494	Derived	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.

Type	Date	Date Unknown
Release	Feb 5, 2024
Reset	Jun 21, 2024

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases