Physician BehaviorNCT01583101
Child Health Improvement Through Computer Automation (CHICA) Highlighting Study
A study testing Receiving Highlighted Prompts and Receiving Non-highlighted Prompts in people with Physician Behavior, run by Indiana University at 1 site in United States.
Trial summary
The investigators have developed a novel decision support system for implementing clinical guidelines in pediatric practice. CHICA (Child Health Improvement through Computer Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a dynamic, scannable paper user interface; and (3) an… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physician Behavior
- What is being tested?
- Receiving Highlighted Prompts and Receiving Non-highlighted Prompts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,237 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Physicians practicing in one of our four CHICA clinics who use CHICA
Who cannot join
- Not being a physician practicing in one of our four CHICA clinics who use CHICA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Prompt Response Rates in the CHICA System
The investigators have developed a novel decision support system for implementing clinical guidelines in pediatric practice. CHICA (Child Health Improvement through Computer Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing electronic medical record systems. The result is a system that both delivers "just-in-time" patient-relevant guidelines to physicians during the clinical encounter, and accurately captures structured data from all who interact with it. Preliminary work with CHICA has demonstrated the feasibility of using the system to implement and evaluate clinical guidelines.
However, analyses have shown that physicians ignore a fair number of prompts. The investigators would like to experiment with changes to the system to see if they can increase physicians' response rates. This could include highlighting prompts, reordering them, or flagging them in other ways. The main outcome of interest in the rate at which physicians answer prompts.
Read the detailed description
We have developed a novel decision support system for implementing clinical guidelines in pediatric practice. CHICA (Child Health Improvement through Computer Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing electronic medical record systems. The result is a system that both delivers "just-in-time" patient-relevant guidelines to physicians during the clinical encounter, and accurately captures structured data from all who interact with it. Preliminary work with CHICA has demonstrated the feasibility of using the system to implement and evaluate clinical guidelines.
However, analyses have shown that physicians ignore a fair number of prompts. We would like to experiment with changes to the system to see if we can increase physicians' response rates. This could include highlighting prompts, reordering them, or flagging them in other ways. The main outcome of interest is the rate at which physicians answer prompts.
This will be a randomized, controlled trial of the CHICA system to see if we can improve prompt response rates. We will randomize physicians or clinics to receive some form of prompt change, including highlighting them, reordering them, or flagging them. No other changes will be made to care.
We will extract data from the CHICA system for all patients seen in our study clinics. This data will include a the clinic location, whether or not a physician responded to a prompt, the prompt's position on the form, the patient's gender, the rule priority of the prompt, rule title, patient insurance category, the patient's age in days, and the name of the provider. The main outcome of interest is whether or not a prompt was answered (discussed/not discussed).
- Conditions
- Physician Behavior
- Being tested
- Receiving Highlighted Prompts, Receiving Non-highlighted Prompts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receiving Highlighted PromptsOther
Prompts received by physicians were highlighted.
Receiving Non-highlighted PromptsOther
Prompts received by physicians were not highlighted.
| Study group | Role | What they receive |
|---|---|---|
| Receiving Highlighted Prompts | Experimental | Prompts received by physicians were highlighted. Receives: Other: Receiving Highlighted Prompts |
| Receiving Non-highlighted Prompts | Active comparator | Prompts received by physicians were not highlighted. Receives: Other: Receiving Non-highlighted Prompts |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Prompts That Were Responded to
The main outcome of interest is whether or not a prompt was answered (discussed/not discussed).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physician BehaviorStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 2,237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Carroll, Indiana University
- Investigators
- Aaron E Carroll, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583101
- Sponsor's protocol ID
- CHICA_Highlight_Study
- Status last verified
- Apr 2017
- First submitted
- 18 Apr 2012
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Prompt Response Rates in the CHICA System
- ClinicalTrials.gov ID
- NCT01583101
- Acronym / sponsor ID
- CHICA_Highlight_Study
- Conditions
- Physician Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,237 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 23 Apr 2012 (estimated)
- Results
- Posted 23 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have developed a novel decision support system for implementing clinical guidelines in pediatric practice. CHICA (Child Health Improvement through Computer Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing electronic medical record systems. The result is a system that both delivers "just-in-time" patient-relevant guidelines to physicians during the clinical encounter, and accurately captures structured data from all who interact with it. Preliminary work with CHICA has demonstrated the feasibility of using the system to implement and evaluate clinical guidelines.
However, analyses have shown that physicians ignore a fair number of prompts. The investigators would like to experiment with changes to the system to see if they can increase physicians' response rates. This could include highlighting prompts, reordering them, or flagging them in other ways. The main outcome of interest in the rate at which physicians answer prompts.
Detailed description
We have developed a novel decision support system for implementing clinical guidelines in pediatric practice. CHICA (Child Health Improvement through Computer Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing electronic medical record systems. The result is a system that both delivers "just-in-time" patient-relevant guidelines to physicians during the clinical encounter, and accurately captures structured data from all who interact with it. Preliminary work with CHICA has demonstrated the feasibility of using the system to implement and evaluate clinical guidelines.
However, analyses have shown that physicians ignore a fair number of prompts. We would like to experiment with changes to the system to see if we can increase physicians' response rates. This could include highlighting prompts, reordering them, or flagging them in other ways. The main outcome of interest is the rate at which physicians answer prompts.
This will be a randomized, controlled trial of the CHICA system to see if we can improve prompt response rates. We will randomize physicians or clinics to receive some form of prompt change, including highlighting them, reordering them, or flagging them. No other changes will be made to care.
We will extract data from the CHICA system for all patients seen in our study clinics. This data will include a the clinic location, whether or not a physician responded to a prompt, the prompt's position on the form, the patient's gender, the rule priority of the prompt, rule title, patient insurance category, the patient's age in days, and the name of the provider. The main outcome of interest is whether or not a prompt was answered (discussed/not discussed).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receiving Highlighted Prompts | Experimental | Other: Receiving Highlighted PromptsPrompts received by physicians were highlighted. |
| Receiving Non-highlighted Prompts | Active comparator | Other: Receiving Non-highlighted PromptsPrompts received by physicians were not highlighted. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Physicians practicing in one of our four CHICA clinics who use CHICA
Key exclusion criteria (1 listed)
- Not being a physician practicing in one of our four CHICA clinics who use CHICA
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 |
|---|---|---|
| Receiving Highlighted PromptsPrompts received by physicians were highlighted. | Other | Receiving Highlighted Prompts |
| Receiving Non-highlighted PromptsPrompts received by physicians were not highlighted. | Other | Receiving Non-highlighted Prompts |
Primary outcome
The Number of Prompts That Were Responded to
Time frame: 1 year
The main outcome of interest is whether or not a prompt was answered (discussed/not discussed).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Aaron E Carroll, MD, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receiving Highlighted Prompts and Receiving Non-highlighted Prompts in people with Physician Behavior, run by Indiana 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 15 May 2017. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Prompts That Were Responded to (time frame: 1 year). 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 15 May 2017.