Attention Deficit Disorder With HyperactivityMAPLENCT01105923
Study of an Intervention to Improve Problem List Accuracy and Use
A study testing MAPLE in people with Attention Deficit Disorder With Hyperactivity and Asthma, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to identify patients with problem list gaps and intervene to correct these gaps by creating clinical decision support interventions that alert providers to likely problem list gaps and offer clinicians the opportunity to correct them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Asthma, COPD
- What is being tested?
- MAPLE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Nov 2017
- 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
- Independent healthcare provider (physician, NP, PA)
- Practices at participating site
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Making Accurate Problem Lists in the EHR
The aim of this study is to identify patients with problem list gaps and intervene to correct these gaps by creating clinical decision support interventions that alert providers to likely problem list gaps and offer clinicians the opportunity to correct them. The investigators will randomize the clinics that will receive the intervention and formally evaluate the study after a period of 6 months for improved problem list completeness to determine the effectiveness of our intervention.
Read the detailed description
The clinical problem list is a cornerstone of the problem-oriented medical record. Problem lists are used in a variety of ways throughout the process of clinical care. In addition to its use by clinicians, the problem list is also critical for decision support and quality measurement.
Patients with gaps in their problem list face significant risks. For example, if a hypothetical patient has diabetes properly documented, his clinician would receive appropriate alerts and reminders to guide care. Additionally, the patient might be included in special care management programs and the quality of care provided to him would be measured and tracked. Without diabetes on his problem list, he might receive none of these benefits.
In this study, the investigators developed an clinical decision support intervention that will identify patients with problem lists gaps. The investigators will alert providers of these likely gaps and offer providers the opportunity to correct them.
- Conditions
- Attention Deficit Disorder With Hyperactivity, Asthma, COPD, Breast Cancer, Coronary Artery Disease, Congestive Heart Failure
- Being tested
- MAPLE
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Asthma, Pulmonary Disease, Chronic Obstructive, Breast Neoplasms, Coronary Artery Disease, Heart Failure, Diabetes Mellitus, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAPLEOther
MAPLE is a CDS intervention within the EHR that will alert providers to problem lists gaps and present an opportunity to correct them.
| Study group | Role | What they receive |
|---|---|---|
| Receive CDS intervention | Experimental | Providers in clinics that will receive the CDS alert, as their clinic was randomized into our study. Receives: Other: MAPLE |
| No CDS intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention acceptance
Of those providers who were shown (or who would have been shown, for the control group) the intervention, the number that added a problem across control and intervention groups.
Measured: 6 months (May 2010-Nov2010)
Secondary outcomes (3)
Problem list prevalence
Number of patients with selected problems on their problem list pre and post intervention across intervention and control groups.
Measured: pre and post intervention
Problem list incidence
For the conditions of interest, the percent of patients that had the problem added during the study period
Measured: pre and post intervention
Quality improvement based on problem list accuracy/completion
For those with problems added due to the intervention, the number of new triggered reminders or other clinical actions.
Measured: post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2010
- Study completionNov 2017 (estimated)
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 Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Wright, Brigham and Women's Hospital
- Investigators
- Adam Wright, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105923
- Sponsor's protocol ID
- 2009P001846
- Acronym
- MAPLE
- Status last verified
- Jan 2015
- First submitted
- 15 Apr 2010
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wright A, Pang J, Feblowitz JC, Maloney FL, Wilcox AR, McLoughlin KS, Ramelson H, Schneider L, Bates DW. Improving completeness of electronic problem lists through clinical decision support: a randomized, controlled trial. J Am Med Inform Assoc. 2012 Jul-Aug;19(4):555-61. doi: 10.1136/amiajnl-2011-000521. Epub 2012 Jan 3.
PubMed 22215056
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Accurate Problem Lists in the EHR
- ClinicalTrials.gov ID
- NCT01105923
- Acronym / sponsor ID
- MAPLE / 2009P001846
- Conditions
- Attention Deficit Disorder With Hyperactivity, Asthma, COPD, Breast Cancer, Coronary Artery Disease, Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2017 (estimated)
- First posted
- 19 Apr 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.
The aim of this study is to identify patients with problem list gaps and intervene to correct these gaps by creating clinical decision support interventions that alert providers to likely problem list gaps and offer clinicians the opportunity to correct them. The investigators will randomize the clinics that will receive the intervention and formally evaluate the study after a period of 6 months for improved problem list completeness to determine the effectiveness of our intervention.
Detailed description
The clinical problem list is a cornerstone of the problem-oriented medical record. Problem lists are used in a variety of ways throughout the process of clinical care. In addition to its use by clinicians, the problem list is also critical for decision support and quality measurement.
Patients with gaps in their problem list face significant risks. For example, if a hypothetical patient has diabetes properly documented, his clinician would receive appropriate alerts and reminders to guide care. Additionally, the patient might be included in special care management programs and the quality of care provided to him would be measured and tracked. Without diabetes on his problem list, he might receive none of these benefits.
In this study, the investigators developed an clinical decision support intervention that will identify patients with problem lists gaps. The investigators will alert providers of these likely gaps and offer providers the opportunity to correct them.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive CDS intervention | Experimental | Other: MAPLEProviders in clinics that will receive the CDS alert, as their clinic was randomized into our study. |
| No CDS intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Independent healthcare provider (physician, NP, PA)
- Practices at participating site
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 |
|---|---|---|
| MAPLEMAPLE is a CDS intervention within the EHR that will alert providers to problem lists gaps and present an opportunity to correct them. | Other | Receive CDS intervention |
Primary outcome
Intervention acceptance
Time frame: 6 months (May 2010-Nov2010)
Of those providers who were shown (or who would have been shown, for the control group) the intervention, the number that added a problem across control and intervention groups.
3 secondary outcomes
Problem list prevalence
Time frame: pre and post intervention
Problem list incidence
Time frame: pre and post intervention
Quality improvement based on problem list accuracy/completion
Time frame: post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
- Derived from this study: PubMed 22215056Wright A, Pang J, Feblowitz JC, Maloney FL, Wilcox AR, McLoughlin KS, Ramelson H, Schneider L, Bates DW. Improving completeness of electronic problem lists through clinical decision support: a randomized, controlled trial. J Am Med Inform Assoc. 2012 Jul-Aug;19(4):555-61. doi: 10.1136/amiajnl-2011-000521. Epub 2012 Jan 3.
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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.
Adam Wright, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAPLE in people with Attention Deficit Disorder With Hyperactivity and Asthma, run by Brigham and Women's Hospital 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 2 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 2 Feb 2015. 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?
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?
Intervention acceptance (time frame: 6 months (May 2010-Nov2010)). 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 NCT01105923, 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 2 Feb 2015.