NCT02596087

Brief Summary

The overall goal of the IQ-MAPLE project is to improve the quality of care provided to patients with several heart, lung and blood conditions by facilitating more accurate and complete problem list documentation. In the first aim, the investigators will design and validate a series of problem inference algorithms, using rule-based techniques on structured data in the electronic health record (EHR) and natural language processing on unstructured data. Both of these techniques will yield candidate problems that the patient is likely to have, and the results will be integrated. In Aim 2, the investigators will design clinical decision support interventions in the EHRs of the four study sites to alert physicians when a candidate problem is detected that is missing from the patient's problem list - the clinician will then be able to accept the alert and add the problem, override the alert, or ignore it entirely. In Aim 3, the investigators will conduct a randomized trial and evaluate the effect of the problem list alert on three endpoints: alert acceptance, problem list addition rate and clinical quality.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,386

participants targeted

Target at P75+ for not_applicable asthma

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

October 19, 2015

Last Update Submit

February 6, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Measuring the rate of acceptance of alerts calculated by number of acceptances for each alert divided by the total number of unique presentations of the alert

    Acceptance of the alerts: This first endpoint is descriptive: the acceptance rate for the alerts presented to providers. This will be calculated by taking the total number of acceptances for each alert and dividing it by the total number or unique presentations of the alert. We will conduct a stratified analysis to look at differences in acceptance rates by institution, specialty, disease and provider demographic characteristics, and will report the results in tabular form.

    Through study completion, or up to 1 year

  • Determining the effect of problem list completion by comparing the number of study-related problems added to problem lists in the electronic health record

    Effect on the rate of problem list completion: In this endpoint, we will compare the number of study-related problems added to patient problems lists in the electronic health record in the intervention and control groups.

    Through study completion, or up to 1 year

  • Determining the quality of care impact of adding suggested problems to the problem list based on 4 outcome measures from NCQA's HEDIS 2013 measure set

    Effect on quality of care: Because a key goal of our study is improving clinical outcomes, we have selected four outcome measures to evaluate from NCQA's Healthcare Effectiveness Data and Information Set (HEDIS) 2013 measure set: LDL control in patients with a history of myocardial infarction, LDL control in patients with coronary artery disease, blood pressure control in patients with coronary artery disease and blood pressure control in patients with hypertension. The details for the numerator and denominator for each measure are given in the HEDIS manuals, and our study team will employ NCQA's procedures for calculation of each measure, with modifications as needed given the clinical nature of our dataset.

    Through study completion, or up to 1 year

Secondary Outcomes (1)

  • Evaluating process measures using key process measures for each study condition from CMS, NHLBI, and NQMC

    Through study completion, or up to 1 year

Study Arms (2)

Normal Use of EHR

NO INTERVENTION

Sites will configure their EHR systems so that alerts will not be triggered for providers in the control arm if the patient does not have the condition on her/his problem list.

Intervention Arm

EXPERIMENTAL

Sites will configure their EHR systems so that alerts for these conditions will be triggered for providers in the intervention arm if the patient does not have the condition on her/his problem list. Each alert will be actionable and allow the provider to add the problem to her or his patient's problem list with a single click. The provider will also be able to override the rule of the patient does not have the condition (in which case the alert will not be displayed again unless new information that would trigger the alert is added to the patient's record), or defer the alert until later.

Other: Problem List Suggestion

Interventions

Sites will configure their EHR systems so that alerts for these conditions will be triggered for providers in the intervention arm if the patient does not have the condition on her/his problem list. each alert will be actionable and allow the provider to add the problem to her or his patient's problem list with a single click. The provider will also be able to override the rule of the patient does not have the condition (in which case the alert will not be displayed again unless new information that would trigger the alert is added to the patient's record), or defer the alert until later.

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All providers over the age of 18 that use the electronic health record at the specific site that the intervention is being observed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Holy Spirit Hospital

Camp Hill, Pennsylvania, 17011, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37235, United States

Location

Related Publications (8)

  • Wright A, Goldberg H, Hongsermeier T, Middleton B. A description and functional taxonomy of rule-based decision support content at a large integrated delivery network. J Am Med Inform Assoc. 2007 Jul-Aug;14(4):489-96. doi: 10.1197/jamia.M2364. Epub 2007 Apr 25.

    PMID: 17460131BACKGROUND
  • Kaplan DM. Clear writing, clear thinking and the disappearing art of the problem list. J Hosp Med. 2007 Jul;2(4):199-202. doi: 10.1002/jhm.242. No abstract available.

    PMID: 17683098BACKGROUND
  • Szeto HC, Coleman RK, Gholami P, Hoffman BB, Goldstein MK. Accuracy of computerized outpatient diagnoses in a Veterans Affairs general medicine clinic. Am J Manag Care. 2002 Jan;8(1):37-43.

    PMID: 11814171BACKGROUND
  • Tang PC, LaRosa MP, Gorden SM. Use of computer-based records, completeness of documentation, and appropriateness of documented clinical decisions. J Am Med Inform Assoc. 1999 May-Jun;6(3):245-51. doi: 10.1136/jamia.1999.0060245.

    PMID: 10332657BACKGROUND
  • Carpenter JD, Gorman PN. Using medication list--problem list mismatches as markers of potential error. Proc AMIA Symp. 2002:106-10.

    PMID: 12463796BACKGROUND
  • Hartung DM, Hunt J, Siemienczuk J, Miller H, Touchette DR. Clinical implications of an accurate problem list on heart failure treatment. J Gen Intern Med. 2005 Feb;20(2):143-7. doi: 10.1111/j.1525-1497.2005.40206.x.

    PMID: 15836547BACKGROUND
  • Wright A, Chen ES, Maloney FL. An automated technique for identifying associations between medications, laboratory results and problems. J Biomed Inform. 2010 Dec;43(6):891-901. doi: 10.1016/j.jbi.2010.09.009. Epub 2010 Sep 25.

    PMID: 20884377BACKGROUND
  • Wright A, Pang J, Feblowitz JC, Maloney FL, Wilcox AR, Ramelson HZ, Schneider LI, Bates DW. A method and knowledge base for automated inference of patient problems from structured data in an electronic medical record. J Am Med Inform Assoc. 2011 Nov-Dec;18(6):859-67. doi: 10.1136/amiajnl-2011-000121. Epub 2011 May 25.

    PMID: 21613643BACKGROUND

MeSH Terms

Conditions

AsthmaAtrial FibrillationPulmonary Disease, Chronic ObstructiveCoronary Artery DiseaseHeart FailureHyperlipidemiasHypertensionMyocardial InfarctionAnemia, Sickle CellSleep Apnea SyndromesSmokingStrokeTuberculosis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsChronic DiseaseDisease AttributesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInfarctionIschemiaNecrosisAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBehaviorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

October 19, 2015

First Posted

November 4, 2015

Study Start

April 1, 2016

Primary Completion

March 1, 2018

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations