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Improving Quality by Maintaining Accurate Problems in the EHR (IQ-MAPLE)

Primary Purpose

Asthma, Atrial Fibrillation, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem List Suggestion
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Brigham and Women's Hospital
  • Oregon Health and Science University
  • Holy Spirit Hospital
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Normal Use of EHR

Intervention Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Evaluating process measures using key process measures for each study condition from CMS, NHLBI, and NQMC
Improvements for process measures To complete the clinical endpoints in the third outcome, we will also evaluate process measures, specifically frequency of LDL testing, prescription of antihyperlipidemic agents, prescription of aspirin or other antiplatelet agents and prescription of antihypertensive agents. We will analyze the results using logistic regression with fixed effects for intervention group (versus control) and site and estimation of the regression parameters with generalized estimating equations (GEE), accounting for clustering between the patients in the same physician as well as patients with different physicians in the same matched pair. We will build separate regression models for each quality measure, and also conduct a pooled analysis with additional effects for quality measure and availability of CDS for the associated measure at the site, in order to estimate the extent to which IQ-MAPLE's effect on quality is mediated by CDS.

Full Information

First Posted
October 19, 2015
Last Updated
February 6, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Geisinger Clinic, Oregon Health and Science University, Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT02596087
Brief Title
Improving Quality by Maintaining Accurate Problems in the EHR
Acronym
IQ-MAPLE
Official Title
Improving Quality by Maintaining Accurate Problems in the Electronic Health Record
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Geisinger Clinic, Oregon Health and Science University, Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Atrial Fibrillation, Chronic Obstructive Pulmonary Disease, Coronary Artery Disease, Congestive Heart Failure, Hyperlipidemia, Hypertension, Myocardial Infarction, Sickle Cell Disease, Sleep Apnea, Smoking, Stroke, Tuberculosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2386 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Use of EHR
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Problem List Suggestion
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Through study completion, or up to 1 year
Title
Determining the effect of problem list completion by comparing the number of study-related problems added to problem lists in the electronic health record
Description
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.
Time Frame
Through study completion, or up to 1 year
Title
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
Description
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.
Time Frame
Through study completion, or up to 1 year
Secondary Outcome Measure Information:
Title
Evaluating process measures using key process measures for each study condition from CMS, NHLBI, and NQMC
Description
Improvements for process measures To complete the clinical endpoints in the third outcome, we will also evaluate process measures, specifically frequency of LDL testing, prescription of antihyperlipidemic agents, prescription of aspirin or other antiplatelet agents and prescription of antihypertensive agents. We will analyze the results using logistic regression with fixed effects for intervention group (versus control) and site and estimation of the regression parameters with generalized estimating equations (GEE), accounting for clustering between the patients in the same physician as well as patients with different physicians in the same matched pair. We will build separate regression models for each quality measure, and also conduct a pooled analysis with additional effects for quality measure and availability of CDS for the associated measure at the site, in order to estimate the extent to which IQ-MAPLE's effect on quality is mediated by CDS.
Time Frame
Through study completion, or up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All providers over the age of 18 that use the electronic health record at the specific site that the intervention is being observed. Exclusion Criteria: -
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Holy Spirit Hospital
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37235
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17460131
Citation
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.
Results Reference
background
PubMed Identifier
17683098
Citation
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.
Results Reference
background
PubMed Identifier
11814171
Citation
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.
Results Reference
background
PubMed Identifier
10332657
Citation
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.
Results Reference
background
PubMed Identifier
12463796
Citation
Carpenter JD, Gorman PN. Using medication list--problem list mismatches as markers of potential error. Proc AMIA Symp. 2002:106-10.
Results Reference
background
PubMed Identifier
15836547
Citation
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.
Results Reference
background
PubMed Identifier
20884377
Citation
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.
Results Reference
background
PubMed Identifier
21613643
Citation
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.
Results Reference
background

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Improving Quality by Maintaining Accurate Problems in the EHR

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