Improving Laboratory Monitoring in Community Practices: A Randomized Trial (Massachusetts)

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Improving Laboratory Monitoring in Community Practices: A Randomized Trial - 2012

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS07-006: Ambulatory Safety and Quality Program: Improving Quality through Clinician Use of Health Information Technology (IQHIT)
  • Grant Number: 
    R18 HS 017201
  • Project Period: 
    September 2007 - February 2012
  • AHRQ Funding Amount: 
    $990,640
  • PDF Version: 
    (PDF, 273.17 KB)

Summary: Medication errors and preventable adverse drug events (ADEs) occur commonly among patients in ambulatory settings, and constitute an important target for patient safety and quality improvement. Laboratory monitoring to ensure the safety and effectiveness of drug therapy and the timely management of abnormal results of laboratory testing have been increasingly recognized as important areas for improving patient safety in ambulatory care. Promising interventions have been developed for
practices affiliated with hospitals and integrated delivery systems, but efforts have not adequately reached physicians practicing solo or in small community practices.

The overall aim of the project was to assess clinical decision support (CDS) point-of-care alerts and evaluate a results management system to improve timeliness of communication of laboratory results to patients. The study used eClinicalWorks, a widely used and commercially available electronic health record (EHR) that allows findings to be generalized to other settings using the same EHR. The project included a qualitative analysis of the barriers and facilitators of laboratory monitoring. This information
was used to develop, implement, and evaluate computerized alerts to facilitate laboratory monitoring of medications at initiation or continuation of therapy. The study team also planned to design and implement an enhanced results management system to allow providers to communicate laboratory results to patients through a patient portal. However, eClinicalWorks developed a results management system with similar functionality so the project team implemented and evaluated it instead.

Specific Aims:

  • Identify barriers to and facilitators of laboratory monitoring and timely followup of abnormal results. (Achieved)
  • Design, implement, and evaluate CDS (point-of-care alerts) for laboratory monitoring in a widely used, commercially available EHR that addresses barriers to and facilitators of laboratory monitoring. (Achieved)
  • Design, implement, and evaluate a results management system to efficiently handle abnormal laboratory test results in ambulatory care. (Retired)
  • Develop a detailed dissemination guide and widely distribute it to other practices and communities interested in implementing similar interventions. (Achieved)

2012 Activities: The focus of the final months of the project was data collection and analysis for the evaluation of the computerized alerts to facilitate laboratory monitoring and the results management system. Data on medications, laboratory tests, and patient portal use were collected through the EHR. Analyses were conducted to measure adherence to laboratory monitoring recommendations and time to test result notification.

Due to delays resulting from the modified study plan, Dr. Simon used a 6-month no-cost extension to complete the research. As last reported in the AHRQ Research Reporting System, progress was on track in some respects, but not others, and project budget funds were underspent. However, at the end of the project, project aim milestones were achieved, with the exception of the retired aim noted above. This project was completed in February 2012.

Impact and Findings: Focus group participants viewed laboratory monitoring as a critical, time-consuming task integral to their practice. Most believed they commit few laboratory monitoring errors and were surprised at the error rates reported in the literature. Participants listed various barriers to monitoring, including not knowing which physician was responsible for laboratory monitoring, uncertainty about the necessity of monitoring, lack of reminders, and patient non-adherence. The primary facilitator of monitoring was ordering laboratory tests while the patient was in the office. Primary care providers felt more strongly than specialists that computerized alerts could improve laboratory monitoring. Participants wanted to individualize alerts for their practices and warned that alerts must not interrupt workflow. Physicians in community practices recognized the potential of computerized alerts to enhance their monitoring protocols for some medications. Interventions to improve laboratory monitoring should address physician workflow issues and increase patient awareness of the importance of fulfilling recommended therapeutic monitoring to prevent ADEs.

The team established a partnership with Take Care New York to evaluate the laboratory monitoring alerts at primary care practices in New York City. Eleven practices with 15 providers were recruited. Six clinics were randomized to the intervention arm and five to the control arm. Significant resources were invested in mapping the laboratory tests at each clinic. Preliminary data analysis showed that for intervention practices, appropriate monitoring of drug therapy decreased from 66.9 percent in the baseline period to
41.6 percent in the intervention period, compared to 57.6 percent and 36.9 percent, respectively, for control practices. These unexpected results led the team to continue conducting data quality checks beyond the grant period to ensure that these results were valid before proceeding with more sophisticated analyses.

The team also partnered with three mid-sized, multi-provider clinics that were early adopters of the results management patient portal. A pre-post study design was used to evaluate the difference between the proportion of patients notified of laboratory results and the time to notification. Primary notification was defined as a sent letter, telephone contact, followup visit, or results sent via the patient portal. Secondary notification was defined as a followup, prescription, or referral to a specialist. The team convened an expert panel to adapt existing inpatient guidelines for the notification of test results in an ambulatory setting. Additionally, a data extraction tool was developed to validate patient notification for a random subsample of patients at each clinic using the EHR. Analyses indicated that over time, the proportion of laboratory results posted to the portal decreased (56 percent to 50 percent) and the proportion of patients who logged into the system decreased as well (40 percent to 31 percent). Patients using the system accessed the laboratory results more quickly following the posting of a result (7.6 to 3.0 days).

Target Population: Adults

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support
patient-centered care, the coordination of care across transitions in care settings, and the electronic
exchange of health information to improve quality of care.

Business Goal: Knowledge Creation

Improving Laboratory Monitoring in Community Practices: A Randomized Trial - 2011

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS07-006: Ambulatory Safety and Quality Program: Improving Quality Through Clinician Use of Health Information Technology (IQHIT)
  • Grant Number: 
    R18 HS 017201
  • Project Period: 
    September 2007 - February 2012
  • AHRQ Funding Amount: 
    $990,640
  • PDF Version: 
    (PDF, 190.82 KB)

Summary: Medication errors and preventable adverse drug events (ADEs) occur commonly among patients in the ambulatory setting, and constitute an important target for patient safety and quality improvement. Laboratory monitoring to ensure the safety and effectiveness of drug therapy and the timely management of abnormal results of laboratory testing have been increasingly recognized as important areas for improving patient safety in ambulatory care. Promising interventions have been developed for practices affiliated with hospitals and integrated delivery systems, but efforts have not adequately reached physicians practicing solo or in small community practices.

The overall aim of the project is the assessment of clinical decision support (CDS) point-of-care alerts to address barriers to and facilitators of laboratory monitoring and a results-management system to improve timeliness of communication of laboratory results to patients. The study uses eClinicalWorks, a widely used and commercially available electronic health record (EHR). Therefore, findings may be generalized to other settings using the same EHR. The project began with a qualitative analysis of the barriers and facilitators of laboratory monitoring and timely followup of abnormal results among clinicians in ambulatory primary care practices. This information was used to develop, implement, and evaluate computerized alerts to facilitate indicated laboratory monitoring of medications at initiation or continuation of therapy. Originally, the study team had planned to design and implement an enhanced results management system. However, eClinicalWorks had developed a similar system so the project team decided to evaluate the system at three clinics where it had been implemented recently.

Specific Aims:

  • Identify barriers to and facilitators of laboratory monitoring and timely followup of abnormal results. (Achieved)
  • Design, implement, and evaluate CDS (point-of-care alerts) for laboratory monitoring in a widely used, commercially available EHR that addresses barriers to and facilitators of laboratory monitoring. (Ongoing)
  • Design, implement, and evaluate a results management system to efficiently handle abnormal laboratory test results in ambulatory care. (Retired)
  • Develop a detailed dissemination guide and widely distribute it to other practices and communities interested in implementing similar interventions. (Ongoing)

2011 Activities: This project was conceived as two clustered randomized controlled trials -first the computerized point-of-care alerts, then the results management system. Due to delays and ultimately changing priorities of the original implementing partner, the project team partnered with other collaborators and changes were made to the project plan. Dr. Simon is working closely in consultation with the Agency for Healthcare Research and Quality (AHRQ) to implement these changes.

The research team established a partnership with Take Care New York, an organization that implemented eClinicalWorks at primary care practices in New York City. With the support of eClinicalWorks, the research team implemented the newly developed alerts to evaluate laboratory monitoring of medications. Eleven practices with 15 providers were recruited and demographic data were collected. Six clinics were randomized to the intervention arm and five to the control arm. Significant resources were invested in mapping the laboratory tests at each clinic. Focus groups were conducted with end users of eClinicalWorks. The analysis plan for the study includes a pre-implementation analysis that will look at correlates of laboratory monitoring errors before and after implementation.

As previously mentioned, Dr. Simon initially proposed to develop and implement a results-management system. However, eClinicalWorks simultaneously developed a plan to expand its EHR to include a patient portal with similar functionality to what the project team had proposed. As a result, the project shifted to the evaluation of the patient portal. The study team partnered with three mid-sized, multi-provider clinics that were early adopters of the patient portal. A pre-post study design is being used to evaluate the difference between the proportion of patients notified of laboratory results and the time to notification. Primary notification is defined as a sent letter, telephone contact, followup visit, or results sent via the patient portal. Secondary notification is defined as a followup, prescription, or referral to a specialist. The research team convened an expert panel to adapt existing inpatient guidelines for the notification of test results in an ambulatory setting. Additionally, a data extraction tool was developed to validate patient notification for a random subsample of patients at each clinic using the EHR.

As last self-reported in the AHRQ Research Reporting System, project progress and activities are mostly on track and project budget funds are slightly underspent to allocate funds for the remainder of the no-cost extension (NCE). During the 6-month NCE period, the research team will focus on data collection and analysis.

Preliminary Impact and Findings: Focus group participants viewed laboratory monitoring as a critical, time-consuming task integral to their practice. Most believed they commit few laboratory monitoring errors and were surprised at the error rates reported in the literature. They listed various barriers to monitoring, including not knowing which physician was responsible for laboratory monitoring, uncertainty regarding the necessity of monitoring, lack of reminders, and patient non-adherence. The primary facilitator of monitoring was ordering laboratory tests while the patient was in the office. Primary care providers felt more strongly than specialists that computerized alerts could improve laboratory monitoring. Participants wanted to individualize alerts for their practices and warned that alerts must not interrupt workflow. Physicians in community practices recognized the potential of computerized alerts to enhance their monitoring protocols for some medications. Interventions to improve laboratory monitoring should address physician workflow issues and increase patient awareness of the importance of fulfilling recommended therapeutic monitoring to prevent ADEs. At the request of the 11 study practices, eClinicalWorks intends to maintain and support the laboratory monitoring alerts beyond this project.

Target Population: Adults

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support patient- centered care, the coordination of care across transitions in care settings, and the electronic exchange of health information to improve quality of care.

Business Goal: Knowledge Creation

Improving Laboratory Monitoring in Community Practices: A Randomized Trial - 2010

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS07-006: Ambulatory Safety and Quality Program: Improving Quality Through Clinician Use of Health Information Technology (IQHIT)
  • Grant Number: 
    R18 HS 017201
  • Project Period: 
    September 2007 – August 2011, Including No-Cost Extension
  • AHRQ Funding Amount: 
    $990,640
  • PDF Version: 
    (PDF, 296.67 KB)


Target Population: Adults

Summary: Medication errors and preventable adverse drug events (ADEs) occur commonly among patients in the ambulatory setting, and constitute an important target for patient safety and quality improvement. Laboratory monitoring to ensure the safety and effectiveness of drug therapy and the timely management of abnormal results of laboratory testing have been increasingly recognized as important areas for improving patient safety in ambulatory care. Promising interventions have been developed for practices affiliated with hospitals and integrated delivery systems, but to date efforts have not adequately reached physicians practicing solo or in small community practices.

The overall aim of the project is the assessment of clinical decision support (CDS) point-of-care alerts and a results management system to address barriers to and facilitators of laboratory monitoring. The study uses eClinicalWorks, a widely used and commercially available Certification Commission for Health Information Technology (CCHIT)-certified electronic health record (EHR); therefore, findings may be generalized to other CCHIT-certified EHRs. The project includes a qualitative analysis of the barriers and facilitators of laboratory monitoring and timely followup of abnormal results among clinicians in ambulatory primary care practices. This information will be used to develop, implement, and evaluate computerized alerts to facilitate indicated laboratory monitoring of medications at initiation or continuation of therapy. The second part of the study is the evaluation of an enhanced results management system to facilitate patient management. Initially, the grantee proposed to design and implement a results management system, however, the EHR vendor developed a similar system. As a result, the grantee will evaluate the vendor results management system at two clinics where the system was recently implemented. Baseline analyses will yield information on the rates and correlates of laboratory monitoring errors, and the management of abnormal test results in community-based primary care settings. The study incorporates a dissemination plan, which includes not only publication and presentation of the results in scientific settings but also the creation of a dissemination guide that will be made freely available to other community-based ambulatory practices implementing EHRs and point-of-care alerts.

Specific Aims:
  • Identify barriers to and facilitators of laboratory monitoring and timely followup of abnormal results. (Achieved)
  • Design, implement, and evaluate CDS (point-of-care alerts) for laboratory monitoring in a widely used, commercially available EHR that addresses barriers to and facilitators of laboratory monitoring. (Ongoing)
  • Design, implement, and evaluate a results management system to efficiently handle abnormal laboratory test results in ambulatory care. (Retired)
  • Develop a detailed dissemination guide and widely distribute it to other practices and communities interested in implementing similar interventions. (Upcoming)

2010 Activities: Dr. Simon received a no-cost extension for a fourth year of his research. Originally this project was conceived as two clustered randomized controlled trials that would be implemented consecutively—first the computerized point-of-care alerts, then the results management system. Due to delays and ultimately changing priorities of the original implementing partner, the grantee sought other collaborators. As a result, the study was changed significantly. Dr. Simon is working closely in consultation with the Agency for Healthcare Research and Quality to implement these changes.

He has established a new partnership with Take Care New York (TCNY), which is rolling out eClinical Works to primary care practices in New York City. TCNY will integrate the grantee’s computerized point-of-care alerts into eClinical Works to evaluate the use of the alerts for facilitation of laboratory monitoring of medications. Based on power calculations, the grantee aims to recruit 10 to 20 practices for a six month study. Participating clinics will be randomized to the alerts intervention arm or the control arm at a one-to-one ratio. The research group has obtained institutional review board approval and enrollment is in progress.

The results management part of the grant has also experienced changes. Initially, Dr. Simon proposed to develop and implement a results management system, however, eClinical Works simultaneously developed a plan to expand its EHR to include a patient portal, which would add much of the same functionality that the grantee proposed to develop. As a result, the grantee has shifted the focus of the study to evaluation of the patient portal. The grantee is currently collaborating with two mid-sized, multi-provider clinics that were early adapters of the patient portal. The grantee will use a pre- and post- study design to evaluate the difference between the proportion of patients notified of laboratory results and the time to notification. The research team has been working with sample data to prepare logic rules to adapt pre-existing outpatient guidelines into inpatient guidelines to develop clinical consensus about the appropriate time interval to notify patients of lab results.

Grantee’s Most Recent Self-Reported Quarterly Status (as of December 2010): Current project plans are delayed, due to issues discussed in the summary section above. A no-cost extension year has been approved. It is expected that all funds will be used by the end of the project.

Preliminary Impact and Findings: Focus group participants viewed laboratory monitoring as a critical, time-consuming task integral to their practice. Most believed they commit few laboratory monitoring errors and were surprised at the error rates reported in the literature. They listed various barriers to monitoring, including not knowing which physician was responsible for ensuring the completion of laboratory monitoring, uncertainty regarding the necessity of monitoring, lack of alerts or reminders, and patient nonadherence. The primary facilitator of monitoring was ordering laboratory tests while the patient was in the office. Primary care providers felt more strongly than specialists that computerized alerts could improve laboratory monitoring. Participants wanted to individualize alerts for their practices and warned that alerts must not interrupt workflow or require too many clicks. Physicians in community practices recognized the potential of computerized alerts to enhance their monitoring protocols for some medications. Interventions to improve laboratory monitoring should address physician workflow issues and increase patient awareness of the importance of fulfilling recommended therapeutic monitoring to prevent ADEs.

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support patient-centered care, the coordination of care across transitions in care settings, and the electronic exchange of health information to improve quality of care.

Business Goal: Knowledge Creation

Project Details - Ended

Project Categories

Summary:

Medication errors and preventable adverse drug events (ADEs) occur commonly among patients in the ambulatory setting, and constitute an important target for patient safety and quality improvement. Laboratory monitoring to ensure the safety and effectiveness of drug therapy and the timely management of abnormal results of laboratory testing has been increasingly recognized as an important way to improve patient safety in ambulatory care. Promising interventions have been developed for practices affiliated with hospitals and integrated delivery systems, but efforts to date have not adequately reached solo physicians practicing solo or in small community practices.

This project was designed to assess clinical decision support (CDS) point-of-care alerts and evaluate a results management system to address barriers to and facilitators of laboratory monitoring. The study used a widely used and commercially available electronic health record (EHR) that allowed findings to be generalized to other settings that use the same EHR. The project included a qualitative analysis of the barriers and facilitators of laboratory monitoring and timely followup of abnormal results among clinicians in ambulatory primary care practices. This information was used to develop, implement, and evaluate computerized alerts to facilitate indicated laboratory monitoring of medications at initiation or continuation of therapy.

The specific aims of the project were to:

  • Identify the barriers to and facilitators of laboratory monitoring and timely followup of abnormal results.
  • Design, implement, and evaluate clinical decision support (point-of-care alerts) for laboratory monitoring in a widely used, commercially available EHR that address the barriers to and facilitators of laboratory monitoring.
  • Design, implement, and evaluate a results management system for the timely handling of abnormal laboratory test results in ambulatory care.
  • Develop a detailed dissemination guide that will be made widely available to other practices and communities interested in implementing the same or similar interventions.         

An evaluation of the impact of the CDS alerts found a decrease from 70.7 to 62.4 percent in appropriate monitoring of drug therapy of medications in control practices; and from 79.4 to 77.7 percent of medications in intervention practices. Although adherence to laboratory monitoring recommendations decreased over time in both groups, this was less pronounced for the intervention group than the control group, suggesting that the intervention may have had a positive effect. Based on these findings it appears that future interventions may need to target both patients and clinicians to improve the complex behavior of laboratory medications monitoring.

For the evaluation of the results management system, the number of laboratory results posted to the portal decreased over time from 30 to 17 percent of all notifications, and the proportion of patients who logged into the system decreased over time. Despite these observations, preliminary analysis from a single pediatric practice showed that after portal adoption there was a 9 percent increase from 54 to 63 percent in laboratory results notifications made within 30 days through all forms of communication. These preliminary data suggest that a large fraction of patients may prefer to have their results communicated by telephone rather than a patient portal. However, while patient portal use decreased over time, those patients who did use the portal were notified more quickly. Therefore, when implementing a portal, understanding patient preferences for test notification will improve timely results management.

Improving Laboratory Monitoring in Community Practices: A Randomized Trial - Final Report

Citation:
Simon S. Improving Laboratory Monitoring in Community Practices: A Randomized Trial - Final Report. (Prepared by Brigham and Women's Hospital under Grant No. R18 HS017201). Rockville, MD: Agency for Healthcare Research and Quality, 2012. (PDF, 215.37 KB)

The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. (Persons using assistive technology may not be able to fully access information in this report. For assistance, please contact Corey Mackison)
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