Harnessing Health Information Technology to Prevent Medication-Induced Birth Defects (Pennsylvania)

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Harnessing Health Information Technology to Prevent Medication-Induced Birth Defects - 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 017093
  • Project Period: 
    September 2007 - September 2011
  • AHRQ Funding Amount: 
    $1,199,370
  • PDF Version: 
    (PDF, 192.66 KB)

Summary: Every year, approximately 150,000 infants-1-3 percent of all births in the United States- are born with some form of physical or neurological birth defect. In its 2000 publication, Envisioning the National Healthcare Quality Report, The Institute of Medicine identified prevention of birth defects as one of six national priorities for the health care system. It is estimated that each year, 12 million women in the United States use medications that might increase the risk of birth defects if used during pregnancy. Studies have also shown that the concurrent use of contraception with such medications can prevent associated birth defects. Unfortunately, when prescribing potentially teratogenic medications that may disturb the growth or development of the embryo, clinicians rarely counsel women about contraception. Due to this issue, approximately 6 percent of pregnant women are exposed to medications that may increase the risk of birth defects.

This project developed and evaluated ways that health information technology (IT) may help doctors counsel women about preventing birth defects that could be caused by the use of certain medications. Dr. Schwarz and her project team conducted a series of focus groups with clinicians and patients from academic and community-based practices in order to find out what information regarding birth defects would be most useful to primary care clinicians and their patients. Data from the focus group discussions were used to refine a multi-faceted clinical decision support (CDS) system that was installed within existing electronic medical records (EMRs) in ambulatory care clinics in Pennsylvania.

The impact of the CDS system was evaluated using a cluster-randomized trial. Data from the following sources were collected to inform the study: 1) data abstracted from the EMR when clinicians prescribed teratogenic medications; 2) phone interviews conducted with women prescribed medications by study clinicians; and 3) participating clinicians surveyed about their satisfaction with the CDS they received. The data were used to test the hypotheses that clinicians in the CDS intervention group prescribed fewer teratogenic medications, were more likely to prescribe contraception when prescribing a teratogenic medication, had more patients report satisfaction with the counseling they received, and reported more satisfaction with the CDS they received.

Specific Aims:

  • Develop and implement two CDS systems designed to alert ambulatory clinicians to the risk of medication-induced birth defects. (Achieved)
  • Evaluate the effect of two CDS systems designed to alert ambulatory clinicians to the risk of medication-induced birth defects. (Achieved)

2011 Activities: Data analysis and manuscript writing were the primary focuses for the research team. During the analysis of the EMR data, the team found that the CDS system was not turned off at the end of the study and that an extra year of data was available for analysis. Dr. Schwarz received approval from the internal review board to access the additional year of data and the analysis was expanded to include an additional year of CDS alerts. Multi-level models with random effects were developed to address clustering by physician and patient. Patient visits were excluded if the patient saw physicians from both the intervention and control groups. Analyses were adjusted for visit characteristics to control for baseline imbalances. Additional analyses were conducted regarding provider perceptions of counseling patients on contraceptives as well as patient and provider perceptions of CDS.

Dr. Schwarz used a 1-year no cost-extension to allow time to analyze the additional year of data that was generated from the CDS system. As last self-reported in the AHRQ Research Reporting System, project progress and activities was mostly on track, and the project budget spending was roughly on target. The project was completed in August 2011.

Impact and Findings: Three types of barriers to contraceptive counseling were identified during the clinician focus groups: patient, provider, and health system barriers. At the provider level, barriers included limited awareness of pregnancy risk; lack of knowledge, training, or comfort providing contraception; beliefs about certain contraceptive methods; a perceived patient responsibility for initiating discussions; a need for skilled personnel to place certain contraceptive methods; and a lack of communication with subspecialists. Health system-level challenges regarding contraceptive counseling included lack of insurance or family planning coverage; limits on provider time; limited access to providers trained to fit or insert contraceptive devices; competing medical priorities for patients and providers; visit type; case mix; and lack of a clinical care system to remind providers.

Evaluation of the CDS system indicated that multi-faceted CDS and streamlined clinical alerts were both associated with slight increases in family planning services, however there was no difference in the relative improvement between the two arms (p=0.87). The multi-faceted CDS group reported a greater increase in the number of times they counseled women about the risks of medication use during pregnancy. The streamlined CDS group reported greater clinician satisfaction with CDS usability (p=0.03). Of note, to avoid alert fatigue, the CDS system was designed such that providers were alerted only once after prescribing a potentially teratogenic medication. An unintended consequence of this design was identified in the analysis; 13 percent of providers responded to the alerts by prescribing an alternate medication that was also a potentially teratogenic medication, however, by design a second alert was not generated in these situations. Overall, the CDS showed potential to improve provision of family planning services but further system refinements are necessary.

Target Population: Women*: Pregnancy

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to improve the quality and safety of medication management via the integration and utilization of medication management systems and technologies.

Business Goal: Synthesis and Dissemination

* This target population is one of AHRQ's priority populations.

Harnessing HIT to Prevent Medication-Induced Birth Defects - 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 017093
  • Project Period: 
    September 2007 – September 2011, Including No-Cost Extension
  • AHRQ Funding Amount: 
    $1,199,370
  • PDF Version: 
    (PDF, 312.15 KB)


Target Population: Women*

Summary: Each year, 150,000 infants – one to three percent of all births in the United States – are born with some form of physical or mental birth defect. The Institute of Medicine has identified prevention of birth defects as one of six national priorities. It is estimated that each year, 12 million women in the United States use medications that might increase the risk of birth defects if used during pregnancy. However, studies show that the concurrent use of contraception with such medications can prevent associated birth defects. Unfortunately, when prescribing potentially teratogenic medications, medications that may disturb the growth or development of the embryo, clinicians rarely counsel women about contraception, and approximately six percent of pregnant women are exposed to medications that may increase the risk of birth defects.

This project proposed to develop and rigorously evaluate ways that health information technology (IT) may help doctors counsel women about preventing birth defects that could be caused by the use of certain medications. Dr. Schwarz and her project team began by conducting a series of focus groups with clinicians and patients seen in academic and community-based practices in order to find out what information would be most useful to primary care clinicians and their patients.

Data from the focus group discussions were used to refine the two distinct health IT application interventions: 1) multi-faceted clinical decision support (CDS), and 2) the networked tablet computer’s electronic collection of machine-actionable information about women’s risk of pregnancy. The impact of each of these interventions is being evaluated using a factorial design randomized controlled trial. In the first trial, multi-faceted CDS (intervention) is being compared to streamlined clinical alerts (control). The second trial evaluates whether collecting machine-actionable information about women’s risk of pregnancy using a networked tablet computer (intervention) is superior to the way clinicians usually collect this information (control).

Data from the following sources were collected to inform the study: 1) data abstracted from the electronic medical record (EMR) when clinicians prescribed teratogenic medications; 2) phone interviews conducted with women prescribed medications by study clinicians; and 3) participating clinicians surveyed about their satisfaction with the CDS they received. These data are being used to confirm the hypotheses that clinicians in the intervention groups will prescribe fewer teratogenic medications, be more likely to prescribe contraception when prescribing a teratogenic medication, have more patients report satisfaction with the counseling they received, and report more satisfaction with the CDS they received. All of the practice sites use the EpicCare EMR system.

This evaluation will provide much-needed information on how health IT can best be harnessed to prevent medication-induced birth defects nationwide. The health IT intervention shown to be most effective will be implemented throughout the University of Pittsburgh Medical Center (UPMC), which supports three million outpatient visits each year.

Specific Aims:

  • Develop and implement two CDS systems designed to alert ambulatory clinicians to the risk of medication-induced birth defects. (Achieved)
  • Evaluate the effect of two CDS systems designed to alert ambulatory clinicians to the risk of medication-induced birth defects. (Ongoing)

2010 Activities: In 2009, decision support was rolled out across UPMC's outpatient clinics. In 2010, project staff abstracted real time data from the EMR to assess use of the CDS system and impact on prescription of teratogenic medications and concordant prescription of contraceptives, and collected surveys from study clinics’ clinicians and patients. The data from these sources were merged to permit assessment of the CDS across control and intervention study arms.

Data analysis and manuscript writing were the primary focuses for the research team in 2010. The team assessed the data collected from four focus groups with women of reproductive age, using a grounded theory approach to content analysis, and produced two manuscripts which were published in 2010. In preliminary analyses of the EMR data, two important issues were identified. First, the team found that the CDS system was not activated for participating resident physicians. As a result, study analyses will be adjusted and this limitation will be described in manuscripts. The project team also determined that approximately 13 percent of providers responded to the alerts generated by the CDS system by prescribing an alternate medication that was also potentially teratogenic. As the CDS system was only designed to issue one alert, the clinician was not alerted if the newly prescribed medication was also potentially teratogenic. To respond to this unintended consequence, the team is looking into modifying the system so that physicians will be alerted to any risks that may result from a newly prescribed medication. In 2011, the team will complete further analyses of the EMR data that incorporate information provided by the physician and patient surveys.

Grantee’s Most Recent Self-Reported Quarterly Status (as of December 2010): The project is progressing well overall despite the fact that the CDS system was never activated for some participating clinicians. Dr. Schwarz reports that the project is mostly on track and spending is roughly on target.

Preliminary Impact and Findings: Three types of barriers to contraception counseling were identified during the clinician focus groups: barriers at the patient, provider, and health system levels. The providers identified patient contraceptive method of preference, outside influences, already on birth control, desire for pregnancy, religion, patient discomfort, and sexual activity confidentiality as patient level barriers to counseling. The bulk of the discussion focused on perception of barriers that providers bring to contraception counseling. At the provider level, barriers included: pregnancy risk; lack of knowledge, training, or comfort; beliefs about certain contraceptive methods; a perceived patient responsibility for initiating discussions; a need for skilled personnel for certain contraceptive methods; and a lack of communication with subspecialists. Finally, health system level challenges regarding contraceptive counseling included lack of insurance or family planning coverage, limitations on time, access to providers trained to fit or insert contraceptive devices, competing medical priorities, visit type, case mix, and lack of a clinical care system to remind providers.

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to improve the quality and safety of medication management via the integration and utilization of medication management systems and technologies.

Business Goal: Synthesis and Dissemination

*AHRQ Priority Population.

Project Details - Ended

Project Categories

Summary:

The Institute of Medicine has identified the prevention of birth defects as one of six priorities for the Nation's health. Between 1 and 3 percent of all U.S. births (150,000 infants annually) are born with some form of physical or mental birth defect, some of which are due to the use of high-risk medications. It is estimated that each year, 12 million U.S. women use medications that increase the risk of birth defects.  With concurrent use of contraception, birth defects associated with these medications can be vastly reduced. Unfortunately, when prescribing these medications clinicians counsel women about contraception less than 20 percent of the time. An estimated 12 million women a year use medications known to increase the risk of birth defects, subsequently exposing approximately 6 percent of those pregnancies. 

Dr. Schwarz and her team developed and evaluated a clinical decision support (CDS) system that alerted clinicians when they prescribed high-risk medications and prompted them to counsel women about the risks and need for adequate contraception. The team conducted a series of focus groups with clinicians and patients seen in academic and community-based practices to learn what information about risk of medication-induced birth defects would be most useful. Data from these discussions informed the design of a CDS that was integrated with an electronic health record.          

The specific aims of the study were to:

  • Develop and implement two CDS systems designed to alert ambulatory clinicians to the risk of medication-induced birth defects.
  • Evaluate the effect of two CDS systems designed to alert ambulatory clinicians to the risk of medication-induced birth defects.        

Evaluation of the CDS compared two types of CDS alerts. One was a multi-faceted alert that provided tailored information with links to assist safe prescribing; the other was streamlined and provided cautionary alert only. The study indicated that multi-faceted and streamlined CDS alerts were both associated with slight increases in family planning services; however there was no difference in the relative improvement between the two arms. The multi-faceted CDS group reported a greater increase in the number of times they counseled women about the risks of medication use during pregnancy. The streamlined CDS group reported greater clinician satisfaction with CDS usability. 

Harnessing Health Information Technology to Prevent Medication-Induced Birth Defects - Final Report

Citation:
Schwarz, E. Harnessing Health Information Technology to Prevent Medication-Induced Birth Defects - Final Report. (Prepared by the University of Pittsburgh under Grant No. R18 HS017093). Rockville, MD: Agency for Healthcare Research and Quality, 2011. (PDF, 779.7 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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