Women & Health, 55:280–296, 2015 Copyright © Taylor & Francis Group, LLC ISSN: 0363-0242 print/1541-0331 online DOI: 10.1080/03630242.2014.996724
Patient-Centered Prenatal Counseling: Aligning Obstetric Healthcare Professionals With Needs of Pregnant Women RUTH M. FARRELL, MD, MA Department of Obstetrics and Gynecology; Department of Bioethics; and Genomic Medicine Institute, Cleveland Clinic, Cleveland, Ohio, USA
BENJAMIN NUTTER, MS Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio, USA
PATRICIA K. AGATISA, PhD, MS Department of Bioethics, Cleveland Clinic, Cleveland, Ohio, USA
The first trimester aneuploidy screen (FTS) continues to be a leading approach to identify the risk of fetal aneuploidy. This study evaluated how obstetric (OB) professionals counsel women about FTS as one of a growing number of options to assess fetal health. A survey was completed by OB professionals (board-certified obstetrician/gynecologists and certified nurse midwives) between February and March 2011: (1) to identify knowledge and practice patterns with regard to FTS, and (2) to compare pregnant women’s educational needs and decision-making preferences with clinicians’ perceptions of these factors. A total of 216 surveys (11 percent) were completed by OB professionals and analyzed. Several barriers to effective patient counseling were identified, including gaps in obstetric professionals’ mastery of the screening test characteristics and variable approaches to discuss concepts of aneuploidy risk. OB participants reported limited confidence in discussing patient-valued topics, specifically post-screen options and pregnancy termination. Discordance was identified between OB professionals’ perceptions of pregnant women’s educational needs and decision-making preferences specific to FTS and historical data recently collected from 139 pregnant women who underwent Received October 19, 2013; revised April 18, 2014; accepted April 29, 2014. Address correspondence to Ruth M. Farrell, MD, MA, Department of Bioethics, Cleveland Clinic, 9500 Euclid Avenue, JJ-60, Cleveland, OH 44195. E-mail: [email protected] 280
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the FTS. Study findings illustrate the need for clinician-targeted strategies to support pregnant women as they formulate informed decisions about the tests that may have a salient impact on their prenatal care decisions. KEYWORDS
genetic testing, prenatal care, reproductive health
INTRODUCTION Advances in genetic science when joined with changes in clinical practice guidelines can have a striking impact on the delivery of women’s reproductive healthcare. Until recently, tests to identify the risk or presence of a fetal aneuploidy were primarily reserved for pregnant women at increased risk for having a pregnancy affected by Trisomy 21 (Down syndrome), Trisomy 13, or 18 because of advanced maternal age. As a result of updates to clinical practice guidelines, it is now recommended that obstetric (OB) professionals offer aneuploidy screening to all pregnant women, independent of their baseline risk of fetal aneuploidy (ACOG 2007; Driscoll and Gross 2009). As approximately four million women deliver in the United States annually (Martin et al. 2011), such policy changes have important ramifications for the care delivered to women during pregnancy. Just prior to this recommendation, the first trimester aneuploidy screen (FTS) emerged as a new approach to screening. FTS provides fetal aneuploidy risk information weeks earlier than the conventional second trimester quadruple screen, allowing pregnant women to make key prenatal care decisions at a much earlier time in pregnancy. FTS was rapidly integrated as a routine part of prenatal care because of this distinct advantage as well as due to its emergence in a timeframe in which aneuploidy screening became universally offered to all pregnant women (Cleary-Goldman et al. 2006; De Graaf et al. 2002; Deverill and Robson 2006; Driscoll, Morgan, and Schulkin 2009; Philipson, Callahan, and Jelovsek 2008; Sharma et al. 2005). FTS continues to be an important approach to aneuploidy screening. Unlike noninvasive prenatal testing, which is currently only recommended for women of advanced maternal age (Norton, Brar, and Weiss 2012), FTS can be used in a diversity of populations, making it available to both low-risk and high-risk patients. One of the key aspects associated with the introduction of a new prenatal screen is to ensure that pregnant women have the information and resources they need to make informed choices that reflect their personal values and beliefs (Harris et al. 2001; Lyerly et al. 2007; Shieh and Halstead 2009). OB healthcare professionals play an integral role in making sure this takes place by facilitating a patient-centered, informed decisionmaking process with their patients. Such a process entails a collaborative
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dialogue between the clinician, who presents information about available medical options, and the patient who has the opportunity to express her preferences and values about those options and integrate them into her healthcare decisions (Barry and Edgman-Levitan 2012; Stewart et al. 2003). A patient-centered discussion about FTS should explore the woman’s values and preferences with regards to prenatal genetic testing; present the indications, benefits, limitations, and risks of this screen; place this information in the context of other available tools to assess fetal health; and explore possible prenatal options based on results. FTS presents a unique challenge to this process as most women do not present for prenatal care until the end of the first trimester (Ayoola et al. 2010). This allows OB professionals often only one opportunity to build the foundations of an effective, patientcentered, informed decision-making process before the window for early risk assessment has passed. The specific characteristics of FTS and its continued role in the delivery of prenatal care highlight the need to examine the methods and resources OB professionals use to counsel patients about FTS as one of a growing array of prenatal screening and diagnostic options. The objective of the study was to identify OB professionals’ clinical counseling practices regarding FTS and compare these practices with the decision-making needs and preferences of pregnant women. Such data are critical, as they speak to the status of patientcentered counseling and informed decision-making regarding a significant aspect of the delivery of prenatal care. In addition, because FTS represents the most recent screen fully integrated into prenatal care, these data also contribute to understanding the challenges inherent to the introduction of new genetic science and technology in prenatal care.
METHODS Study Design A cross-sectional study was conducted from February–March 2011 to identify OB professionals’ clinical counseling practices regarding FTS. Participants included a sample of OB professionals who deliver prenatal care and counsel pregnant women about available prenatal screen and diagnostic tests. A contact list of OB professionals was compiled from Ohio Medical Board registries and used for distribution of the questionnaire. Inclusion criteria included board-certified obstetrician/gynecologists and certified nurse midwives (CNMs) who were currently in practice, provided prenatal care, and offered FTS. Individuals who met inclusion criteria were contacted via an email, which contained a description of the study and a link to complete an online survey. Potential participants received up to two email reminders over a period of 8 weeks to complete the survey. Participants completed the survey online using Research Electronic Data Capture Survey
Aligning Obstetric Professionals With Pregnant Women
283
(REDCap), a tool for building and managing surveys (Harris et al. 2009). The REDCap instrument ensured compliance with informed consent procedures, as participants could not proceed with the survey unless they checked a box providing consent to participate. A total of 2,013 invitations to participate were distributed to board-certified OB professionals, and 216 surveys (11 percent) were sufficiently completed for data analysis. Five physicians were retired and/or were no longer practicing obstetrics, and six surveys were returned as undeliverable. All procedures and materials were approved by the Cleveland Clinic Institutional Review Board prior to study initiation.
Data Collection The survey was used to evaluate measures related to OB professionals’ knowledge, communication skills, and practice patterns regarding FTS. The instrument was developed in conjunction with experts in the areas of clinical genetics, obstetrics/gynecology, and medical decision making and was based on the investigators’ previous work (Farrell, Nutter, and Agatisa 2011; Farrell et al. 2011). The survey consisted of a combination of multiple choice questions, Likert-scale responses, and open-ended items to assess: (1) medical knowledge pertinent to fetal aneuploidy, agerelated risk of fetal aneuploidy, and procedures and protocols associated with FTS; (2) clinical practice patterns regarding patient education and informed consent for FTS; (3) self-assessment of communication skills specific to prenatal genetic testing and FTS; and (4) perception of patients’ FTS decision-making needs and priorities. The latter items mirrored those included in a survey completed by patients at the time of FTS that was previously reported (Farrell, Nutter, and Agatisa 2011). These parallel items allowed for a comparison of informational needs from the perspectives of OB professionals and pregnant women. In this prior study, the study coordinator recruited pregnant women 18–45 years of age who presented for FTS at the Cleveland Clinic between June 2010 and January 2011. Of the 154 women recruited, 139 completed a survey (90.3 percent). The mean age of this group was 33.9 years (range 20–45 years). Over half of the patients described themselves as white (74 percent) and had a prior pregnancy (69 percent). The survey instrument was developed to include knowledge domains from current professional guidelines for patient (ACOG 2007). Items were also developed using qualitative data collected from focus groups as reported elsewhere (Farrell et al. 2011), as well as after piloting the survey at eight Cleveland Clinic prenatal clinics.
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Statistical Analysis Analyses were performed using R 2.12.2 statistical software. Categorical responses were summarized by frequency and percentages for the total sample, type of training (obstetrician/gynecologist or CNM), years of clinical experience (
Patient-Centered Prenatal Counseling: Aligning Obstetric Healthcare Professionals With Needs of Pregnant Women RUTH M. FARRELL, MD, MA Department of Obstetrics and Gynecology; Department of Bioethics; and Genomic Medicine Institute, Cleveland Clinic, Cleveland, Ohio, USA
BENJAMIN NUTTER, MS Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio, USA
PATRICIA K. AGATISA, PhD, MS Department of Bioethics, Cleveland Clinic, Cleveland, Ohio, USA
The first trimester aneuploidy screen (FTS) continues to be a leading approach to identify the risk of fetal aneuploidy. This study evaluated how obstetric (OB) professionals counsel women about FTS as one of a growing number of options to assess fetal health. A survey was completed by OB professionals (board-certified obstetrician/gynecologists and certified nurse midwives) between February and March 2011: (1) to identify knowledge and practice patterns with regard to FTS, and (2) to compare pregnant women’s educational needs and decision-making preferences with clinicians’ perceptions of these factors. A total of 216 surveys (11 percent) were completed by OB professionals and analyzed. Several barriers to effective patient counseling were identified, including gaps in obstetric professionals’ mastery of the screening test characteristics and variable approaches to discuss concepts of aneuploidy risk. OB participants reported limited confidence in discussing patient-valued topics, specifically post-screen options and pregnancy termination. Discordance was identified between OB professionals’ perceptions of pregnant women’s educational needs and decision-making preferences specific to FTS and historical data recently collected from 139 pregnant women who underwent Received October 19, 2013; revised April 18, 2014; accepted April 29, 2014. Address correspondence to Ruth M. Farrell, MD, MA, Department of Bioethics, Cleveland Clinic, 9500 Euclid Avenue, JJ-60, Cleveland, OH 44195. E-mail: [email protected] 280
Aligning Obstetric Professionals With Pregnant Women
281
the FTS. Study findings illustrate the need for clinician-targeted strategies to support pregnant women as they formulate informed decisions about the tests that may have a salient impact on their prenatal care decisions. KEYWORDS
genetic testing, prenatal care, reproductive health
INTRODUCTION Advances in genetic science when joined with changes in clinical practice guidelines can have a striking impact on the delivery of women’s reproductive healthcare. Until recently, tests to identify the risk or presence of a fetal aneuploidy were primarily reserved for pregnant women at increased risk for having a pregnancy affected by Trisomy 21 (Down syndrome), Trisomy 13, or 18 because of advanced maternal age. As a result of updates to clinical practice guidelines, it is now recommended that obstetric (OB) professionals offer aneuploidy screening to all pregnant women, independent of their baseline risk of fetal aneuploidy (ACOG 2007; Driscoll and Gross 2009). As approximately four million women deliver in the United States annually (Martin et al. 2011), such policy changes have important ramifications for the care delivered to women during pregnancy. Just prior to this recommendation, the first trimester aneuploidy screen (FTS) emerged as a new approach to screening. FTS provides fetal aneuploidy risk information weeks earlier than the conventional second trimester quadruple screen, allowing pregnant women to make key prenatal care decisions at a much earlier time in pregnancy. FTS was rapidly integrated as a routine part of prenatal care because of this distinct advantage as well as due to its emergence in a timeframe in which aneuploidy screening became universally offered to all pregnant women (Cleary-Goldman et al. 2006; De Graaf et al. 2002; Deverill and Robson 2006; Driscoll, Morgan, and Schulkin 2009; Philipson, Callahan, and Jelovsek 2008; Sharma et al. 2005). FTS continues to be an important approach to aneuploidy screening. Unlike noninvasive prenatal testing, which is currently only recommended for women of advanced maternal age (Norton, Brar, and Weiss 2012), FTS can be used in a diversity of populations, making it available to both low-risk and high-risk patients. One of the key aspects associated with the introduction of a new prenatal screen is to ensure that pregnant women have the information and resources they need to make informed choices that reflect their personal values and beliefs (Harris et al. 2001; Lyerly et al. 2007; Shieh and Halstead 2009). OB healthcare professionals play an integral role in making sure this takes place by facilitating a patient-centered, informed decisionmaking process with their patients. Such a process entails a collaborative
282
R. M. Farrell et al.
dialogue between the clinician, who presents information about available medical options, and the patient who has the opportunity to express her preferences and values about those options and integrate them into her healthcare decisions (Barry and Edgman-Levitan 2012; Stewart et al. 2003). A patient-centered discussion about FTS should explore the woman’s values and preferences with regards to prenatal genetic testing; present the indications, benefits, limitations, and risks of this screen; place this information in the context of other available tools to assess fetal health; and explore possible prenatal options based on results. FTS presents a unique challenge to this process as most women do not present for prenatal care until the end of the first trimester (Ayoola et al. 2010). This allows OB professionals often only one opportunity to build the foundations of an effective, patientcentered, informed decision-making process before the window for early risk assessment has passed. The specific characteristics of FTS and its continued role in the delivery of prenatal care highlight the need to examine the methods and resources OB professionals use to counsel patients about FTS as one of a growing array of prenatal screening and diagnostic options. The objective of the study was to identify OB professionals’ clinical counseling practices regarding FTS and compare these practices with the decision-making needs and preferences of pregnant women. Such data are critical, as they speak to the status of patientcentered counseling and informed decision-making regarding a significant aspect of the delivery of prenatal care. In addition, because FTS represents the most recent screen fully integrated into prenatal care, these data also contribute to understanding the challenges inherent to the introduction of new genetic science and technology in prenatal care.
METHODS Study Design A cross-sectional study was conducted from February–March 2011 to identify OB professionals’ clinical counseling practices regarding FTS. Participants included a sample of OB professionals who deliver prenatal care and counsel pregnant women about available prenatal screen and diagnostic tests. A contact list of OB professionals was compiled from Ohio Medical Board registries and used for distribution of the questionnaire. Inclusion criteria included board-certified obstetrician/gynecologists and certified nurse midwives (CNMs) who were currently in practice, provided prenatal care, and offered FTS. Individuals who met inclusion criteria were contacted via an email, which contained a description of the study and a link to complete an online survey. Potential participants received up to two email reminders over a period of 8 weeks to complete the survey. Participants completed the survey online using Research Electronic Data Capture Survey
Aligning Obstetric Professionals With Pregnant Women
283
(REDCap), a tool for building and managing surveys (Harris et al. 2009). The REDCap instrument ensured compliance with informed consent procedures, as participants could not proceed with the survey unless they checked a box providing consent to participate. A total of 2,013 invitations to participate were distributed to board-certified OB professionals, and 216 surveys (11 percent) were sufficiently completed for data analysis. Five physicians were retired and/or were no longer practicing obstetrics, and six surveys were returned as undeliverable. All procedures and materials were approved by the Cleveland Clinic Institutional Review Board prior to study initiation.
Data Collection The survey was used to evaluate measures related to OB professionals’ knowledge, communication skills, and practice patterns regarding FTS. The instrument was developed in conjunction with experts in the areas of clinical genetics, obstetrics/gynecology, and medical decision making and was based on the investigators’ previous work (Farrell, Nutter, and Agatisa 2011; Farrell et al. 2011). The survey consisted of a combination of multiple choice questions, Likert-scale responses, and open-ended items to assess: (1) medical knowledge pertinent to fetal aneuploidy, agerelated risk of fetal aneuploidy, and procedures and protocols associated with FTS; (2) clinical practice patterns regarding patient education and informed consent for FTS; (3) self-assessment of communication skills specific to prenatal genetic testing and FTS; and (4) perception of patients’ FTS decision-making needs and priorities. The latter items mirrored those included in a survey completed by patients at the time of FTS that was previously reported (Farrell, Nutter, and Agatisa 2011). These parallel items allowed for a comparison of informational needs from the perspectives of OB professionals and pregnant women. In this prior study, the study coordinator recruited pregnant women 18–45 years of age who presented for FTS at the Cleveland Clinic between June 2010 and January 2011. Of the 154 women recruited, 139 completed a survey (90.3 percent). The mean age of this group was 33.9 years (range 20–45 years). Over half of the patients described themselves as white (74 percent) and had a prior pregnancy (69 percent). The survey instrument was developed to include knowledge domains from current professional guidelines for patient (ACOG 2007). Items were also developed using qualitative data collected from focus groups as reported elsewhere (Farrell et al. 2011), as well as after piloting the survey at eight Cleveland Clinic prenatal clinics.
284
R. M. Farrell et al.
Statistical Analysis Analyses were performed using R 2.12.2 statistical software. Categorical responses were summarized by frequency and percentages for the total sample, type of training (obstetrician/gynecologist or CNM), years of clinical experience (
