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Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr.

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Patient Safety and Quality: An Evidence-Based Handbook for Nurses.

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Chapter 16Prevention—Safety and Quality

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Carol J. Loveland-Cherry, Ph.D., R.N., F.A.A.N., professor and executive associate dean, University of Michigan School of Nursing. E-mail: ude.hcimu@dnalevoL

Background

To date, the preponderance of research on patient safety and the transformation of the work environment has focused on inpatient, acute care settings. Institute of Medicine (IOM) reports1, 2 clearly recommend that work be done on “studies and development of methods to better describe, both qualitatively and quantitatively, the work nurses perform in different care settings”2 (p. 325). Specifically, the recommendation is that research on patient safety needs to be addressed across care settings. Preventive services, primary care, and ambulatory care settings are areas in which there is a more limited body of work related to patient safety. Yet, these nonacute care settings constitute growing loci of health care services. This chapter will review the extant research on patient safety in preventive services, primary care, and ambulatory care settings. Preventive services, broadly defined, include screening, counseling, and chemoprophylaxis. This chapter will not focus on prevention of adverse events in ambulatory care or inpatient settings.

The Surgeon General’s report3 and subsequent plans for ensuring the health of the nation4, 5 emphasize the role of prevention in addressing the leading causes of morbidity and mortality. Clinicians play important roles in both primary and secondary prevention.6 Primary prevention is directed at measures to avoid or prevent the onset of disease or adverse condition. Secondary prevention focuses on the identification and treatment of asymptomatic individuals who have identified risk factors to prevent the development of active disease and/or reduce morbidity and mortality. Preventive services encompass health care provided in primary care settings, such as office-based practices and clinics, and in community-based settings. Preventive services are less regulated and controlled than health care services provided in institutions such as hospitals, long-term care facilities, and nursing homes. Not only have preventive services increased and become a central component of primary health care, these services also have become a focus of scrutiny in terms of quality and safety6 (p. 13). Screening, counseling, preventive medications, skill building, and behavioral change strategies comprise the major foci of preventive services.

Two national task forces have been charged with the evaluation of preventive services. The Agency for Healthcare Research and Quality (AHRQ) convened the United States Preventive Services Task Force (USPSTF), an independent body of experts, to evaluate and make recommendations for clinical preventive services. The Centers for Disease Control and Prevention (CDC) established the Community Task Force to evaluate public health prevention programs.7 Both task forces focus on establishing the efficacy of prevention strategies and also consider the relative harms and benefits of preventive services. The recommendations of these two task forces are available in print and online (http://www.ahrq.gov/clinic/prevenix.htm; http://www.thecommunityguide.org/) and will not be reviewed in this chapter.

Several IOM reports have emphasized the need to address not only the efficacy and effectiveness of health care strategies, but also patient safety.8 The report To Err is Human: Building a Safer Health System8 defines important terms. Safety is defined as “freedom from accidental injury” (p. 4) and error as “failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim” (p. 28). Error can occur in either the planning or execution of health care services. In preventive services, the challenges are defining and tracking safety issues or adverse events. Thus, identification of literature related to patient safety and quality of care in preventive services is difficult. Further, with few exceptions, the studies are of medical errors. The studies of medical errors and adverse events cover doctors and other primary health care providers, such as nurse practitioners.

The research evidence for patient safety in preventive services falls into five distinct groups: identification and classification of errors in primary care, harms of screening, harms of information technology, errors arising from language in preventive services, and potential interventions to prevent errors and adverse events. The evidence in each of the first four groups will be summarized and assessed in this chapter; the potential interventions will be included within each of the relevant categories.

Research Evidence

Errors in Preventive Services/Primary Care

In the United States, the literature on patient safety has focused primarily on the inpatient, acute care setting. In contrast, a growing literature in the United Kingdom focuses on identifying, tracking, and assessing errors in primary care. Seven manuscripts describe some aspect of errors in preventive services, primary care, or ambulatory services. The first priority for promoting patient safety in primary care was to identify the most common errors that occur in primary care.9

Researchers have used several different methodologies to identify errors in primary care. The approaches include observational prospective studies,10, 11 review of malpractice claims,12 reports from physicians,13, 14 and interviews with adult patients.15 One systematic review has summarized literature in this area published between 1965 and 2001.16 The different methodologies, including study length and modes of data collection, make it difficult to compare rates of errors or adverse events. The number of events reported were

  • 117 errors for 15 physicians in 83 visits across 7 offices over 3 half-day sessions11
  • 221 incidents from interviews with 38 patients asking them to recall events that occurred at any time in the past15
  • 344 incidents from 42 physicians over 20 weeks13
  • 940 incidents over 2 weeks across 10 practices14
  • 805 incidents occurring between October 1993 and June 1995 from 324 physicians10
  • 5,921 incidents from claims data for over a 15-year period12
  • 1,223 incidents from 4 articles published 1995-200216

Regardless of the methodology, similar categories of errors and events were identified and patterns emerged that provided the basis for development of classification systems. Dovey and colleagues13 developed a taxonomy based on the identified types of errors and sources of errors. The most general groupings of errors resulted in two major categories: process errors, and knowledge and skills errors. Each of the two categories had three additional levels of specificity. For example, a process error in investigating a patient’s condition, specifically in the process of laboratory investigations, might involve a wrong test being ordered or a test not ordered when appropriate. Bhasale and colleagues10 classified incidents as pharmacological (e.g., inappropriate drug), nonpharmacological (e.g., treatment omitted/delayed), diagnostic (e.g., missed), or equipment (e.g., malfunction/ineffective). Preventable harms identified by patients were classified as psychological (e.g., personal worth), physical (e.g., pain) or economic/other (e.g., avoidable personal medical expense).15 Elder and colleagues11 described office administration errors (i.e., charting, general office administration), physician-related errors, patient communication errors, and preventable adverse events. Rubin and colleagues14 noted six categories of errors: prescriptions, communication, equipment, appointments, clinical, and others. Elder and Dovey16 identified three categories: diagnosis—related to symptoms or prevention with either missed or delayed diagnosis; treatment—either drug or nondrug as incorrect/inappropriate, delayed or omitted; and preventive services—inappropriate, delayed, omitted, or procedural complication. In addition to classifying types of errors, Elder and Dovey identified related factors, such as clinician factors (clinical judgment and procedural skills error), communication factors (clinician–patient, clinician–clinician/health care system personnel), administration factors (clinician, pharmacy, ancillary providers, office setting), and blunt-end factors (personal and family issues of clinicians and staff, insurance company regulations, government regulations, funding and employers, physical size and location of practice, general health care system).16 Kuzel and colleagues15 offered a similar list of access breakdown, communication breakdown, relationship breakdown, technical error, and inefficiency of care.

Bhasale and colleagues10 also identified differences in individuals involved in preventable incidents. The incidents involved slightly more females (58 percent) than males and more older individuals 25 years and older (around 85 percent) than younger ones. Overall, infants and females older than 75 years were overrepresented in the incidents. The same study described factors that mitigated the outcomes of adverse events: early intervention by reporting physician, patients, patient’s relative, another provider; plain good fortune; patient’s good physical or psychological condition; prior experience or training; reliability of professional backup; skilled assistant; high awareness via quality assurance activities; and reliability of equipment.

The data from this group of studies, regardless of the methodology, provide both identification of errors or adverse events in preventive services or primary or ambulatory care and direction for interventions. Dovey and colleagues’13 major classifications of process and knowledge and skills errors provide major conceptual groupings within which to examine the specific error identified in the schema. Combined with Bhasale and colleagues’10 identification of mitigating factors, this group of studies provides direction for both identifying errors and adverse events and for proposing interventions to address them. The findings specific to preventive services imply that errors or adverse events result from screening, counseling, or chemoprophylaxis being inappropriate, delayed, or omitted, or involve procedural complications. These errors or adverse events may arise from either process errors or knowledge and skill errors. Process errors are defined as resulting from some aspect of care delivery systems.13 Examples of process errors include care that was provided but not documented in the patient’s chart (e.g., a mammogram performed but not recorded) or a medication not being dispensed as ordered. Knowledge and skill errors are related to providers’ clinical skills and knowledge (e.g., a wrong or missed diagnosis or a wrong treatment based on lack of clinician knowledge).

The next section examines two groups of studies that represent specific instances of areas with potential harms: medication errors and screening activities.

Adverse Drug Events in Preventive Services/Primary Care/Ambulatory Care

Twelve studies17–28 examined adverse drug events in primary or ambulatory care. None of these studies were specific to chemoprophylaxis. Rather, the foci were similar to those in acute care or inpatient care, but occurred in ambulatory or primary care settings. Thus, this group of studies was not included in this review as adverse drug events are covered in other chapters in this book.

Potential Harms Related to Screening in Preventive Services

Screening is a major intervention in preventive services. Although a number of benefits have been associated with screening activities in preventive services, risks have also been identified. Potential risks of screening include misunderstanding test results, misdiagnosis, mislabeling, stigmatization, and decreased psychological well-being.28 Three major reviews30–32 and 10 studies33–42 examined the benefits, risks, and harms associated with screening activities. The most common screening tests reported were for breast, cervical, prostate, and colorectal cancers.

Screening mammography is recommended for women ages 40 years and older, but there is limited evidence for the upper age for screening. There are potential harms associated with mammography. The incidence of ductal carcinoma in situ (DCIS) increases in elderly women. The risk of death from DCIS progressing to invasive breast cancer is very low; therefore, the risks of surgery to treat DCIS outweigh the benefits. Three studies found that approximately 8 percent of women ages 70 years and older had an abnormal result from mammography, and 85 percent to 92 percent of those with an abnormal result did not have cancer.31, 33, 35 A slightly lower percentage of clinical breast examinations (3.9 percent) resulted in abnormal results, but a higher percentage of these women (97 percent) did not have cancer on followup.33 Thus, potential harms of screening mammography or clinical breast examination include unnecessary biopsy and the stress and worry related to the possibility have having cancer.20

Similarly, overdiagnosis and overtreatment in 40 percent of women34 are potential harms of cervical cancer screening. Results of a cohort study of Pap smear results in postmenopausal women 44–79 years of age37, 31 demonstrated a high incidence of false positive results (all but 1 of 110 abnormal Pap smears). Other harms of Pap smear screening include identification and treatment of inconsequential disease, high anxiety, low self-esteem, and disrupted partner relationships.31

In addition to the potential harms of psychological distress and false-positive results, perforation, bleeding, stroke, myocardial infarctions, Fournier gangrene and thrombophlebitis, and treatment of inconsequential disease are harms associated with colonoscopy in 3 of 1,000 screenings.31 Woolf 36 identified potential harms of PSA testing for men without disease and for those with prostate cancer. False-positive results cause unnecessary followup procedures and anxiety. Treatment of inconsequential disease results in unnecessary procedures and potential complications.

These potential harms of cancer screening are especially important in decisionmaking for elderly individuals, as there are fewer studies and evidence for this segment of the population. Based on analysis of all-cause and cancer-specific mortality from the National Center for Health Statistics and Surveillance Epidemiology and End Results Survey (SEER), Rich and Black38 concluded that potential harms may outweigh the small benefit of screening for breast cancer, colon cancer, and cervical cancer in elderly individuals. Volk and colleagues39 evaluated a patient-educational approach to shared decisionmaking for prostate cancer screening that included both potential benefits and harms of screening. The results of the randomized clinical trial indicated positive outcomes in terms of increased knowledge and more informed decisions regarding prostate cancer screening. Walter and Covinsky40 advocated including potential harms in their framework for individual decisionmaking in cancer screening in elderly individuals.

In summary, harms of various cancer screening procedures have been identified. However, it is important to evaluate the potential harms for each procedure relative to the benefits for specific age groups and other individual considerations. Thus, the USPSTF recommends routine screening mammography for women ages 40 years and older; routine screening for cervical cancer in women who have been sexually active and have a cervix, but against routine screening for women older than 65; and routine colorectal cancer screening for men and women 50 years and older. However, the USPSTF is currently updating recommendations for screening for colorectal, cervical, and breast cancer. The USPSTF currently recommends against routine screening for pancreatic cancer or ovarian cancer. The task force concluded that there was insufficient evidence to recommend for or against routine screening for prostate cancer, skin cancer, oral cancer, or lung cancer.

Errors and Adverse Events Related to Language in Preventive Services

A small but interesting group of studies41, 42 and one review43 examined the role of language either as a barrier to receiving care or as a factor in adverse events. This area of study is particularly relevant given the growth of ethnic populations in the United States. Nearly 20 percent of U.S. citizens over the age of 5 years speak a language other than English at home.41 However, it is estimated that “more than 50 percent of adults over the age of 18 who speak a language other than English at home speak English ‘very well’”41 (p. 254). Lack of proficiency in English may result in communication problems with health care providers and decreased utilization of care, and it may reflect cultural values and beliefs.42 Results of two studies supported the potential for harm resulting from women not receiving preventive services42 and infants of parents whose primary language is not English not receiving recommended preventive care.41 Using data from a cross-sectional survey of 22,448 women completing the 1990 Ontario Health Survey, logistic regression calculated odds ratios for receiving breast examinations, mammograms, and Pap tests for women who reported a language other than English as spoken at home versus those who reported English as the primary language, adjusting for socioeconomic factors, contact with the health care system, and cultural measures.42 Results indicated that women who reported a language other than English spoken at home were less likely to receive important preventive services than those who spoke English at home. These findings persisted after adjusting for the confounding variables. French-speaking women were less likely to receive breast examinations or mammograms, and women speaking other languages were less likely to receive Pap tests.

In a retrospective cohort study of 38,793 year-old infants enrolled in Medicaid, relative risk of receiving appropriate and timely preventive care was estimated using multivariate regression.41 Primary language of parents, race and ethnicity, rural residence, and managed-care plan were independent variables. Results indicated that “fewer than one in six infants enrolled in Medicaid in their first year of life received recommended preventive care as defined by the [American Academy of Pediatrics]”41 (p. 257). Further, infants whose parents reported that English was not their primary language were half as likely to receive recommended preventive care. When confounding factors were considered, results indicated that Asian-American infants were less likely to experience disparities in preventive care associated with primary language than White, Hispanic, and African-American infants.

While the evidence is limited, the results of these two studies support the potential for adverse events resulting from language barriers. An obvious strategy would be to reduce the language barriers. A systematic review of the impact of medical interpreter services on the quality of health care43 indicated that health care was compromised for patients not proficient in English; they were less likely to receive preventive screening, more likely to have a greater number of tests done at higher costs; and were less satisfied with care. Additionally, the quality of care is further compromised when untrained or ad hoc interpreters, especially children, are used. However, availability of trained interpreters was positively associated with obtaining preventive screening, such as mammograms. In light of the changing demographics and diversity of the U.S. population, this small but growing body of literature on language as a barrier or factor in adverse events in preventive services provides another challenge for the health care systems.

Errors and Adverse Events Related to Information Technology in Preventive Services

A final group of studies explored the impact of the growing use of information technology (IT) in health care. IT in health care has been examined from several perspectives. There is a literature on the use of e-mail and the Internet by consumers, another on the adoption of IT by health care systems, and a third on the unintended consequences of the use of IT in health care.

Although reports of the extent of use of the Internet and e-mail for health care vary from 35 percent to 80 percent of adults in the United States,44 the actual and potential impact of IT in health care is significant. A survey of a nationally representative sample of 8,935 (69.4 percent of a random sample of 12,878) adults age 21 years and over, individuals age 50 and older, and veterans identified four frequent uses of the Internet and e-mail.44 The most common use of the Internet (reported by 40 percent of respondents) was for information or advice about health or health care. This was followed by use of e-mail or the Internet to communicate with family or friends about health, use of e-mail or the Internet to communicate with a health care professional, and use of these technologies to communicate with other people with similar health conditions. However, use of the Internet for health care was a relatively infrequent activity (every 2 to 3 months or less frequently). Individuals younger than 75 years old and women were more likely to use the Internet and e-mail for health. Results also indicated that e-mail and the Internet were used most often to gain health-related information and had little effect on the number of contacts with health care providers or to obtain a prescription drug.

IT has been more developed and adopted for financial management than for quality and safety purposes.45 Results from a study of IT use in a variety of health care settings in the Boston and Denver areas indicate that physician practices (the most common site of preventive services), which are generally run as “small independent practices”46 (p. 6), use IT primarily to manage billing and schedule patients. Poon and colleagues46 propose that the limited use of electronic health records in these practices is related to the perception of limited proven benefits relative to the required financial and time commitments needed.

Based on results from separate qualitative studies, Ash, Berg, and Coiera47 presented evidence that implementation of electronic patient care information systems (PCISs) in many instances appears to promote rather than limit errors. They argued that factors, including the complexity of PCISs and the physical space and other system characteristics, contributed to the occurrence of “unintended consequences”47 (p. 104). The authors identified errors in two general areas: process of entering and retrieving information, and communication and coordination processes. They attributed errors in entry and retrieval of information to the high level of interruption and “cognitive overload” related to practice environments. Further, the authors proposed that errors in communication and coordination were related to the assumptions of a linear workflow and communication as information transfer. They advocated for educating health care providers to have a critical approach to PCISs, that developers and vendors of PCISs be clearer about the limitations of the systems, and that clinicians be supported in continuing interactions that are part of monitoring the safety of clinical systems.

Research that evaluates the ability of IT systems to promote patient safety and reduce errors is limited but growing,45 especially in preventive services. Five studies48–52 examined the use of an electronic health record system to generate physician, telephone, and letter reminders for patients to obtain preventive services. Results indicated that all three types of reminders were effective. There is evidence supporting the reduction of medication errors and adverse events through the use of computerized physician order entry and online decision support.53 Bakken and colleagues54 advocated the use of informatics to address errors associated with impaired access to information through the use of personal digital assistants, to address communication failures associated with adverse events, to promote the use of standardized practice patterns, and to provide automated surveillance to detect and prevent real-time errors. The proposed approaches have direct application in preventive care settings.

Evidence-Based Practice Implications

The evidence on errors and adverse events in preventive care provides preliminary direction for practice. Few if any studies proposed or evaluated approaches to avoid or reduce errors and adverse events in prevention. However, a growing number of studies have evaluated strategies to reduce errors and adverse events in acute, inpatient, ambulatory, primary, and home care, and they provide potential direction for prevention as the field matures. Leape’s55 directives—identify what works, ensure that the patient receives it, and deliver it flawlessly—are relevant for ensuring safety in prevention. At this point, perhaps the most viable approach to assure patient safety in prevention practice is use of the guidelines of the USPSTF, AHRQ, the Community Task Force, and CDC.

Research Implications

The greatest challenge in patient safety and quality in preventive care is the lack of a strong body of evidence on which to base our understanding of errors and adverse events in prevention and, more broadly, in ambulatory and primary care settings. Research in preventive care is limited relative to that in acute care, inpatient settings, and home care. The focus has been on research evaluating the efficacy of preventive services, which includes an evaluation of the potential and actual harms of the services in order to determine the net benefit. While there is a growing body of evidence for safety and quality in health care in primary and ambulatory settings, there is very limited literature on harms or adverse events in preventive care and how to avoid them. Additionally, much of the research is observational and descriptive, with few interventions being tested. The research on identifying and describing errors in primary and ambulatory care has relevance for preventive care. However, there is a need for research directed at explicating errors and adverse events in preventive care.

Once the types of errors and adverse events have been identified and described, then research describing the factors associated with these events is needed. Further, there is limited evidence on basic questions, such as when to begin or discontinue screening, chemoprophylaxis, or counseling and implications for adverse events or potential harms. Only then can nurses and other health care professionals develop and test strategies to reduce risk related to preventive services. For example, the evaluation of the use of IT to decrease risks and adverse events is a major focus in acute care, ambulatory care, and primary care settings. Would the use of IT approaches be appropriate in preventive services? How can the human factor principles of standardization, simplification, and use of protocols and checklists55 be facilitated by the use of IT in prevention? Finally, the difficulties inherent in research on preventive services present significant challenges, including timing of services and consideration of contextual factors (age, culture, race/ethnicity, gender, setting, etc.).

Thus far, the evidence presented attempts to answer the following: (1) How do errors and adverse events in prevention differ from those for other types of health care services? (2) How do contextual factors contribute to potential errors and adverse events in prevention? and (3) What are potential areas of research for nursing that would contribute to addressing patient safety in prevention? The following areas are the critical research gaps:

  • Descriptive data on errors and adverse events in preventive services
  • Data on factors related to errors and adverse events in preventive services
  • Evaluation of interventions to reduce errors and adverse events in preventive services.

Conclusion

The limited body of evidence on errors and adverse events in preventive services, especially from a nursing perspective, supports the need for additional research to move ahead in the area of patient safety. It is likely that some of the evidence from studies in ambulatory and primary care will provide direction for research and subsequent evidence-based practice in preventive care. However, there may be unique errors and adverse events associated with preventive services. It is clear that there is potential for errors and adverse events in preventive services, but additional evidence is needed to explicate what they are. The evidence that is available is largely from either descriptive studies or from randomized controlled trials (RCTs) examining the efficacy of preventive services, specifically in cancer screening. There is less systematic evaluation of counseling interventions for prevention. The nature of preventive services and their outcomes and where they are delivered increase the complexity of both establishing an evidence base and implications for practice. The continued evaluation of using information technology to address risks and adverse events is a promising area for study and practice.

The focus in safety and quality research in health care has been on preventable events rather than on preventive services. Screening, counseling, and chemoprophylaxis are the key elements of preventive services. The evidence base on errors and adverse events in preventive services is limited and needs to be developed to provide direction for practice.

Search Strategy

A search of the CINAHL®, Ovid MEDLINE®, Cochrane Database of Systematic Reviews electronic databases, and the AHRQ Web site from 1990 to 2006 was conducted using the following search terms: patient safety, safety, quality, preventive services. The search was further limited to research studies and reviews. A total of 115 references were identified and the abstracts reviewed. The criteria for inclusion in the review for this chapter were (1) systematic review of published research; (2) nonsystematic review of published research; and (3) published research that used randomized control, comparison, and pretest–post-test no control designs. Based on the review of the abstracts using these criteria, 6 reviews, 10 commentary or background articles, and 32 studies were selected for inclusion in the review.

Evidence Table

Evidence Table

Prevention—safety and quality

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