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Veterans Health Administration Primary Care Provider Adherence to Prescribing Guidelines for Systemic Hormone Therapy in Menopausal Women

Cordasco, Kristina M.; Yuan, Anita H.; Danz, Marjorie J.; Jackson, LaShawnta; Yee, Ellen F.; Tcheung, Lueng Sophia; Washington, Donna L.

The Journal for Healthcare Quality (JHQ): March/April 2019 - Volume 41 - Issue 2 - p 99–109
doi: 10.1097/JHQ.0000000000000183
Original Article
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Background: Systemic hormone therapy (HT) is effective for treating menopausal symptoms but also confers risks. Therefore, experts have developed clinical guidelines for its use.

Purpose: We assessed primary care guideline adherence in prescribing systemic HT, and associations between adherence and provider characteristics, in four Veterans Health Administration (VA) facilities.

Methods: We abstracted medical records associated with new and renewal systemic HT prescriptions examining adherence to guidelines for documenting indications and contraindications; prescribing appropriate dosages; and prescribing progesterone.

Results: Average guideline adherence was 58%. Among new prescriptions, 74% documented a guideline-adherent indication and 28% documented absence of contraindications. Among renewals, 39% documented a guideline-adherent indication. In prescribing an appropriate dose, 45% of new prescriptions were guideline-adherent. Among renewal prescriptions with conjugated equine estrogen doses ≥0.625 mg or equivalent, 16% documented the dosing rationale. Among 116 prescriptions for systemic estrogen in women with a uterus, progesterone was not prescribed in 8.

Conclusions: Guideline adherence in prescribing systemic HT was low among VA primary care providers. Failures to coprescribe progesterone put women at increased risk for endometrial cancer.

Implications: Intervention development is urgently needed to improve guideline adherence among primary care prescribers of systemic HT for menopause. Similar assessments should be conducted in community settings.

For more information on this article, contact Kristina M. Cordasco, Kristina.Cordasco@va.gov.

Funders: This work was funded by VA Health Services Research & Development CREATE project #CRE-12-031, “Controlled Trial of Tele-Support and Education for Women's Health Care in CBOCs.” Data from the DWHP Assessment of Workforce Capacity were provided by Dr. Susan Frayne, MD, MPH, which was created with funding from VA Women's Health Services (Patient Care Services). The views expressed within are solely those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

Presented at The Society of General Internal Medicine Annual Meeting; Denver, CO, April 11, 2018.

The authors declare no conflicts of interest.

This work was reviewed for compliance with ethical standards by the Institutional Review Board of the VA Greater Los Angeles Healthcare System. Trial registration: ClinicalTrials.gov, NCT01918072.

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Introduction

Women undergoing menopause, the permanent cessation of menstrual periods, commonly experience hot flashes, sweats, insomnia, and vaginal dryness.1,2 For some women, these symptoms significantly diminish their quality of life, and may be debilitating.3-5 Furthermore, the estrogen deficiency associated with the postmenopausal state is associated with bone loss leading to osteoporosis and fractures.6

Systemic hormone therapy (HT) with estrogen is effective in treating these menopausal symptoms.7-9 However, using systemic HT also confers increased risks of cancers, thromboembolic disease, gallbladder disease, and, potentially, cardiovascular events in older women.10-16 The 2002 and 2004 findings from the Women Health Initiative resulted in a paradigm-shift in practice and substantial declines in HT use.10,11,17,18 However, given their potentially significant benefits in treating menopausal symptoms, use of systemic HT persists, and experts have developed prescribing guidelines for HT.12-16,18,19

Current prescribing guidelines include specific indications for systemic HT use. Significant vasomotor symptoms, commonly referred to as “hot flashes,” are the primary indication for their use.12-15 A second indication for systemic HT is prevention of fractures in patients with osteoporosis, or significant risk for osteoporosis, when other osteoporosis therapies have already been considered.12-15 Systemic HT is also effective in treating vaginal dryness caused by atrophy. Although topical or local preparations without systemic absorption should be used first when treating isolated vaginal atrophy, systemic HT has been approved by the U.S. Food and Drug Administration (FDA) for this indication as well.12,13 Systemic HT should not be used to treat other menopause-associated symptoms, including sexual dysfunction, depression, cognitive decline, urinary tract disorders, nor the prevention of cardiovascular disease, diabetes, or other chronic diseases because current evidence does not support sufficient benefit outweighing risks.12-16 Contraindications to systemic HT include the patient having had breast cancer or any estrogen-sensitive malignant condition; endometrial hyperplasia; idiopathic venous thromboembolism; recent or current angina; myocardial infarction or stroke; untreated hypertension; active liver disease; or porphyria cutanea tarda.14,15 Experts agree that duration of systemic HT should be tailored for each patient, with symptoms being reassessed regularly to reconsider its risks and benefits, so that the patient is exposed to these risks for the shortest duration needed to relieve symptoms.12-16 As risks associated with systemic HT increase with higher doses of estrogen, experts recommend prescribing the lowest effective dose.12,13 Treatment should be initiated at a dose less than 0.625 mg of conjugated equine estrogen (CEE) or equivalent dosing for other formulations, and escalated only if therapeutic goals have not been met. Finally, multiple consensus guidelines state that concurrent administration of progesterone with estrogen is paramount for protecting against endometrial cancer.12-16 A woman with a uterus should always receive progesterone. Conversely, progesterone should not be prescribed to a woman with a total hysterectomy unless she has extensive endometriosis.

Despite the considerable effort to develop these guidelines to improve the safety of systemic HT prescribing, little is known about the extent to which providers adhere to these guidelines. Previous work has shown that women veterans using Veterans Health Administration (VA) care are more than twice as likely as non-VA users to be prescribed HT, with more than 10% of women VA users being prescribed systemic or topical HT.20 These higher rates of HT use may be based on veterans' physiologic needs, including higher rates of hysterectomies among veterans and/or women veterans' mental health comorbidities increasing their sensitivities to vasomotor symptoms. It is also possible that these higher rates represent overprescribing. Further work is therefore needed to assess the extent to which VA HT prescribing is guideline-adherent.21

Achieving high levels of quality in delivering female-specific primary care is a challenge in VA given that women comprise less than 10% of the VA patient population.22-25 To address this challenge, VA concentrates patients into the panels of Designated Women's Health Providers (DWHPs), with the rationale that primary care providers (PCPs) with higher caseloads of women will maintain higher proficiency in sex-specific care.26 In actuality, DWHPs vary in their actual women Veteran caseloads.26 Studies have shown that veterans assigned to DWHPs are more likely to receive appropriate female-specific cancer screening and have better experiences of care compared with those receiving care from non-DWHPs.27,28 However, assessments of this strategy on other female-specific conditions, and potential variations in impact by actual size of women Veteran caseload, are needed.

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Methods

Our objectives were to assess for guideline adherence in PCPs' prescribing of systemic HT for menopausal symptoms, and to assess for associations between guideline adherence and providers' DWHP status and women Veteran caseload. The steps for achieving these objectives are outlined in Table 1.

Table 1

Table 1

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Developing Quality Indicators

We formulated quality indicators (QIs) for prescribing systemic HT. Quality indicators measure the proportion of care that is adherent to a clinical guideline. By convention, QIs use “if/then” statements to specify the patients or clinical circumstances to which the measure should be applied (the denominator, indicated by “if”) as well as the conditions under which the care is considered guideline-adherent (the numerator, specified by “then”).

To develop QIs, we compiled and reviewed relevant guidelines from professional societies and government agencies, including the American Association of Clinical Endocrinologists; North American Menopause Society; American College of Obstetrics & Gynecology; U.S. Preventive Task Force; and U.S. FDA.12-16 From these guidelines, we defined seven QIs, shown in table 2, across three domains: documenting indications and contraindications; prescribing an appropriate dose; and appropriate coprescribing of progesterone. Four QIs are applicable to new prescriptions for systemic HT, and three to prescription renewals. We also developed specifications for operationalizing these QIs, shown in table 3.

Table 2

Table 2

Table 3

Table 3

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Identifying Systemic Hormone Therapy Prescriptions

To identify our sample, we used VA's Corporate Data Warehouse (CDW) electronic medical data, accessed through VA's Informatics and Computing Infrastructure (VINCI) platform.29,30 We identified all prescriptions (pharmacy orders) for HT (systemic and topical) between June 1, 2013, and September 30, 2015, within a cohort of 5,250 women veterans, aged 40 years or older, who had at least one encounter with PCPs, across four VA facilities participating in a women's health educational program.31 These four facilities were located in core metropolitan areas, across three states, in two geographic regions of the United States. For each Veteran with one or more prescriptions for HT, we also obtained the text of all primary care and gynecology specialty care notes in this same timeframe. As we were focusing on the guideline adherence provided by PCPs, we excluded prescriptions for patients whose notes indicated that gynecologists were managing the prescription. In addition, we excluded prescriptions if the notes indicated the Veteran was transgender. For each Veteran, we included the first prescription occurring within our timeframe and any prescriptions 12 or more months after this initially included prescription. We then selected the subset of prescriptions that were for systemic HT: oral, transdermal, or estradiol acetate vaginal ring.32

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Data Collection

For each included prescription, we used pharmacy records to determine the name of the prescriber. For other data relevant to the seven QIs, an experienced and trained medical record abstractor reviewed the primary care notes and pharmacy orders using a structured abstraction tool we created using Research Electronic Data Capture (REDCap).33 The tool used branching logic and prompted abstractors to use the documentation in the primary care notes and pharmacy orders to specify, for each prescription, its route; whether the Veteran had received a systemic HT prescription within VA in the previous 12 months; the prescription dose; documentation of indications for a dose equivalent to CEE 0.625 mg daily or greater, for prescriptions in that dose category; whether progesterone was ordered, or already being used by the Veteran; and whether the patient had undergone a hysterectomy. For all prescriptions in which there was no indication of progesterone having been ordered and the primary care and gynecology notes in the abstraction timeframe did not document the Veteran as having had a previous hysterectomy, a physician investigator (KMC) accessed the veterans' medical records to perform a broader search of the veterans' notes before our timeframe and from other disciplines (e.g., preoperative history and physicals listing previous surgeries), to determine whether the Veteran had undergone a hysterectomy or was using progesterone provided by another source.

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Data Analysis

We classified each systemic HT prescription as being “new” if the Veteran had not received a systemic HT prescription within VA in the previous 12 months and as a “renewal” if they had. We used this classification, as well as information about dose, and whether the patient had undergone a hysterectomy, to identify, for each QI, the subcohort of applicable prescriptions. Then, for each QI, we determined the number of prescriptions in that subcohort for which the PCP's documentation indicated guideline adherence. For each prescription, we calculated a composite adherence score as the proportion of eligible indicators for which the care was adherent, then determined the mean across prescriptions to report overall guideline adherence. Furthermore, for each indicator, we assessed the proportion of prescriptions that were guideline-adherent.

Using VA administrative data (the 2013, 2014, and 2015 DWHP Assessment of Workforce Capacity databases),26 we ascertained whether the provider who ordered the systemic HT was a DWHP and assessed for differences in overall guideline adherence by whether the PCP was or was not a DWHP. We determined, for each PCP, their average monthly volume of clinical encounters with women during the study period. For prescribing providers who were trainees, we used the characteristics of their supervising provider. We compared overall guideline adherence between PCPs with less than 34 (the median), to those with 34 or more, average monthly encounters with women veterans. To assess for associations between guideline adherence and PCP DWHP status and volume of encounters with women, we used simple linear regression, adjusting for clustering of prescriptions within providers. To assess for potential independent relationships between provider characteristics and overall guideline adherence, we conducted multivariate linear regression analysis, including both provider characteristics in the same model, adjusting for clustering of prescriptions within providers. Data analysis was performed using STATA version 15 (StataCorp, 2017). All study procedures were approved by the VA Greater Los Angeles Healthcare System Institutional Review Board.

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Results

Sample Characteristics

Across the 5,250 women in our study cohort, there were 859 prescriptions for HT provided by 81 PCPs during our study timeframe. Of these, 254 (30%) were being managed by gynecologists, and three were in transgender women. Of the remaining 602 prescriptions, 247 (41%) were for topical preparations. Therefore, our analytic sample was 355 prescriptions, provided to 266 women. Women's mean age was 58, ranging from 40 to 93 years of age, with 31% aged 65 years or more. Fifty-eight (16%) of the prescriptions were new, whereas 297 (84%) were renewals.

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Guideline Adherence

Across QIs, average adherence to prescribing guidelines for systemic HT was 57.7%. For prescriptions that were new, average adherence was 60.3%, and for renewals, adherence was 57.2%.

Table 4 shows, for each QI, the number of prescriptions meeting eligibility criteria for quality assessment, and, of those eligible, the number and percent of episodes for which the patient's notes demonstrated that the care was guideline-adherent. Among the 58 new prescriptions, in 43 (74.1%), there was a guideline-adherent indication documented for initiating the medication, and in 16 (27.6%), there was documentation regarding the absence of contraindications. Among the 299 renewal prescriptions, 115 (38.5%) documented the persistence of guideline-adherent indications for the renewal. With respect to prescribing an appropriate dose, 26 (44.8%) of the 58 new prescriptions were guideline-adherent, in that the dose was less than 0.625 mg of CEE or equivalent. For the 299 renewal prescriptions, 193 (65%), were at a dose of 0.625 mg or higher, of which 30 (15.5%) had a reason for this higher dose documented.

Table 4

Table 4

Among the 355 new and renewal prescriptions, 239 (67%) were written for women having undergone hysterectomies, and therefore, coprescribing of progesterone was not indicated. In all but one of these prescriptions (>99%), progesterone was not prescribed. Among the 116 remaining women with an intact uterus, progesterone was concurrently ordered in 108 (93.1%). The eight orders for systemic estrogen without concurrent progesterone were for seven veterans cared for by six unique PCPs, across three VA sites.

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Guideline Adherence by Provider Characteristics

Among the 355 prescriptions, 305 (86%) were provided by DWHPs and 50 (14%) were provided by non-DWHPs. As shown in table 5, guideline adherence was similar for prescriptions provided by DWHPs and non-DWHPs (58% vs. 55%, p = .410). Most prescriptions, 292 (82%), were managed by PCPs with a monthly average of 34 or more encounters with women. Overall adherence was also similar for episodes managed by providers with 34 or more, versus less than 34, monthly encounters with women (58% vs. 55%, p = .291). Table 5 also shows predicted values for these provider characteristics, from a multivariate linear regression model adjusted for clustering. This adjusted analysis revealed no significant relationships between either provider characteristics and overall guideline adherence.

Table 5

Table 5

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Limitations

Our findings should be interpreted in the context of their limitations. Primary care providers vary in the extent to which they comprehensively document the elements of a clinical encounter.34-36 Therefore, providers may have considered, but did not document, HT indications and contraindications. However, lack of documentation is less likely to affect initiating systemic HT at higher doses, or failing to appropriately prescribe progesterone. A further limitation of our work is that our assessment examines prescriptions by 81 PCPs in four metropolitan VA sites between 2013 and 2015; we do not know the generalizability of our findings to other VA sites, especially those in nonmetropolitan areas, nor the effects of VA's more recent efforts to improve women's health care quality.21,37,38 In addition, our findings are limited to PCP prescriptions, and prescriptions from specialists (e.g., gynecologists) should be studied separately. However, in VA, gynecology staffing is generally limited, and PCPs are more likely to be the prescribers of systemic HT.39

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Discussion

This is the first measurement of the extent to which VA providers are adhering to current guidelines for prescribing systemic HT. To our knowledge, comparable studies of adherence to systemic HT prescribing guidelines in patient populations and practices outside VA have not been published. However, multiple studies have shown that, in general, clinical practice guidelines have limited effect on provider behavior, with only half of patients in the United States receiving guideline-adherent care.40,41 Our finding, that average adherence was 58%, is unfortunately consistent with previous work in other conditions and populations.

Prescribing systemic HT is an area of medical practice for which the evidence base changed, and even reversed, over a short period.17,42,43 New recommendations have recently been released for providers to further tailor HT treatment decisions based on the patient's age and number of years since menopause onset.42 These new recommendations recommend a more nuanced approach to HT prescribing, necessitating a higher level of provider knowledge and judgment than basic considerations of FDA indications and contraindications used in this study. This evolution in guidelines is reflective of a broader challenge of practitioners maintaining proficiency in the context of a continuously rapid shift in evidenced-based care.44,45 To ensure that patients are getting care guided by the current evidence, health care systems must reach beyond traditional modalities for providing continuing education to their providers, and supply “just-in-time” information and decision support, such as using computerized clinical decision support (CDS) systems, at the point-of-care and/or in support of panel management programs.46-51 Computerized CDS systems electronically match characteristics of patients with evidence-based algorithms to provide providers with recommendations in support of guideline-adherent decisions.51

Veterans Health Administration, with its fully integrated electronic medical record system, has effectively implemented CDS tools for a variety of conditions.51,52 These tools may explain why studies have shown that guideline adherence for prescribing is generally higher in VA compared with non-VA practices.53 For example, elderly VA patients have been shown to be less likely to receive inappropriate medications (VA 21% vs. private sector 28%).54 Veterans Health Administration is primed for similarly developing CDS tools to support prescribing of systemic HT. However, the literature also demonstrates that CDS tools may have unintended and even adverse consequences.55,56 Poorly designed interfaces lead to inadvertent ordering of incorrect medications, dosages, or instructions.55 Too many notifications results in providers ignoring messages and missing crucial warnings.56 Therefore, it is essential to use user-centered design, which maximizes utility of computerized information systems by using cognitive science, psychology, and computer science principles.51,57,58

We assessed for variations in guideline adherence by two provider characteristics, DWHP status and volume of encounters with women, but did not detect differences. As foundation for intervention development, future work should assess for other potential determinants of variation, such as other provider characteristics, as well as those of the patient and practice.59 Determinants of provider behavior are generally multifactorial, and, therefore, approaches to changing behavior must similarly use a multitude of approaches.40,60,61

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Conclusions

Our review of primary care management of menopause symptoms in women veterans at four VA sites revealed that adherence to prescribing guidelines for systemic HT occurred 58% of the time. Guideline adherence was similar for initial and renewal prescriptions. With respect to indications for systemic HT, adherence was highest for documenting indications for initial prescriptions, but this documentation occurred less than 75% of the time. An inappropriately high dose was used in new prescriptions more than half of the time, and most renewals were maintained at this high dose, or escalated to it, without documented justification. Finally, although adherence was greater than 90% for appropriately prescribing progesterone for patients with uteri, the eight failures are striking given the severity of preventable risk (i.e., endometrial hyperplasia and cancer), these failures may pose for patients.

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Implications

The QIs we developed to measure guideline adherence for systemic HT should be used for assessing prescriptions in other patient populations and health care systems. These quality assessments should be conducted in all settings through which VA delivers or contracts for health care delivery; guideline adherence in non-VA community care practices should be measured and compared with our results. Our findings lay important foundation for interventions for improving guideline adherence, and further examination of determinants of variation would add to this foundation. Interventions, such as computerized CDS tools at the point-of-care and/or supporting panel management, are urgently needed to ensure the safe use of HT in women veterans.

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Acknowledgments

The authors thank Mark Canning for project management. The authors would also acknowledge the editorial review and feedback of Chloe Bird, PhD, Senior Sociologist, RAND Corporation, Santa Monica. Her time was supported through the VA Los Angeles HSR&D Center for the Study of Healthcare Innovation, Implementation, and Policy (Project #CIN 13-417).

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Authors' Biographies

Kristina M. Cordasco, MD, MPH, MSHS, is a core investigator VA HSR&D Center for the Study of Healthcare Innovation, Implementation, and Policy; internal medicine physician with VA Greater Los Angeles Healthcare System; and associate clinical professor of Medicine at The University of California, Los Angeles (UCLA). Her research focuses on quality, care coordination, and organization of care.

Anita H. Yuan, is an investigator and Quantitative Sociologist with VA Health Services Research & Development (HSR&D) Center for the Study of Healthcare Innovation, Implementation, and Policy. She specializes in data management and analysis of surveys and electronic medical records.

Marjorie J. Danz, is a health services researcher with VA Greater Los Angeles Healthcare System and an associate scientist (Adjunct) with the RAND Corporation. Her research focuses on assessing and improving quality of care and quality of care reporting.

LaShawnta Jackson, is a research health scientist with VA Health Services Research & Development (HSR&D) Center for the Study of Healthcare Innovation, Implementation, and Policy. Her interests include social determinants of health, health equity, and implementation research.

Ellen F. Yee, is an internal medicine physician with the New Mexico VA Healthcare System, and professor of medicine at the University of New Mexico. Her interests include women's health care, cancer screening and prevention, and education.

Lueng Sophia Tcheung, is an internal medicine physician with VA Greater Los Angeles Healthcare System, and assistant clinical professor of medicine at the University of California, Los Angeles. Her interests include women's health care and quality measurement.

Donna L. Washington, is Women's Health Focused Research Area Lead at VA HSR&D Center for the Study of Healthcare Innovation, Implementation and Policy, and professor of medicine at UCLA. Her research examines health care access, quality, and equity for women and vulnerable populations.

Keywords:

women; veterans; menopause; guideline adherence

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