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1 VERDICT Health Services Research Center, South Texas Veterans Health Care System, San Antonio, Tex
2 Department of Family & Community Medicine, University of Texas Health Science Center-San Antonio, San Antonio, Tex
3 Department of Medicine, University of Texas Health Science Center-San Antonio, San Antonio, Tex
CORRESPONDING AUTHOR: Michael L. Parchman, MD, MPH, South Texas Veterans Health Care System, VERDICT 11C6, 7400 Merton Minter Blvd, San Antonio, TX 78229-4404, parchman{at}uthscsa.edu
| ABSTRACT |
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METHODS We observed 211 primary care encounters by adult patients with type 2 diabetes in 20 primary care clinics and documented changes in hypoglycemic medications. Competing demands were assessed from length of encounter, number of concerns patients raised, and number of topics brought up by the clinician. Days to the next scheduled appointment were obtained at patient checkout. Recent A1c values and dates were determined from the chart.
RESULTS Among patients with an A1c level greater than 7%, each additional patient concern was associated with a 49% (95% confidence interval, 35%60%) reduction in the likelihood of a change in medication, independent of length of the encounter and most recent level of A1c. Among patients with an A1c level greater than 7% and no change in medication, for every additional minute of encounter length, the time to the next scheduled appointment decreased by 2.8 days (P = .001). Similarly, for each additional 1% increase in A1c level, the time to the next scheduled appointment decreased by 8.6 days (P=.001).
CONCLUSIONS The concept of clinical inertia is limited and does not fully characterize the complexity of primary care encounters. Competing demands is a principle for constructing models of primary care encounters that are more congruent with reality and should be considered in the design of interventions to improve chronic disease outcomes in primary care settings.
Key Words: Diabetes mellitus, type 2 hemoglobin A, glycosylated ambulatory care primary care health care delivery health services research quality of care practice-based research networks office visits
| INTRODUCTION |
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An alternative explanation for failure to intensify therapy despite poor glucose control is the presence of competing demands.1418 Encounters are bounded by a time constraint within which multiple diagnoses, problems, and patient concerns compete with each other for a place on the agenda. Physicians and patients prioritize demands and only deal with the most pressing or symptomatic problem.14 Problems perceived to be less urgent, for example, intensifying medication therapy for poorly controlled glycosylated hemoglobin (A1c) levels, may not be addressed and may be deferred to future encounters. Competing demands have been shown to interfere with depression care,16 mammography screening,17 and tobacco cessation counseling,15 and they limit the treatment of unrelated medical disorders.18 A primary determinant of intensification of therapy for an elevated A1c level may thus be the presence of competing demands during the encounter, not clinical inertia. If competing demands are present, we hypothesize that for patients with an elevated A1c level:
| METHODS |
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Patients and Data Collection
Within each clinic, consecutive patients seeking care with an established diagnosis of type 2 diabetes were recruited to participate in the study. None of the patients approached declined participation. A trained observer accompanied the first 8 to 10 consenting patients in each clinic to the examination room and directly observed the encounter. In the final sample, the range of patients per clinic was 8 to 10 and the range per physician was 1 to 10. The encounter was audio recorded, and a checklist of services performed was completed to record the length and content of each encounter. After each encounter, patients completed a survey form and their medical record was abstracted.
Definition of Variables
The observer noted and recorded any increase in dose or any addition or substitution of an oral hypoglycemic agent or insulin during the encounter. We defined these events as changes in medication. The length of encounter was defined as the number of minutes the clinician was present in the examination room with the patient. The observer listened carefully to the exchange between the patient and physician, and recorded any symptom or complaint brought up by the patient and any topic brought up by the physician. A symptom or complaint was any type of physical or emotional distress expressed verbally by the patient. For example, in one encounter, the patient reported new-onset knee pain, and this was counted as 1 symptom or complaint. We called these collectively patient concerns. The most recent value of A1c in the medical record was used to evaluate glycemic control at the time of the encounter. Length of time between the observed encounter and the most recent A1c measurement was also noted out of concern that physicians may not act to intensify therapy if values are too distant in time. Because the trend in A1c value is often used in making clinical decisions about changes in medications, we created a variable to indicate whether the most recent A1c value was worse than the previous value.
Analysis
We used descriptive statistics to examine the central tendency of the observed variables. A Student t test was used to evaluate differences in means. Random effects logistic regression models were used to adjust for the clustering of patients within clinics. We chose clinic as the level of analysis because of the sparse number of patients per physician and because in 12 of the 20 clinics, only 1 physician participated in the study. For the first 2 hypotheses, we included only patients with an A1c level greater than 7%. Change in medication (yes or no) was the dependent variable, and a Bournelli distribution was used because of the dichotomous nature of this variable. To test the third hypothesis, the number of days to the next scheduled appointment was the dependent variable. This model included only patients with both an A1c level greater than 7% and no change in medication. We did not enter any explanatory variables at the clinic level in either model. Descriptive and univariate statistics were performed with SPSS 13.0 (SPSS Inc, Chicago, Ill).20 All random effects models were performed using HLM 6.0 (Scientific Software International, Inc, Lincolnwood, Ill).21
Finally, there was a possibility that the interaction style of the physician during the encounter might influence the likelihood of a change in medication. For example, if some physicians tended to address A1c results and the need for a change in medication early during the encounter, they might have been less likely to elicit patient concerns. We evaluated this possibility in a separate analysis to determine whether these discussions occurred earlier in encounters with a medication change. Using the Davis Observation Codes,22 we examined the proportion of the encounter that occurred before the first of 2 behaviors appeared: (1) an "evaluation or feedback" code for when the physician tells the patient about results of recent test results, such as an A1c level, and (2) the "planning treatment" for when the physician and patient discussed a treatment plan, such as a change in medication. In addition, we used the Davis Observation Codes to compare the amount of time spent discussing diet, exercise, and medication adherence between patients with and without a change in medication.
This study was reviewed and approved by the institutional review board at the University of Texas Health Science Center, San Antonio, Tex.
| RESULTS |
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| DISCUSSION |
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As previously mentioned, soft reasons to avoid intensification of therapy are cited as an explanation for clinical inertia. For example, clinicians may substitute a discussion of self-care activities for therapy intensification. Our data fail to support this explanation: there was no difference in the amount of encounter time spent discussing self care between encounters with and without a change in medication for patients whose A1c value was greater than 7%. It also does not appear that physicians are deferring a decision to change medications because the most recent A1c value was obtained too long ago: the number of days since the last A1c measurement was not a significant predictor of a change in medication.
Another explanation cited for clinical inertia is "... unawareness on the part of the clinician about the limitations of the care they provide."8 Our findings also fail to support this explanation: when there was no change in medication, as length of encounter increased, days to next appointment decreased, suggesting that when the agenda of the encounter was full, clinicians were aware of the need to address the elevated A1c level and requested that the patient return sooner. In addition, when there was no change in medication, encounters with higher A1c values had shorter return times, again suggestive that clinicians were aware of the elevated A1c value but deferred action to the next encounter. This finding is consistent with those of a recent longitudinal study of intensification of therapy for poor glucose control: among patients with an A1c value exceeding 8%, therapy was intensified in 58.1% within 3 months and in 69.7% within 6 months.23
Some limitations exist in interpreting findings from this study. One is the potential for change in physician behavior because of the presence of an observer in the examination room during the encounter. If such a performance bias existed, it would most likely have resulted in a bias away from the null hypotheses in this study. That is, given that the purpose of the study as explained to physicians was to "... examine predictors of quality and outcomes of care for patients with type 2 diabetes," physicians may have focused more on following current evidence-based guidelines with an observer in the room. On the other hand, prior studies of clinical inertia have been limited to medical record or administrative data.712 Our use of direct observation is particularly well suited to the study of clinical inertia and is a strength of this study. For example, none of the prior studies of clinical inertia measured length of encounter. A second limitation is the lack of follow-up data. Although patients were scheduled to return sooner if there was no change in medication, we were unable to ascertain whether any action was taken in the subsequent encounter. As mentioned above, when follow-up encounters are analyzed in administrative data, approximately 70% of patients with elevated A1c levels do have a change in therapy within 6 months.23
Why should it matter whether we use the term clinical inertia or competing demands in describing primary care encounters? To understand why a change is or is not made in medication in the face of inadequate glucose control or any other observed phenomenon in a scientific manner, we develop an abstract representation, or a model, that helps us simplify reality so that we can understand what we observe.24 To construct a model, we use general principles that are rules for constructing models. One example of such a principle is that of natural selection. Different principles result in very different models. The empirical question that one must then answer is how well one model developed with one principle fits the intended aspects of the real world compared with a different model developed using a different principle. In this study, the principle of competing demands, when applied to a model of the clinical encounter, results in a better fit than a model constructed using the principle of clinical inertia. Studies conducted using a model based on the principle of clinical inertia thus are likely to provide misleading results, and interventions designed based on this principle are likely to be ineffective.
The principle of competing demands is also consistent with recent observations that primary health care delivery demonstrates properties of a complex adaptive system.25 These systems have nonlinear dynamic patterns over time, contrary to the notion that encounters are linear and mechanistic and follow the rules of Newtonian physics, such as demonstrating the property of inertia. Newtonian inertia states that objects at rest will remain at rest and those in motion will remain in motion until acted on by a force. Our findings suggest that primary care encounters are neither static nor linear, but instead are filled with multiple activities, suggesting movement. The problem with calculating a vector for movement (velocity plus direction) is that we do not know in which direction the agents in the system (physician and patient) are moving. It is therefore somewhat pejorative to assert that physicians are moving in the wrong direction when they are addressing problems other than a change in medication for glucose control as suggested by the clinical inertia model.
The comprehensiveness of the care provided by primary care clinicians to patients with one or more chronic illness is a strength of primary care but is also a balancing act that requires prioritization and goal setting by both patient and physician during each encounter in a manner that takes into consideration patient resources, expectations, and willingness to intensify therapy.2628 In contrast, much of the work published using the term clinical inertia has been from the limited perspective of diabetes specialists interested only in the quality of diabetes care without incorporating any evaluation of care for other concurrent problems. Development of models to advance our understanding of the delivery of primary care to patients with multiple chronic illnesses, including type 2 diabetes, should incorporate the principle of competing demands and complex adaptive system principles, rather than clinical inertia, as should interventions designed to improve outcomes for these patients in primary care settings.29
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| ACKNOWLEDGMENTS |
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| FOOTNOTES |
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Disclaimer: The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs.
Conflicts of interest: none reported
Received for publication July 2, 2006. Revision received October 20, 2006. Accepted for publication November 18, 2006.
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