Encouraging Innovation, Unintended Consequences, and Group-Level Research

Abstract

200P rimary care clinicians face a daunting set of challenges in today's health care environment. Health care reform is creating a constantly evolving context for providing care. Time and productivity pressures contrast with a growing set of clinical expectations and responsibilities in the patient encounter. Chronic and behavioral conditions increasingly dominate the lives of our patients, yet we have a limited set of tools for making consistent and meaningful improvement in the trajectory of these diseases. At the same time, patients can fi nd it diffi cult to adopt truly effective preventive or early intervention tools. Underlying all of these issues is the role of socioeconomic and community factors in the conditions that we see.In response, primary care researchers have sought and tested new ideas by which clinicians can meet these challenges. In so doing, these researchers have established a strong record of innovation-and of respect for persons and communities. Examples include the use of multimethod research to understand processes in primary care, the use of practice-based research networks for testing interventions in real-world settings, and the use of complexity science concepts in understanding care delivery.1-3 Primary care researchers have also been leaders in advocating the importance of respectful partnerships with communities in the search for new solutions to the challenges we face. 4 The article by Shaw et al in this issue of the Annals extends this record of innovation and respectfulness of family medicine researchers. 5 This research team designed a state-of-the-art, cluster randomized trial of a strategy to increase the proportion of patients in practices who had received up-to-date screening for colorectal cancer. Conducted in a practice-based research network, the intervention included multimethod practice assessment, followed by within-practice teams engaged in refl ective adaptive processes strategizing improvements in screening, and by crosspractice learning collaboratives. The analysis showed a nonsignifi cant trend toward greater net increase in screening rates of intervention compared with control practices. Although the overall rate of screening was the primary outcome in this trial in which individual practices were the unit of study (whole practices received either the intervention or control condition), this analysis appeared to obscure important effect modifi cation. That is, some practices in the intervention group got much better while, surprisingly, at least 1 intervention practice's overall screening rate got much worse.There are several possible explanations for this surprising fi nding. It could represent concurrent, unrelated changes in the practice, such as staff turnover. It could represent normal statistical variation-some practices randomly improve while some randomly worsen. It could refl ect a delayed response to changes in screening approaches in the practice. As Shaw et al note, however, the disturbing possibility is that the worsened screening rates could repre...

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“…59 The impact of an intervention could be unexpected (worse than expected or even harmful). 60 It would be pertinent to analyze the behavior within each group to understand such changes, as was done in a recent cluster study.…”

“…This analysis of behavior of each cluster in a clustered response test is one of the challenges of research in primary care. 59 …”

The role of data and safety monitoring boards in implementation trials: When are they justified?

“…potential risk to organizational participants [18][19][20]. These may be indirect and collateral participants in pragmatic clinical trials that are directly affected by the implementation of the interventions [21].…”

Use of Asthma APGAR Tools in Primary Care Practices: A Cluster-Randomized Controlled Trial

“…Introducing a new tool or care system may also have unintended consequences, such as replacing some existing activity with those for the new tool. 60 The enrolled practices did comment that they were unable to begin other new quality improvement projects for any medical condition for at least the first 6 to 12 months of working to implement the Asthma APGAR tools, but did not believe they eliminated any preexisting practice activities.The Asthma APGAR tools provide a broad array of information beyond what is included with most control assessments and beyond what is collected in most primary care asthma visits. 6,23,31 Unlike other assessments for asthma control, these tools highlight multiple reasons for inadequate control, including unrecognized or unavoidable triggers, incomplete adherence to asthma medications, and patient perception of response to therapy that may be due to poor inhaler technique.…”

“…Introducing a new tool or care system may also have unintended consequences, such as replacing some existing activity with those for the new tool. 60 The enrolled practices did comment that they were unable to begin other new quality improvement projects for any medical condition for at least the first 6 to 12 months of working to implement the Asthma APGAR tools, but did not believe they eliminated any preexisting practice activities.…”