Minimally Disruptive Research: a respectful approach to conducting clinical studies

As a study coordinator at the Knowledge and Evaluation Research (KER) Unit, I have over 10 years of experience in conducting research across a broad array of contexts and designs. Most often, we evaluate patient-centered interventions and their impact in the clinical encounter. These interventions are not drugs or devices, in which participants are often extracted from their personal and clinical care contexts to participate in strict protocols, but rather are tools to support clinicians and patients in improving their conversations and decisions. To see the effects of our tools, we record the clinical encounters and ask users (clinicians and patients) for their experiences. Because our recruitment and data collection takes place in the context of clinical practice without time deliberately allocated for research effects, often in a tightly scheduled and carefully choreographed setting (or in a chaotic mess, depending on the clinic), and because clinicians and patients may be overwhelmed or anxious, it is important that all protocols for recruitment and data collection are designed and implemented with minimal disruption to the clinical workflow and to the patient agenda.

When we conduct our research, we immerse ourselves in the clinical settings to understand the clinical workflow and identify patients while being as visible (as to keep staff aware of our study) and invisible (as to avoid disrupting the staff) as possible. We consent patients in the exam rooms (a private location) during the wait time between being roomed and seeing the clinician, which has led to higher enrollment than calling the patient ahead of time. Importantly, by assessing eligibility prior to the encounter and by finishing data collection (i.e. surveys) at the same visit, we prevent scheduling extra patient visits to the medical center for the study (with its associated interruption to patients’ daily routines, time away from work and family, parking woes, and other burdens). This means that everything, from informed consent documents to post-intervention surveys, must be succinct. Our researchers must give up “nice-to-have” items in the surveys, for example, that can be omitted as nonessential. This means briefer study time and less effort for the research participants and a faster flow of study patients through the clinic. The purpose of our research is to learn how to support kind and careful medical encounters.  In order to observe clinical conversations, we use a small camera that, while unobtrusive, stays evident in the room, and has a clear and easy way to be turned off or to be reoriented (e.g., toward the ceiling or the floor to capture audio only) if any of the participants prefer not to be recorded at any time. The recorder reduces the research presence in the encounter as the researcher does not need to be in the room observing the discussion or taking notes. As patients and clinicians engage, it is evident that the small camera becomes ignored or forgotten as the visit progresses.  This is as close to the real world as we can get while minimizing the research imprint.

Our experience in conducting single and multi-site studies- for examples, conducting Chest Pain Choice in the emergency department, Depression Medication Choice and Diabetes Medication Choice in primary care, Graves Disease Treatment Choice and PCI Choice in specialty ambulatory clinics, and AMI Choice in hospital care- is that research can be designed and implemented in this fashion across a wide range of clinical settings and in urban, suburban, and rural settings.

Along with colleagues at the KER UNIT, we are working toward a new standard.  In our view, the design and conduct of clinical studies must achieve the research goals while minimizing the work allocated to participants.  Protocols are not only reviewed to meet ethical standards, but also to maximally collect information (about outcomes that matter to patients and clinicians), while imposing the smallest possible footprint on clinical care activities.  Importantly, by minimally disrupting practice, our outcomes best reflect the effect of the intervention in daily routine.

I recognize that other projects (i.e. FDA regulated) may have more stringent protocols that cannot be bent to fit the context of care.  They could still benefit however, from review that ensures their protocols meet ethical standards, and impose on participants the smallest possible burden necessary to effectively answer the research question.   This may require extra effort and conversations with funders and designers but is crucial to conduct research that is respectful of patients and clinicians time and energy.

Our adherence to this new standard, Minimally Disruptive Research, requires participants (both patients and clinicians) as research partners to engage with investigators at every step of the research process to ensure that all procedures are as easy as possible. The test the implemented protocol must pass in all eyes is that it results in CAREFUL and KIND RESEARCH.

What strategies does your team use to be kind and careful when conducting research about the experience and delivery of clinical care?

Submitted by Sara Dick, MSc, CCRP

Contributing Authors: Gabriela Spencer Bonilla, BA, and Marleen Kunneman, PhsaraD

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