Need for tailored clinical trials: hypertension and fall risk

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DESCRIPTION (provided by applicant): Co-existing hypertension and fall risk, two common conditions in elderly persons, illustrate the gaps in knowledge regarding therapeutic decisions that best meet patients' priorities in the face of competing morbidities. Evidence suggests that anti-hypertensive medications improve cardiovascular, but worsen fall- related, outcomes. Clinical decision-making in the face of competing conditions should rely on patients' articulations of priorities and on tailoring therapy to meet these priorities, hallmarks of patient-centered care and shared decision-making. Unfortunately, there is currently little RCT evidence to guide this decision- making. The ultimate goal of the proposed line of investigation, of which this exploratory study is the first step, is to design trials that assess the effectiveness of interventions tailored to participants' outcome priorities in the face of coexisting competing conditions. In addition to showing that there is variability in outcome priorities in older persons with competing conditions - an important aim in itself - the proposed study will inform the future clinical trial by articulating the outcome priorities that need to be considered in designing the trial and in selecting the subarms of the tailored intervention arm. The primary aim of this exploratory study is to determine whether there is inter-individual variability in the priority given to optimizing cardiovascular versus fall- and medication symptom-related outcomes among elderly (70+years) persons with coexisting hypertension and fall risk, defined as a fall within the last 6 months or self-reported or observed difficulty with balance or gait. The secondary aim will be to determine the association between outcome priorities and sociodemographic and health-related characteristics. We will use a cluster sampling design to enroll 232 community-living persons 70+ years with coexisting hypertension and fall risk. All data collection will take place during a single approximately one- hour visit in participants' homes. Outcome priorities will be obtained with Adaptive Conjoint Analysis, a well- validated, reliable approach to eliciting health outcome priorities in the face of competing risks. The 3 priority outcome options include: 1) Maximum reduction of CVD outcomes, possible presence of anti-hypertensive medication symptoms, maximum increase in the risk of serious fall injury; 2) Moderate decrease in the risk of CVD outcomes, absence of anti-hypertensive medication symptoms, moderate increase in the risk of serious fall injury; and 3) No decrease in CVD outcomes, absence of anti-hypertensive medication symptoms, no increase in the risk of serious fall injury. Although studies of persons with life-threatening illness suggest that prioritization of outcomes in the face of competing morbidities will be variable, this hypothesis has not been examined. The proposed study will test this hypothesis.