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Principal Investigator: MIGUEL A VAZQUEZ
Organization: UT SOUTHWESTERN MEDICAL CENTER
Fiscal Year: 2024
Award: $1,238,148
Funding agency: National Institute on Aging
SPRINT, and its accompanying cognitive-focused substudy SPRINT-MIND recently showed that blood pressure control (goal SBP<120 mm Hg) reduced incident mild cognitive impairment as well as a combined outcome of MCI and dementia. Divergence in opinion among experts and professional societies about BP goals still remain due to the concerns of potential harms. There is a clear need to implement new practical approaches to control blood pressure in clinical practice and test their effectiveness. Pragmatic clinical trials embedded in health systems (ePCTs) offer a unique opportunity to study the effectiveness of implementation of evidence- based interventions in real-world clinical settings. Our team is currently conducting ICD-Pieces (NCT02587936), the largest ePCT in patients with the coexistent chronic conditions of chronic kidney disease, hypertension and diabetes as part of a demonstration project in the NIH Health Care Systems Research Collaboratory. We now propose the Preventing Cognitive Decline by Reducing BP Target Trial (PCOT), to examine the effects of lowering BP to less than 130/80 upon the incidence of cognitive decline. Our main hypothesis is that patients who receive care with a collaboratory model that combines clinical decision support applied to home BPs and team-based care delivered in primary care practices will have better blood pressure control and a lower incidence of mild cognitive impairment and dementia than patients receiving usual medical care.
In this ePCT (1) Will compare the effects of intensive BP control between the intervention and usual care arm on the rate of cognitive decline measuring the change in TICS-m per year. We will recruit 4,000 patients over 70 years of age with BP >130/80 mmHg from 2 diverse health systems and randomize patients within each health system to usual care or to a combination of care with clinical decision support using home BPs and practice facilitators and Pharm Ds to lower home BP to < 130/80 mmHg. The primary outcome will be development cognitive decline as determined by a decrease in TICS-m scores from baseline; (2) Determine the potential harms of intensive lowering BP home BP below 130/80 mmHg with usual care on hospitalizations, emergency department visits, cardiovascular events, deaths, syncope, falls, fractures, hypotension, electrolyte abnormalities and acute kidney injury and; (3) Determine the impact of intensive BP management on QOL with scores obtained using the PROMIS Scale v1.2 - Global Health instrument annually
This trial is pragmatic, with broad inclusion criteria and evidence-based interventions informed by patients and delivered in primary care settings by the clinical teams in health systems serving ethnically and socioeconomically diverse population. Lessons from this trial should provide valuable insights to guide clinical practices in BP control and cognitive assessments in real-world settings as well as design and implementation of future pragmatic trials.
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Terms: <Acute Renal Failure with Renal Papillary Necrosis><Age Years><Amentia><BP control><BP management><BP reduction><Cardiovascular><Cardiovascular Body System><Cardiovascular Organ System><Cardiovascular system><Caring><Cessation of life><Chronic><Chronic Kidney Failure><Chronic Renal Disease><Chronic Renal Failure><Clinical><Clinical Evaluation><Clinical Testing><Cognitive><Cognitive Disturbance><Cognitive Impairment><Cognitive decline><Cognitive function abnormal><Death><Dementia><Development><Diabetes Mellitus><Disturbance in cognition><Drug Combinations><Drugs><ED visit><ER visit><Effectiveness><Electrolytes><Emergency care visit><Emergency department visit><Emergency hospital visit><Emergency room visit><Enrollment><Ethnic Origin><Ethnicity><Event><Evidence based intervention><Fainting><Fracture><Goals><Guidelines><Health Care Systems><Health system><Healthcare Systems><Heart Vascular><Home><Home Blood Pressure Monitoring><Hospital Admission><Hospitalization><Hypertension><Hypotension><Impaired cognition><Incidence><Intervention><Intervention Strategies><Intervention Studies><Intervention Trial><Interventional trial><Life><Low Blood Pressure><Measures><Medical><Medication><Meta-Analysis><Modeling><Monitor><NIH><National Institutes of Health><Outcome><Participant><Patients><Pharmaceutical Preparations><Pharmacists><Population Heterogeneity><Pragmatic clinical trial><Primary Care><Professional Organizations><QOL><Quality of life><Randomized><Research><Sample Size><Self Blood Pressure Monitoring><Syncope><Testing><Titrations><United States National Institutes of Health><Vascular Hypertensive Disease><Vascular Hypertensive Disorder><Vascular Hypotensive Disorder><acute kidney injury><adjudication><adjudicative process and procedure><blood pressure control><blood pressure management><blood pressure reduction><bone fracture><care as usual><chronic kidney disease><circulatory system><clinical decision support><clinical practice><clinical test><cognitive assessment><cognitive dysfunction><cognitive loss><cognitive testing><collaboratory><community intervention><community level intervention><community-based intervention><design><designing><developmental><diabetes><diverse populations><drug/agent><effectiveness/implementation hybrid study><effectiveness/implementation study><enroll><evidence base><falls><future implementation><global health><hazard><heterogeneous population><high blood pressure><homes><hyperpiesia><hyperpiesis><hypertensive disease><hypertensive disorder><inclusion criteria><insight><instrument><intervention research><interventional research><interventional strategy><interventional study><interventions research><lower BP><lower blood pressure><lowers blood pressure><mid life><mid-life><middle age><middle aged><midlife><mild cognitive disorder><mild cognitive impairment><older adult><older adulthood><patient subclass><patient subcluster><patient subgroups><patient subpopulations><patient subsets><patient subtypes><population diversity><pragmatic effectiveness trial><pragmatic trial><prevent><preventing><primary care practice><primary care setting><primary outcome><professional association><professional membership><professional society><randomisation><randomization><randomly assigned><recruit><reduce BP><reduce blood pressure><reduction in BP><reduction in blood pressure><research clinical testing><secondary outcome><socio-economic><socio-economically><socioeconomically><socioeconomics><systems research><team-based care><treatment as usual><usual care><usual care arm><usual care control group>