Pilot/Exploratory Studies Core
The Pilot/Exploratory Studies Core (PESC) is the backbone of our OAIC’s science and scholarly training, responsible for the solicitation, peer-review, selection, support, and monitoring of pilot and exploratory studies (PES) conducted as part of our Pepper Scholars Program.
PES awards are equivalent to an NIH R03, with funding of up to $100,000 in direct costs over two years, designed to gather preliminary data in support of a federal grant (K or R) submission. Awardees receive guidance and mentorship from our Research Education Core and projects receive additional ‘in-kind’ support from our innovative Resource Cores (Design Core, Measurement Core, Analytics Core). Smaller awards may also be offered.
Mary McDermott, MD
Professor of Medicine (General Internal Medicine and Geriatrics) and Preventive Medicine (Epidemiology)
Emily Rogalski, PhD
Associate Director of the Mesulam Center for Cognitive Neurology and Alzheimer Disease
Professor of Psychiatry and Behavioral Sciences
Guisselle del Salto Wismer, MPH
Research Project Manager, CAHRA
Funded Pilot Exploratory Studies
Read below for descriptions of our funded pilot studies. To read more about the Pepper Scholars leading the pilot projects, visit the Pepper Scholar Program page.
Wave 3 PES - 2022 Cohort
Adaptation and Pilot Testing of the Phenotyping Adherence Through Technology-Enabled Reports and Navigation (PATTERNS) Study
Pepper Scholar Lead: Allison Pack, PhD
We will adapt and pilot test a technology-enabled, primary care strategy for routinely monitoring medication use and adherence among older adults with multiple chronic conditions and polypharmacy. An ongoing Northwestern trial (‘TAKE IT’; R01DK110172) has been able to leverage an electronic health record (EHR) platform and its linked patient portal (Epic, MyChart [MyNM]) to: 1) routinely engage new adult kidney transplant recipients via monthly portal-based adherence assessments; 2) flag and phenotype reported adherence concerns; 3) alert care teams via secure messaging of the specific adherence concern(s); and 4) mobilize available resources tailored to identified barriers (e.g. SMS text reminders for cognitive barriers, a comprehensive medication review via phone or video telehealth to address regimen complexity, social work referral for social or economic concerns, etc.) following a standard protocol. With this award, we will adapt the TAKE IT strategy for use in primary care, targeting older adults with MCC and polypharmacy (using Medicare Part D medication therapy management criteria of ≥8 medications). This intervention, renamed as the PATTERN study (Phenotyping Adherence Through Technology-Enabled Reports and Navigation) will then be pilot tested at one Northwestern Medicine (NM) primary care practice to determine its acceptability, feasibility, and preliminary fidelity.
Aim 1: Adapt the PATTERN intervention for use in primary care using input from key stakeholders.
Aim 2: Assess the PATTERN intervention’s feasibility and acceptability for use in primary care.
Leveraging Computer-Human Interaction and Learning Sciences to Support Older Adults' Use of Telehealth Software for Chronic Disease Self-care
Pepper Scholar Lead: Daniel Rees Lewis, PhD
There is currently a gap between the existing and needed clinical support to help older adults learn to manage their conditions. The current system of care does not help patients with chronic conditions (e.g., diabetes) learn effective self-care, and there are few programs developed for older adults. Consequently, there is increased pressure on primary care clinicians, who must help teach older adults to manage their conditions in just a few short minutes they have to meet. This project will seek to leverage Human Computer Interaction (HCI) and Learning Science (LS) methods and designs to create telehealth supports for older adults responsible for learning to manage their own health. I will focus on older adults with type II diabetes, and at least one of hypertension and high cholesterol. While older adults can find software challenging, HCI research shows by attending to their needs we can help them effectively use software (Brewer et al., 2016). Helping older adults to better use telehealth can increase learning and improve health outcomes for older adults while reducing the burden on primary care.
Aim 1: Use cognitive task analysis (CTA) methods to understand the barriers older adults have when using telehealth for self-care management.
Aim 2: Apply findings from Aim 1 to design a learning module to support using existing diabetes telehealth software and then engage in iterative redesign for and with older adults
Technology-Enabled Screening Strategy for Obstructive Sleep Apnea (TEST-OSA) in Primary Care Older Patients with Multiple Chronic Conditions
Pepper Scholar Lead: Minjee Kim, MD
We will adapt and pilot test a technology-enabled, primary care strategy to promote the timely detection and treatment of sleep apnea among older adults at high risk due to multiple chronic conditions.
Obstructive sleep apnea (OSA), characterized by repeated episodes of upper-airway obstruction during sleep, is estimated to affect up to 35% of older adults 65 and older, yet it is vastly underdiagnosed. Undiagnosed and untreated OSA is associated with an increased risk for incident hypertension, coronary heart disease, heart failure, stroke, and mortality, as well as increased motor vehicle crashes, mood disorders and reduced quality of life. OSA is a leading cause of sleep disturbance in older adults and has been linked to more rapid accumulation of chronic diseases and multimorbidity.12
Many approaches have been taken to improve primary care detection of OSA, yet evidence has been highly variable with regard to the acceptability, feasibility, and effectiveness of what has been recently summarized as a range of ‘fragmented’ interventions not limited to high-risk older adults. Yet with widespread use of electronic health records (EHR), there are opportunities to overcome existing screening barriers, streamline clinical workflows, and activate care teams to enable the timely diagnosis of OSA and initiation of appropriate treatment. With this Pepper Scholar application, I will model an existing intervention (Toolbox Detect; R01AG069762) leveraging consumer technology (iPad), tethered to the EHR for routinely screening for cognitive impairment as part of Medicare Annual Wellness Visits (AWV), for use in the early detection of OSA among high-risk adults meeting AHA criteria or with MCC. This Technology-Enabled Screening Targeting Obstructive Sleep Apnea (TEST-OSA) strategy will promote the primary care detection and treatment of OSA among high-risk adults.
It is hypothesized that TEST-OSA, compared to usual care, will increase timely diagnosis of OSA and treatment initiation, without added burden to clinicians.
Aim 1: Develop and refine the TEST-OSA primary care strategy for high-risk older adults, including those with MCC using input from key stakeholders.
Aim 2: Pilot Test the TEST-OSA strategy to determine its acceptability, feasibility, and fidelity in primary care and explore any patient, provider, or health system barriers to implementation.
Heart-Brain MRI Evaluation of Hemodynamic Coupling in Hypertension and Healthy Aging
Pepper Scholar Lead: Kelly Jarvis, PhD
Cardiovascular risk factors, such as hypertension and physical inactivity, are among “potentially modifiable” dementia risk factors that can be influenced in mid to later life. However, mechanisms underlying heart-brain hemodynamic coupling are not well understood. In order to successfully inform new approaches for preventing, delaying or improving quality of life for those suffering from multiple chronic conditions of the heart and brain, interactions between these two major organs need to be further explored.
MRI is an established diagnostic tool for assessing cardiovascular function and neuroimaging markers of cerebrovascular disease and neurodegeneration. In the past decade, 4D flow MRI has emerged as a powerful technique for measuring 3D hemodynamics in the heart and brain vessels. Previously, I developed imaging tools for visualization and quantification of cardiovascular hemodynamics, demonstrating the comprehensive and individualized analysis of complex flow pathways. Using these techniques, I found significant age-related changes in aortic stiffness assessed by pulse wave velocity (PWV). Results in 100 healthy controls (19-79 years) showed a strong correlation with age (r=0.79, p<0.001) (8). Next, will be to study how these changes interact with cerebrovascular hemodynamics and neuroimaging markers of disease.
Abnormalities in heart and brain regions, however, have been historically assessed independently in scanners dedicated for either cardiovascular or neuroimaging studies. Recent developments in MRI provide the ability to image faster and thus an opportunity for integrating cardiovascular 4D flow MRI with neuroimaging in a single patient exam. I have designed a preliminary “heart-brain MRI” protocol and acquired pilot data in 12 healthy individuals (age: 24-76) to demonstrate its feasibility (Jarvis et. al. ISMRM abstract 2022). This novel approach will be used for comprehensive assessment of heart-brain coupling in an initial study of cognitively healthy adults.
Specific Aim: Apply novel heart-brain MRI methods in study of hypertension and normal cognitive aging.
a. Establish normative heart-brain MRI values and quantify interactions across adult lifespan.
b. Evaluate potential impacts of hypertension on hemodynamic coupling.
The Development of Novel Therapeutic Walking Exercise Strategies in Sedentary Individuals with Knee Osteoarthritis
Pepper Scholar Lead: Prakash Jayabalan, MD
Knee osteoarthritis (OA) and cardiovascular disease (CVD) are the two most prevalent medical conditions in individuals above the age of 70. Physical inactivity resulting from OA is known to increase CVD risk in elderly patients and thus shorten their lifespan. Muscle weakness and chronic inflammation are also known to be a significant component of both diseases, and non-steroidal anti-inflammatory drugs (NSAIDs), commonly used to treat OA-related pain are also associated with an increased risk of CVD. Moderate intensity physical activity is strongly advocated for the treatment of both diseases. Randomized clinical trials of walking exercise have shown significant short-term improvements in knee pain, functional status, and quality of life in patients with OA and, in turn, beneficial effects on cardiovascular parameters. However, more recent randomized controlled trials of walking exercise programs in elderly persons with knee OA reported dropout rates as high as 20-40%, indicating reluctance to adopt walking as a lasting form of exercise. Evidence suggests that patients stop exercising due to exercise-induced exacerbation of symptoms, beliefs that exercise could be damaging to their knees, and reduced capacity to perform exercises at intensities and durations recommended, further worsening concurrent CVD parameters. In elderly sedentary individuals with knee OA and CVD, there remains a pivotal need for a physical activity intervention that allows for sustained walking exercise engagement, reducing joint pain and cardiometabolic risk while improving function and cardiovascular parameters.
The study we propose is a randomized controlled trial in individuals with mild to moderate knee OA (n=30 in each group), evaluating the symptomatic, biochemical, and biomechanical benefits of 3 walking exercise treatments: 1) LBPP treadmill walking 2) aquatic walking 3) standard of care land-based walking exercise for the same duration.
Aim 1: Delineate within-participant longitudinal changes in joint pain, quadriceps strength, function (Knee Osteoarthritis Outcome score, KOOS), quality of life (SF-36), NSAID use and serum biomarkers of joint disease, following 12 weeks of off-loaded walking exercise (either LBPP or aquatic walking versus land walking exercise).
Aim 2: Delineate differences in longitudinal changes of cardiovascular parameters (blood pressure, VO2 max, HbA1c and lipid profile) and cardiometabolic markers (serum adiponectin, and inflammatory mediators), following 12 weeks of these respective walking strategies.
Ready for Advances In Bladder health for Older Women (The RAInBOW Study)
Pepper Scholar Lead: Carol Emi Bretschneider, MD
I will develop a patient-centered, individualized overactive bladder (OAB) program uniquely designed for older women that: 1) systematically assesses baseline comorbid conditions and medication use using an integrated online portal-based tool; 2) closely monitors OAB symptoms, treatment response and adverse effects via an online portal-based tool; and 3) proactively adjusts treatments to minimize bothersome OAB symptoms utilizing telehealth visits and expediting the transition to advanced therapies as indicated. I aim to study the impact of this program on patient symptom severity and bother, overall health status and overall quality of life. Over 1-year, women 65 years of age or older with OAB who present to Northwestern’s Integrated Pelvic Health Program (N=60) will be invited to participate in a study comparing outcomes in women (n=30) treated via normal care pathway and (n=30) treated in an OAB program with the integrated online portal-based tools.
Aim 1: To develop an online portal-based tool using a human-centered design to systematically assess patient-reported medication use, comorbid conditions and overall health status as well as OAB-condition specific questions such as symptoms, symptom severity, treatment adherence, treatment response, treatment-related adverse effects and patient satisfaction.
Aim 2: To perform a pilot study of the online portal-based technology compared to usual care in order to test the usability, acceptability and feasibility of the tool.
Wave 2 PES - 2021 Cohort
Designing a Telehealth-Based Tool for Rural Older Adults with Cancer and Cancer-Related Distress: Testing for Usability and Acceptability
Pepper Scholar Lead: Marquita Lewis-Thames, PhD
Older adults have difficulties identifying symptoms of anxiety and reduced likelihood of knowing when to access mental health services. One in four adults >65 years old lives in a rural or small town, where mental health specialists and similar resources are often dispersed or located in distal urban centers. To this end, rural older adults with cancer-related anxiety or distress (CRD) are particularly vulnerable to poorer mental health and cancer-related outcomes. This project proposes a strategy to improve CRD outcomes for rural older adults via a telehealth–based program that supports the management of CRD by integrating clinical and community-based resources.
The specific aims of PES 4 are:
Aim 1: Assess barriers and facilitators of telehealth access from rural older cancer patients, caregivers, and healthcare professionals to guide the development of a telehealth delivered CRD management tool.
Aim 2: Develop a theoretically-grounded telehealth CRD management tool using a human-centered design.
Aim 3: Conduct user testing to inform the final version and an intervention protocol to test the implementation an effectiveness of the telehealth CRD management tool.
Remote Sensor-Based Frailty Detection in Older Adults
Pepper Scholar Lead: Whitney Welch, PhD
Over 30% of older adults report at least one fall each year, with 20% reporting multiple falls. These falls are often associated with serious injury that need medical attention, in addition to lasting disability, loss of independence, and decreased quality of life. Additionally, falls place a significant burden on the healthcare system with an estimated yearly cost of 19.2 billion dollars due to fall-related medical care. With a large aging population, numbers of falls are projected to substantially increase over the next 15 years placing a significant burden on the healthcare system. Due to this substantial healthcare burden, it is critical to first accurately and reliably identify older adults who are at high risk of falling. Further, due to COVID-19, there has been a shift in provider care with a significant increase in telehealth visits. Therefore, there is an immediate and essential need to remotely monitor and detect those patients at high risk for falls.
Strong evidence exists showing that physical activity reduces decline in physical functioning and subsequent risk of falls in older adults. However, less than 10% of older adults meet physical activity guidelines. More recently during the COVID-19 pandemic, these low activity levels have become even further pronounced.
The Specific Aims are:
Aim 1. Calibrate a fall risk machine learning algorithm integrating remote movement sensor data, in addition to electronic health records (health history, patient characteristics) to remotely monitor and identify older adults who are at high risk of falling. The end product will be an algorithm using data integrated from movement sensors and electronic health records that can accurately predict older adults at high risk for falling.
Aim 2. Validate a fall risk machine learning algorithm integrating remote movement sensor data, in addition to electronic health records (health history, patient characteristics, psychosocial factors) to remotely monitor and identify older adults who are at high risk of falling in an independent sample of older adults.
Aim 3. Identify factors (cognitive functioning, psychosocial factors) that may mediate the relationship between sensor-derived variables (physical function, physical activity) and fall risk.
Results from this study will inform the administration of a preventative, remote physical activity fall risk program in order to increase physical functioning and help to preserve long-term independence and quality of life.
Wave 1 PES - 2020 Cohort, Complete
Improving Infection Prevention and Control in Nursing Homes in the Era of COVID
Pepper Scholar Lead: Theresa Rowe, DO, MS, Assistant Professor, Geriatrics
Senior/Key: Lee Lindquist, MD, MPH, MBA; Michael Wolf, PhD MPH; Anne Marie Piper, PhD
Primary care has historically been delivered in the outpatient ambulatory setting. However, as our population ages, many older adults reside in long-term care facilities (LTCFs, i.e. nursing homes) where they receive primary care. Almost half of older adults who live in a nursing home are over the age of 85 and many have functional and cognitive impairments such as Alzheimer’s dementia. These multiple comorbidities and the congregate living environment put residents of LTCFs at increased risk from communicable diseases such as influenza and more recently the novel coronavirus (SARS-COV2).
To perform this project we will examine two large national databases including the 1) national healthcare safety network (NHSN) managed by the CDC and 2) nursing home health citations managed by CMS. This proposal will merge two large publically available nursing home databases using the LTCF identification code to determine if current methods for detecting deficiencies in IPC are effective in minimizing the spread of communicable diseases. The findings from this project may provide useful information to how we approach and evaluate infection prevention and control policies in nursing homes, especially for the older adult residents who reside in facilities long-term.
Intelligent Personal Assistant for Managing Depression in Homebound Older Adults
Pepper Scholar Lead: Katherine O’Brien, MD, Assistant Professor, Geriatrics
Senior/Key: Sara Bradley, MD; David C. Mohr, PhD; Mary Kwasny, PhD
Homebound older adults with MCC are more likely than their ambulatory peers to suffer from depression. While over 70% receive pharmacotherapy, most homebound older adults with depression cannot access needed psychological services. Family caregivers commonly play the role of care coordinator, implementing clinician recommendations and encouraging the loved one with depression. Older adults have often been on the fringe of benefitting from technology. However, voice-controlled intelligent personal assistants (VIPAs; e.g. Google Home, Amazon Echo) may be useful to homebound older adults with depression, connecting them to caregivers and primary care; providing functional, cognitive, and social stimulation; and improving anti-depressant medication adherence through reminders. The objective of this pilot study is to design and pilot VIPAs to provide caregivers with skills and tools manage the care of older adults with depression.
Building off prior work with VIPAs where their current real-world use by older adults with MCC and their caregivers was explored, the specific aims of PES-2 are to: (1) Design a VIPA application for improving depression care and communication for homebound older adults, including their caregivers; (2) Assess the feasibility and implementation of VIPA and its impact on clinical and functional outcomes for older adults with depression.
Prevalence of Microvascular Dysfunction and Association with Functional Limitation in Older Adults with Chronic Obstructive Pulmonary Disease
Pepper Scholar Lead: Sadiya Khan, MD MSc, Assistant Professor, Medicine
Senior/Key: Mary McDermott, MD; Mercedes Carnethon, PhD; Donald Lloyd-Jones, MD ScM; Leah Welty, PhD
Chronic obstructive pulmonary disease (COPD) and heart failure (HF) are major public health epidemics and commonly coexist in older adults (≥65 years). Broadly, cardiovascular causes account for 50% of all deaths in patients with COPD. Specifically, 1 in 3 patients with COPD also have prevalent HF, and this associated with greater functional intolerance, worse health-related quality of life, and increased healthcare expenditures compared with patients with COPD and without HF. Given the high burden of mortality and morbidity with comorbid COPD and HF, identifying key risk factors to prevent functional decline related to HF risk in older adults is critically important. Therefore, we propose an observational, cross-sectional study in older adults (≥65 years) with COPD who have no known history of coronary artery disease or heart failure to examine cross-sectional associations between severity of COPD and microvascular dysfunction, functional status with 6-minute walk test, dyspnea symptoms, and cardiac biomarkers.
The specific aims of PES 3 are: (1) Determine the cross-sectional association between severity of COPD (GOLD Stages) and microvascular dysfunction; (2) Determine the cross-sectional association between severity of COPD (GOLD Stages) and 6-minute walk test, patient reported outcome for dyspnea, and cardiovascular biomarkers.
Interested in leading a PES?
Northwestern Pepper Center's pilot/exploratory studies are conducted by our Pepper Scholars. If you have are interested in applying to become a Pepper Scholar and have a project proposal, we invite you to apply during our next funding cycle.