2023 – 2024
PRINCIPAL Investigator:
Parag Goyal, MD, MSc – Weill Cornell Medicine
Pilot award:
N-of-1 Trials to Promote Deprescribing in Older Adults with Transthyretin Cardiac Amyloidosis
Evidence Gap This Study Seeks to Address: A medical condition called Transthyretin Cardiac Amyloidosis primarily affects adults at older ages. It is important to figure out strategies to help patients with this condition feel better. A medication known as beta-blocker is often used to treat this condition; but some data shows that beta-blockers may be harmful for thiscondition. This proposal seeks to understand the effect of stopping beta-blocker in this condition.
Primary Study Aims: Aim 1) To pilot test whether beta-blocker withdrawal leads to improvements in heart failure symptoms, quality of life and exercise tolerance; Aim 2) To understand the acceptability and feasibility of N-of-1 trials for deprescribing beta-blockers from the patient, caregiver, and physician perspective.
Study Design: 20 N-of-1 trials using a two-arm crossover withdrawal/reversal design with 2 periods (On and Off). The team will review the study and findings with a group of patients and doctors to get their input about the study and its findings.
PRINCIPAL Investigator:
Lisa LaRowe, PhD – Massachusetts General Hospital
Pilot award:
Evaluating Substance Use-Related Outcomes in Opioid Deprescribing among Older Adults with Chronic Pain: A Mixed Methods Study
Evidence Gap This Study Seeks to Address: Substance use can lead to deleterious pain outcomes and interfere with pain treatments via substance-specific and general neurobiological effects. To reduce risk for adverse substance-related outcomes and improve pain/function and among this population, it is imperative to assess and ultimately mitigate problematic substance use behaviors in the context of deprescribing opioids.
Primary Study Aims: (Aim 1) to conduct a retrospective cohort study using electronic health record and Medicare claims data from patients at Mass General Brigham (MGB) to compare the effects of five opioid dose trajectories (i.e., abrupt discontinuation, gradual taper to discontinuation, gradual taper without discontinuation, stable dose, increasing dose) on the development of SUDs and the occurrence/frequency of substance-related adverse events among older adults with chronic pain who were previously prescribed long-term opioid therapy and (Aim 2) to conduct focus groups to explore the perspectives of patient stakeholders regarding biopsychosocial factors that may influence the likelihood of using opioid and nonopioid substances during and following opioid deprescribing.
Study Design: A retrospective cohort study to examine the effects of opioid dose trajectories on substance-related outcomes (Aim 1) and conduct focus groups to elicit perspectives on biopsychosocial factors that influence substance use during opioid deprescribing (Aim 2). Quantitative and qualitative findings will be integrated upon completion of both aims.
PRINCIPAL Investigator:
Malinee Neelamegam, PhD – University of North Texas Health Science Center
Pilot award:
Understanding Barriers and Facilitators of Deprescribing to Aid the Development of a Shared Decision-making Aid for Deprescribing for Older Latinx Adults with Multimorbidity
Evidence Gap This Study Seeks to Address: Older Latinx adults are reported to accumulate multimorbidity at an accelerated rate compared to non-Hispanic white older adults. Poor access to healthcare, low socioeconomic status, poor health behaviors and chronic stress, which are some of the significant social determinants of health faced by Latinx communities in the United States, are linked to multimorbidity and thus polypharmacy. Therefore, deprescribing of potentially harmful, or unrequired medications in older Latinx adults is needed. Significant barriers to successfully deprescribing for many minority populations, as such older Latinx adults, include poor communication between clinicians and patients/caregivers and negligence in taking patients’ values, beliefs and preferences into consideration.
Primary Study Aims: Aim 1: Identify physician-level, patient-level, and caregiver-level facilitators and barriers to deprescribing for older Latinx adults with multimorbidity. Aim 2: Develop a shared decision-making aid to support deprescribing for multimorbid older Latinx adults.
Study Design: In-depth interviews with older Latinx adults living with 2 or more chronic conditions, their caregivers, and their physicians. Based on the findings of these interviews, the research team will convene a stakeholder advisory committee, to allow patients, caregivers and physicians to dynamically develop the shared decision-making aid that will be ideal for the target population.
PRINCIPAL Investigator:
Sion Scott, MPharm, PhD – University of Leicester
Pilot award:
Validation of the Patient Experience of Deprescribing Questionnaire (PED-Q)
Evidence Gap This Study Seeks to Address: There have been studies exploring what needs to happen for healthcare professionals to work with older adults and their family to stop medicines. But none have evaluated the experience older adults and family of going through the process of having a medicine stopped. Dr. Scott’s team developed a pilot questionnaire, called the Patient Experience of Deprescribing Questionnaire (PED-Q), that older adults and family can answer that lets them share their experience of having a medicine stopped.
Primary Study Aims: Aim 1) Evaluate the extent to which PED-Q items measure their intended proactive deprescribing process constructs (discriminant construct validity). Aim 2) Evaluate the PED-Qs face and content validity.
Study Design: Phase 1: With the SAG, we will formulate up to three versions of each PED-Q prototype item in order to identify one which is the best measure of the item’s intended proactive deprescribing activity. Phase 2: Cognitive interviews of 30-60 minutes with older adults and consultees representative of the PED-Q respondent population will be undertaken in order to establish face validity. Cognitive interviews will identify any difficulties in understanding of and responding to the PED-Q items retained from phase 1 to inform refinement.
