2021 – 2022
PRINCIPAL Investigator:
Matthew Duprey, PharmD, PhD – Brown University
Pilot award:
Novel Methods for Estimating the Effects of Deprescribing using Observational Data
Evidence Gap This Study Seeks to Address: There is a methodological challenge with using observational data: difficulty determining precisely when a medication has been discontinued from secondary data. Methods must be developed to address mismeasurement of medication discontinuation in observational studies to ensure unbiased evidence is available.
Primary Study Aims: Aim 1)Utilize both simulation software (SIMEX) and a naïve estimator to compare their ability to reduce bias due to mismeasurement of medication discontinuation in observational studies. Aim 2) Apply the SIMEX approach for reducing bias as proof of concept in a real-world example. Utilize Medicare claims and Minimum Data Set (MDS) data to emulate and replicate the findings of the previously conducted Statin Discontinuation in Advanced Illness trial.
Study Design: Overall Strategy: Our multidisciplinary collaborative research team will generate simulated data that mimics actual observational studies of deprescribing using standard Monte Carlo methods to validate that SIMEX works under known conditions (Aim 1). We will then leverage a wealth of existing data already available at Brown University, specifically the Medicare fee-for-service (FFS) claims and MDS clinical assessments, to conduct a real-world observational study that emulates a trial of statin discontinuation among individuals with limited life expectancy by Kutner et al.30and assesses whether SIMEX can recover the same “gold-standard” estimates as the trial when applied to observational data (Aim 2).
Principal Investigator:
Maria Papaleontiou, MD – University of Michigan
Pilot award:
Deprescribing thyroid hormone replacement therapy in older adults with dementia
Evidence Gap This Study Seeks to Address: There are critical gaps in our understanding about the process, tactics, acceptability of and attitudes towards thyroid hormone deprescribing, as well as how dementia progression influences decisions to continue or discontinue thyroid hormone.
Primary Study Aims: Aim 1) To identify physician-level facilitators, barriers and attitudes related to thyroid hormone medication deprescribing in older adults with dementia. Aim 2) To identify patient-and caregiver-level facilitators, barriers and attitudes related to thyroid hormone medication deprescribing in older adults with dementia.
Study Design: Aim 1) We will obtain a purposeful sample of 12-20 physicians (endocrinologists, primary care physicians and geriatricians) from an academic institution caring for adults aged ≥65 years on thyroid hormone therapy in order to achieve thematic saturation. Based on prior literature, 6-12 interviews per homogeneous group typically provide adequate qualitative data to reach thematic saturation. The study team will conduct45–60 minute interviews via telephone or video conference after finalizing the interview guides. The interviews will provide rich and contextualized information. Potential facilitators and barriers for physicians’ willingness to deprescribe may include patient characteristics (e.g., age, comorbidities, quality of life, etc.) Aim 2) We will conduct in-depth semi-structured patient interviews with up to a total of 20 patients/caregivers to achieve thematic saturation. Patients will be eligible to participate if aged ≥65, speak English, on thyroid hormone therapy for at least a year and have no history of thyroid cancer. The patient and caregiver interviews will be conducted in the same manner as the physician interviews, using refined interview guides through an iterative process.
Principal Investigator:
Min Kwak, MD, MS, DrPH – The University of Texas Health Science Center at Houston
Pilot award:
Intensity of Heart Failure Pharmacotherapy among Older Adults
Evidence Gap This Study Seeks to Address: Clinicians encounter significant knowledge gaps in guidance for optimizing heart failure with reduced ejection fraction (HFrEF) medication regimens for older adults. Older adults historically have been underrepresented in clinical trials.
Primary Study Aims: The purpose of this pilot project is to produce preliminary data for a future comprehensive pharmacoepidemiologic and pharmacoeconomic study to establish the optimal intensity of heart failure medications among older adults with heart failure. Our research team’s overall goal is to provide clinicians with practical guidance to prescribe the most appropriate dose of medications and appropriate numbers of medications to maximize the benefit but minimize the harm.
Study Design: Aim 1) To conduct a scoping review to define the intensity of HFrEF medications. The questions to answer through this review are: In the research regarding HFrEF medications, 1) What is the most commonly used definition of high and low dose intensity in HFrEF medications and what are the medications?, 2)What is the rationale of their definition?, 3) What study population did they include? Aim2)To assess the most commonly prescribed daily doses of HFrEF medications (dose intensity) and the median number of HFrEF medications (number intensity) among Medicare beneficiaries with HFrEF and compare it with the definition of intensity from the literature or standard dose from the guideline. For this specific aim, we will conduct a retrospective cohort study using a 10% sample of Medicare Fee-For-Service (FFS) national claims data (part A, B, and D), which are available through the Center for Health Care Data (CHCD).
Principal Investigator:
Jinjiao Wang, PhD, RN – University of Rochester
Pilot award:
Interdisciplinary Deprescribing via Telehealth in Home Health Care: An Intervention Development Study
Evidence Gap This Study Seeks to Address: Despite the prevalent polypharmacy among home health (HH) care recipients and the potential advantages of utilizing HH care nurses to facilitate deprescribing, no published evidence exists on deprescribing interventions in HH care.
Primary Study Aims: Aim 1) Obtain stakeholder input on the content, format and delivery of the HH-based, interdisciplinary, telehealth-delivered deprescribing intervention. Aim 2) Develop the structure and process of the intervention. Aim 3) Develop a pilot HH deprescribing protocol for future testing.
Study Design: We propose a mixed-methods study, employing 1) qualitative focus groups, and 2) mixed-methods concept mapping to develop the intervention in 3 stages. We conducted a literature review of deprescribing tools (e.g., the Beers criteria), studies, and theories to identify key features and contextual considerations of effective deprescribing strategies, feasibility and potential modifications in the HH setting. This review will serve as the foundation for focus groups and concept mapping.
Principal Investigator:
Nagham Ailabouni, BPharm, PhD – University of South Australia
Pilot award:
Empowering people living with dementia and their caregivers to initiate deprescribing conversations by developing the PRIME (Preparing people living with dementia and their caregivers to Initiate deprescribing conversations about MEdications) tool
Evidence Gap This Study Seeks to Address: No educational materials and/or resources about deprescribing have been designed with, and evaluated in, people living with dementia and their caregivers. The proposed research aims to address this gap by developing a consumer-centric, educational tool for people living with dementia and their caregivers to initiate a deprescribing conversation with their healthcare providers.
Primary Study Aims: Aim 1) Design the PRIME tool using a co-design approach with a stakeholder steering group. This will consist of consumers and healthcare providers (HCPs) from Australia and the United States. Aim 2) Alpha-test the PRIME tool with consumers and HCPs. Aim 3) Pilot (beta-test) the PRIME tool to assess the feasibility of its use and implementation in clinical practice by recruiting consumers and HCPs in Australia and the United States.
Study Design: Aim 1) We will draft the PRIME tool by employing International Standards to adapt an existing, validated, research patient questionnaire [revised Patients’ Attitudes Towards Deprescribing–people with cognitive impairment (rPATD-cog)]. Aim 2) Up to four focus groups (with up to 10 participants each) and individual, in-depth interviews (approximately 10) will be conducted to gain insight into consumer perspectives of their information needs and opinions on the tool. Aim 3) We will conduct a before/after pilot study to beta-test the feasibility of implementing the PRIME tool in clinical practice.
