Medication Empowerment and Deprescription for Safety (MEDS) Study

Summary

The long-term goal of this pragmatic, cluster randomized study is to develop a sustainable program for healthcare systems to reduce fatal and nonfatal falls among high-risk older adults living independently in their communities. This study will examine how a medication care plan, grounded in established medication deprescribing and tapering frameworks, can be implemented in primary care clinics to reduce falls among older adults living in rural Iowa communities. The study is a collaboration between researchers and clinical pharmacists at the University of Iowa and a clinical team from the MercyOneSM Health Network, which is a non-academic healthcare system with significant reach into rural Iowa communities

The study's specific goals are as followed:

* Aim 1: Examine the effectiveness of a clinic-based, individualized medication care plan in reducing rates of all falls including medically treated falls (sub-aim 1a) and motor vehicle charges and crashes (sub-aim 1b) among older adults seen in rural primary care clinics.
* Aim 2: Identify provider and patient factors that are associated with patient adherence to medication deprescribing and discontinuation recommendations.
* Aim 3\*: Evaluate implementation of the medication care plan to understand its acceptability, usability and relevance among healthcare system administrators, clinics (clinic managers and clinical staff), providers (health coaches, pharmacists, prescribers) and participants.

Note\*: Only Aims 1 and 2 (i.e., pertinent to the clinical trial) will be described in this clinicaltrials.gov study description.

Intervention and control participants will participate in:

* Baseline assessment
* Quarterly follow-up assessments
* Monthly falls tracking

Additionally, intervention participants will receive:

• An individualized medication action plan to deprescribe medications that put them at high risk for a fall

Researchers will compare intervention and control participants for changes in self-reported fall rates (primary outcome), EMR-indicated medically-treated falls (secondary outcome), traffic-related charges (secondary outcome), and motor vehicle crashes (secondary outcome).

Conditions

• Aging
• Fall Injury

Interventions

BEHAVIORAL

Medication Action Plan and Patient Empowerment (MAP-PE )

Intervention participants (after consenting) will meet with a study health coach for an in-person meeting where the health coach will review the Medication Action Plan (MAP) for deprescription of high-risk medication. The MAP will have previously been approved by both the participant and the participant's primary care physician. If the participant is on more than one high risk medication, the medication that puts them at the highest risk will be deprescribed first and only one medication will be decreased at a time. During this initial meeting, the health coach will use motivational interviewing and distribute materials to empower and support the participant in the medication reduction as outlined on their MAP. The health coach will then follow up with the participant on a schedule determined by the type and dosage of medication being reduced. Follow ups will decrease in frequency over time (starting with at least once a week). The participant will be followed for up to 12 months.

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  collaborator FED

• University of Iowa

  lead OTHER

Principal Investigators

• Carri Casteel, MPH, PhD · University of Iowa

• Korey A Kennelty, PharmD, MS, PhD · University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-01

Primary Completion

2023-12-31

Completion

2024-06-30

Countries

• United States

Study Locations