RECRUITING

Medication Empowerment and Deprescription for Safety (MEDS) Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 patients. 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 patients 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).

Official Title

Implementation of a Medication Care Plan to Reduce Unintentional Injury Among Rural Older Adults 60+ Years of Age

Quick Facts

Study Start:2020-08-01
Study Completion:2023-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04612166

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 110 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 60 years of age
  2. * Speaks English
  3. * Lives independently in the community (not in assisted living, skilled nursing, rehabilitation facility or hospice)
  4. * Currently taking at least one medication (prescription or OTC) regularly (at least once a week) that puts an older adult at high risk for a fall and plan on taking the medication for at least the next month
  5. * Receives most medical care at a MercyOne clinic
  1. * Does not meet inclusion criteria
  2. * Alzheimer's diagnosis
  3. * Receiving treatment for active cancer

Contacts and Locations

Study Contact

Carri Casteel, MPH, PhD
CONTACT
319-384-4388
carri-casteel@uiowa.edu
Korey A Kennelty, PharmD, MS, PhD
CONTACT
319-335-8862
korey-kennelty@uiowa.edu

Principal Investigator

Carri Casteel, MPH, PhD
PRINCIPAL_INVESTIGATOR
University of Iowa
Korey A Kennelty, PharmD, MS, PhD
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

MercyOne Population Health Services
Clive, Iowa, 50325
United States

Collaborators and Investigators

Sponsor: University of Iowa

  • Carri Casteel, MPH, PhD, PRINCIPAL_INVESTIGATOR, University of Iowa
  • Korey A Kennelty, PharmD, MS, PhD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-01
Study Completion Date2023-09-30

Study Record Updates

Study Start Date2020-08-01
Study Completion Date2023-09-30

Terms related to this study

Keywords Provided by Researchers

  • Medically Treated Falls
  • Deprescription
  • Opioids
  • Benzodiazepines
  • Anticholinergics
  • Older Adults
  • Motor Vehicle Crashes
  • Health Coaches
  • Patient Empowerment

Additional Relevant MeSH Terms

  • Aging
  • Fall Injury