Medication Empowerment and Deprescription for Safety (MEDS) Study

NCT04612166 | Unknown

• 1 other identifier: 201812791
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Aging; Fall Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Frequency of Self-reported Falls (intervention vs control group)

  Self-reported measure of the number of times the participant experienced a fall each month using a falls calendar. The participant will document each fall and whether the fall resulted in medical treatment, such as hospitalization, an emergency department visit, and/or a visit to their physician or other healthcare provider. We will compare frequency between intervention and control groups.

  12 months

Secondary Outcomes (3)

• Frequency of Medically Treated Falls using EMR (intervention vs control group)

  12 months

• 3. Frequency of Traffic-Related Charges (intervention vs control group)

  12 months

• Frequency of Motor Vehicle Crashes (intervention vs control group)

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Patients will receive a medication action plan approved by themselves and their primary care providers to reduce their medications. They will also receive check in calls and follow ups from study health coaches to monitor their progress. During health coaching sessions motivational interviewing techniques and patient empowerment strategies will be used by trained health coaches. Participants will also participate in assessments for the study (baseline and quarterly follow ups) and will complete up to 12 months of falls calendars.

Behavioral: Medication Action Plan and Patient Empowerment (MAP-PE )

Control

NO INTERVENTION

Will participate in assessments for the study (baseline and quarterly follow ups) and will complete up to 12 months of falls calendars. No intervention will be given to this group, but standard practices of care delivered by the MercyOneSM Health Network.

Interventions

Medication Action Plan and Patient Empowerment (MAP-PE ) BEHAVIORAL

Intervention patients (after consenting) will meet with a study health coach for an in-person meeting where the health coach will review the pharmacists Medication Action Plan (MAP) for deprescription of high-risk medication. The MAP will have previously been approved by both the patient and the patient's primary care physician. If the patient 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 patient in the reduction of the medication as outlined on their MAP. The health coach will then follow up with the patient 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 patients will be followed for up to 12 months.

Intervention

Eligibility Criteria

• Age: 60 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Speaks English
• Lives independently in the community (not in assisted living, skilled nursing, rehabilitation facility or hospice)
• 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
• Receives most medical care at a MercyOne clinic

You may not qualify if:

• Alzheimer's diagnosis
• Receiving treatment for active cancer

Sponsors & Collaborators

• University of Iowa: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

MercyOne Population Health Services

Clive, Iowa, 50325, United States

RECRUITING

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Carri Casteel, MPH, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Korey A Kennelty, PharmD, MS, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomization done at the hospital level in the MercyOneSM Health Network. Patients that are attributed to clinics that report to the participating intervention hospitals, will be screened and recruited as intervention patients. Patients that are attributed to clinics that report to participating control hospitals, will be screened and recruited as control patients.

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: November 2, 2020
• Study Start: August 1, 2020
• Primary Completion: May 31, 2023
• Study Completion: September 30, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The above information will be available following completion of study team's deliverables but no more than 3 years after completion of the study.
• Access Criteria: Analysis datasets that are generated from the proposed project will be available for public use. These datasets will be completely de-identified and will have gone through a series of data cleaning procedures (e.g., checking for missing data, consistency of coding). They will also include derived variables that were created for dissemination activities and materials. Data dictionaries will be developed for the analysis datasets and will include definitions of all variables, including how the derived variables were created. The project's final report will accompany the analysis datasets and data dictionaries. This will allow users to examine the original data collection instruments and data requests, understand how the data were collected/retrieved, and assess the limitations of the data collection processes and the data itself. All analysis datasets and accompanying materials will be submitted to the NCIPC. Data requests can be made to project PI's: Dr Casteel or Dr Kennelty.

Locations

US (1)