Medication Empowerment and Deprescription for Safety (MEDS) Study (MEDS)

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

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).

Study Overview

• Status: Completed
• Conditions: Aging; Fall Injury
• Intervention / Treatment: Behavioral: Medication Action Plan and Patient Empowerment (MAP-PE )

Detailed Description

Intervention and Control Participants:

After completion of screening and consenting, a University of Iowa (UIowa) researcher will mail a welcome packet to the intervention and control participants. A UIowa pharmacy technician will call the intervention and control participants to conduct the baseline assessment interview during the scheduled interview time. The baseline assessment interview will take approximately 30 minutes to complete.

Intervention Participants:

After the baseline assessment is complete, a UIowa study pharmacist will review the baseline assessment and contact the participant via phone to discuss any medications the participant is taking that are included in the study list of medications of concern. This discussion will include risks and benefits of the medication as well as options for deprescribing or dose reduction if appropriate. The participant will be assessed for willingness to consider the various options for the medication and be made aware that any recommendations will be discussed an approved by the participant's PCP or specialist.

After discussion with the participant, the pharmacist will create one of five versions of the medication action plans (MAP). Two versions of the MAP are created to guide participants when the plan is to taper a medication until it is discontinued (one for PCP and one for specialist). The third version of the MAP is to document when no tapering or dose reduction is recommended. The fourth and fifth versions of the MAP are for when a dose reduction of medication is recommended without a plan for tapering the medication to discontinuation (one for PCP and one for specialist). The drafted MAP will be sent to one of the study health coaches over the secure DataShop System. The study health coach will then send the map to the participant's primary care physician for approval over the secure DataShop system. If the prescribing provider is a specialist and the primary care physician does not want to make adjustments to the medication, a research team health coach will send a letter and study information sheet via fax to the specialist with the MAP. The specialist will return it via fax or mail.

The provider can approve the MAP, approve the MAP with modifications, or decline the MAP recommendations through the DataShop system. If changes in the MAP are requested by the provider, the pharmacist will make needed modifications or negotiate modifications with the provider through the Datashop system or other available secure communication methods for specialists. Once the MAP is approved by the participant's provider, the study health coach will contact the participant by telephone up to five times to schedule an initial visit to review the approved MAP. This review will take about 30 minutes. The participant can then approve the MAP, request modifications, or decline the MAP. If modifications are needed, the pharmacist will be contacted to decide if a revised MAP is needed. If a revised MAP is needed, it will be sent to the physician for approval through DataShop or via fax for specialists. If a revised MAP is not needed, the study health coach will communicate the minor changes to the provider via the EMR or other secure communication methods for specialists. The UIowa pharmacist, participant and participant's provider must agree on the MAP before a MercyOne study health coach sets up an initial visit with the participant. If at any point the provider refuses to approve the plan or the participant refuses to move forward with the medication action plan, the participant will still be asked to complete the monthly falls calendars. If the provider declines the MAP the participant will be mailed a letter from the health coach.

For participants with a taper to discontinuation MAP: once a medication action plan is agreed upon, a MercyOne study health coach will contact the participant up to five times to set up an in-person visit at the clinic to which the participant is attributed or schedule a virtual visit. Virtual visits will be conducted using MercyOne approved processes for health coaches. During this visit the study health coach will complete the initial visit worksheet with the participant and review potential withdrawal symptoms and the tapering schedule outlined in the medication action plan. Initial visit worksheet data will be entered into RedCap. The health coach will answer any questions regarding the plan the participant may have during this meeting as well. The initial visit will take about one hour. Follow up calls between the participant and the study health coach will continue throughout the taper to discuss progress and assess any adverse symptoms. The call schedule for this will depend on tapering schedule designated by the UIowa pharmacist based on type of medication, dose and withdrawal symptoms. Each follow-up call will take about 5-10 minutes, and the health coach will try to connect with the participant up to five times per follow-up call. At the conclusion of the final follow-up call, a thank participant letter will be mailed to the intervention participant. If at any time during the follow-up the intervention participant is no longer receiving health care from MercyOne, the investigators will need to terminate that participant's participation in the intervention. This is due to the necessity of including the MercyOne primary care providers and MercyOne health coaches in the deprescribing communication.

For participants with a non-taper MAP: a MercyOne study health coach will contact the participant up to five times to conduct an initial visit. During this visit the study health coach will complete the initial visit worksheet. Initial visit worksheet data will be entered into RedCap. The health coach will answer any questions the participant may have during this meeting as well. The initial visit will take about ten minutes. Given the participant is not tapering, one follow-up call will occur two months later. This follow up call will take about five minutes. If during the course of the quarterly check-ins, a participant's health status changes (worsening symptoms or fall risk), the health coach or pharmacist may reach out and ask if the individual would like to revisit the non-taper medication action plan. If at any time during the follow-up the intervention participant is no longer receiving health care from MercyOne, the investigators will need to terminate that participant's participation.

For participants with a dose reduction MAP: once a medication action plan is agreed upon, a MercyOne study health coach will contact the participant up to five times to set up an initial visit. During this visit the study health coach will complete the initial visit worksheet with the participant and review potential withdrawal symptoms and the tapering schedule outlined in the medication action plan. Initial visit worksheet data will be entered into RedCap. The health coach will answer any questions the participant may have during this meeting as well. The initial visit will take about one hour. Follow up calls between the participant and the study health coach will depend on the complexity of the dose reduction recommended by the UIowa pharmacist based on type of medication, dose and withdrawal symptoms and will include at least one follow-up call to discuss progress and assess any adverse symptoms. Each follow-up call will take about 5-10 minutes, and the health coach will try to connect with the participant up to five times per follow-up call. At the conclusion of the final follow-up call, a thank participant letter will be mailed to the intervention participant. If at any time during the follow-up the intervention participant is no longer receiving health care from MercyOne, the investigators will need to terminate that participant's participation.

Control Participants:

After the baseline assessment is complete, the study health coach will then send notification of enrollment to the participant's primary care physician over the secure DataShop system.

Intervention and Control Participants:

Every quarter (for at least six month but up to one year) after the baseline assessment, both intervention and control participants will be recontacted up to five times by the pharmacy technician to conduct a follow up interview. If the participant is not interested in completing the follow up interview, they can refuse. The follow up interview will take about 15-20 minutes to complete.

Participants will also be asked to complete monthly falls calendars for at least six months but up to one year following completion of the baseline assessment interview. They will be encouraged to complete the calendar on a daily basis. Participants will be mailed falls calendars with a pre-stamped and pre-addressed return envelope. If the participant does not return their falls calendar or if they indicate a fall, a UIowa researcher will call the participant up to five times to remind them to return their calendar or to confirm that the fall(s) reported meet the study's definition of a fall. These calls will take about 5 minutes. If the investigators are unable to reach the participant by phone due to a bad phone number or voicemail issue, the investigators will send a letter to notify the participant if the falls calendars are missing. Participants can end their participation in the study at any time.

In the event an enrolled participant cannot be reached by phone for the quarterly follow-up or for falls calendar delinquency, research staff will call the alternate contact once. If unable to reach anyone regarding the participant's status, the participant will be sent a letter to notify that he/she has been withdrawn from the study.

• Study Type: Interventional
• Enrollment (Actual): 398
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Clive, Iowa, United States, 50325
      • MercyOne Population Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 60 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

Exclusion Criteria:

• Does not meet inclusion criteria
• Alzheimer's diagnosis
• Receiving treatment for active cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Experimental: Intervention; Participants 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 participant 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 ); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. The investigators will compare frequency between intervention and control groups.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Medically Treated Falls using EMR (intervention vs control group)	Any evidence of fall (calendar + EMR), evidence of injury (EMR), and a highly likelihood that the injury was due to the fall (as adjudicated by two reviewers). Adjudication is based on review of diagnosis codes and dates of service.	12 months
3. Frequency of Traffic-Related Charges (intervention vs control group)	Traffic-related charges are publicly available through the Iowa Court Information System (ICIS), which contains electronic court information used by Clerks of the Court in all Iowa counties. The system maintains up-to-date information about charges at the individual level and includes: the offense date, explanatory codes identifying the type of offense, and identification of the individual who is charged. Traffic related charges are identified as either scheduled traffic violations (i.e., a set fine is associated with the charge)or non-scheduled violations (i.e., penalties are determined by the court). In the proposed study, two subcategories of traffic-related charges will be examined: (1) moving violations, and (2) administrative violations. Participants in the study will be linked to ICIS. The investigators compare frequency between intervention and control groups.	12 months
Frequency of Motor Vehicle Crashes (intervention vs control group)	In the state of Iowa, crash reports are filed for any crash causing death, personal injury, or total property damage of at least $1,500. These reports are maintained in a database by the Iowa Department of Transportation (DOT) and contains information about the crash, vehicle, and individual (driver and passengers) involved. The investigators compare frequency between intervention and control groups.	12 months

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Carri Casteel, MPH, PhD, University of Iowa; Principal Investigator: Korey A Kennelty, PharmD, MS, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Benzodiazepines; Older Adults; Opioids; Patient Empowerment; Deprescription; Anticholinergics; Health Coaches; Medically Treated Falls; Motor Vehicle Crashes
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Patient Participation
• Other Study ID Numbers: 201812791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Given the sensitive nature of the data, the research dataset will not contain protected health information (PHI) and all appropriate procedures consistent with the Office of Civil Rights' Privacy Rule (HIPPA) will be taken to preserve the anonymity of the records. Upon request, the investigator will provide the research dataset to qualified investigators under a data use agreement (DUA) that will require approval of the PIs and the research team participating partners.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No