AgingMEDSNCT04612166
Medication Empowerment and Deprescription for Safety (MEDS) Study
A study testing Medication Action Plan and Patient Empowerment (MAP-PE ) in people with Aging and Fall Injury, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 110 years
- Conditions the study is for
- Aging, Fall Injury
- What is being tested?
- Medication Action Plan and Patient Empowerment (MAP-PE )
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not meet inclusion criteria
- Alzheimer's diagnosis
- Receiving treatment for active cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
MercyOne Population Health Services
Clive, Iowa, 50325
About this study
Official title: 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:
Read more
- 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).
Read the 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.
- Conditions
- Aging, Fall Injury
- Being tested
- Medication Action Plan and Patient Empowerment (MAP-PE )
- Keywords
- Medically Treated Falls, Deprescription, Opioids, Benzodiazepines, Anticholinergics, Older Adults, Motor Vehicle Crashes, Health Coaches, Patient Empowerment
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Action Plan and Patient Empowerment (MAP-PE )Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization done at the hospital level in the MercyOneSM Health Network. Participants that are attributed to clinics that report to the participating intervention hospitals, will be screened and recruited as intervention participants. Participants that are attributed to clinics that report to participating control hospitals, will be screened and recruited as control participants.
- Masking
- None (open label)
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Carri Casteel, University of Iowa
- Investigators
- Carri Casteel, MPH, PhD, Principal investigator, University of IowaKorey A Kennelty, PharmD, MS, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612166
- Sponsor's protocol ID
- 201812791
- Acronym
- MEDS
- Status last verified
- Feb 2025
- First submitted
- 19 Oct 2020
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Medication Care Plan to Reduce Unintentional Injury Among Rural Older Adults 60+ Years of Age
- ClinicalTrials.gov ID
- NCT04612166
- Acronym / sponsor ID
- MEDS / 201812791
- Conditions
- Aging, Fall Injury
- Keywords
- Medically Treated Falls, Deprescription, Opioids, Benzodiazepines, Anticholinergics, Older Adults, Motor Vehicle Crashes, Health Coaches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization done at the hospital level in the MercyOneSM Health Network. Participants that are attributed to clinics that report to the participating intervention hospitals, will be screened and recruited as intervention participants. Participants that are attributed to clinics that report to participating control hospitals, will be screened and recruited as control participants.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Medication Action Plan and Patient Empowerment (MAP-PE )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. |
| 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. |
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Does not meet inclusion criteria
- Alzheimer's diagnosis
- Receiving treatment for active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
Primary outcome
Frequency of Self-reported Falls (intervention vs control group)
Time frame: 12 months
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.
3 secondary outcomes
Frequency of Medically Treated Falls using EMR (intervention vs control group)
Time frame: 12 months
3. Frequency of Traffic-Related Charges (intervention vs control group)
Time frame: 12 months
Frequency of Motor Vehicle Crashes (intervention vs control group)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carri Casteel, MPH, PhD principal investigator
University of Iowa
Korey A Kennelty, PharmD, MS, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Action Plan and Patient Empowerment (MAP-PE ) in people with Aging and Fall Injury, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Self-reported Falls (intervention vs control group) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.