Implementation of a Medication Care Plan to Reduce Unintentional Injury Among Rural Older Adults 60+ Years of Age
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Iowa
- Enrollment
- 398
- Locations
- 2
- Primary Endpoint
- Frequency of Self-reported Falls (intervention vs control group)
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 110 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
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.
Intervention: Medication Action Plan and Patient Empowerment (MAP-PE ) (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
Investigators
Carri Casteel
Professor
University of Iowa