An interventional study of Educational Materials in Polypharmacy, Dementia and Multiple Chronic Conditions, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Health services research
The Shared Decision Making about Medication Use for People with Multiple Health Problems study will assess the feasibility and acceptability of a deprescribing educational intervention in primary care for patients with mild cognitive impairment or dementia and/or multiple chronic conditions (MCC), the patients' care partners, clinicians, and medical assistants.
The intervention consists of the following strategies: 1) a patient/caregiver component focused on education and activation about deprescribing, and 2) a clinician component focused on increasing clinician awareness about options and processes for deprescribing in the MCI/dementia and/or MCC population. Clinicians will each be asked to participate in a single, 15-minute educational session on deprescribing, and medical residents will receive a 45-minute lecture. Patients, caregivers, clinicians, and medical assistants will participate in a single one-on-one debriefing interview.
People living with dementia are prescribed more medications and have more complex medication regimens than people without dementia. These problems are exacerbated in people with dementia and multiple chronic conditions (MCC). Having multiple diseases simultaneously (e.g., diabetes and hypertension, and dementia) leads to the use of multiple drugs (polypharmacy) and potentially inappropriate medications, in which the risks of medications outweigh the benefits, or medications do not align with the patient's treatment goals. For individuals with dementia and MCC, taking more medications is associated with a greater risk of adverse drug events, drug interactions, and treatment burden. Medication regimen complexity is a major source of burden for family caregivers of people living with dementia and has been associated with numerous adverse outcomes. Studies suggest that as many as 56% of people with dementia take at least one potentially inappropriate medication, including medications that can negatively affect cognitive function. Optimizing medication use through deprescribing (the process of reducing or stopping the use of potentially inappropriate medications or medications unlikely to be beneficial) can improve outcomes for patients with dementia and MCC. Therefore, the investigator proposes a patient-centered deprescribing educational intervention for older adults with mild cognitive impairment or dementia and/or MCC, generalizable to a range of primary care settings. This study builds on OPTIMIZE, a multisite randomized trial within Kaiser Permanente Colorado that has been recently completed. OPTIMIZE is the investigator team's primary care-based deprescribing intervention for patients with mild cognitive impairment and dementia, and MCC. OPTIMIZE consists of a patient and family component focused on education and activation about deprescribing and a clinician component to increase awareness about processes and language for deprescribing.
The investigators propose a pilot study of medication optimization through increased awareness of deprescribing for older adults with cognitive impairment and/or MCC. The intervention will have two components: a patient/ care partner component focused on education and activation about deprescribing, and a clinician component focused on increasing clinician awareness about options and processes for deprescribing in the cognitive impairment-MCC population. The proposed intervention has the following aims:
To establish the feasibility and acceptability of the intervention among patients, caregivers, clinicians, and medical assistants in one healthcare system by assessing:
a. Acceptability and process measures from a qualitative analysis of debriefing interviews with patients, care partners, clinicians, and medical assistants.
To determine the preliminary efficacy of the intervention by assessing:
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's enrollment of 22 is below the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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This study has two cohorts: A Mild Cognitive Impairment (MCI)/Dementia cohort and a non-dementia cohort.
MCI/Dementia cohort:
Non-dementia cohort:
Care partners:
Primary care physicians and medical assistants:
Exclusion Criteria:
The intervention consists of providing educational materials on deprescribing to: 1. Patient and care partner cohort 2. Primary care physician cohort
Other: Educational Materials
1. Patient care partner cohort: a. mailing of an educational brochure introducing deprescribing to patients with mild cognitive impairment or dementia and/or MCC and MCC care partners. 2. Primary care physician cohort: 1. education on deprescribing through a 15-45-minute presentation 2. one-page weekly tip sheets on options for deprescribing in specific clinical situations and suggested language for deprescribing conversations.
Preliminary Efficacy of the Intervention to be Assessed From Primary Care Clinician's Intervention Visit Clinical Notes and EHR
The investigators will assess the impact of the intervention by assessing the primary care clinician's documentation from the clinic visit immediately after the patient and care partner receive the intervention brochure. The following will be evaluated: 1. Primary care clinician's documentation of discussions about medication appropriateness, safety, or effectiveness. 2. Primary care clinician's documentation of planned medication changes (new medications to be added, dose increases, dose reductions, or medications to be stopped). 3. The proportion of patients who deprescribe one or more medications 4. The proportion of patients who add one or more medications These measures will be extracted from the electronic medical record.
Time frame: 1 year
Acceptability of the Intervention to be Assessed Qualitatively From Debriefing Interviews
The investigators will evaluate the acceptability of the intervention among patients, care partners, clinicians, and medical assistants by: a) determining which materials and features of the intervention are most and least acceptable to clinicians, medical assistants, patients, and care partners. These data will be obtained through the qualitative analysis of debriefing interviews.
Time frame: 1 year
Feasibility of the Intervention to be Assessed Qualitatively From Debriefing Interviews
The investigators will evaluate the feasibility of the intervention among patients, care partners, clinicians, and medical assistants by: a) identifying features of the clinic's culture or workflow that served as barriers or facilitators of the intervention. These data will be obtained through the qualitative analysis of debriefing interviews.
Time frame: 1 year
| Milestone | Intervention (Deprescribing Education) |
|---|---|
| Started | 22 |
| Completed | 21 |
| Not completed | 1 |
| Withdrew: Patient canceled appointment with pcp | 1 |
The investigators will assess the impact of the intervention by assessing the primary care clinician's documentation from the clinic visit immediately after the patient and care partner receive the intervention brochure. The following will be evaluated: 1. Primary care clinician's documentation of discussions about medication appropriateness, safety, or effectiveness. 2. Primary care clinician's documentation of planned medication changes (new medications to be added, dose increases, dose reductions, or medications to be stopped). 3. The proportion of patients who deprescribe one or more medications 4. The proportion of patients who add one or more medications These measures will be extracted from the electronic medical record.
| Participants | Intervention (Deprescribing Education) |
|---|---|
| Documentation of a discussion about medication appropriateness, safety, or effectiveness | 15 |
| Documentation of any medications being discontinued | 7 |
| Documentation of a new medicine being started | 7 |
| Documentation of actions taken as part of the deprescribing process (e.g., order a blood test) | 7 |
| Proportion of patients who deprescribed 1+ medicines | 10 |
| The proportion of patients who added 1+ new medicine | 10 |
The investigators will evaluate the acceptability of the intervention among patients, care partners, clinicians, and medical assistants by: a) determining which materials and features of the intervention are most and least acceptable to clinicians, medical assistants, patients, and care partners. These data will be obtained through the qualitative analysis of debriefing interviews.
No measurements were reported for this outcome.
The investigators will evaluate the feasibility of the intervention among patients, care partners, clinicians, and medical assistants by: a) identifying features of the clinic's culture or workflow that served as barriers or facilitators of the intervention. These data will be obtained through the qualitative analysis of debriefing interviews.
No measurements were reported for this outcome.
Collected over Up to 60 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention (Deprescribing Education) | 0/22 (0%) | 3/22 (13.6%) | 0/22 (0%) |
| Event | Intervention (Deprescribing Education) |
|---|---|
| HospitalizationGeneral disorders | 2/22 |
| Emergency Department VisitGeneral disorders | 1/22 |
| Age, Continuous(years) | Intervention (Deprescribing Education) |
|---|---|
| Mean | 76.5 ± 7.70 |
| Sex: Female, Male(Participants) | Intervention (Deprescribing Education) |
|---|---|
| Female | 13 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Intervention (Deprescribing Education) |
|---|---|
| Hispanic or Latino | 11 |
| Not Hispanic or Latino | 11 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Intervention (Deprescribing Education) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 8 |
| Medications Prescribed to the Patient(medications) | Intervention (Deprescribing Education) |
|---|---|
| Mean | 13.3 ± 5.46 |
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