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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG054742 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Reading Hospital Family Health Care Center | UNKNOWN |
| National Institute on Aging (NIA) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention consists of providing educational materials on deprescribing to:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Materials | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
These measures will be extracted from the electronic medical record. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
• All primary care physicians and medical assistants at the pilot site will be included. Physicians who only provide urgent care will be excluded.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel Green, MD, MPH, PhD | Johs Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reading Hospital Family Health Care Center | Reading | Pennsylvania | 19611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16091574 | Background | Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005 Aug 10;294(6):716-24. doi: 10.1001/jama.294.6.716. | |
| 27570871 | Background | Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016 Apr;12(4):459-509. doi: 10.1016/j.jalz.2016.03.001. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention (Deprescribing Education) | The intervention consists of providing educational materials on deprescribing to:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention (Deprescribing Education) | The intervention consists of providing educational materials on deprescribing to:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
These measures will be extracted from the electronic medical record. | A total of 22 participants were enrolled and received the intervention brochure by mail. Data on clinical documentation was not available for two participants, therefore a total of 20 participants were analyzed in rows 1-4. Additionally, medication data was missing for three more participants in rows 5-6, thus a total of 17 participants were included in the analysis of rows 5-6. | Posted | Count of Participants | Participants | 1 year |
Up to 60 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention (Deprescribing Education) | The intervention consists of providing educational materials on deprescribing to:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ariel Green | Johns Hopkins University School of Medicine | (410) 550-6733 | ariel@jhmi.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 16, 2023 | Nov 3, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000071069 | Multiple Chronic Conditions |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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|
| 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. | 1 year |
| 23305822 | Background | Lin PJ, Fillit HM, Cohen JT, Neumann PJ. Potentially avoidable hospitalizations among Medicare beneficiaries with Alzheimer's disease and related disorders. Alzheimers Dement. 2013 Jan;9(1):30-8. doi: 10.1016/j.jalz.2012.11.002. |
| 26502320 | Background | Kelley AS, McGarry K, Gorges R, Skinner JS. The burden of health care costs for patients with dementia in the last 5 years of life. Ann Intern Med. 2015 Nov 17;163(10):729-36. doi: 10.7326/M15-0381. Epub 2015 Oct 27. |
| 24259639 | Background | Willson MN, Greer CL, Weeks DL. Medication regimen complexity and hospital readmission for an adverse drug event. Ann Pharmacother. 2014 Jan;48(1):26-32. doi: 10.1177/1060028013510898. Epub 2013 Nov 5. |
| 32552857 | Background | Bayliss EA, Shetterly SM, Drace ML, Norton J, Green AR, Reeve E, Weffald LA, Wright L, Maciejewski ML, Sheehan OC, Wolff JL, Gleason KS, Kraus C, Maiyani M, Du Vall M, Boyd CM. The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial. Trials. 2020 Jun 18;21(1):542. doi: 10.1186/s13063-020-04482-0. |
| 15266038 | Background | George J, Phun YT, Bailey MJ, Kong DC, Stewart K. Development and validation of the medication regimen complexity index. Ann Pharmacother. 2004 Sep;38(9):1369-76. doi: 10.1345/aph.1D479. Epub 2004 Jul 20. |
| 12810899 | Background | Travis SS, Bernard MA, McAuley WJ, Thornton M, Kole T. Development of the family caregiver medication administration hassles scale. Gerontologist. 2003 Jun;43(3):360-8. doi: 10.1093/geront/43.3.360. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Medications Prescribed to the Patient | Mean | Standard Deviation | medications |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Intervention (Deprescribing Education) | The intervention consists of providing educational materials on deprescribing to:
|
|
|
| Secondary | 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. | Data Not Collected | Posted | 1 year |
|
|
| Secondary | 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. | Data Not Collected | Posted | 1 year |
|
|
| 0 |
| 22 |
| 3 |
| 22 |
| 0 |
| 22 |
| Emergency Department Visit | General disorders | Systematic Assessment |
|
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| D001523 | Mental Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |