Shared Decision Making About Medication Use for People With Multiple Health Problems
Study Details
Study Description
Brief Summary
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, and clinicians.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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, the investigator team's primary care-based deprescribing intervention for patients with mild cognitive impairment, dementia, and MCC that is currently in the midst of a multisite randomized trial within Kaiser Permanente Colorado. 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:
Specific Aim 1: To assess the feasibility and acceptability of the intervention among patients, care partners, and clinicians.
Specific Aim 2: To assess the feasibility of the primary and secondary outcome measures.
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To determine the feasibility of measuring the primary outcome, the chronic medication count.
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To determine the feasibility of measuring two secondary outcomes, the patient-level Medication Regimen Complexity Index (pMRCI), and the Family Caregiver Medication Administration Hassles Scale (FCMAHS), a caregiver-reported outcome measure.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention The intervention consists of providing educational materials on deprescribing to: Patient and care partner cohort Primary care physician cohort |
Other: Educational Materials
Patient care partner cohort:
a. mailing of an educational brochure introducing deprescribing to care partners and patients with mild cognitive impairment or dementia and/or MCC.
Primary care physician cohort:
education on deprescribing through a 15-minute presentation
one-page weekly tip sheets on options for deprescribing in specific clinical situations and suggested language for deprescribing conversations.
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Outcome Measures
Primary Outcome Measures
- Feasibility as assessed by enrollment rate [1 year]
Dyads are comprised of the person living with mild cognitive impairment or dementia and/or one or two other chronic condition and their care partner. We will measure the number of dyads enrolled per month.
- Feasibility as assessed by net enrollment rate [1 year]
We will measure the number of dyads enrolled divided by the number of active patients age 65 with mild cognitive impairment and dementia and the number of active patients age 75 with two or more chronic conditions at the clinic.
- Feasibility as assessed by the proportion of care partners who remember receiving the study materials [1 year]
We will measure the proportion of care partners who self-reported receiving the study materials divided by the number of study mailings.
- Feasibility as assessed by the number of patients with correct care partners identified in the Electronic Health Records (EHR) [1 year]
We will measure the number of patients with correct and available care partners' contact information divided by the number of participants.
- Feasibility as assessed by participant retention [3 months]
We will measure the percentage of dyads who complete the 3-month follow-up visit.
- Feasibility as assessed by the number of safety concerns reported by participants [1 year]
We will measure the number of safety concerns brought to the Principal Investigator's attention by clinicians involved in the study.
- Acceptability as assessed by questionnaire administered to care partners [1 year]
We will measure the proportion of care partners who agree or strongly agree with questions about intervention acceptability.
- Acceptability as assessed by questionnaire administered to clinicians [1 year]
We will measure the proportion of clinicians who agree or strongly agree with questions about intervention acceptability.
- Acceptability as assessed by visit length questionnaire reported by clinicians [1 year]
We will measure the proportion of clinicians who agree or strongly agree that the intervention increased visit length.
- Acceptability will be assessed from data from recorded primary care visits [1 year]
We will measure the proportion of Primary Care Practitioners (PCPs), patients, or care partners who reference the educational materials. We will measure the proportion of PCPs who use suggested language from the educational materials. We will measure the proportion of patients, care partners, and clinicians who bring up the topic of deprescribing during the conversation. If deprescribing is discussed, we will measure the proportion of conversations that resulted in a stated decision to reduce or stop a medicine.
- Acceptability will be assessed from clinicians' responses to qualitative interview questions [1 year]
We will evaluate acceptability by determining which materials and features of the intervention were most and least acceptable to clinicians, based on clinicians' responses to this question during the qualitative interviews. We will evaluate acceptability by identifying features of the clinic's culture or workflow that served as barriers or facilitators of the intervention, based on clinicians' responses to these questions during the qualitative interviews.
Secondary Outcome Measures
- Feasibility as assessed by number of discrepancies between Epic medication lists and patient-reported medication lists [Up to 3 months after enrollment]
Number of discrepancies between Epic medication lists and patient-reported medication lists at baseline and 3 months: 1) additions, 2) deletions, and 3) dose or frequency changes).
- Feasibility as assessed by measuring the Patient-level Medication Regimen Complexity Index (pMRCI) [Up to 3 months after enrollment]
Percentage of participants with different pMRCI scores based on the Epic medication lists and the patient-reported lists.
- Feasibility as assessed by the time to complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) [Up to 3 months after enrollment]
The FCMAHS is a validated caregiver-reported outcome measure that assesses the burden associated with medication administration. We will measure the time required to complete the FCMAHS.
Eligibility Criteria
Criteria
Inclusion Criteria:
This study has two cohorts: A Mild Cognitive Impairment (MCI)/Dementia cohort and a non-dementia cohort.
MCI/Dementia cohort:
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Age 65 or greater
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Diagnosis of MCI or dementia from International Classification of Diseases ICD-9 and ICD-10 codes
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At least one other chronic condition
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Five or more chronic medications (to include all prescription and over-the-counter medications, both scheduled and as needed)
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Have a primary care physician at the pilot clinic who has enrolled in the study
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Have a routine, scheduled visit with a primary care physician during the pilot study period (not an urgent, acute or pre-op visit)
Non-dementia cohort:
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Age 75 or older
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No MCI or dementia diagnosis
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At least two chronic conditions documented
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5 or more chronic medications (to include all prescription and over-the-counter medications, both scheduled and as needed)
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Have a primary care physician at the pilot clinic who has enrolled in the study
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Have a routine, scheduled visit with a primary care physician during the pilot study period (not an urgent, acute or pre-op visit).
Care partners:
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Family or other companions age 21 years or greater who regularly help the patient with managing medications
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The patient can identify a care partner who assists with medication management to complete the enrollment dyad.
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Patient or care partner must be able to hear well enough to participate in interviews on the telephone.
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Patient agrees to answer "Older Adult Screening Questions" as detailed on the Patient Screening Script.
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Patient's care partner must be willing to participate in the study with the patient and answer the FCMAHS at the baseline visit and at the 3-month visit.
Primary care physicians:
• All primary care physicians at the pilot site will be included.
Exclusion Criteria:
Patient/Care partner dyads:
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Individuals residing in long term care facilities or enrolled in hospice care at baseline will be excluded.
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The patient does not have a care partner that assists with medication management.
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The patient takes 4 or fewer different medications for all his/her health needs
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The patient declines to identify his/her care partner
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For the MCI/Dementia cohort: Answers all memory questions correctly, thus receiving a score of "0" for the screening assessment
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If the patient has a designated Legal Authorized Representative (LAR) but the patient's LAR is unreachable or declines to have the patient involved in the study.
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The care partner declines to participate in the study as part of the patient/care partner dyad.
Primary care physicians:
• Physicians who only provide urgent care will be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Reading Hospital Family Health Care Center | Reading | Pennsylvania | United States | 19611 |
Sponsors and Collaborators
- Johns Hopkins University
- Reading Hospital Tower Health
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Ariel Green, MD, MPH, PhD, Johs Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
- Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016 Apr;12(4):459-509.
- 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.
- 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.
- 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. Epub 2004 Jul 20.
- 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.
- 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.
- 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.
- 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.
- IRB00253480
- K23AG054742