Shared Decision Making About Medication Use for People With Multiple Health Problems

Dementia Clinical Trial

Official title:

Shared Decision Making About Medication Use for People With Multiple Health Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05156073
• Other study ID #: IRB00253480
• Secondary ID: K23AG054742
• Status: Completed
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: November 3, 2023

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

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, 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: 1. 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. 2. To determine the preliminary efficacy of the intervention by assessing: 1. Clinical documentation of deprescribing, defined as medication discontinuation or dose reduction. 2. Clinical documentation of a discussion about medication appropriateness, safety, or effectiveness (yes/possible vs. no/absent).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 3, 2023
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

This study has two cohorts: A Mild Cognitive Impairment (MCI)/Dementia cohort and a non-dementia cohort.

MCI/Dementia cohort:

• Age 65 or greater
• Diagnosis of MCI or dementia from International Classification of Diseases ICD-9 and ICD-10 codes
• At least one other chronic condition
• Five or more chronic medications (to include all prescription and over-the-counter medications, both scheduled and as needed)
• Have a primary care physician at the pilot clinic who has enrolled in the study
• Have a routine, scheduled visit with a primary care physician during the pilot study period (not an urgent, acute or pre-op visit)
• Patient must be able to hear well enough to participate in interviews on the telephone.

Non-dementia cohort:

• Age 75 or older
• No MCI or dementia diagnosis
• At least two chronic conditions documented
• 5 or more chronic medications (to include all prescription and over-the-counter medications, both scheduled and as needed)
• Have a primary care physician at the pilot clinic who has enrolled in the study
• Have a routine, scheduled visit with a primary care physician during the pilot study period (not an urgent, acute, or pre-op visit).
• Patient must be able to hear well enough to participate in interviews on the telephone.

Care partners:

• Age 21 years or greater
• Must be able to hear well enough to participate in interviews on the telephone.

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:

• As the pilot will be based in primary care, individuals residing in long-term care facilities or enrolled in hospice care at baseline will be excluded.
• Patients taking 4 or fewer different medications for all their health needs will be excluded.

Related Conditions & MeSH terms

• Chronic Disease
• Cognitive Dysfunction
• Dementia
• Deprescribing
• Mild Cognitive Impairment
• Multiple Chronic Conditions
• Polypharmacy

Intervention

Other:
• Educational Materials
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. Primary care physician cohort: education on deprescribing through a 15-45-minute presentation one-page weekly tip sheets on options for deprescribing in specific clinical situations and suggested language for deprescribing conversations.

Locations

Country	Name	City	State
United States	Reading Hospital Family Health Care Center	Reading	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA), Reading Hospital Family Health Care Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.	1 year
Secondary	Preliminary efficacy to be assessed from primary care clinician's clinical notes	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: Primary care clinician's documentation of discussions about medication appropriateness, safety, or effectiveness.; Primary care clinician's documentation of planned medication changes (new medications to be added, dose increases, dose reductions, or medications to be stopped).; These measures will be extracted from the electronic medical record.	1 year