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

NCT05156073 | Completed Results

• 2 other identifiers: IRB00253480K23AG054742
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Polypharmacy; Dementia; Multiple Chronic Conditions; Deprescribing; Mild Cognitive Impairment

Keywords

Deprescribing; Dementia

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (2)

• Acceptability of the Intervention to be Assessed Qualitatively From Debriefing Interviews

  1 year

• Feasibility of the Intervention to be Assessed Qualitatively From Debriefing Interviews

  1 year

Study Arms (1)

Intervention

EXPERIMENTAL

The intervention consists of providing educational materials on deprescribing to: 1. Patient and care partner cohort 2. Primary care physician cohort

Other: Educational Materials

Interventions

Educational Materials OTHER

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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Reading Hospital Family Health Care Center: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Reading Hospital Family Health Care Center

Reading, Pennsylvania, 19611, United States

Location

Related Publications (8)

• 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.

  PMID: 16091574 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.

  PMID: 27570871 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.

  PMID: 23305822 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.

  PMID: 26502320 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.

  PMID: 24259639 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.

  PMID: 32552857 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.

  PMID: 15266038 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.

  PMID: 12810899 BACKGROUND

MeSH Terms

Conditions

Dementia; Multiple Chronic Conditions; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders

Results Point of Contact

• Title: Dr. Ariel Green
• Organization: Johns Hopkins University School of Medicine

ariel@jhmi.edu

(410) 550-6733

Study Officials

• Ariel Green, MD, MPH, PhD

  Johs Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: May 22, 2023
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: November 27, 2024
• Results First Posted: November 27, 2024

Record last verified: 2024-11

Locations

US (1)