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

Primary Purpose

Polypharmacy, Dementia, Multiple Chronic Conditions

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Materials
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Polypharmacy focused on measuring Deprescribing, Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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)

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).

Care partners:

  • Family or other companions age 21 years or greater who regularly help the patient with managing medications
  • The patient can identify a care partner who assists with medication management to complete the enrollment dyad.
  • Patient or care partner must be able to hear well enough to participate in interviews on the telephone.
  • Patient agrees to answer "Older Adult Screening Questions" as detailed on the Patient Screening Script.
  • 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:

  • Individuals residing in long term care facilities or enrolled in hospice care at baseline will be excluded.
  • The patient does not have a care partner that assists with medication management.
  • The patient takes 4 or fewer different medications for all his/her health needs
  • The patient declines to identify his/her care partner
  • For the MCI/Dementia cohort: Answers all memory questions correctly, thus receiving a score of "0" for the screening assessment
  • 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.
  • 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.

Sites / Locations

  • Reading Hospital Family Health Care CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 1, 2021
Last Updated
March 28, 2023
Sponsor
Johns Hopkins University
Collaborators
Reading Hospital Family Health Care Center, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05156073
Brief Title
Shared Decision Making About Medication Use for People With Multiple Health Problems
Official Title
Shared Decision Making About Medication Use for People With Multiple Health Problems
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Reading Hospital Family Health Care Center, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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, 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.
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, 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: Clinical documentation of deprescribing, defined as medication discontinuation or dose reduction. Clinical documentation of a discussion about medication appropriateness, safety, or effectiveness (yes/possible vs. no/absent).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypharmacy, Dementia, Multiple Chronic Conditions, Deprescribing, Mild Cognitive Impairment
Keywords
Deprescribing, Dementia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention consists of providing educational materials on deprescribing to: Patient and care partner cohort Primary care physician cohort
Intervention Type
Other
Intervention Name(s)
Educational Materials
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the intervention to be assessed qualitatively from debriefing interviews
Description
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
Title
Acceptability of the intervention to be assessed qualitatively from debriefing interviews
Description
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
Secondary Outcome Measure Information:
Title
Preliminary efficacy to be assessed from primary care clinician's clinical notes
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel Green, MD, MPH, PhD
Phone
410-550-6733
Email
ariel@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel Green, MD, MPH, PhD
Organizational Affiliation
Johs Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reading Hospital Family Health Care Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariel Green, MD, MPH, PhD
First Name & Middle Initial & Last Name & Degree
Mary Alderfer

12. IPD Sharing Statement

Citations:
PubMed Identifier
16091574
Citation
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Results Reference
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PubMed Identifier
27570871
Citation
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.
Results Reference
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PubMed Identifier
23305822
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.
Results Reference
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PubMed Identifier
26502320
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.
Results Reference
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PubMed Identifier
24259639
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.
Results Reference
background
PubMed Identifier
32552857
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.
Results Reference
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PubMed Identifier
15266038
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.
Results Reference
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PubMed Identifier
12810899
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.
Results Reference
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Shared Decision Making About Medication Use for People With Multiple Health Problems

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