N/A
Completed N=22
Shared Decision Making About Medication Use for People With Multiple Health Problems
Source: ClinicalTrials.gov NCT05156073 ↗Enrolled (actual)
22
Serious AEs
13.6%
Results posted
Nov 2024
Primary outcomePrimary: Preliminary Efficacy of the Intervention to be Assessed From Primary Care Clinician's Intervention Visit Clinical Notes and EHR — 15; 7; 7; 7 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Preliminary Efficacy of the Intervention to be Assessed From Primary Care Clinician's Intervention Visit Clinical Notes and EHR |
15; 7; 7; 7; 10; 10 | — |
| SECONDARY Acceptability of the Intervention to be Assessed Qualitatively From Debriefing Interviews |
— | — |
| SECONDARY Feasibility of the Intervention to be Assessed Qualitatively From Debriefing Interviews |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT05156073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.