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NCT05156073

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

Completed NA Results posted Last updated 27 November 2024
What this trial tests

NA trial testing Educational Materials in Polypharmacy in 22 participants. Completed in 3 November 2023.

Timeline
22 May 2023
Primary endpoint
3 November 2023
3 November 2023

Quick facts

Lead sponsorJohns Hopkins University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposehealth services research
Enrollment22
Start date22 May 2023
Primary completion3 November 2023
Estimated completion3 November 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins University

Who can join

65 and older, any sex, with Polypharmacy or Dementia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Preliminary Efficacy of the Intervention to be Assessed From Primary Care Clinician's Intervention Visit Clinical Notes and EHR Primary · 1 year

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 med

Documentation of a discussion about medication appropriateness, safety, or effectiveness
GroupValue95% CI
Intervention (Deprescribing Education)15
Documentation of any medications being discontinued
GroupValue95% CI
Intervention (Deprescribing Education)7
Documentation of a new medicine being started
GroupValue95% CI
Intervention (Deprescribing Education)7
Documentation of actions taken as part of the deprescribing process (e.g., order a blood test)
GroupValue95% CI
Intervention (Deprescribing Education)7
Proportion of patients who deprescribed 1+ medicines
GroupValue95% CI
Intervention (Deprescribing Education)10
The proportion of patients who added 1+ new medicine
GroupValue95% CI
Intervention (Deprescribing Education)10

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 60 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention (Deprescribing Education)
Serious: 3/22 (14%)
Deaths: 0/22

Serious adverse events (2 terms)

ReactionSystemIntervention (Deprescribin…
HospitalizationGeneral disorders
Emergency Department VisitGeneral disorders

Most-reported serious reactions: Hospitalization, Emergency Department Visit.

Data from ClinicalTrials.gov NCT05156073 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Shared decision-making interventions for people with mental health conditions.
    Aoki Y, Yaju Y, Utsumi T, Sanyaolu L, et al · · 2022 · cited 34× · PMID 36367232 · DOI 10.1002/14651858.cd007297.pub3

Verify or expand the search:

Other trials of Educational Materials

Trials testing the same drug.

Other recruiting trials for Polypharmacy

Currently open trials in the same condition.

Other Johns Hopkins University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05156073.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing