Trial Outcomes & Findings for Shared Decision Making About Medication Use for People With Multiple Health Problems (NCT NCT05156073)
NCT ID: NCT05156073
Last Updated: 2024-11-27
Results Overview
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.
COMPLETED
NA
22 participants
1 year
2024-11-27
Participant Flow
Participant milestones
| Measure |
Intervention (Deprescribing Education)
The intervention consists of providing educational materials on deprescribing to:
1. Patient and care partners, including the 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 physicians, including education on deprescribing through a 15-45-minute presentation and one-page weekly tip sheets on options for deprescribing in specific clinical situations and suggested language for deprescribing conversations.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Intervention (Deprescribing Education)
The intervention consists of providing educational materials on deprescribing to:
1. Patient and care partners, including the 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 physicians, including education on deprescribing through a 15-45-minute presentation and one-page weekly tip sheets on options for deprescribing in specific clinical situations and suggested language for deprescribing conversations.
|
|---|---|
|
Overall Study
Patient canceled appointment with PCP
|
1
|
Baseline Characteristics
Shared Decision Making About Medication Use for People With Multiple Health Problems
Baseline characteristics by cohort
| Measure |
Intervention (Deprescribing Education)
n=22 Participants
The intervention consists of providing educational materials on deprescribing to:
1. Patient and care partners, including the 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 physicians, including education on deprescribing through a 15-45-minute presentation and one-page weekly tip sheets on options for deprescribing in specific clinical situations and suggested language for deprescribing conversations.
|
|---|---|
|
Age, Continuous
|
76.5 years
STANDARD_DEVIATION 7.70 • n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
|
Medications Prescribed to the Patient
|
13.3 medications
STANDARD_DEVIATION 5.46 • n=99 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: A total of 22 participants were enrolled and received the intervention brochure by mail. Data on clinical documentation was not available for two participants, therefore a total of 20 participants were analyzed in rows 1-4. Additionally, medication data was missing for three more participants in rows 5-6, thus a total of 17 participants were included in the analysis of rows 5-6.
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.
Outcome measures
| Measure |
Intervention (Deprescribing Education)
n=20 Participants
The intervention consists of providing educational materials on deprescribing to:
1. Patient care partner cohort, including the 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, including the education on deprescribing through a 15-45-minute presentation and one-page weekly tip sheets on options for deprescribing in specific clinical situations and suggested language for deprescribing conversations.
|
|---|---|
|
Preliminary Efficacy of the Intervention to be Assessed From Primary Care Clinician's Intervention Visit Clinical Notes and EHR
Documentation of a discussion about medication appropriateness, safety, or effectiveness
|
15 Participants
|
|
Preliminary Efficacy of the Intervention to be Assessed From Primary Care Clinician's Intervention Visit Clinical Notes and EHR
Documentation of any medications being discontinued
|
7 Participants
|
|
Preliminary Efficacy of the Intervention to be Assessed From Primary Care Clinician's Intervention Visit Clinical Notes and EHR
Documentation of a new medicine being started
|
7 Participants
|
|
Preliminary Efficacy of the Intervention to be Assessed From Primary Care Clinician's Intervention Visit Clinical Notes and EHR
Documentation of actions taken as part of the deprescribing process (e.g., order a blood test)
|
7 Participants
|
|
Preliminary Efficacy of the Intervention to be Assessed From Primary Care Clinician's Intervention Visit Clinical Notes and EHR
Proportion of patients who deprescribed 1+ medicines
|
10 Participants
|
|
Preliminary Efficacy of the Intervention to be Assessed From Primary Care Clinician's Intervention Visit Clinical Notes and EHR
The proportion of patients who added 1+ new medicine
|
10 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Data Not Collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data Not Collected
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.
Outcome measures
Outcome data not reported
Adverse Events
Intervention (Deprescribing Education)
Serious adverse events
| Measure |
Intervention (Deprescribing Education)
n=22 participants at risk
The intervention consists of providing educational materials on deprescribing to:
1. Patient care partner cohort, including 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, including education on deprescribing through a 15-45-minute presentation and one-page weekly tip sheets on options for deprescribing in specific clinical situations and suggested language for deprescribing conversations.
|
|---|---|
|
General disorders
Hospitalization
|
9.1%
2/22 • Number of events 3 • Up to 60 days
|
|
General disorders
Emergency Department Visit
|
4.5%
1/22 • Number of events 1 • Up to 60 days
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ariel Green
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place