Trial Outcomes & Findings for A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease (NCT NCT05147428)
NCT ID: NCT05147428
Last Updated: 2024-11-27
Results Overview
The primary outcome will be defined as dispensing of the targeted inappropriate prescription class from day 91 to day 270 during the 6 months observation period following receipt of intervention, or days 91-270.
COMPLETED
NA
14442 participants
6 months
2024-11-27
Participant Flow
Patients with 1 year of health plan coverage who met the following criteria: 1\) AD/ADRD, defined as either presence of International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes for AD/ADRD associated with 2 different claims or as 2 dispensings for an agent used for AD in the 365 days prior to or on cohort entry; (2) age 50 or older; and (3) a dispensing of any of the 3 targeted drug classes in the 3 months prior to or on cohort entry.
To address the potential for within-prescriber contamination, only 1 randomly selected eligible patient was randomized per prescribing clinician.
Participant milestones
| Measure |
Patient-Provider
Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Provider Only
Only providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Usual Care
Usual care - no intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4814
|
4814
|
4814
|
|
Overall Study
COMPLETED
|
4286
|
4230
|
4271
|
|
Overall Study
NOT COMPLETED
|
528
|
584
|
543
|
Reasons for withdrawal
| Measure |
Patient-Provider
Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Provider Only
Only providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Usual Care
Usual care - no intervention.
|
|---|---|---|---|
|
Overall Study
Removed prior to mailing
|
289
|
306
|
270
|
|
Overall Study
Died or disenrolled during blackout period
|
239
|
278
|
273
|
Baseline Characteristics
A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Patient-Provider
n=4 Participants
Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Provider Only
n=4 Participants
Only providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Usual Care
n=4 Participants
Usual care - no intervention.
|
Total
n=12787 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
431 Participants
n=99 Participants
|
427 Participants
n=107 Participants
|
428 Participants
n=206 Participants
|
1286 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
3855 Participants
n=99 Participants
|
3803 Participants
n=107 Participants
|
3843 Participants
n=206 Participants
|
11501 Participants
n=7 Participants
|
|
Age, Continuous
|
77.4 Years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
77.3 Years
STANDARD_DEVIATION 9.4 • n=107 Participants
|
77.2 Years
STANDARD_DEVIATION 9.3 • n=206 Participants
|
77.3 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2971 Participants
n=99 Participants
|
2860 Participants
n=107 Participants
|
2911 Participants
n=206 Participants
|
8742 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1315 Participants
n=99 Participants
|
1370 Participants
n=107 Participants
|
1360 Participants
n=206 Participants
|
4045 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4286 Participants
n=99 Participants
|
4230 Participants
n=107 Participants
|
4271 Participants
n=206 Participants
|
12787 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
32 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
84 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
40 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
111 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
451 Participants
n=99 Participants
|
447 Participants
n=107 Participants
|
443 Participants
n=206 Participants
|
1341 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2779 Participants
n=99 Participants
|
2717 Participants
n=107 Participants
|
2761 Participants
n=206 Participants
|
8257 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
983 Participants
n=99 Participants
|
1000 Participants
n=107 Participants
|
993 Participants
n=206 Participants
|
2976 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4286 Participants
n=99 Participants
|
4230 Participants
n=107 Participants
|
4271 Participants
n=206 Participants
|
12787 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Modified intention to treat cohort.
The primary outcome will be defined as dispensing of the targeted inappropriate prescription class from day 91 to day 270 during the 6 months observation period following receipt of intervention, or days 91-270.
Outcome measures
| Measure |
Patient-Provider
n=4286 Participants
Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Provider Only
n=4230 Participants
Only providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Usual Care
n=4271 Participants
Usual care - no intervention.
|
|---|---|---|---|
|
Time to Dispensing of Inappropriate Medication Prescription
|
76.7 Percentage of Cumulative Incidence
Interval 75.45 to 78.0
|
77.9 Percentage of Cumulative Incidence
Interval 76.5 to 79.1
|
77.5 Percentage of Cumulative Incidence
Interval 76.2 to 78.8
|
SECONDARY outcome
Timeframe: 6 monthsDose reduction was measured as the percentage of patients who achieved a reduction in the patient-specific and medication-specific mean daily dose of the medication targeted for deprescribing of 50% or more during the 6-month study observation period compared with the mean daily dose for the 6-month period immediately preceding the date of mailing of the educational materials. Mean daily dose was calculated using days of supply, dispensed quantity, and unit strength of all dispensings occurring during the 6-month period of interest (either the 6-month study observation period or the 6-month period immediately preceding the date of the mailing).
Outcome measures
| Measure |
Patient-Provider
n=3498 Participants
Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Provider Only
n=3463 Participants
Only providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Usual Care
n=3463 Participants
Usual care - no intervention.
|
|---|---|---|---|
|
Dose Reduction
|
25.8 percentage of participants
Interval 24.4 to 27.3
|
24.2 percentage of participants
Interval 22.8 to 25.6
|
24.8 percentage of participants
Interval 23.4 to 26.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.
Polypharmacy was defined as being dispensed 5 or more unique prescription medications, assessed on the last day of the 6-month study observation period. Polypharmacy was based on medications administered by any route (including topical or ocular medications) and included AD medications and the 3 medication classes targeted for deprescribing. A combination drug was considered a single medication for the purpose of this analysis.
Outcome measures
| Measure |
Patient-Provider
n=3498 Participants
Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Provider Only
n=3463 Participants
Only providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Usual Care
n=3463 Participants
Usual care - no intervention.
|
|---|---|---|---|
|
Percentage of Participants With Polypharmacy
|
81.3 Percentage of participants
Interval 80.0 to 82.6
|
82.3 Percentage of participants
Interval 81.0 to 83.5
|
82.0 Percentage of participants
Interval 80.8 to 83.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.
We assessed the occurrence of any ambulatory encounter over the 6-month observation period.
Outcome measures
| Measure |
Patient-Provider
n=3498 Participants
Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Provider Only
n=3463 Participants
Only providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Usual Care
n=3463 Participants
Usual care - no intervention.
|
|---|---|---|---|
|
Percentage of Participants With Ambulatory Encounters
|
94.2 Percentage of participants
Interval 93.4 to 94.9
|
93.8 Percentage of participants
Interval 93.0 to 94.6
|
94.5 Percentage of participants
Interval 93.7 to 95.2
|
SECONDARY outcome
Timeframe: 6 monthsWe assessed all-cause inpatient mortality in all study participants (n=12,787) during the 6-month study observation period.
Outcome measures
| Measure |
Patient-Provider
n=4286 Participants
Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Provider Only
n=4230 Participants
Only providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Usual Care
n=4271 Participants
Usual care - no intervention.
|
|---|---|---|---|
|
Percentage of Participants Who Died
|
1.2 Percentage of participants
Interval 0.9 to 1.5
|
1.4 Percentage of participants
Interval 1.1 to 1.8
|
1.2 Percentage of participants
Interval 0.9 to 1.6
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data were not collected on this measure.
Switching of agents within the following targeted drug classes: sedative/ hypnotics, antipsychotics, highly anticholinergic agents.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.
We assessed the occurrence of any emergency department encounters over the 6-month observation period.
Outcome measures
| Measure |
Patient-Provider
n=3498 Participants
Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Provider Only
n=3463 Participants
Only providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Usual Care
n=3463 Participants
Usual care - no intervention.
|
|---|---|---|---|
|
Percentage of Participants With Emergency Department Encounters
|
31.7 Percentage of participants
Interval 30.1 to 33.2
|
33.0 Percentage of participants
Interval 31.4 to 34.6
|
33.6 Percentage of participants
Interval 32.1 to 35.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.
We assessed the occurrence of any hospitalizations over the 6-month observation period.
Outcome measures
| Measure |
Patient-Provider
n=3498 Participants
Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Provider Only
n=3463 Participants
Only providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Usual Care
n=3463 Participants
Usual care - no intervention.
|
|---|---|---|---|
|
Percentage of Participants With Hospitalizations
|
12.0 Percentage of participants
Interval 10.9 to 13.1
|
12.9 Percentage of participants
Interval 11.8 to 14.1
|
12.8 Percentage of participants
Interval 11.7 to 13.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.
We assessed the occurrence of any non-acute institutional admissions over the 6-month observation period.
Outcome measures
| Measure |
Patient-Provider
n=3498 Participants
Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Provider Only
n=3463 Participants
Only providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
|
Usual Care
n=3463 Participants
Usual care - no intervention.
|
|---|---|---|---|
|
Percentage of Participants With Non-acute Institutional Admissions
|
7.2 Percentage of participants
Interval 6.3 to 8.1
|
6.9 Percentage of participants
Interval 6.1 to 7.8
|
6.8 Percentage of participants
Interval 5.9 to 7.6
|
Adverse Events
Patient-Provider
Provider Only
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place