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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14442 participants

Primary outcome timeframe

6 months

Results posted on

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

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

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

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 months

Population: 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

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 months

Dose 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

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 months

Population: 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

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 months

Population: 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

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 months

We assessed all-cause inpatient mortality in all study participants (n=12,787) during the 6-month study observation period.

Outcome measures

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 months

Population: 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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 51 deaths

Provider Only

Serious events: 0 serious events
Other events: 0 other events
Deaths: 59 deaths

Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 51 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jerry H. Gurwitz, MD

UMass Chan Medical School

Phone: 508-856-3085

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place