An interventional study of Educational Materials in Alzheimer Disease, sponsored by University of Massachusetts, Worcester. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Health services research
Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of educational interventions designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be conducted in two large, national health plans.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 14,442 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing.
Other: Educational Materials
Only providers will receive educational materials on inappropriate prescribing and deprescribing.
Other: Educational Materials
Educational materials on inappropriate prescribing and deprescribing.
Time to Dispensing of Inappropriate Medication Prescription
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.
Time frame: 6 months
Dose Reduction
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).
Time frame: 6 months
Percentage of Participants With Polypharmacy
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.
Time frame: 6 months
Percentage of Participants With Ambulatory Encounters
We assessed the occurrence of any ambulatory encounter over the 6-month observation period.
Time frame: 6 months
Percentage of Participants Who Died
We assessed all-cause inpatient mortality in all study participants (n=12,787) during the 6-month study observation period.
Time frame: 6 months
Switching Within Classes
Switching of agents within the following targeted drug classes: sedative/ hypnotics, antipsychotics, highly anticholinergic agents.
Time frame: 6 months
Percentage of Participants With Emergency Department Encounters
We assessed the occurrence of any emergency department encounters over the 6-month observation period.
Time frame: 6 months
Percentage of Participants With Hospitalizations
We assessed the occurrence of any hospitalizations over the 6-month observation period.
Time frame: 6 months
Percentage of Participants With Non-acute Institutional Admissions
We assessed the occurrence of any non-acute institutional admissions over the 6-month observation period.
Time frame: 6 months
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.
| Milestone | Patient-Provider | Provider Only | Usual Care |
|---|---|---|---|
| Started | 4814 | 4814 | 4814 |
| Completed | 4286 | 4230 | 4271 |
| Not completed | 528 | 584 | 543 |
| Withdrew: Removed prior to mailing | 289 | 306 | 270 |
| Withdrew: Died or disenrolled during blackout period | 239 | 278 | 273 |
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.
| Percentage of Cumulative Incidence | Patient-Provider | Provider Only | Usual Care |
|---|---|---|---|
| Time to Dispensing of Inappropriate Medication Prescription | 76.7 (75.45 to 78.0) | 77.9 (76.5 to 79.1) | 77.5 (76.2 to 78.8) |
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).
| percentage of participants | Patient-Provider | Provider Only | Usual Care |
|---|---|---|---|
| Dose Reduction | 25.8 (24.4 to 27.3) | 24.2 (22.8 to 25.6) | 24.8 (23.4 to 26.2) |
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.
| Percentage of participants | Patient-Provider | Provider Only | Usual Care |
|---|---|---|---|
| Percentage of Participants With Polypharmacy | 81.3 (80.0 to 82.6) | 82.3 (81.0 to 83.5) | 82.0 (80.8 to 83.3) |
We assessed the occurrence of any ambulatory encounter over the 6-month observation period.
| Percentage of participants | Patient-Provider | Provider Only | Usual Care |
|---|---|---|---|
| Percentage of Participants With Ambulatory Encounters | 94.2 (93.4 to 94.9) | 93.8 (93.0 to 94.6) | 94.5 (93.7 to 95.2) |
We assessed all-cause inpatient mortality in all study participants (n=12,787) during the 6-month study observation period.
| Percentage of participants | Patient-Provider | Provider Only | Usual Care |
|---|---|---|---|
| Percentage of Participants Who Died | 1.2 (0.9 to 1.5) | 1.4 (1.1 to 1.8) | 1.2 (0.9 to 1.6) |
Switching of agents within the following targeted drug classes: sedative/ hypnotics, antipsychotics, highly anticholinergic agents.
No measurements were reported for this outcome.
We assessed the occurrence of any emergency department encounters over the 6-month observation period.
| Percentage of participants | Patient-Provider | Provider Only | Usual Care |
|---|---|---|---|
| Percentage of Participants With Emergency Department Encounters | 31.7 (30.1 to 33.2) | 33.0 (31.4 to 34.6) | 33.6 (32.1 to 35.2) |
We assessed the occurrence of any hospitalizations over the 6-month observation period.
| Percentage of participants | Patient-Provider | Provider Only | Usual Care |
|---|---|---|---|
| Percentage of Participants With Hospitalizations | 12.0 (10.9 to 13.1) | 12.9 (11.8 to 14.1) | 12.8 (11.7 to 13.9) |
We assessed the occurrence of any non-acute institutional admissions over the 6-month observation period.
| Percentage of participants | Patient-Provider | Provider Only | Usual Care |
|---|---|---|---|
| Percentage of Participants With Non-acute Institutional Admissions | 7.2 (6.3 to 8.1) | 6.9 (6.1 to 7.8) | 6.8 (5.9 to 7.6) |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient-Provider | 51/4,286 (1.2%) | 0/4,286 (0%) | 0/4,286 (0%) |
| Provider Only | 59/4,230 (1.4%) | 0/4,230 (0%) | 0/4,230 (0%) |
| Usual Care | 51/4,271 (1.2%) | 0/4,271 (0%) | 0/4,271 (0%) |
Modified intention to treat cohort.
| Age, Categorical(Participants) | Patient-Provider | Provider Only | Usual Care | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 431 | 427 | 428 | 1286 |
| >=65 years | 3855 | 3803 | 3843 | 11501 |
| Age, Continuous(Years) | Patient-Provider | Provider Only | Usual Care | Total |
|---|---|---|---|---|
| Mean | 77.4 ± 9.3 | 77.3 ± 9.4 | 77.2 ± 9.3 | 77.3 ± 9.4 |
| Sex: Female, Male(Participants) | Patient-Provider | Provider Only | Usual Care | Total |
|---|---|---|---|---|
| Female | 2971 | 2860 | 2911 | 8742 |
| Male | 1315 | 1370 | 1360 | 4045 |
| Ethnicity (NIH/OMB)(Participants) | Patient-Provider | Provider Only | Usual Care | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 4286 | 4230 | 4271 | 12787 |
| Race (NIH/OMB)(Participants) | Patient-Provider | Provider Only | Usual Care | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 8 | 9 | 18 |
| Asian | 32 | 27 | 25 | 84 |
| Native Hawaiian or Other Pacific Islander | 40 | 31 | 40 | 111 |
| Black or African American | 451 | 447 | 443 | 1341 |
| White | 2779 | 2717 | 2761 | 8257 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 983 | 1000 | 993 | 2976 |
| Region of Enrollment(Participants) | Patient-Provider | Provider Only | Usual Care | Total |
|---|---|---|---|---|
| United States | 4286 | 4230 | 4271 | 12787 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Massachusetts, Worcester