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| ID | Type | Description | Link |
|---|---|---|---|
| 4R33AG069794-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Harvard Pilgrim Health Care | OTHER |
| Humana Co.Ltd. | INDUSTRY |
| Elevance Health |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-Provider | Experimental | Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing. |
|
| Provider Only | Experimental | Only providers will receive educational materials on inappropriate prescribing and deprescribing. |
|
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Materials | Other | Educational materials on inappropriate prescribing and deprescribing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry H Gurwitz, MD | UMass Chan Medical School; UMass Memorial Medical Center; Meyers Health Care Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umass Chan Medical School | Worcester | Massachusetts | 01605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39432286 | Derived | Singh S, Li X, Cocoros NM, Antonelli MT, Avula R, Crawford SL, Dashevsky I, Fouayzi H, Harkins TP, Mazor KM, Michnick AI, Parlett L, Paullin M, Platt R, Rochon PA, Saphirak C, Si M, Zhou Y, Gurwitz JH. High-Risk Medications in Persons Living With Dementia: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1426-1433. doi: 10.1001/jamainternmed.2024.5632. | |
| 38346025 | Derived | Singh S, Cocoros NM, Li X, Mazor KM, Antonelli MT, Parlett L, Paullin M, Harkins TP, Zhou Y, Rochon PA, Platt R, Dashevsky I, Massino C, Saphirak C, Crawford SL, Gurwitz JH. Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in the Elderly with Alzheimer's Disease (D-PRESCRIBE-AD): Trial protocol and rationale of an open-label pragmatic, prospective randomized controlled trial. PLoS One. 2024 Feb 12;19(2):e0297562. doi: 10.1371/journal.pone.0297562. eCollection 2024. |
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To address the potential for within-prescriber contamination, only 1 randomly selected eligible patient was randomized per prescribing clinician.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient-Provider | Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing. Educational Materials: Educational materials on inappropriate prescribing and deprescribing. |
| FG001 | Provider Only | Only providers will receive educational materials on inappropriate prescribing and deprescribing. Educational Materials: Educational materials on inappropriate prescribing and deprescribing. |
| FG002 | Usual Care | Usual care - no intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Modified intention to treat cohort.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient-Provider | Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing. Educational Materials: Educational materials on inappropriate prescribing and deprescribing. |
| BG001 | Provider Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified intention to treat cohort. | Posted | Number | 95% Confidence Interval | Percentage of Cumulative Incidence | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient-Provider | Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing. Educational Materials: Educational materials on inappropriate prescribing and deprescribing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerry H. Gurwitz, MD | UMass Chan Medical School | 508-856-3085 | jerry.gurwitz@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2023 | Sep 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| INDUSTRY |
| HealthCore, Inc. | INDUSTRY |
The study design will be a prospective, randomized, "open-label" educational intervention trial with three arms: (1) a combined patient/caregiver and provider educational intervention; (2) a provider only educational intervention; and (3) usual care.
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| 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. | 6 months |
| Percentage of Participants With Ambulatory Encounters | We assessed the occurrence of any ambulatory encounter over the 6-month observation period. | 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. | 6 months |
| Switching Within Classes | Switching of agents within the following targeted drug classes: sedative/ hypnotics, antipsychotics, highly anticholinergic agents. | 6 months |
| Percentage of Participants With Emergency Department Encounters | We assessed the occurrence of any emergency department encounters over the 6-month observation period. | 6 months |
| Percentage of Participants With Hospitalizations | We assessed the occurrence of any hospitalizations over the 6-month observation period. | 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. | 6 months |
Only providers will receive educational materials on inappropriate prescribing and deprescribing. Educational Materials: Educational materials on inappropriate prescribing and deprescribing. |
| BG002 | Usual Care | Usual care - no intervention. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Only providers will receive educational materials on inappropriate prescribing and deprescribing.
Educational Materials: Educational materials on inappropriate prescribing and deprescribing.
| OG002 | Usual Care | Usual care - no intervention. |
|
|
|
| Secondary | 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). | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
|
|
| Secondary | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
|
|
|
| Secondary | Percentage of Participants With Ambulatory Encounters | We assessed the occurrence of any ambulatory encounter over the 6-month observation period. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
|
|
|
| Secondary | Switching Within Classes | Switching of agents within the following targeted drug classes: sedative/ hypnotics, antipsychotics, highly anticholinergic agents. | Data were not collected on this measure. | Posted | 6 months |
|
|
| Secondary | Percentage of Participants With Emergency Department Encounters | We assessed the occurrence of any emergency department encounters over the 6-month observation period. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
|
|
|
| Secondary | Percentage of Participants With Hospitalizations | We assessed the occurrence of any hospitalizations over the 6-month observation period. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
|
|
|
| Secondary | Percentage of Participants With Non-acute Institutional Admissions | We assessed the occurrence of any non-acute institutional admissions over the 6-month observation period. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
|
|
|
| 51 |
| 4,286 |
| 0 |
| 4,286 |
| 0 |
| 4,286 |
| EG001 | Provider Only | Only providers will receive educational materials on inappropriate prescribing and deprescribing. Educational Materials: Educational materials on inappropriate prescribing and deprescribing. | 59 | 4,230 | 0 | 4,230 | 0 | 4,230 |
| EG002 | Usual Care | Usual care - no intervention. | 51 | 4,271 | 0 | 4,271 | 0 | 4,271 |
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| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |