A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease: Implementation Phase 2

Alzheimer Disease Clinical Trial

— DPRESCRIBE-AD2  

Official title:

D- PRESCRIBE-AD Phase 2(The Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly With Alzheimer's Disease Study: Trial 2)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368115
• Other study ID #: 00023453
• Secondary ID: 4R33AG069794
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: University of Massachusetts, Worcester
• Contact: Cassie L Saphirak, MA
• Phone: 5088563493
• Email: cassandra.saphirak[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 mailed educational interventions, including the effect of a second reminder mailing, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Patient Inclusion Criteria:

1. Diagnosis of AD/ADRD based on a combination of AD/ADRD codes or treatment with a pharmacologic therapy used for AD (e.g., donepezil, rivastigmine, galantamine, and memantine) in the 365 days prior to or on cohort entry date.

2. Evidence of potentially inappropriate prescribing with antipsychotics, sedative-hypnotics, and strong anticholinergics within the past 3 months

3. Age =50 years of age as of cohort entry date

4. Continuous medical and pharmacy insurance coverage for at least the prior year

Patient Exclusion Criteria:

1. Evidence of residing in a nursing home or skilled nursing facility or receiving palliative care.

2. Incomplete/missing prescriber ID or incomplete contact information for either patient or prescribing provider.

3. On "do not contact" list

Provider Inclusion Criteria:

1. Prescribing provider associated with most recent prescribing of target drug.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• Educational Materials
Educational materials on inappropriate prescribing and deprescribing.

Locations

Country	Name	City	State
United States	UMass Chan Medical School	Worcester	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Carelon Research, Harvard Pilgrim Health Care, Humana Healthcare Research, Inc., National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of Inappropriate Medication Prescription Dispensing	The primary outcome will be defined as absence of any dispensing of the targeted inappropriate prescription class from day 91 to day 270 during the 9 months following receipt of intervention. These 9 months are split into a 3-month black-out period followed by a six-month observation period, or days 91-270.	9 months
Secondary	Dose Change	Dose change (defined as > 50% reduction in dose of the selected inappropriate medication), assessed at the participant level using health claims data (outpatient dispensing) during days 91-270.	9 months
Secondary	Polypharmacy	Proportion of patients with polypharmacy (defined as >5 active prescriptions for different agents) during days 91-270.	9 months
Secondary	Rates of Health Care and Emergency Care Utilization	Rates of: emergency room visits; rates of hospitalizations; rates of non-acute institutional stays (e.g., skilled nursing facilities); and overall health care utilization (number of outpatient visits, days hospitalized, emergency department visits, and non-acute institutional days) during days 91-270.	9 months
Secondary	Mortality	In-hospital all-cause mortality during days 91-270.	9 months
Secondary	Switching within Classes	Switching of agents within the following targeted drug classes: sedative/ hypnotics, antipsychotics, highly anticholinergic agents.	9 months