Overview

This trial is active, not recruiting.

Condition dementia
Treatment educational activities to improve dementia care
Sponsor University of Iowa
Collaborator Patient Centered Outcome Research Institute
Start date January 2011
End date May 2016
Trial size 60000 participants
Trial identifier NCT02455310, 201212784

Summary

This study will perform a retrospective analysis to evaluate the effectiveness of a multicomponent educational intervention to improve medication use and management of behavioral and psychological symptoms of dementia, relative to a statewide intervention that has been ongoing. Medication use and symptom severity outcomes will be compared among intervention counties and demographically similar non-intervention counties.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective retrospective
Arm
Medication use will be evaluated among outpatients with dementia in intervention and control counties, as well as statewide to evaluate the long-term effectiveness of the statewide intervention.
educational activities to improve dementia care
The multicomponent intervention included active dissemination of educational resources and optional participation in specialist consultation sessions for up to 6 months. The standard intervention included education through a website or conferences, including clinical tools to support implementation of best practices.
Medication use and behavioral outcomes will be evaluated among nursing home residents in intervention and control counties, as well as statewide to evaluate the long-term effectiveness of the statewide intervention.
educational activities to improve dementia care
The multicomponent intervention included active dissemination of educational resources and optional participation in specialist consultation sessions for up to 6 months. The standard intervention included education through a website or conferences, including clinical tools to support implementation of best practices.

Primary Outcomes

Measure
Antipsychotic use
time frame: Up to 4 years
Anticholinergic Use
time frame: Up to 4 years

Secondary Outcomes

Measure
Olanzapine use in patients with metabolic disorders
time frame: Up to 4 years
Excessive antipsychotic dose
time frame: Up to 4 years
Benzodiazepine use
time frame: Up to 2 years
Quetiapine or clozapine use only among antipsychotic users with Parkinson's disease or Lewy body dementia
time frame: Up to 4 years
Antipsychotic use in people with dementia
time frame: Up to 4 years
Antipsychotic use in nursing home residents with a potentially appropriate indication
time frame: Up to 4 years
Antipsychotic use in nursing home residents without a potentially appropriate indication, and proportion with evidence of an inappropriate indication
time frame: Up to 4 years
Antipsychotic use in nursing home residents with a recent history of falls
time frame: Up to 4 years
Antipsychotic use in nursing home residents with an unsteady gait
time frame: Up to 4 years
Hypnotic use
time frame: Up to 4 years
Changes in behavioral symptom frequency
time frame: Up to 4 years

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: 1. Current Medicare fee-for-service plan and Part D enrollment for at least 3 months prior to the month of interest and during the month of interest (allowing a gap of one month to be considered as continuous enrollment if the person is enrolled during the month of interest) 2. Age greater than or equal to 66 years at the end of a year of interest 3. Any dementia diagnosis prior to the month of interest, or current resident of a nursing home 4. For the nursing home analysis, at least 14 days in the facility in the month being classified Exclusion Criteria: 1. Greater than 15 days of the month of interest when prescription fills are unobservable from Medicare Part D claims due to hospital inpatient status, skilled nursing facility resident status, or hospice enrollment 2. A diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, Huntington's disease, Down's syndrome, or mental retardation or developmental disability at any time during the study period. Diagnoses after entry into the study sample will be included because of the limited look-back period to define some conditions for some individuals, and because these are generally not conditions with late-life onset so they are assumed to have been present prior to the first occurrence of a diagnosis in the available data 3. Currently comatose based on the most recent MDS assessment—if currently in a nursing home

Additional Information

Official title Extension Connection: Dissemination Effectiveness Evaluation
Principal investigator Ryan Carnahan, PharmD, MS
Description This study will perform a retrospective analysis to evaluate the effectiveness of a multicomponent educational intervention to improve medication use and management of behavioral and psychological symptoms of dementia, relative to a statewide intervention that has been ongoing. Medication use and symptom severity outcomes will be compared among 29 intervention counties and 10 demographically similar non-intervention counties. The long-term effectiveness of the statewide intervention will also be evaluated. Medicare and Minimum Data set data from 2011 to 2014 will be used to evaluate prescribing and other outcomes in 1) outpatients with dementia, and 2) nursing home residents, based on exposure to interventions among healthcare and nursing home providers. Measurable goals included increasing the appropriateness of antipsychotic prescribing and reducing anticholinergic use. Effect modification will be evaluated by level of participation in the intervention and other prescriber and nursing home facility characteristics.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Iowa.