Clinical trial NCT02455310: Extension Connection Evaluation
Official title: Extension Connection: Dissemination Effectiveness Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Iowa State University
First posted: 2015-05-27
Enrollment: 44524
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Iowa Medicare beneficiaries who are nursing home residents or diagnosed with dementia and meet other eligibility criteria, for each year from 2011 to 2014.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Antipsychotic use
timeFrame: Up to 4 years
measure: Anticholinergic Use
timeFrame: Up to 4 years
Secondary outcomes:
measure: Olanzapine use in patients with metabolic disorders
timeFrame: Up to 4 years
measure: Excessive antipsychotic dose
timeFrame: Up to 4 years
measure: Benzodiazepine use
timeFrame: Up to 2 years
measure: Quetiapine or clozapine use only among antipsychotic users with Parkinson's disease or Lewy body dementia
timeFrame: Up to 4 years
measure: Antipsychotic use in people with dementia
timeFrame: Up to 4 years
measure: Antipsychotic use in nursing home residents with a potentially appropriate indication
timeFrame: Up to 4 years
measure: Antipsychotic use in nursing home residents without a potentially appropriate indication, and proportion with evidence of an inappropriate indication
timeFrame: Up to 4 years
measure: Antipsychotic use in nursing home residents with a recent history of falls
timeFrame: Up to 4 years
measure: Antipsychotic use in nursing home residents with an unsteady gait
timeFrame: Up to 4 years
measure: Hypnotic use
timeFrame: Up to 4 years
measure: Changes in behavioral and psychological symptom presence
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The University of Iowa College of Public Health
state: Iowa
Study officials:
affiliation: University of Iowa
name: Ryan Carnahan, PharmD, MS
role: PRINCIPAL_INVESTIGATOR
References: