Extension Connection Evaluation

NCT02455310 | Completed

• 1 other identifier: 201108751
• Study Type: observational
• Target: 44,524
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (2)

• Antipsychotic use

  Antipsychotic use

  Up to 4 years

• Anticholinergic Use

  Anticholinergic use

  Up to 4 years

Secondary Outcomes (11)

• Olanzapine use in patients with metabolic disorders

  Up to 4 years

• Excessive antipsychotic dose

  Up to 4 years

• Benzodiazepine use

  Up to 2 years

• Quetiapine or clozapine use only among antipsychotic users with Parkinson's disease or Lewy body dementia

  Up to 4 years

• Antipsychotic use in people with dementia

  Up to 4 years

Study Arms (2)

Outpatients with dementia

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.

Behavioral: Educational activities to improve dementia care

Nursing home residents

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.

Behavioral: Educational activities to improve dementia care

Interventions

Educational activities to improve dementia care BEHAVIORAL

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.

Nursing home residents; Outpatients with dementia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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)
• Age greater than or equal to 66 years at the end of a year of interest
• Any dementia diagnosis prior to the month of interest, or current resident of a nursing home
• For the nursing home analysis, at least 14 days in the facility in the month being classified

You may not qualify if:

• 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
• 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
• Currently comatose based on the most recent MDS assessment-if currently in a nursing home

Sponsors & Collaborators

• Ryan M. Carnahan: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Iowa State University: collaborator

Study Sites (1)

The University of Iowa College of Public Health

Iowa City, Iowa, 52246, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ryan Carnahan, PharmD, MS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 27, 2015
• Study Start: January 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: November 1, 2018
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)