Extension Connection Evaluation (ExConEval)

Extension Connection: Dissemination Effectiveness Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Educational activities to improve dementia care

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.

• Study Type: Observational
• Enrollment (Actual): 44524

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52246
      • The University of Iowa College of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antipsychotic use	Antipsychotic use	Up to 4 years
Anticholinergic Use	Anticholinergic use	Up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Olanzapine use in patients with metabolic disorders	Proportion of antipsychotic users with diabetes mellitus, hyperlipidemia, or hypertension (based on diagnosis indicators from claims) who receive olanzapine, the least appropriate antipsychotic when these conditions are present due to its metabolic effects.	Up to 4 years
Excessive antipsychotic dose	Antipsychotic doses as defined as excessive by CMS standards for nursing home residents with dementia	Up to 4 years
Benzodiazepine use	Benzodiazepine use. Time frame differs because Medicare Part D did not pay for these drugs until 2013.	Up to 2 years
Quetiapine or clozapine use only among antipsychotic users with Parkinson's disease or Lewy body dementia	Quetiapine or clozapine use only among antipsychotic users with Parkinson's disease or Lewy body dementia. These are the most appropriate antipsychotics in these conditions.	Up to 4 years
Antipsychotic use in people with dementia	Antipsychotic use in people with dementia. This is a subgroup analysis of the nursing home population.	Up to 4 years
Antipsychotic use in nursing home residents with a potentially appropriate indication	Proportion of antipsychotic users with evidence of a potentially appropriate indication, stratified by indication, as follows: verbal or physical aggression, delusions, hallucinations, delirium	Up to 4 years
Antipsychotic use in nursing home residents without a potentially appropriate indication, and proportion with evidence of an inappropriate indication	Antipsychotic use in those without a potentially appropriate indication, and proportion of those users with evidence of an inappropriate indication	Up to 4 years
Antipsychotic use in nursing home residents with a recent history of falls	Antipsychotic use in those with a recent history of falls (fall indicator on any MDS assessment in the prior 6 months)	Up to 4 years
Antipsychotic use in nursing home residents with an unsteady gait	Antipsychotic use in nursing home residents with an unsteady gait, as evaluated by MDS records	Up to 4 years
Hypnotic use	Hypnotic use as measured by MDS indicator	Up to 4 years
Changes in behavioral and psychological symptom presence	Changes in behavioral symptom frequency (each of verbal aggression, physical aggression, delirium, hallucinations, delusions)	Up to 4 years

Collaborators and Investigators

• Sponsor: Ryan M. Carnahan
• Collaborators: Patient-Centered Outcomes Research Institute; Iowa State University
• Investigators: Principal Investigator: Ryan Carnahan, PharmD, MS, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 201108751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Other than exposure data which is identifiable, the evaluation is based on CMS data which cannot be shared without a data reuse agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No