Extension Connection Evaluation

Dementia Clinical Trial

— ExConEval  

Official title:

Extension Connection: Dissemination Effectiveness Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455310
• Other study ID #: 201108751
• Status: Completed
• Start date: January 2011
• Est. completion date: November 2018

Study information

• Verified date: May 2019
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44524
• Est. completion date: November 2018
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

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.

Locations

Country	Name	City	State
United States	The University of Iowa College of Public Health	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Ryan M. Carnahan	Iowa State University, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antipsychotic use	Antipsychotic use	Up to 4 years
Primary	Anticholinergic Use	Anticholinergic use	Up to 4 years
Secondary	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
Secondary	Excessive antipsychotic dose	Antipsychotic doses as defined as excessive by CMS standards for nursing home residents with dementia	Up to 4 years
Secondary	Benzodiazepine use	Benzodiazepine use. Time frame differs because Medicare Part D did not pay for these drugs until 2013.	Up to 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hypnotic use	Hypnotic use as measured by MDS indicator	Up to 4 years
Secondary	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