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Extension Connection Evaluation (ExConEval)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02455310
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : May 14, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Iowa State University
Information provided by (Responsible Party):
Ryan M. Carnahan, University of Iowa

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.

Condition or disease Intervention/treatment
Dementia 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.

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Study Type : Observational
Actual Enrollment : 44524 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Extension Connection: Dissemination Effectiveness Evaluation
Actual Study Start Date : January 2011
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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.




Primary Outcome Measures :
  1. Antipsychotic use [ Time Frame: Up to 4 years ]
    Antipsychotic use

  2. Anticholinergic Use [ Time Frame: Up to 4 years ]
    Anticholinergic use


Secondary Outcome Measures :
  1. Olanzapine use in patients with metabolic disorders [ Time Frame: Up to 4 years ]
    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.

  2. Excessive antipsychotic dose [ Time Frame: Up to 4 years ]
    Antipsychotic doses as defined as excessive by CMS standards for nursing home residents with dementia

  3. Benzodiazepine use [ Time Frame: Up to 2 years ]
    Benzodiazepine use. Time frame differs because Medicare Part D did not pay for these drugs until 2013.

  4. Quetiapine or clozapine use only among antipsychotic users with Parkinson's disease or Lewy body dementia [ Time Frame: Up to 4 years ]
    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.

  5. Antipsychotic use in people with dementia [ Time Frame: Up to 4 years ]
    Antipsychotic use in people with dementia. This is a subgroup analysis of the nursing home population.

  6. Antipsychotic use in nursing home residents with a potentially appropriate indication [ Time Frame: Up to 4 years ]
    Proportion of antipsychotic users with evidence of a potentially appropriate indication, stratified by indication, as follows: verbal or physical aggression, delusions, hallucinations, delirium

  7. 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 those without a potentially appropriate indication, and proportion of those users with evidence of an inappropriate indication

  8. Antipsychotic use in nursing home residents with a recent history of falls [ Time Frame: Up to 4 years ]
    Antipsychotic use in those with a recent history of falls (fall indicator on any MDS assessment in the prior 6 months)

  9. Antipsychotic use in nursing home residents with an unsteady gait [ Time Frame: Up to 4 years ]
    Antipsychotic use in nursing home residents with an unsteady gait, as evaluated by MDS records

  10. Hypnotic use [ Time Frame: Up to 4 years ]
    Hypnotic use as measured by MDS indicator

  11. Changes in behavioral and psychological symptom presence [ Time Frame: Up to 4 years ]
    Changes in behavioral symptom frequency (each of verbal aggression, physical aggression, delirium, hallucinations, delusions)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455310


Locations
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United States, Iowa
The University of Iowa College of Public Health
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
Ryan M. Carnahan
Patient-Centered Outcomes Research Institute
Iowa State University
Investigators
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Principal Investigator: Ryan Carnahan, PharmD, MS University of Iowa
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Responsible Party: Ryan M. Carnahan, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT02455310    
Other Study ID Numbers: 201108751
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders