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OpenTrials
Completed

NCT Number: NCT02455310

Extension Connection 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Iowa College of Public Health

Iowa City, Iowa, 52246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Antipsychotic use

    Time frame: Up to 4 years

    Antipsychotic use

  2. Anticholinergic Use

    Time frame: Up to 4 years

    Anticholinergic use

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Ryan M. Carnahan

Other

Collaborators

  • Iowa State University
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Extension Connection: Dissemination Effectiveness Evaluation

Acronym: ExConEval

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
May 27, 2015
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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