Extension Connection Evaluation (ExConEval)

May 10, 2019 updated by: Ryan M. Carnahan

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44524

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Antipsychotic use
Time Frame: Up to 4 years
Antipsychotic use
Up to 4 years
Anticholinergic Use
Time Frame: Up to 4 years
Anticholinergic use
Up to 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 4 years
Excessive antipsychotic dose
Time Frame: Up to 4 years
Antipsychotic doses as defined as excessive by CMS standards for nursing home residents with dementia
Up to 4 years
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.
Up to 2 years
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.
Up to 4 years
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.
Up to 4 years
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
Up to 4 years
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
Up to 4 years
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)
Up to 4 years
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
Up to 4 years
Hypnotic use
Time Frame: Up to 4 years
Hypnotic use as measured by MDS indicator
Up to 4 years
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)
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ryan M. Carnahan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
Iowa State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ryan Carnahan, PharmD, MS, University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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