DementiaExConEvalNCT02455310
Extension Connection Evaluation
An observational study of Dementia, run by Ryan M. Carnahan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Educational activities to improve dementia care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 44,524 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Iowa College of Public Health
Iowa City, Iowa, 52246
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Educational activities to improve dementia care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational activities to improve dementia careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Educational activities to improve dementia care | |
| 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. Receives: Behavioral: Educational activities to improve dementia care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antipsychotic use
Antipsychotic use
Measured: Up to 4 years
Anticholinergic Use
Anticholinergic use
Measured: Up to 4 years
Secondary outcomes (11)
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.
Measured: Up to 4 years
Excessive antipsychotic dose
Antipsychotic doses as defined as excessive by CMS standards for nursing home residents with dementia
Measured: Up to 4 years
Benzodiazepine use
Benzodiazepine use. Time frame differs because Medicare Part D did not pay for these drugs until 2013.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Up to 4 years
Hypnotic use
Hypnotic use as measured by MDS indicator
Measured: 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)
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJan 2011
- Primary completion1 Jun 2017
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 44,524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryan M. Carnahan
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Iowa State University
- Responsible party
- Sponsor-investigator, Ryan M. Carnahan, University of Iowa
- Investigators
- Ryan Carnahan, PharmD, MS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455310
- Sponsor's protocol ID
- 201108751
- Acronym
- ExConEval
- Status last verified
- May 2019
- First submitted
- 30 Apr 2015
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other than exposure data which is identifiable, the evaluation is based on CMS data which cannot be shared without a data reuse agreement.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Connection: Dissemination Effectiveness Evaluation
- ClinicalTrials.gov ID
- NCT02455310
- Acronym / sponsor ID
- ExConEval / 201108751
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44,524 participants (actual)
- Lead sponsor
- Ryan M. CarnahanUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Iowa State University
- Study start
- Jan 2011 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatients with dementia | – | Behavioral: Educational activities to improve dementia careMedication 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. |
| Nursing home residents | – | Behavioral: Educational activities to improve dementia careMedication 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational activities to improve dementia careThe 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. | Behavioural | Nursing home residents, Outpatients with dementia |
Primary outcome
Antipsychotic use
Time frame: Up to 4 years
Antipsychotic use
Anticholinergic Use
Time frame: Up to 4 years
Anticholinergic use
11 secondary outcomes
Olanzapine use in patients with metabolic disorders
Time frame: Up to 4 years
Excessive antipsychotic dose
Time frame: Up to 4 years
Benzodiazepine use
Time frame: 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
Antipsychotic use in people with dementia
Time frame: Up to 4 years
Antipsychotic use in nursing home residents with a potentially appropriate indication
Time frame: 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 nursing home residents with a recent history of falls
Time frame: Up to 4 years
Antipsychotic use in nursing home residents with an unsteady gait
Time frame: Up to 4 years
Hypnotic use
Time frame: Up to 4 years
Changes in behavioral and psychological symptom presence
Time frame: Up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Carnahan, PharmD, MS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Ryan M. Carnahan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antipsychotic use (time frame: Up to 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.