Extension Connection Evaluation

NCT ID: NCT02455310

Last Updated: 2019-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

44524 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Educational activities to improve dementia care

Intervention Type 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.

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.

Educational activities to improve dementia care

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Iowa State University

OTHER

Sponsor Role collaborator

Ryan M. Carnahan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ryan M. Carnahan

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ryan Carnahan, PharmD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Iowa College of Public Health

Iowa City, Iowa, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201108751

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Changing Talk Online Training (CHATO) National Trial
NCT04610944 ACTIVE_NOT_RECRUITING NA