- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03367416
Organizational Change in Dental Care
Test of an Organizational Change Model in Dental Care Settings
The proposed research will test the ability of the NIATx Organizational Change Model to improve patient no-show rates as compared to typical training approaches used in dental offices. The purpose of the pilot study is to improve no-show rates and, in the process, test an evidence-based organizational change model that can increase use of evidence-based practices in dental care.
NIATx is not an acronym, it is a proper noun.
Study Overview
Detailed Description
For designing the pilot study, it is assumed that the no-show rates in dental clinics will have similar characteristics and response patterns to previous studies.
The preliminary summary data provided by the participating dental clinics, the current average no-show rate is approximately 20%, which would reduce to 10% using the upper limit of the confidence interval from the preliminary data. Based on a simulation study incorporating the above assumptions, with 5 sites each contributing 160 appointments before and after the intervention, the study will have 84% power to detect the hypothesized effect (OR=0.44) at a two-sided 5% significance level. The probability of observing a decrease in no-show rates in at least 4 out of 5 of the clinics is approximately 90%. We expect over 80 appointments per month in each clinic, so the target number of appointments would be expected to be available in 2-3 months.
For the NIATx Fidelity Scale, if an organization has an average score of 2 or higher on the NIATx Fidelity Scale for 8 of the 13 measures that will be considered significant. In a previous study using a similar process, 73% of the organizations that achieved gains of +10%, had 8 measures or more with an average score of 2 or greater, compared to 40% of those who had gains at <10%.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53703
- More Smiles Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Children's Hospital of Wisconsin
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Milwaukee, Wisconsin, United States, 53201
- Community Dental Clinic North-Marquette School of Dentistry
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Milwaukee, Wisconsin, United States, 53215
- Community Dental Clinic South-Marquette School of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Community dental clinics that:
- Serve at least a 50 percent minority population
- Accept a high number of Medicaid patients
- Are able to provide de-identified clinic data to the research team
- Are willing to undertake and support an organizational improvement project to decrease no-show rates
Description
Inclusion Criteria:
In order to be eligible to participate in this study, staff must be:
- 18 or older
- A paid staff member at a dental clinic participating in the study
- Willing to participate in the interviews and share their ideas and experiences
- Involved in an organizational improvement project at a participating clinic
- Be able and willing to provide verbal consent
Exclusion Criteria:
An individual who does not regularly interact with patients in a dental clinic.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Intervention
This study will test the NIATx model, an evidence-based behavioral intervention for implementing organizational change and quality improvement in community based health settings with a high proportion of underserved individuals.
The goal of the study will be to use the model to identify and implement organizational changes in dental practices that will improve the no-show rate in underserved populations.
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The NIATx model engages organizations through a multi-clinic learning collaborative and coaching. NIATx teaches organizations how to implement change by using their own organization as the teaching mechanism. Key components of the model include:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analyze clinic data for trends and patterns in patient no-show behaviour.
Time Frame: 7 months
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Data from clinic patient records will be gathered and analyzed to determine the percent of cancelled appointments in a given time period, to detect patterns over time and determine if no-shows are more prevalent with certain populations or procedures.
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7 months
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Staff surveys to test clinic adherence to the components of the NIATx model.
Time Frame: 7 months
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Paper surveys will be used to collect data from clinic staff.
Surveys will measure how the clinic conducts organizational change, the degree to which the clinics are using elements of the NIATx model and which proven no-show practices clinics have adopted.
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7 months
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Patient qualitative interviews to assess the patient experience in missing an appointment.
Time Frame: 2 months
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Interviews will be open questions to understand the process from the users point of view.
This information will help the study team understand the root causes of patient behaviour and propose model improvements that address these causes.
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2 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Todd Molfenter, PhD, University of Wisconsin, Madison
- Principal Investigator: Christopher Okunseri, BDS, Marquette University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017-1247
- U56DE027442 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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