Organizational Change in Dental Care

August 5, 2019 updated by: University of Wisconsin, Madison

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

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

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

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.
43

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
    • Wisconsin
      • Madison, Wisconsin, United States, 53703
        • More Smiles Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • Community Dental Clinic North-Marquette School of Dentistry
      • Milwaukee, Wisconsin, United States, 53215
        • Community Dental Clinic South-Marquette School of Dentistry

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

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.
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.
Behavioral: NIATx model

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:

  1. educating executives on how to promote effective process change techniques
  2. training staff teams in the theory and practice of organizational change techniques
  3. training staff to develop and implement a process improvement intervention
  4. implementing a sustainability plan to institutionalize change and avoid reverting to previous methods

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
Analyze clinic data for trends and patterns in patient no-show behaviour.
Time Frame: 7 months
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.
7 months
Staff surveys to test clinic adherence to the components of the NIATx model.
Time Frame: 7 months
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.
7 months
Patient qualitative interviews to assess the patient experience in missing an appointment.
Time Frame: 2 months
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.
2 months

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.
University of Wisconsin, Madison

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.
Medical College of Wisconsin
National Institute of Dental and Craniofacial Research (NIDCR)
Marquette 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: Todd Molfenter, PhD, University of Wisconsin, Madison
  • Principal Investigator: Christopher Okunseri, BDS, Marquette University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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, 2018

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.
August 1, 2019

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.
August 1, 2019

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).
November 27, 2017

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.
December 4, 2017

First Posted (Actual)

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.
December 8, 2017

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.
August 7, 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.
August 5, 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.
August 1, 2019

More Information

Terms related to this study

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.
  • 2017-1247
  • U56DE027442 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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