Patient No ShowNCT03367416
Organizational Change in Dental Care
An observational study of Patient No Show, run by University of Wisconsin, Madison at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient No Show
- What is being tested?
- NIATx model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 43 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jan 2018to 1 Aug 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- An individual who does not regularly interact with patients in a dental clinic.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
More Smiles Wisconsin
Madison, Wisconsin, 53703
Community Dental Clinic North-Marquette School of Dentistry
Milwaukee, Wisconsin, 53201
Community Dental Clinic South-Marquette School of Dentistry
Milwaukee, Wisconsin, 53215
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: 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.
Read the 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%.
- Conditions
- Patient No Show
- Being tested
- NIATx model
- Medical subject headings
- No-Show Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIATx modelBehavioural
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:
- educating executives on how to promote effective process change techniques
- training staff teams in the theory and practice of organizational change techniques
- training staff to develop and implement a process improvement intervention
- implementing a sustainability plan to institutionalize change and avoid reverting to previous methods
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: NIATx model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze clinic data for trends and patterns in patient no-show behaviour.
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.
Measured: 7 months
Staff surveys to test clinic adherence to the components of the NIATx model.
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.
Measured: 7 months
Patient qualitative interviews to assess the patient experience in missing an appointment.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Jan 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient No ShowStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Medical College of Wisconsin, Marquette University, National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Todd Molfenter, PhD, Principal investigator, University of Wisconsin, MadisonChristopher Okunseri, BDS, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367416
- Sponsor's protocol ID
- 2017-1247
- Other IDs
- U56DE027442
- Status last verified
- Aug 2019
- First submitted
- 27 Nov 2017
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test of an Organizational Change Model in Dental Care Settings
- ClinicalTrials.gov ID
- NCT03367416
- Acronym / sponsor ID
- 2017-1247
- Conditions
- Patient No Show
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Medical College of Wisconsin, Marquette University, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 8 Dec 2017 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Behavioral: NIATx modelThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- An individual who does not regularly interact with patients in a dental clinic.
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 |
|---|---|---|
| NIATx modelThe 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 | Behavioural | Intervention |
Primary outcome
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.
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.
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.
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 7 Aug 2019.
- NIATx websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Todd Molfenter, PhD principal investigator
University of Wisconsin, Madison
Christopher Okunseri, BDS principal investigator
Marquette University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient No Show, run by University of Wisconsin, Madison at 4 sites 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 6 inclusion and 1 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Analyze clinic data for trends and patterns in patient no-show behaviour. (time frame: 7 months). The study lists 3 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 7 Aug 2019.