A Cluster Randomized Controlled Trial in Primary Oral Care

Tooth, Impacted Clinical Trial

Official title:

Impact of Multifaceted Peer Group Education to Improve Routine Oral Examinations in Primary Care A Cluster-Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618215
• Other study ID #: CVZ-538/001/2001/RL000003
• Status: Completed
• Phase: Phase 0
• First received: February 5, 2008
• Last updated: February 18, 2008
• Start date: September 2006
• Est. completion date: July 2007

Study information

• Verified date: February 2008
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Medical Ethics Review Committee (METC) Country:The Netherlands
• Study type: Interventional

Clinical Trial Summary

Background: Routine oral examination (ROE) refers to periodic monitoring of the general and oral health status of patients. In most developed Western countries a decreasing prevalence of oral diseases underpins the need for a more individualised approach in assigning recall intervals for regular attendees instead of systematic decision making of fixed intervals. From a quality of care perspective as well, one can also question the effectiveness of the widespread prophylactic removal of mandibular impacted asymptomatic third molars (MIM) in adolescents and adults. It is as yet unclear how quality of oral care can be improved. Research data on effectiveness of interventions to promote continuing professional development for dentists are rare.

Methods/Design: This implementation study is a cluster randomised controlled trial with groups of GDPs as the unit of randomisation. The aim of the study is to determine the effectiveness and efficiency of small group quality improvement on professional decision making of general dental practitioners (GDPs) in daily practice. Six peer groups ('IQual-groups') shall be randomised either to the intervention group I or group II. Groups of GDPs allocated to either of these arms act as each other's control group. An IQual peer group consists of 8-10 GDPs who attend in monthly structured sessions scheduled for discussion on practice related topics.

GDPs in both trail arms receive recent developed evidence-based CPG on ROE or MIM respectively. The implementation strategy consists of 1 interactive IQual circle meeting of mostly 2-3 hours. In addition, both groups of GDPs receive feedback on personal and group characteristics and are invited to make use of web-based patient vignettes for further individual training on risk assessment policy. A few weeks after the interactive meeting reminders (flow charts) will be send by mail.

The main outcome measure for the ROE-study and control group is the use and appropriateness of individualised risk assessment in assigning recall intervals and for the MIM-study the use and appropriateness of individualised mandibular impacted third molar risk management.

Measurements (pre-intervention data collection) will take place in months 1-3, starting in September 2006. Post-intervention data collection will be performed after 9 months.

Discussion: In most developed Western countries a decreasing prevalence of oral diseases underpins the need for a more individualised approach in assigning recall intervals for regular attendees. If the evaluation of this multifaceted implementation study reveals a shift in individual performance of GDPs in assessing risks for oral disease, further research questions and efforts to a risk-based professional education could be promoted.

Scientific hypothesis Multifaceted implementation of consensus based clinical practice guidelines (CPGs) for GDPs on ROEs and the management of asymptomatic impacted third molars (MIM) in daily dental practice is more effective and efficient compared to only dissemination of CPGs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1161
• Est. completion date: July 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

GDPs inclusion criteria

• GDPs have to work in general dental practice for at least three days/week and should have practice experience for at least three years. They were eligible if their practice population was characterised by primary oral care patients, consisting of regular attendees, and patient recordkeeping was conducted electronically. GDPs had to give their informed consent to assess and evaluate electronically patient records. Patient data were collected anonymously.

Patient's inclusion criteria

To be eligible for inclusion, patients should meet (fulfil) several criteria, depending on the IQual's CPG to be used (ROE or MIM):

ROE:

• All patients regularly visiting their dentist (at least once a year) over the past three years for ROEs will be included in the study.

MIM:

• All patients regularly visiting their dentist (at least once a year) over the past three years for ROEs are included for the study and, in addition, have to be aged between 17 and 35 years, with disease-free impacted mandibular third molars in retention.

For both group of patients, it is important that they can be linked particular to the participating GDP, especially in practices with more than one GDP occupied

Exclusion Criteria:

Patient's exclusion criteria

ROE:

• Patients with symptomatic driven (emergency) attendance in dental practice, or recently started regular attendance in the participating dental practice (within past three years).

MIM:

• Patients with symptomatic third molars in dental practice, or recently started regular attendance (past three years) or who already had their third molars removed.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Tooth, Impacted

Intervention

Behavioral:
• peer group educational implementation strategy
Delivery CPG Education session IQual group Online training website (individual feed back) Reminder (flow chart), individual feed back record form Feed back by email Registration in practice

Locations

Country	Name	City	State
Netherlands	University Medical Centre St Radboud	Nijmegen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University	Department of Preventive and Restorative Dentsitry and Centre of Quality of Care Research (WOK), The health Care Insurance Board (CVZ)

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Mettes TG, van der Sanden WJ, Wensing M, Grol RP, Plasschaert AJ. A cluster randomised controlled trial in primary dental care based intervention to improve professional performance on routine oral examinations and the management of asymptomatic impacted third molars: study protocol. Implement Sci. 2007 Apr 20;2:12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients per GDP with assigned recall interval (months) based on individual recall assessment. For high risk children and adolescents <7 months, in case of low risk > 7 months. For adults 9 months or more for low risk profiles, and = than 9 mo		September 2006 and June 2007	No
Secondary	Number of patients per GDP with prescribed individual frequency of BWs (months). For high-risk children and adolescents <24 months frequency, in low risk profiles >36 months. For high-risk adults < 36 months frequency versus low risk >48 months.		september 2006 and june 2007	No