A Cluster Randomized Controlled Trial in Primary Oral Care

This study has been completed.
Sponsor:
Collaborators:
The health Care Insurance Board (CVZ)
Department of Preventive and Restorative Dentsitry and Centre of Quality of Care Research (WOK)
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00618215
First received: February 5, 2008
Last updated: February 18, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Tooth, Impacted
Behavioral: peer group educational implementation strategy
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
Official Title: Impact of Multifaceted Peer Group Education to Improve Routine Oral Examinations in Primary Care A Cluster-Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 [ Time Frame: September 2006 and June 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: september 2006 and june 2007 ] [ Designated as safety issue: No ]

Enrollment: 1161
Study Start Date: September 2006
Study Completion Date: July 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I

ROE Group

Interventions:behaviorial

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

Experimental: 2

MIM Group

Interventions:behaviorial

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


  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618215

Locations
Netherlands
University Medical Centre St Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
The health Care Insurance Board (CVZ)
Department of Preventive and Restorative Dentsitry and Centre of Quality of Care Research (WOK)
Investigators
Principal Investigator: Alphons Plasschaert, Prof Phd University Medical Centre St Radboud Nijmegen The Netherlands
Study Chair: dirk Mettes, DMD UMC St Radboud Medical Centre Nijmegen The Netherlands
  More Information

Publications:
Responsible Party: Prof. dr. A. Plasschaert, Prof. dr R. Grol
ClinicalTrials.gov Identifier: NCT00618215     History of Changes
Other Study ID Numbers: CVZ-538/001/2001/RL000003
Study First Received: February 5, 2008
Last Updated: February 18, 2008
Health Authority: Medical Ethics Review Committee (METC) Country:The Netherlands

Keywords provided by Radboud University:
cluster-randomised trial
routine oral examination
implementation research
practice based research
CPG
recall interval assignment for routine oral examination
prescription bitewing radiographs
preventive advice and feed back oral disease

Additional relevant MeSH terms:
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 25, 2014