Oral Health Training Program for Pediatric Residents

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Completed
CT.gov ID
NCT00846066
Collaborator
(none)
56
1
2
20
2.8

Study Details

Study Description

Brief Summary

The purpose of this study was to compare the effect of the addition of hands on training by a pediatric dentist on the pediatric residents skills, confidence, opinions and practice related to preventive oral health.

Condition or Disease Intervention/Treatment Phase
  • Other: Hands on training
  • Other: Web based training
N/A

Detailed Description

Objectives:

To compare the addition of Hands on Training (HOT) to Web Based Training (WBT)on residents' skills, confidence, opinions and practice .

Methods: Pediatric residents participated in WBT on preventive oral health. Then the WBT subjects were randomly assigned to receive HOT by a dentist, or WBT alone. All subjects were assessed on skills in the performance of an oral exam, by direct observation. Residents' confidence regarding oral health counseling, and their opinions about the importance of the incorporation of oral health into the well child visit, was measured by surveys utilizing a Likert scale. Residents' change in practice was assessed by a retrospective chart audit.

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Official Title:
Effective Educational Instruction in Preventive Oral Health: Hands On Training (HOT)Versus Web Based Training (WBT): A Randomized Control Trial
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hands on Training

Hands on Training by a pediatric dentist

Other: Hands on training
Hands on training by a pediatric dentist on preventive oral health
Other Names:
  • Active educational training with a pediatric dentist
  • Other: Web based training
    Web based training alone
    Other Names:
  • Educational Web Based Training for all residents
  • Active Comparator: Web Based Training

    Web Based Training for all residents before randomization

    Other: Web based training
    Web based training alone
    Other Names:
  • Educational Web Based Training for all residents
  • Outcome Measures

    Primary Outcome Measures

    1. Mean Percentage of Correct Skills [3 months after Hands-on Training (HOT)]

      Skills were observed by pediatric dentists for each resident utilizing a six item checklist 3 months after the intervention (HOT) was completed.Each correct skill demonstrated was scored as 1 (16.67%) with a maximum of 6 representing 100%.The mean pecentage of correct skills were measured by direct observation by a pediatric dentist among the WBT alone and WBT+HOT groups

    2. Percent Change From Baseline in Confidence at 4 Months [Baseline and 4 months]

      Confidence was measured by self-administered surveys regarding knowledge and practice of oral health. The surveys used a 4 point Likert scale (1=not confident, 4=very confident).The mean percent of change in the responses of "very confident" was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%

    3. Percent Change From Baseline in Opinions Regarding Incorporating Oral Health Into a Well Child Visit at 4 Months [Baseline and 4 months]

      Opinions regarding incorporating oral health into a well child visit was measured by self administered surveys. The surveys used a 4 point Likert scale from 1 for (strongly disagree) to 4 for (strongly agree). Mean percentage change in the "agree" and "strongly agree" responses by the residents was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%

    4. Percent Change From Baseline in Practice of Oral Health Based on Pre and Post Study Chart Audit at 6 Months [At baseline and 6 months]

      The mean percent change in the documentation of oral health components at a well child visit. This was done by an audit of a random selection of 5 charts of patients who came in for well child visits, completed by each resident at baseline and at 6 months later.We scored this utilizing a 4 item checklist each correct item was scored as 1 (25%), with a maximum of 4(100%). The percentage change used the following formula {(mean score at 6 months-mean score at baseline)/mean score at baseline}*100%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Pediatric Residents in the Continuity Care Clinics at Children's Mercy Hospital during the months of January and February 2007

    Exclusion Criteria:
    1. Residents on leave of absence

    2. Residents who have their Continuity Care Clinics off site

    3. Residents refusing consent for inclusion of results in study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Childrens Mercy Hospital Kansas City Missouri United States 64108

    Sponsors and Collaborators

    • Children's Mercy Hospital Kansas City

    Investigators

    • Principal Investigator: Nasreen J Talib, MD,MPH, Children's Mercy Hospital Kansas City

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nasreen Talib, Pediatrician, Children's Mercy Hospital Kansas City
    ClinicalTrials.gov Identifier:
    NCT00846066
    Other Study ID Numbers:
    • IRB# 06 10-150E
    First Posted:
    Feb 18, 2009
    Last Update Posted:
    Aug 14, 2015
    Last Verified:
    Jul 1, 2015

    Study Results

    Participant Flow

    Recruitment Details All Pediatric residents, in the Continuity Clinic Rotation (CCC) at a general pediatric ambulatory clinic, in an urban tertiary care children's hospital, were invited to participate. Residents in any year of training were considered eligible for the study, recruitment took place in January, 2007
    Pre-assignment Detail 59 participants were evaluated for the pre-test knowledge, they were next administered the Web Based Training and were then evaluated for the post-test knowledge. 56 participants were then randomized into two groups, 3 were excluded, (2 refused consent and 1 deviated from the protocol).
    Arm/Group Title Web Based Training Only (WBT) WBT Plus Hands on Training (HOT)
    Arm/Group Description This group received only the web based training prior to randomization(control group) This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)
    Period Title: Overall Study
    STARTED 27 29
    COMPLETED 27 29
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title WBT Only WBT+HOT Total
    Arm/Group Description Control Group Web Based Training only Web Based Training plus Hands on Training Total of all reporting groups
    Overall Participants 27 29 56
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    27
    100%
    29
    100%
    56
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    19
    70.4%
    23
    79.3%
    42
    75%
    Male
    8
    29.6%
    6
    20.7%
    14
    25%
    Level of Training (participants) [Number]
    First year Residents
    12
    44.4%
    11
    37.9%
    23
    41.1%
    Second and Third year Residents
    15
    55.6%
    18
    62.1%
    33
    58.9%

    Outcome Measures

    1. Primary Outcome
    Title Mean Percentage of Correct Skills
    Description Skills were observed by pediatric dentists for each resident utilizing a six item checklist 3 months after the intervention (HOT) was completed.Each correct skill demonstrated was scored as 1 (16.67%) with a maximum of 6 representing 100%.The mean pecentage of correct skills were measured by direct observation by a pediatric dentist among the WBT alone and WBT+HOT groups
    Time Frame 3 months after Hands-on Training (HOT)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title WBT Only WBT+HOT
    Arm/Group Description Control Group Web Based Training only Web Based Training plus Hands on Training
    Measure Participants 27 29
    Mean (Standard Deviation) [Percentage of correct skills]
    73
    (27)
    87
    (21)
    2. Primary Outcome
    Title Percent Change From Baseline in Confidence at 4 Months
    Description Confidence was measured by self-administered surveys regarding knowledge and practice of oral health. The surveys used a 4 point Likert scale (1=not confident, 4=very confident).The mean percent of change in the responses of "very confident" was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%
    Time Frame Baseline and 4 months

    Outcome Measure Data

    Analysis Population Description
    Only completed paired (pre/post intervention) surveys were analyzed
    Arm/Group Title WBT Only WBT + HOT
    Arm/Group Description Control Group Web Based Training only Web Based Training plus Hands on Training
    Measure Participants 22 19
    Mean (Standard Deviation) [Percent change.]
    14
    (.33)
    19
    (.38)
    3. Primary Outcome
    Title Percent Change From Baseline in Opinions Regarding Incorporating Oral Health Into a Well Child Visit at 4 Months
    Description Opinions regarding incorporating oral health into a well child visit was measured by self administered surveys. The surveys used a 4 point Likert scale from 1 for (strongly disagree) to 4 for (strongly agree). Mean percentage change in the "agree" and "strongly agree" responses by the residents was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%
    Time Frame Baseline and 4 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title WBT Only WBT+HOT
    Arm/Group Description Control Group Web Based Training only Web Based Training plus Hands on Training
    Measure Participants 27 29
    Mean (Standard Deviation) [Percent change]
    -11
    (.33)
    -33
    (.42)
    4. Primary Outcome
    Title Percent Change From Baseline in Practice of Oral Health Based on Pre and Post Study Chart Audit at 6 Months
    Description The mean percent change in the documentation of oral health components at a well child visit. This was done by an audit of a random selection of 5 charts of patients who came in for well child visits, completed by each resident at baseline and at 6 months later.We scored this utilizing a 4 item checklist each correct item was scored as 1 (25%), with a maximum of 4(100%). The percentage change used the following formula {(mean score at 6 months-mean score at baseline)/mean score at baseline}*100%
    Time Frame At baseline and 6 months

    Outcome Measure Data

    Analysis Population Description
    Analysis per protocol. Subjects dropped from analysis because charts not available within the time frame of the study and incomplete data.
    Arm/Group Title WBT Only WBT+HOT
    Arm/Group Description Control Group Web Based Training only Web Based Training plus Hands on Training
    Measure Participants 19 18
    Mean (Standard Deviation) [Percent change]
    26.32
    (13.25)
    36.67
    (22.42)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Total number of Participants Risk is 0. This is because serious and other non serious adverse events were not collected or assessed. This was an educational intervention
    Arm/Group Title Web Based Training Only (WBT) WBT Plus Hands on Training (HOT)
    Arm/Group Description This group received only the web based training prior to randomization(control group) This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)
    All Cause Mortality
    Web Based Training Only (WBT) WBT Plus Hands on Training (HOT)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Web Based Training Only (WBT) WBT Plus Hands on Training (HOT)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Web Based Training Only (WBT) WBT Plus Hands on Training (HOT)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Nasreen Talib MD, MPH.
    Organization Childrens Mercy Hospital
    Phone 816-234-3242
    Email ntalib@cmh.edu
    Responsible Party:
    Nasreen Talib, Pediatrician, Children's Mercy Hospital Kansas City
    ClinicalTrials.gov Identifier:
    NCT00846066
    Other Study ID Numbers:
    • IRB# 06 10-150E
    First Posted:
    Feb 18, 2009
    Last Update Posted:
    Aug 14, 2015
    Last Verified:
    Jul 1, 2015