Oral Cancer
Conditions
Brief summary
The purpose of the proposed research project is to evaluate and enhance the feasibility and acceptability of integrating a tele-mentoring component into the identification of oral lesions at the 6 dental clinics of Family Health Centers at NYU Langone (FHC), a Federally Qualified Health Center (FQHC) in Brooklyn, NY.
Detailed description
The tele-mentoring intervention involves training dental faculty members and residents to use intraoral cameras to take photographs of oral lesions and place them in the Dentrix electronic health record (EHR), along with descriptions of the lesions. Using a mixed-methods approach, the study will evaluate and enhance the feasibility and acceptability of integrating a tele-mentoring component into the identification of oral lesions at the 6 FHC dental clinics.
Interventions
OTHERImaging using intraoral cameras
The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations and as intra-oral camera to visualize anatomical details that are invisible to the naked eye or with a mirror. In CARIO mode, the camera helps the dental practitioner to highlight carious warning on pits and fissures of the occlusal side of the teeth. In DAYLIGHT mode, the camera enables you to visualize anatomical details invisible to the naked eye or with a mirror. In PERIO mode, the camera helps the dental practitioner to see the presence of dental plaque but also to highlight gingival inflammations . This mode offers to the dentist and/or hygienist a tool for an improved communication, motivation and education of his/her patients, who will then become aware of their oral health condition.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Dental patients will be eligible for study participation if they meet the following criteria: 1. Greater than or equal to 18 years of age. 2. Live in any of the 5 boroughs of New York, NY and visit a participating FHC dental clinic for routine dental care. 3. Able and willing to provide informed consent, have their oral lesion(s) photograph(s) and accompanying data entered into the Dentrix EHR, and participate in an exit interview. Dental providers will be eligible for study participation if they meet the following criteria: 1. Greater than or equal to 18 years of age. 2. Be employed as a dentist or placed as a dental resident at a participating FHC dental clinic. 3. Able and willing to provide informed consent and participate in feasibility testing (provider survey or semi-structured interview).
Exclusion criteria
Dental patients will be excluded from study participation if they meet the following criteria: 1. Have an acute or terminal illness or a serious mental illness or any other severe health condition(s) that might preclude visiting an oral health care provider. 2. Are currently participating in another oral health study. Dental providers will be excluded from study participation if they meet the following criteria: 1\. Have an acute or terminal illness or a serious mental illness or any other severe health condition(s) that might preclude them from completing the feasibility testing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Dental Patients Who Strongly Agreed or Agreed That the Use of an Intra-Oral Camera By Their Dentists Helped Them to Better Understand Oral Cancer Screening | At the end of the dental appointment, 30-45 minutes | Consented patients will be asked to complete a brief Patient Exit Survey (5 statements) at the end of their dental appointments after being screened for oral cancer lesions using an intraoral camera. Responses to the second statement are reported for this outcome measure. The statement is scored on a Likert Scale from 1 - Strongly Disagree to 5 - Strongly Agree. |
| Percentage of Dental Patients Who Strongly Agreed or Agreed That Dentists Answered Their Questions About Oral Cancer and Were Able to Provide Them With Resources | At the end of the dental appointment, 30-45 minutes | Consented patients will be asked to complete a brief Patient Exit Survey (5 statements) at the end of their dental appointments after being screened for oral cancer lesions using an intraoral camera. Responses to the fourth statement are reported for this outcome measure. The statement is scored on a Likert Scale from 1 - Strongly Disagree to 5 - Strongly Agree. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Dental Providers Who Reported Successfully Providing the Tele-Mentoring Intervention | At the end of the dental appointment, 30-45 minutes | Dentists are given a Provider Essential Components Checklist to fill out. This checklist summarizes the essential components of incorporating a tele-mentoring intervention into the identification of oral lesions via use of intraoral cameras to take photographs of oral lesions at chairside, uploading them into Dentrix, and conferring with an oral pathology expert. Successful provision of the intervention is indicated by marking item met for all 10 intervention elements listed in the checklist. |
| Percentage of Dental Providers Who Reported That The Process Was Clear and Straightforward | At the end of the dental appointment, 30-45 minutes | The process includes from EHR data entry to interaction with the oral surgeon over findings to patient referral |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dental Providers The tele-mentoring intervention involves training dental faculty members and residents to use intraoral cameras to take photographs of oral lesions and place them in the Dentrix electronic health record (EHR), along with descriptions of the lesions. | 12 |
| Dental Patients The tele-mentoring intervention involves training dental faculty members and residents to use intraoral cameras to take photographs of oral lesions and place them in the Dentrix electronic health record (EHR), along with descriptions of the lesions. | 39 |
| Total | 51 |
Baseline characteristics
| Characteristic | Dental Providers | Total | Dental Patients |
|---|---|---|---|
| Age, Continuous | 26.7 years STANDARD_DEVIATION 1.4 | 37.6 years STANDARD_DEVIATION 10.9 | 40.9 years STANDARD_DEVIATION 20.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 26 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 18 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 8 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 33 Participants | 32 Participants |
| Race (NIH/OMB) White | 3 Participants | 9 Participants | 6 Participants |
| Region of Enrollment United States | 12 participants | 51 participants | 39 participants |
| Sex: Female, Male Female | 10 Participants | 30 Participants | 20 Participants |
| Sex: Female, Male Male | 2 Participants | 21 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 39 |
| other Total, other adverse events | 0 / 12 | 0 / 39 |
| serious Total, serious adverse events | 0 / 12 | 0 / 39 |
Outcome results
Primary
Percentage of Dental Patients Who Strongly Agreed or Agreed That Dentists Answered Their Questions About Oral Cancer and Were Able to Provide Them With Resources
Consented patients will be asked to complete a brief Patient Exit Survey (5 statements) at the end of their dental appointments after being screened for oral cancer lesions using an intraoral camera. Responses to the fourth statement are reported for this outcome measure. The statement is scored on a Likert Scale from 1 - Strongly Disagree to 5 - Strongly Agree.
Time frame: At the end of the dental appointment, 30-45 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dental Patients | Percentage of Dental Patients Who Strongly Agreed or Agreed That Dentists Answered Their Questions About Oral Cancer and Were Able to Provide Them With Resources | 94.8 percentage of participants |
Primary
Percentage of Dental Patients Who Strongly Agreed or Agreed That the Use of an Intra-Oral Camera By Their Dentists Helped Them to Better Understand Oral Cancer Screening
Consented patients will be asked to complete a brief Patient Exit Survey (5 statements) at the end of their dental appointments after being screened for oral cancer lesions using an intraoral camera. Responses to the second statement are reported for this outcome measure. The statement is scored on a Likert Scale from 1 - Strongly Disagree to 5 - Strongly Agree.
Time frame: At the end of the dental appointment, 30-45 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dental Patients | Percentage of Dental Patients Who Strongly Agreed or Agreed That the Use of an Intra-Oral Camera By Their Dentists Helped Them to Better Understand Oral Cancer Screening | 94.9 percentage of participants |
Secondary
Percentage of Dental Providers Who Reported Successfully Providing the Tele-Mentoring Intervention
Dentists are given a Provider Essential Components Checklist to fill out. This checklist summarizes the essential components of incorporating a tele-mentoring intervention into the identification of oral lesions via use of intraoral cameras to take photographs of oral lesions at chairside, uploading them into Dentrix, and conferring with an oral pathology expert. Successful provision of the intervention is indicated by marking item met for all 10 intervention elements listed in the checklist.
Time frame: At the end of the dental appointment, 30-45 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dental Patients | Percentage of Dental Providers Who Reported Successfully Providing the Tele-Mentoring Intervention | 100 percentage of participants |
Secondary
Percentage of Dental Providers Who Reported That The Process Was Clear and Straightforward
The process includes from EHR data entry to interaction with the oral surgeon over findings to patient referral
Time frame: At the end of the dental appointment, 30-45 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dental Patients | Percentage of Dental Providers Who Reported That The Process Was Clear and Straightforward | 100 percentage of participants |