Cutaneous Melanoma
Conditions
Brief summary
Skin cancer screening may help find melanoma sooner, when it may be easier to treat. If found early melanoma and other types of skin cancer may be curable. Multi-component education may be an effective method to help primary care physicians (PCPs) learn about skin cancer screening. This clinical trial examines whether a clinician-focused educational intervention can improve PCP's knowledge and clinical performance to identify and triage skin cancer. This intervention may increase the PCP's ability to diagnose, treat and/or triage early-stage melanoma.
Detailed description
PRIMARY OBJECTIVE: I. Evaluate whether a multi-component education strategy improves the ability of PCPs to identify and triage skin cancer. OUTLINE: Participants are assigned to 1 of 2 groups. PCP participants complete group training. All training participants will also be offered series of short booster teaching points delivered virtually. Participants who complete the training also take part in pre-post knowledge assessments. PCP participants may also participate in a qualitative interview. PCPs at the two clinics who do not receive the group training will serve as study comparators.
Interventions
BEHAVIORALTraining and Education
Undergo group trainings
Sponsors
Oregon Health and Science University
National Cancer Institute (NCI)
OHSU Knight Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Clinicians at two Oregon Health & Science University (OHSU) primary care clinics will be invited to receive exposure to the melanoma early detection intervention * Clinicians at the two clinics who do not receive the intervention will serve as study comparators * These individuals are all aged 18 years or older * All practice members speak English
Exclusion criteria
* No one will be intentionally excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician Knowledge in Melanoma Risk and Lesion Identification | Immediately before and after the training session | KnChange in melanoma risk, knowledge based upon survey questions prior to training and post-training. Content covered melanoma risk, knowledge of electronic health record tools specific to the training and lesion identification and biopsy procedure knowledge. A total score of correct responses for the 27 items was generated and transformed to represent the percent of correct items with zero being no correct items and 100% being all items correct. A change score from pre-training to post-training was generated where a positive change score represented the gain in knowledge in percent points and a negative change score representing a lower percent of correct responses from pre-training to post-training. |
| Dermatology Referral | minimum of 3 months and up to 1 year of EHR data for each clinician prior to the start of the training and the same months in the year post-training. | Mean percent of dermatology referrals per 1000 patients |
| Use of Dermatology E-consults | minimum of 3 months and up to 1 year of EHR data for each clinician prior to the start of the training and the same months in the year post-training. | number of dermatology e-consults |
Countries
United States
Participant flow
Recruitment details
Forty-five clinicians (physicians, PAs, and NPs) received an email inviting them to participate in the MelaNOma training. Seventeen participated in the training. A total of 37 clinicians who weren't invited or chose not to participate in the MelaNOma training session were assigned to the comparator group. The total study sample size is 54.
Participants by arm
| Arm | Count |
|---|---|
| Comparison Group PCPs at the two clinics who do not receive the group training will serve as study comparators. | 29 |
| Training Group PCP participants complete group training. All training participants will also be offered series of short booster teaching points delivered virtually. Participants who complete the training also take part in pre-post knowledge assessments. PCP participants may also participate in a qualitative interview.
Training and Education: Undergo group trainings | 15 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | incomplete outcome data | 2 | 8 |
Baseline characteristics
| Characteristic | Training Group | Total | Comparison Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 44 Participants | 29 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 15 participants | 44 participants | 29 participants |
| Sex: Female, Male Female | 10 Participants | 28 Participants | 18 Participants |
| Sex: Female, Male Male | 5 Participants | 16 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 17 |
| other Total, other adverse events | 0 / 29 | 0 / 17 |
| serious Total, serious adverse events | 0 / 29 | 0 / 17 |
Outcome results
Primary
Change in Clinician Knowledge in Melanoma Risk and Lesion Identification
KnChange in melanoma risk, knowledge based upon survey questions prior to training and post-training. Content covered melanoma risk, knowledge of electronic health record tools specific to the training and lesion identification and biopsy procedure knowledge. A total score of correct responses for the 27 items was generated and transformed to represent the percent of correct items with zero being no correct items and 100% being all items correct. A change score from pre-training to post-training was generated where a positive change score represented the gain in knowledge in percent points and a negative change score representing a lower percent of correct responses from pre-training to post-training.
Time frame: Immediately before and after the training session
Population: Knowledge was assessed before and after the training session for those clinicians who attended the training. We conducted a paired t-test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Training group | Change in Clinician Knowledge in Melanoma Risk and Lesion Identification | Immediately before the training | 72.1 score on a scale | Standard Deviation 7.2 |
| Training group | Change in Clinician Knowledge in Melanoma Risk and Lesion Identification | Immediately after the training | 80.8 score on a scale | Standard Deviation 9.6 |
p-value: 0.05paired t-test
Primary
Dermatology Referral
Mean percent of dermatology referrals per 1000 patients
Time frame: minimum of 3 months and up to 1 year of EHR data for each clinician prior to the start of the training and the same months in the year post-training.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comparison group | Dermatology Referral | pre-training period | 13.8 percent per 1000 patients | Standard Deviation 9.2 |
| Comparison group | Dermatology Referral | post-training period | 14.1 percent per 1000 patients | Standard Deviation 11.1 |
| Training group | Dermatology Referral | pre-training period | 16.9 percent per 1000 patients | Standard Deviation 9 |
| Training group | Dermatology Referral | post-training period | 11.4 percent per 1000 patients | Standard Deviation 6.7 |
p-value: 0.05generalized estimating equation (GEE)
Primary
Use of Dermatology E-consults
number of dermatology e-consults
Time frame: minimum of 3 months and up to 1 year of EHR data for each clinician prior to the start of the training and the same months in the year post-training.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comparison group | Use of Dermatology E-consults | pre-training period | 5.1 percent per 1000 patients | Standard Deviation 7.8 |
| Comparison group | Use of Dermatology E-consults | post-training period | 7.2 percent per 1000 patients | Standard Deviation 9.2 |
| Training group | Use of Dermatology E-consults | pre-training period | 5.5 percent per 1000 patients | Standard Deviation 7.8 |
| Training group | Use of Dermatology E-consults | post-training period | 7.8 percent per 1000 patients | Standard Deviation 7.5 |
p-value: 0.05generalized estimating equation (GEE)