Same-day Versus Separate-day Preoperative Consultation for Mohs Surgery

The purpose of this study is to determine whether separate- versus same-day preoperative consultation affects time to treatment (start to finish), utilization rate of Mohs, rate of case cancellations, cost, and patient satisfaction. The investigators hypothesize that patients with same-day preoperative consultation will have a shorter time between cancer diagnosis and removal but, only when coordination of care is needed, longer time between removal and consultation with other specialists, as compared to patients with separate-day consultation. The investigators anticipate that patients with same-day preoperative consultation will have a decrease in travel cost as compared to patients with separate-day consultation. The investigators expect that there will be no difference in various satisfaction matters between groups, with the exception of potentially greater convenience reported by patients in the same-day preoperative consultation group. Finally, the investigators hypothesize that there will be no difference between groups in regards to rates of surgery cancellation.

Study Overview

• Status: Withdrawn
• Conditions: Basal Cell Carcinoma; Non-melanoma Skin Cancer; Squamous Cell Carcinoma of Skin
• Intervention / Treatment: Other: Same-day preoperative consultation

Detailed Description

Procedure: Prospective trial which randomly assigns patients to either separate- or same-day preoperative consultation for Mohs surgery. A phone consultation will take place, which will assist in determining whether the patient is appropriate for enrollment into the study. If so, the patient will be randomized to either separate-day or same-day preoperative consultation.

Materials: Patient survey

Methods of data collection: The patient-specific data obtained from the medical record will include: Patient age, number of previous skin cancers, preoperative size, history of cutaneous surgery, employment status, and distance between home address and dermatology facility. Outcome measures that will be obtained from the medical record will include: Time between cancer diagnosis, removal and defect repair, rate of proceeding with Mohs as opposed to other treatment options, and rate of cancelling surgery (due to site discrepancy, anticoagulation issues). A survey will be used to assess patient satisfaction.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients will be considered for enrollment if they have been referred to a Mohs surgeon for consideration of Mohs surgery for non-melanoma skin cancer

Exclusion Criteria:

• Patients would be excluded if there is a lack of indication for Mohs
• Significant comorbidities, or
• In the case of a high-risk location or tumor size, for which in advance it is known that they will need consultation with other specialties

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Separate-day preoperative consultation; Patients referred for Mohs surgery for non-melanoma skin cancer will have a preoperative consultation in advance of the day of the procedure.
Experimental: Same-day preoperative consultation; Patients referred for Mohs surgery for non-melanoma skin cancer will have a preoperative consultation on the day same day as the procedure.	Other: Same-day preoperative consultation; Preoperative consultation occurs on the same day as Mohs surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to treatment	Assess the total amount of time elapsed between skin cancer diagnosis and defect repair	Eight weeks
Time to consultation with other specialties	Assess the amount of time between cancer diagnosis and consultation with non-dermatologic specialties	Eight weeks
Time to repair	Assess the amount of time elapsed between cancer removal and defect repair	Eight weeks
Patient satisfaction	Administer a survey to assess patient's perception of convenience, level of comfort with the procedure, and self-evaluation of knowledge regarding the diagnosis and treatment	Eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilization rate of Mohs surgery	Assess the percentage of patients who actually proceed with undergoing Mohs surgery in each arm	Eight weeks
Rate of case cancellation	Assess the number of cases that are cancelled due to site discrepancy, anticoagulation or other medical issues in each arm	Eight weeks
Travel cost	Assess the total distance traveled by each patient coming and going to Mohs appointment(s)	Eight weeks

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Faramarz Samie, MD, PhD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): June 29, 2017
• Study Completion (Actual): June 29, 2017

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 22, 2014

Study Record Updates

• Last Update Posted (Actual): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Mohs surgery; Preoperative consultation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: D15025