Objectives: This is a Type 1 hybrid pre-implementation study whose specific aims are to: 1) Compare retention of genetic counseling information provided to patients via telephone versus videoconferencing;2) Use validated surveys to quantitatively assess satisfaction with genetic counseling conducted via telephone versus videoconferencing;3) Conduct interviews with patients to qualitatively assess positive and negative aspects of their experience, barriers, and facilitators with genetic counseling via telephone or videoconferencing;4) Conduct interviews with the genetic counselors at Genomic Medicine Service (GMS) to qualitatively assess barriers and facilitators to conducting genetic counseling via telephone and videoconferencing;and 5) Conduct a cost analysis of the telephone and videoconferencing genetic counseling modalities. Methods: We will undertake a randomized controlled trial of Veterans that are willing to have genetic counseling conducted either via telephone or videoconferencing. Veterans with multiple polyps referred to GMS for genetic counseling will undergo a screening interview by telephone to obtain information about personal and family history and study inclusion and exclusion criteria eligibility. If criteria are met, they will be given information about the study and asked to provide informed consent. If consent is provided, baseline questions will be asked to collect demographic information and assess genetic knowledge. Randomization via random number generation will be used to assign subjects to either the telephone or videoconferencing arms. Lastly, a genetic counseling session will be scheduled for each patient. After genetic counseling is received, the counseled Veterans will receive documentation outlining risk assessment as well as information regarding polyposis syndromes and potential for future VA registry. Within one week of receiving genetic counseling, participants will be called to assess knowledge retention, conduct the satisfaction surveys and numeracy, and to schedule the qualitative interview for the subset of patients (10-12 per study arm) who agree to participate. We will use the Consolidated Framework for Implementation Research to develop and conduct qualitative interviews with the GMS staff. Based on power calculation, we will need a sample size of 56 subjects. To achieve this sample size we will need to recruit approximately two to three subjects per week over a seven month period. This requires a reasonable participation rate between 32-40% of polyposis patients referred to GMS for genetic counseling. Data analysis will begin with descriptive statistics to describe our study sample. To assess differences in knowledge retention and satisfaction between the telephone and videoconferencing groups, we will use Chi- square test for categorical variables and the Wilcoxon-rank sum test for discrete ordinal and continuous variables. We will also conduct multivariable ordinary least squares regression to assess whether knowledge retention or satisfaction differs according to patient characteristics, numeracy, or genetic counselor. The qualitative interviews will be digital audio recorded and transcribed for analysis. We will use a directed approach to content analysis. Analysis will be conducted with Atlas.ti qualitative analysis software that facilitates management of coding and analysis of patterns across transcripts. Cost analysis of the two counseling options will be assessed by direct measurement of equipment and labor input costs as well as travel reimbursement by the VA. From the patient's perspective, the costs associated with traveling to a VA clinic site with videoconferencing equipment will also be considered.
Genetic counseling has become a part of standard cancer care. Until recently, genetic counseling for Veterans was provided in non-VA settings through Fee Basis. This led to suboptimal utilization of genetic counseling. To better comply with clinical guidelines and to improve access to genomic services, the Genomic Medical Service (GMS) was set up as a part of Patient Care Services within the Department of Veterans Affairs (VA). GMS provides most of their genetic counseling via videoconference or telephone, each modality having advantages and limitations. As GMS increases scale and more VA facilities begin to utilize GMS for genomic services, a pre-implementation study is needed to assess potential differences in knowledge retention, patient satisfaction, barriers and facilitators to receiving genetic counseling, and the costs of providing genetic counseling by telephone and videoconferencing to Veterans in an optimal manner.
