Evaluation of Videoconferencing Versus Telephone Genetic Counseling

Study Overview
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Brief Summary
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Genetic counseling has benefits for individuals and their family members in their health care decision-making. Provision of genetic counseling has been deemed standard of care by several medical organizations and incorporated into clinical guidelines, such as those of the US Preventive Services Task Force. To better comply with these guidelines, Genomic Medicine Service (GMS) recently established at the Salt Lake City, Utah VA medical center to provide genomic services and counseling as a part of VA Patient Care Services. For Veterans for whom in-person genetic counseling in not feasible, GMS conducts counseling either via telephone or videoconferencing. Although both of these methods can be effective for delivering genetic counseling, each has its relative advantages and disadvantages. The specific aim of this study is to gain a better understanding of the advantages and disadvantages of these two modalities. This information will be useful not only for genetic counseling but also other interventions that use telephone or videoconferencing to access patients.

Detailed Description
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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. 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.

Official Title
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Evaluation of Videoconferencing vs Telephone Genetic Counseling Consultations

Conditions
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Remote Consultation, Teleconsultation, Remote Consultation, Video

Intervention / Treatment
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* Other: Videoconferencing Genetic Consultation
* Other: Teleconferencing Genetic Consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50 or greater, a finding of 10 or more lifetime adenomatous polyps or sessile polyps, no contributing family history, and the patient must be able to be reached by telephone and speak English Exclusion Criteria: Complex family history (family members with other cancers) or one suggestive of a known colon cancer syndrome, unwillingness to travel to a VA site with videoconferencing capability, diagnosis of colon cancer

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Videoconferencing Genetic Consultation<br>Patients will travel to CBOC and receive genetic counseling session via videoconferencing | Other: Videoconferencing Genetic Consultation<br>* Patients will travel to CBOC and receive genetic counseling session via videoconferencing<br>|
| Active Comparator: Teleconferencing Genetic Consultation<br>Patients will receive genetic counseling session via telephone (usual treatment) | Other: Teleconferencing Genetic Consultation<br>* Patients will receive genetic counseling session via telephone (usual treatment)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Knowledge Retention of Genetic Counseling Information Via 8-Question Pre- and Post-Counseling Assessment | Subjects will be asked 8 True/False genetics-related questions before and after counseling to assess improvement and retention of genetic counseling knowledge and information | Pre- and post- (within 2 weeks) genetic counseling | 
| Satisfaction With Genetic Counseling Session Using the Genetic Counseling Satisfaction Scale | 6-question Genetic Counseling Satisfaction Scale using 5-point Likert scale responses Strongly Disagree (1) to Strongly Agree (5) | Within two weeks of receiving genetic counseling | 
| Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by PATIENTS | We asked the subjects to discuss specific aspects of each modality including the ease of use, navigation, and adaptability of each modality, conveying and comprehending genetic and numeric information, and perceived advantages and disadvantages of each modality. | Within six weeks of receiving genetic counseling | 
| Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by GENETIC COUNSELORS | Five counselors agreed to be interviewed. We asked them to discuss specific aspects of each modality including the ease of use, navigation, and adaptability of each modality, conveying and comprehending genetic and numeric information, and perceived advantages and disadvantages of each modality. | Within 4 weeks after study data collection was completed | 
| Cost Analysis | Labor (including training) and non-labor (e.g., equipment cost) inputs required to provide counseling via telephone versus videoconferencing. Patient travels costs will be included via self-report. | Cost analysis will be conducted in months 10-12 of grant period (projected January 1-March 31, 2015) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote Consultation, Teleconsultation, Videoconferencing, Genetic Counseling, Costs and Cost Analysis, Comparative Effectiveness Research, Telehealth