Clinical trial NCT02108977: Evaluation of Videoconferencing Versus Telephone Genetic Counseling
Official title: Evaluation of Videoconferencing vs Telephone Genetic Counseling Consultations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Remote Consultation, Teleconsultation
Remote Consultation, Video
Keywords: Remote Consultation
Teleconsultation
Videoconferencing
Genetic Counseling
Costs and Cost Analysis
Comparative Effectiveness Research
Telehealth
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-04-09
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Knowledge Retention of Genetic Counseling Information Via 8-Question Pre- and Post-Counseling Assessment
timeFrame: Pre- and post- (within 2 weeks) genetic counseling
measure: Satisfaction With Genetic Counseling Session Using the Genetic Counseling Satisfaction Scale
timeFrame: Within two weeks of receiving genetic counseling
measure: Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by PATIENTS
timeFrame: Within six weeks of receiving genetic counseling
measure: Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by GENETIC COUNSELORS
timeFrame: Within 4 weeks after study data collection was completed
measure: Cost Analysis
timeFrame: Cost analysis will be conducted in months 10-12 of grant period (projected January 1-March 31, 2015)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Santanu K. Datta, PhD
role: PRINCIPAL_INVESTIGATOR
References: