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Evaluation of Videoconferencing Versus Telephone Genetic Counseling (EVTGC)

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ClinicalTrials.gov Identifier: NCT02108977
Recruitment Status : Completed
First Posted : April 9, 2014
Results First Posted : April 21, 2016
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Remote Consultation, Teleconsultation Remote Consultation, Video Other: Videoconferencing Genetic Consultation Other: Teleconferencing Genetic Consultation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Videoconferencing vs Telephone Genetic Counseling Consultations
Study Start Date : April 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Videoconferencing Genetic Consultation
Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Other: Videoconferencing Genetic Consultation
Patients will travel to CBOC and receive genetic counseling session via videoconferencing

Active Comparator: Teleconferencing Genetic Consultation
Patients will receive genetic counseling session via telephone (usual treatment)
Other: Teleconferencing Genetic Consultation
Patients will receive genetic counseling session via telephone (usual treatment)




Primary Outcome Measures :
  1. Assessment of Knowledge Retention of Genetic Counseling Information Via 8-Question Pre- and Post-Counseling Assessment [ Time Frame: Pre- and post- (within 2 weeks) genetic counseling ]
    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

  2. Satisfaction With Genetic Counseling Session Using the Genetic Counseling Satisfaction Scale [ Time Frame: Within two weeks of receiving genetic counseling ]
    6-question Genetic Counseling Satisfaction Scale using 5-point Likert scale responses Strongly Disagree (1) to Strongly Agree (5)

  3. Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by PATIENTS [ Time Frame: Within six weeks of receiving genetic counseling ]
    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.

  4. Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by GENETIC COUNSELORS [ Time Frame: Within 4 weeks after study data collection was completed ]
    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.

  5. Cost Analysis [ Time Frame: Cost analysis will be conducted in months 10-12 of grant period (projected January 1-March 31, 2015) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108977


Locations
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United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Santanu K. Datta, PhD Durham VA Medical Center, Durham, NC

Additional Information:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02108977     History of Changes
Other Study ID Numbers: PPO 13-364
First Posted: April 9, 2014    Key Record Dates
Results First Posted: April 21, 2016
Last Update Posted: March 28, 2019
Last Verified: March 2019

Keywords provided by VA Office of Research and Development:
Remote Consultation
Teleconsultation
Videoconferencing
Genetic Counseling
Costs and Cost Analysis
Comparative Effectiveness Research
Telehealth