Evaluation of Videoconferencing Versus Telephone Genetic Counseling (EVTGC)

March 13, 2019 updated by: VA Office of Research and Development

Evaluation of Videoconferencing vs Telephone Genetic Counseling Consultations

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center, Durham, NC
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • VA Salt Lake City Health Care System, Salt Lake City, UT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Pre- and post- (within 2 weeks) genetic counseling
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)
Within two weeks of receiving genetic counseling
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.
Within six weeks of receiving genetic counseling
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.
Within 4 weeks after study data collection was completed
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.
Cost analysis will be conducted in months 10-12 of grant period (projected January 1-March 31, 2015)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Santanu K. Datta, PhD, Durham VA Medical Center, Durham, NC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PPO 13-364

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