ClinicalTrials.gg
CompletedNCT02108977EVTGCUpdated Mar 28, 2019Results posted

Evaluation of Videoconferencing Versus Telephone Genetic Counseling

An interventional study of Videoconferencing Genetic Consultation and Teleconferencing Genetic Consultation in Remote Consultation, Teleconsultation and Remote Consultation, Video, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-03-28.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Remote Consultation, Teleconsultation
  • Remote Consultation, Video

Keywords

  • Remote Consultation
  • Teleconsultation
  • Videoconferencing
  • Genetic Counseling
  • Costs and Cost Analysis
  • Comparative Effectiveness Research
  • Telehealth
03

In context

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,768 studies on the registry; 393 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 183 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Videoconferencing Genetic Consultation

    Patients will travel to CBOC and receive genetic counseling session via videoconferencing

    Other: Videoconferencing Genetic Consultation

  • Active comparator
    Teleconferencing Genetic Consultation

    Patients will receive genetic counseling session via telephone (usual treatment)

    Other: Teleconferencing Genetic Consultation

Interventions

  • OtherVideoconferencing Genetic Consultation

    Patients will travel to CBOC and receive genetic counseling session via videoconferencing

  • OtherTeleconferencing Genetic Consultation

    Patients will receive genetic counseling session via telephone (usual treatment)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Pre- and post- (within 2 weeks) genetic counseling

  2. 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)

    Time frame: Within two weeks of receiving genetic counseling

  3. 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.

    Time frame: Within six weeks of receiving genetic counseling

  4. 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.

    Time frame: Within 4 weeks after study data collection was completed

  5. 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.

    Time frame: Cost analysis will be conducted in months 10-12 of grant period (projected January 1-March 31, 2015)

07

Results

Posted Apr 21, 2016
Limitations and caveats
We did not achieve the study sample that we hoped to achieve. Patients randomized to the telephone arm participated in the study, whereas patients randomized to the videoconferencing arm often dropped out of the study.

Participant flow

Participant flow — Overall Study
MilestoneVideoconferencing Genetic ConsultationTeleconferencing Genetic Consultation
Started1820
Completed819
Not completed101

Outcome measures

PrimaryAssessment 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

Time frame:
Pre- and post- (within 2 weeks) genetic counseling
Reported as:
Mean · Number of correct answers (out of 8)
Assessment of Knowledge Retention of Genetic Counseling Information Via 8-Question Pre- and Post-Counseling Assessment
Number of correct answers (out of 8)Videoconferencing Genetic ConsultationTeleconferencing Genetic Consultation
Correct Answers Pre-Consultation5.63 ± 1.194.37 ± 1.54
Correct Answers Post-Consultation6.50 ± 0.934.74 ± 1.19
PrimarySatisfaction 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)

Time frame:
Within two weeks of receiving genetic counseling
Reported as:
Mean · points on a scale of 30 (most satisfied)
Satisfaction With Genetic Counseling Session Using the Genetic Counseling Satisfaction Scale
points on a scale of 30 (most satisfied)Videoconferencing Genetic ConsultationTeleconferencing Genetic Consultation
Satisfaction With Genetic Counseling Session Using the Genetic Counseling Satisfaction Scale26.88 ± 3.0425.21 ± 2.64
PrimaryQualitative 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.

Time frame:
Within six weeks of receiving genetic counseling
Reported as:
Number · participants
Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by PATIENTS
participantsVideoconferencing Genetic ConsultationTeleconferencing Genetic Consultation
Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by PATIENTSNANA
PrimaryQualitative 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.

Time frame:
Within 4 weeks after study data collection was completed
Reported as:
Count of participants · Participants
Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by GENETIC COUNSELORS
ParticipantsVideoconferencing Genetic ConsultationTeleconferencing Genetic Consultation
Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by GENETIC COUNSELORSNANA
PrimaryCost 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.

Time frame:
Cost analysis will be conducted in months 10-12 of grant period (projected January 1-March 31, 2015)
Reported as:
Median · Loss of Productivity Cost in US Dollars
Cost Analysis
Loss of Productivity Cost in US DollarsVideoconferencing Genetic ConsultationTeleconferencing Genetic Consultation
Cost Analysis67.29 (44.78 to 97.88)—

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Videoconferencing Genetic Consultation—0/8 (0%)0/8 (0%)
Teleconferencing Genetic Consultation—0/19 (0%)0/19 (0%)

Baseline characteristics

We define baseline participants as those who enrolled in the study and participated in the knowledge pre-test.

Age, Customized
Age, Customized(Not collected)Videoconferencing Genetic ConsultationTelephone Genetic ConsultationTotal
NumberNANANA
Sex: Female, Male
Sex: Female, Male(Participants)Videoconferencing Genetic ConsultationTelephone Genetic ConsultationTotal
Female000
Male81927
08

Study locations

2 sites
  • Durham VA Medical Center, Durham, NC
    Durham, North Carolina 27705, United States
  • VA Salt Lake City Health Care System, Salt Lake City, UT
    Salt Lake City, Utah 84148, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2014, a primary completion of Mar 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Apr 2016, 1 year 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2014
First posted
Apr 9, 2014
Start
Apr 2014
Primary completionActual
Mar 2015
CompletionActual
Mar 2015
Results first posted
Apr 21, 2016
Last update
Mar 28, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02108977
Responsible party
Sponsor
First posted
Apr 9, 2014
Start date
Apr 2014
Primary completion
Mar 2015
Completion
Mar 2015
Results posted
Apr 21, 2016
Last update
Mar 28, 2019

Study contacts

Santanu K. Datta, PhD
principal investigator · Durham VA Medical Center, Durham, NC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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