Evaluation of Videoconferencing Versus Telephone Genetic Counseling

NCT02108977 | Completed Results

• 1 other identifier: PPO 13-364
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Remote Consultation, Teleconsultation; Remote Consultation, Video

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (2)

Videoconferencing Genetic Consultation

EXPERIMENTAL

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

Other: Videoconferencing Genetic Consultation

Teleconferencing Genetic Consultation

ACTIVE COMPARATOR

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

Other: Teleconferencing Genetic Consultation

Interventions

Videoconferencing Genetic Consultation OTHER

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

Videoconferencing Genetic Consultation

Teleconferencing Genetic Consultation OTHER

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

Teleconferencing Genetic Consultation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148, United States

Location

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.

Results Point of Contact

• Title: Dr. Santanu Datta, Health Sciences Research Specialist, HSR&D
• Organization: Health Services Research & Development, Durham VAMC

Santanu.Datta@va.gov

(919) 286-0411

Study Officials

• Santanu K. Datta, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 9, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 28, 2019
• Results First Posted: April 21, 2016

Record last verified: 2019-03

Locations

US (2)