Evaluation of Videoconferencing versus Telephone Genetic Counseling Consultations

视频会议与电话遗传咨询咨询的评估

• 批准号: 8677200
• 负责人: Santanu K. Datta
• 金额: --
• 依托单位: DURHAM VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8677200
• 关键词: Address; Adherence; Advisory Committees; Affect; Area; Atlases; Capital; Caring; Characteristics; Chi-Square Tests; Cities; Client satisfaction; Clinic; Clinical; Code; Collaborations; Complex; Computer software; Consent; Consultations; Continuity of Patient Care; Cost Analysis; Counseling; Data Analyses; Decision Making; Disadvantaged; Documentation; Eligibility Determination; Emotions; Equipment; Evaluation; Evaluation Studies; Exclusion Criteria; Facial Expression; Failure; Family; Family member; Fees; Future; Generations; Genetic; Genetic Counseling; Genetic screening method; Genomics; Gestures; Goals; Graph; Guidelines; Health; Health Services Accessibility; Health Services Research; Healthcare; Healthcare Systems; Housing; Hybrids; Improve Access; Individual; Informatics; Informed Consent; Interview; Knowledge; Least-Squares Analysis; Life; Measurement; Medical; Medicine; Methods; Modality; Participant; Patient Care; Patients; Pattern; Persons; Play; Population; Prevention Guidelines; Preventive; Professional counselor; Provider; Randomized; Randomized Controlled Trials; Rank-Sum Tests; Recording of previous events; Recruitment Activity; Registries; Relative (related person); Research Priority; Research Project Grants; Resources; Risk Assessment; Role; Sample Size; Sampling Studies; Schedule; Services; Site; Sodium Chloride; Strategic Planning; Surveys; Syndrome; Technology; Telephone; Telephone Interviews; Testing; Time; Transcript; Transportation; Travel; Utah; Veterans; Videoconferences; Videoconferencing; Visual; Vulnerable Populations; arm; base; cancer care; cost; digital; empowered; experience; flexibility; follow-up; genetic pedigree; health care model; implementation research; improved; inclusion criteria; mathematical ability; medical specialties; meetings; opportunity cost; outreach; polyposis; research and development; rural area; satisfaction; screening; standard of care; statistics; telehealth

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. After genetic counseling is received, the counseled Veterans will receive documentation outlining risk assessment as well as information regarding polyposis syndromes and potential for future VA registry. 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.

目标：这是一项1型混合实施前研究，其具体目标是：1）比较 保留通过电话与视频会议向患者提供的遗传咨询信息; 2） 使用有效的调查来定量评估通过电话进行遗传咨询的满意度 与视频会议相比; 3）与患者进行访谈，以定性评估积极和消极因素 他们的经验，障碍和通过电话遗传咨询的促进者方面， 视频会议; 4）与基因组医学服务（GMS）的遗传咨询师进行访谈， 定性评估通过电话进行遗传咨询的障碍和促进因素， 视频会议; 5）对电话和视频会议遗传咨询进行成本分析 方式。 方法：我们将进行一项随机对照试验的退伍军人，愿意有遗传 通过电话或视频会议进行咨询。退伍军人与多个息肉提到 遗传咨询的GMS将通过电话进行筛选面试，以获得以下信息： 个人和家族史以及研究入选和排除标准合格性。如果符合标准，将 提供有关研究的信息，并要求提供知情同意书。如果提供了知情同意，基线 将提出问题以收集人口统计信息和评估遗传知识。随机化通过 将使用随机数字生成将受试者分配到电话或视频会议组。 最后，将为每位患者安排遗传咨询会议。接受遗传咨询后， 接受咨询的退伍军人将收到概述风险评估的文件以及有关 息肉综合征和未来VA登记的可能性。 接受遗传咨询后一周内，参与者将被要求评估知识保留情况， 进行满意度调查和计算，并为以下子集安排定性访谈： 同意参与的患者（每个研究组10-12例）。我们将使用综合框架， 实施研究，以制定和进行与GMS工作人员的定性访谈。 根据功效计算，我们需要56名受试者的样本量。为了达到这个样本量，我们 将需要在七个月内每周招募大约两到三名受试者。这需要一个 32-40%的息肉病患者转介GMS进行遗传咨询。 数据分析将从描述性统计开始，以描述我们的研究样本。为了评估 电话和视频会议组之间的知识保留和满意度，我们将使用Chi- 分类变量的平方检验和离散有序和连续变量的Wilcoxon秩和检验 变量我们也将进行多变量普通最小二乘回归，以评估知识是否 保留或满意度根据患者特征、计算能力或遗传咨询师而不同。的 定性访谈将进行数字录音和转录，以供分析。我们将使用定向 内容分析方法。将使用Atlas.ti定性分析软件进行分析， 便于管理编码和跨转录本的模式分析。两者的成本分析 咨询方案将通过直接测量设备和劳动力投入成本以及 旅行报销由VA。从患者的角度来看，前往VA的相关费用 亦会考虑设立设有视像会议设备的诊所。