Comparison of 3 Modes of Genetic Counseling in High-Risk Public Hospital Patients
Condition: Genetic Counseling
Study type: Interventional

Summary: 
      Using mixed methods, investigators will conduct a multicenter partially randomized preference
      noninferiority trial with high-risk English-, Spanish-, and Cantonese-speaking patients
      assigned by (1) patients´ preference or (2) randomization to three counseling modes: (a)
      in-person; (b) phone; or (c) video conference. A total of 600 patients will complete
      counseling and 540 will complete the final survey. Baseline and post-counseling surveys will
      use validated measures (adapted for literacy and language) of study outcomes. All counseling
      sessions will be audio-taped. A sample of 90 tapes will be analyzed for counseling content
      and to identify 30 participants for in-depth interviews and analysis triangulating all forms
      of data. Genetic counselors will be interviewed in depth to elicit their perceptions of the
      strengths and limitations of each counseling mode.
    

Detailed description: 
      Specific Aims.

      The specific aims of this mixed methods study are:

      Aim 1. Compare the effectiveness of 3 modes of genetic counseling in a diverse sample of
      patients at high risk for HBOC in 3 public hospitals. Conduct a multicenter partially
      randomized preference noninferiority trial with high-risk patients assigned by (a)
      randomization to three counseling modes: in-person, phone, video conference; or (b) patients´
      preference. Utilize validated measures of study outcomes adapted as needed for literacy and
      language. Recognizing that some potential participants may have a strong preference for one
      counseling mode, after explaining the study design and obtaining informed consent,
      participants will be asked if they have such a preference. Those who do will be offered that
      mode, and those who do not will be randomized. Randomization will be stratified according to
      hospital and personal history of breast cancer in order to ensure that there is no imbalance
      in important factors that may be associated with outcome.

      Aim 2. Explore inductively and qualitatively variation in patients' genetic counseling
      experiences and understandings, genetic counselor satisfaction and perceptions, counseling
      session similarities and differences, and implications of organizational context across three
      modes of genetic counseling.

      Aim 3 employs inductive, qualitative methods to explore in depth the cases of 30 patients
      using their pre- and post-counseling survey responses, audio tapes of their counseling
      session, and in-depth interviews to explore questions common to all respondents and those
      specific to what was learned about the individual from the other data sources. In-depth
      interviews will also be conducted with genetic counselors.

      Study Design:

      Using mixed methods, investigators will conduct a multicenter partially randomized preference
      noninferiority trial with high-risk English-, Spanish-, and Cantonese-speaking patients
      assigned by (1) patients´ preference or (2) randomization to three counseling modes: (a)
      in-person; (b) phone; or (c) video conference. A total of 600 patients will complete
      counseling and 540 will complete the final survey. Baseline and post-counseling surveys will
      use validated measures (adapted for literacy and language) of study outcomes. All counseling
      sessions will be audio-taped. A sample of 90 tapes will be analyzed for counseling content
      and to identify 30 participants for in-depth interviews and analysis triangulating all forms
      of data. Genetic counselors will be interviewed in depth to elicit their perceptions of the
      strengths and limitations of each counseling mode.

      Investigators' mixed methods combine a multicenter partially randomized preference
      noninferiority trial with inductive methods that embed this research in the real world of
      public health system patients. This is practice-based research, designed to emphasize
      external validity, (relevance and generalizability that enhance translation into actual use),
      as well as internal validity. The purpose of a non-inferiority trial is to compare an
      intervention to an active control or standard treatment when the intervention is not expected
      to have superior efficacy, but to have other benefits, e.g., greater convenience or fewer
      side effects. In the case of genetic counseling, in- person counseling is the standard of
      care, with well-documented efficacy.4 Since video and telephone counseling do not offer a
      more personalized approach or more pertinent content than in-person counseling, it seems
      unlikely that either mode would produce superior psychosocial outcomes or greater knowledge
      gains; similarly, investigators do not expect telephone counseling to be more efficacious
      than video counseling.

      The gold standard for assessing the effectiveness of interventions is the randomized clinical
      trial; yet patients who have a strong preference for one of the intervention conditions may
      decline to participate, which is a threat to external validity, or (if randomized)
      participate half-heartedly or drop out, threatening internal validity. Investigators will
      address this issue with a partially randomized preference trial in which patients with a
      strong preference are assigned to their preferred treatment (i.e., intervention condition)
      and those without a strong preference are randomized. This study design enables comparison of
      treatment outcomes among patients who receive their preferred treatment (the desired real
      world situation) and ascertainment of the effects of preference-as well as the evaluation of
      treatment outcomes in a randomized trial. However, comparisons involving preference
      participants are subject to confounding, since patients who prefer a particular treatment may
      differ in ways that affect outcome. In analyses involving preference participants it is
      possible to reduce confounding substantially using covariate adjustment. Nevertheless,
      because residual confounding may be present, preference participant outcomes should be
      considered observational data.

      Investigators will blend qualitative and quantitative, deductive and inductive methods using
      varied forms of data from in-depth interviews, surveys, and audio taped observations. This
      will allow us to address our central question from different perspectives triangulated in the
      analysis for a rich understanding of patient-counselor- institution relationships most of
      which are too complex to describe using one dimension alone (e.g., cognitive understanding
      captured in surveys). While the randomized trial is the gold standard for comparative
      effectiveness, it cannot answer questions such as what it is about the counseling interaction
      that was reassuring or anxiety-provoking to a patient? what techniques enabled a patient to
      recall important points? or what about the conversation precluded such recall? It is only by
      embedding the survey data in open-ended inductive exploration and audio observations that
      investigators can determine if a counselor provided too much information to a low-literacy
      patient, or alternatively used plain language to emphasize key points, checking frequently
      for patient comprehension. Importantly, was the counselor able to do this as well by phone or
      video? Thus, mixed methods illuminates important dynamics that informants may not be
      consciously aware of.
    

Intervention name(s): In-person; By phone; By video
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): At all sites, patients randomized to/preferring in-person counseling will meet with a counselor.; Patients in the phone arm will receive a scheduled call at their home.; Because low income patients are not likely to have video conference capability at home, this service will be offered at all three hospitals, and patients will have scheduled appointments to come to the hospital to receive counseling delivered through a computer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Genetic counseling modes