Effectiveness of Web-based Teaching to Traditional Patient Education in the Use of Injectable Fertility Medications
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The study will be a prospective randomized trial involving human subjects. The study
      population will consist of all infertility patients presenting to the Carolinas Medical
      Center Women's Institute who will require injectable use.

      Exclusion criteria: Any patient with prior history of IVF injectable use will be excluded
      from the study.

      Independent Variables: The independent variable is the random assignment of each participant
      to receive either web-based or one on one teaching.

      Outcome Variables: The primary outcome variable is the level of knowledge after the
      intervention. Secondary outcome variables include level of satisfaction with education,
      preference of educational method, and time required to teach.

      Confounding Variables: Potentially confounding variables include age, race, and prior
      experience with web-based teaching.
    

Detailed description: 
      Study Design:

      The study will be a prospective randomized trial involving human subjects. The study
      population will consist of all infertility patients presenting to the Carolinas Medical
      Center Women's Institute who will require injectable use.

      Exclusion criteria: Any patient with prior history of IVF injectable use will be excluded
      from the study.

      Independent Variables: The independent variable is the random assignment of each participant
      to receive either web-based or one on one teaching.

      Outcome Variables: The primary outcome variable is the level of knowledge after the
      intervention. Secondary outcome variables include level of satisfaction with education,
      preference of educational method, and time required to teach.

      Confounding Variables: Potentially confounding variables include age, race, and prior
      experience with web-based teaching.

      Methods:

        1. A responsible clinician who has acquainted himself/herself with the research protocol
           will explain the study to each patient. Patients who agree to participate will sign a
           form documenting informed consent. The patient will then be handed an envelope that
           determines whether they will receive web-based teaching or one-on-one teaching.

        2. The patients receiving web-based teaching will be taken to a private room to watch a
           video on injectable medication use. The amount of time required to view the video will
           be recorded. The video can be paused, rewound and watched as many times as the patient
           desires.

        3. The patients randomized to one-on-one teaching will be taken to a separate room where
           they will be taught injectable medication use by one of two training healthcare
           providers with experience teaching injectable medications. The time spent in the
           teaching session will be recorded.

        4. After the teaching session, each patient in the study will complete a multiple choice
           post-test regarding their knowledge of injectable medication use. They will also
           complete a satisfaction survey which will use a Likert scale to assess the patients'
           responses. The instructors teaching the one-on-one sessions will not have access to the
           post-test.

      Statistics:

      The categorical variables will be summarized with frequencies and percentages while the
      continuous variables will be evaluated with means and standard deviations. A difference in
      proportion will be tested based on the data collected between the web-based group and
      didactic group. Non-inferiority testing will be conducted based on these differences with a
      5% significance level. Data analysis will be conducted using SAS statistical software
      (9.2,Cary,NC,USA) .

      Sample Size Estimate:

      To predict that the web-based testing group is not inferior to the Didactic testing group
      about 40 people in each group would be needed to achieve 80% power with a 5% significance
      level. The sample size needed was calculated using the Z-test. Here it is assumed that the
      didactic group would get 80% of their answers correct and the web-based group would actually
      have 90% of their answers correct.
    

Intervention name(s): video instruction; Nurse instruction
Intervention type(s): Other; Other
Intervention description(s): Patient Directed Video Instruction; Nurse directed instruction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: injectable; teaching methods