Evaluation of Computer Generated After Visit Summaries
Condition: Primary Care Patients With Chronic Conditions
MeSH terms: Chronic Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The electronic medical record (EMR) offers a new method to provide patients with information
      about their visits with a clinician. The EMR can generate personalized and patient specific
      handouts at the end of the visit that can recap the topics covered during that visit. These
      After Visit Summaries (AVS) can be automatically generated with information contained in the
      patient's chart. The AVS has the potential to improve patient retention of information needed
      for adherence to treatment plans, and follow-up instructions, and to facilitate information
      transfer between healthcare settings. However, the content and formatting of the AVS to
      optimize patients' information retention and satisfaction with the visit is not known. In
      this study, we will develop and test in a randomized trial three different versions of an AVS
      to determine the AVS content that maximizes patient satisfaction and retention of information
      on the AVS,and adherence to physician instructions. The three versions of the AVS developed
      from patient and physician input will be compared to a control condition which consists of
      current practice in each setting.
    

Detailed description: 
      We will conduct an experiment in the four selected primary care clinics to test objectively
      the effect of three levels of AVS content on patient recall of personal visit information,
      satisfaction with the information received from their providers, and uses of the information
      after their visits.

      The four clinics were selected to provide a diverse patient sample with regard to
      socioeconomic status, race/ethnicity and language preference. The study is planned to have a
      total of 68 patients in each AVS form group (272 total), and 136 patients in each language
      group. In our previous research in these SPUR-Net clinics, we found that it is very difficult
      to recruit Spanish-language preference individuals in private practice settings. The great
      majority of persons of Hispanic ethnicity who attend private practice clinics prefer to
      communicate in English. For this reason, we will not attempt to recruit Spanish-speakers from
      the Baylor Family Medicine Clinic. Patients will be approached, and if they agree to
      participate they will be consented for the study. At the end of the visit, each study patient
      will be randomized either to the control group or one of the three experimental groups. The
      RA will accomplish this by opening a sealed envelope that contains the randomly generated
      group assignment. For the experimental AVS's, the RA will select and generate the appropriate
      study AVS in Epic. For the control group, the AVS that is currently being used in that clinic
      will be printed and distributed to the patient. All research subjects will then be contacted
      in 24 hours, and then again in 2-3 weeks to study the following outcomes.

      We are not able to test a control condition that withholds an AVS altogether, in as much as
      JACHO standards governing some of the participating clinics require an AVS of some kind.

      Primary Outcome: The primary outcome measure will be the amount of information recalled by
      patients at two time points: 2 days after the primary care visit, and 2-3 weeks after the
      visit. The recall test will consist of two parts. Part 1 will involve recall of the general
      categories of information contained on the AVS. Sample questions are:

        -  Did the form have information about your blood pressure?

        -  Did the form have information about your medications?

        -  Did the form have a list of your health problems?

      The responses will be scored as correct or incorrect, depending on the version of the AVS
      randomly assigned to the patient. The final version of the recall test will be developed
      after the focus group analysis, when a final determination of the content of the three forms
      of the AVS is completed.

      Part 2 of the recall test will ask the patient to generate the list of medications prescribed
      and instructions given. This represents the content of the minimum information AVS (Form 3),
      which can be answered by all study participants. The patients' answers will be recorded in
      the data base verbatim, and at the completion of data collection, the investigators will
      develop scoring rules to assign a score to each item. These rules will account for informal
      names for medications (such as "water pill," "sugar pill," etc.). The score on this part will
      be the percent of medication information correctly recalled, including name of pill (formal
      or informal), number of doses to be taken per day, and timing of dose. The total test score
      will be the percent of items correctly recalled. The two parts can be analyzed separately and
      as a total score.

      Secondary Outcomes

      Patient Satisfaction with the AVS will be assessed with a 9-item questionnaire adapted from a
      longer patient satisfaction scale developed by researchers in Baylor's Department of Family
      and Community Medicine for evaluating patient responses to educational materials. Response
      options to a series of questions regarding satisfaction with various characteristics of the
      AVS range from "strongly agree" to "strongly disagree." Two open ended questions will provide
      patients the opportunity to mention elements of the AVS, or their reaction to it, that might
      not have been anticipated by the research team. The form will be available in both English
      and Spanish versions.

      Adherence to Treatment will be assessed to examine whether the different AVS formats
      influence patients' self-reported adherence to the provider's recommendations. We will use a
      general measure of adherence that summarizes information about the patient's tendency to
      adhere to medical recommendations, regardless of type of treatment recommended. The items in
      this measure are:

        1. I had a hard time doing what the doctor suggested I do;

        2. I found it easy to do the things my doctor suggested I do;

        3. I was unable to do what was necessary to follow my doctor's treatment plans;

        4. I followed my doctor's suggestions exactly; and

        5. Generally speaking, how often during the past 4 weeks were you able to do what the
           doctor told you?

      Response options for each item range from "none of the time" to "all of the time." The
      general adherence scale was constructed by averaging responses to the five items and
      transforming the result linearly to a 0-100 distribution. This scale, developed in
      conjunction with the Health Outcomes Study, has demonstrated good internal reliability
      approaching .80, and acceptable stability over time. Standard back translation procedures
      have been used to construct an equivalent Spanish version.

      Other Study Variables

      Health Literacy will be assessed with the Short Test of Functional Health Literacy in Adults
      (S-TOFHLA)in order to account for the effect of functional health literacy on response to the
      AVS. Patients' health literacy skills are increasingly recognized as a critical variable in
      primary care research. The S-TOFHLA is a timed reading comprehension test that measures
      patients' ability to read and understand passages describing common medical instructions. It
      is available in English and Spanish versions, takes approximately 7 minutes for patients to
      complete, and is scored on a scale of 0 to 36. Patients are categorized as having adequate
      health literacy if the S-TOFHLA score is 23-36, marginal health literacy if it is 17-22, and
      inadequate health literacy if the score is 0-16.

      Demographic and Health variables will be collected, including such standard variables as age,
      sex, race/ethnicity, and number of years of education completed. In order to adjust analyses
      for disease severity, we will document the total number of health problems included in the
      patient's problem list on the day of their study visit. In addition, because the salience of
      the AVS may be related to the presence or absence of an acute condition, we will classify
      each visit as to whether the problem list for the visit includes chronic conditions only, and
      acute condition only, or a combination of acute and chronic problems. This categorical
      variable will be included as a covariate in the outcomes analysis.

      Analysis

      If the potential confounders are evenly distributed across the study groups, the differences
      among groups on the primary and secondary outcome measures will be tested by one-way ANOVA or
      Chi-square analysis as appropriate for continuous or discrete variables.
    

Intervention name(s): Maximum After Visit Summary Content; Intermediate After Visit Summary Content; Minimum After Visit Summary Content; Usual AVS
Intervention type(s): Other; Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research