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Evaluation of Computer Generated After Visit Summaries

Primary Purpose

Primary Care Patients With Chronic Conditions

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Maximum After Visit Summary Content
Intermediate After Visit Summary Content
Minimum After Visit Summary Content
Usual AVS
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Primary Care Patients With Chronic Conditions

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Adult 21 or over
  • At least one previous visit to the clinic
  • Has one chronic condition require medications
  • Willing to participate and answer questionnaires by phone

Exclusion Criteria:

  • No previous visits to the clinic
  • Unwilling to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Maximum AVS Content

    Intermediate AVS content

    Minimum AVS content

    Control Group (Usual AVS)

    Arm Description

    AVS includes patient name, visit date, chief complaining, allergies, immunizations, vital signs, medications, problem list, lab order, physician contact information, referrals, instructions

    AVS includes patient name, visit date, vital signs, medications, diagnosis, problem list, physician contact information, referrals, instructions

    AVS contains patient name, visit date, medications, diagnosis, physician contact information, referrals, instructions

    Content differed by clinic site

    Outcomes

    Primary Outcome Measures

    Recall of After Visit Summary Content

    Secondary Outcome Measures

    Satisfaction with the After Visit Summary

    Full Information

    First Posted
    September 12, 2012
    Last Updated
    September 13, 2012
    Sponsor
    Baylor College of Medicine
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01685541
    Brief Title
    Evaluation of Computer Generated After Visit Summaries
    Official Title
    Evaluation of Computer Generated After Visit Summaries to Support Patient-Centered Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    January 2012 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baylor College of Medicine
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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: I had a hard time doing what the doctor suggested I do; I found it easy to do the things my doctor suggested I do; I was unable to do what was necessary to follow my doctor's treatment plans; I followed my doctor's suggestions exactly; and 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Care Patients With Chronic Conditions

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    272 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Maximum AVS Content
    Arm Type
    Experimental
    Arm Description
    AVS includes patient name, visit date, chief complaining, allergies, immunizations, vital signs, medications, problem list, lab order, physician contact information, referrals, instructions
    Arm Title
    Intermediate AVS content
    Arm Type
    Experimental
    Arm Description
    AVS includes patient name, visit date, vital signs, medications, diagnosis, problem list, physician contact information, referrals, instructions
    Arm Title
    Minimum AVS content
    Arm Type
    Experimental
    Arm Description
    AVS contains patient name, visit date, medications, diagnosis, physician contact information, referrals, instructions
    Arm Title
    Control Group (Usual AVS)
    Arm Type
    Active Comparator
    Arm Description
    Content differed by clinic site
    Intervention Type
    Other
    Intervention Name(s)
    Maximum After Visit Summary Content
    Intervention Type
    Other
    Intervention Name(s)
    Intermediate After Visit Summary Content
    Intervention Type
    Other
    Intervention Name(s)
    Minimum After Visit Summary Content
    Intervention Type
    Other
    Intervention Name(s)
    Usual AVS
    Primary Outcome Measure Information:
    Title
    Recall of After Visit Summary Content
    Time Frame
    2 days post visit
    Secondary Outcome Measure Information:
    Title
    Satisfaction with the After Visit Summary
    Time Frame
    2 days post visit
    Other Pre-specified Outcome Measures:
    Title
    Adherence to physician treatment recommendations
    Time Frame
    2 days post visit and 2 weeks post visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria Adult 21 or over At least one previous visit to the clinic Has one chronic condition require medications Willing to participate and answer questionnaires by phone Exclusion Criteria: No previous visits to the clinic Unwilling to participate

    12. IPD Sharing Statement

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    Evaluation of Computer Generated After Visit Summaries

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