Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01685541 |
| Other study ID # |
H-25343 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
December 2010 |
| Est. completion date |
June 2012 |
Study information
| Verified date |
November 2023 |
| Source |
Baylor College of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
