Key words
digital patient briefing - computed tomography
Introduction
On February 25, 2013, the German Bundestag enacted the “Act to Improve Patient Rights”
dated February 20, 2013 [1]. According to § 630e Paragraph 2, patients are to be given copies of documents signed
in connection with patient briefing and informed consent.
Patient briefing is a regular part of the clinical routine. It is important for “informed
patients” to have a good understanding of planned examinations and the associated
risks. Patient briefing is currently usually performed in writing on paper. Tablet
computers, whose potential uses in medicine have already been examined in various
studies [2]
[3]
[4]
[5]
[6]
[7]
[8], have made it possible to replace conventional briefing documentation with digital
patient briefing.
The goal of this pilot project is to evaluate the technical implementation of digital
patient briefing and its use in the clinical routine as well as personnel requirements.
Moreover, an analysis of the time requirement provides information regarding differences
in briefing times and costs between digital and paper-based processes.
Materials and Methods
Digital patient briefing
Digital patient briefing was performed using the software E-Consent Pro from Theme
Compliance [9] installed on an Apple i Pad R2 (Cupertino, CA, USA) running operating system OS
10. This tablet-based software can be used for recording patient information and for
individualized patient briefing. At the time of a patient's examination, an order
for the requested radiology service, in our case the CT examination, is available
in the HIS for the patient. Using a link in the HIS, a print order for a paper-based
patient briefing form can be generated or the patient can be assigned to digital patient
briefing. In the case of assignment to digital patient briefing, an 8-digit code is
generated and is to be entered by the patient prior to beginning to use of the tablet.
However, for the sake of practicality, at our institute this code is not entered by
the patient but rather by an administrative employee who then hands the tablet to
the patient. This process step is referred to as “assignment”. Since the software
does not contain the same level of examination information as provided in paper-based
patient briefing and patient medical history forms, we give the patient the tablet
as well as a printout of the examination information. The patient is greeted by the
tablet by name and must provide authentication by entering his date of birth. Upon
successful authentication, the patient can begin answering the questions. All twelve
questions must be answered, see [Tab. 1]. Depending on the responses, the patient may be required to answer additional secondary
questions. In the case of open questions or ambiguities, the patient can select the
option “discuss with physician”. The software provides the physician with an overview
of all patient briefings currently in progress with the status “started”, “in progress”,
and “complete”. As a result, the physician who is exclusively responsible for reviewing
the indication, defining the examination protocols, and briefing patients at our institute
always has a detailed overview of the status of waiting patients. As soon as a patient
achieves the status “complete”, the physician can select the relevant patient on his
tablet in order to view all questions with the patient's corresponding responses.
Open questions are marked separately for faster processing. The physician then has
a discussion with the patient and can enter comments and notes directly on the tablet.
Table 1
Questions included in the digital patient briefing and number of patients unable to
answer these questions on their own.
|
Question
|
Number of open questions
|
|
1
|
Height/weight
|
16
|
|
2
|
Do you currently take medication on a regular basis?
|
66
|
|
If yes, please describe.
|
9
|
|
3
|
Do you have seasonal allergies, allergic asthma, or an intolerance to certain substances?
|
8
|
|
i
|
If yes, please describe.
|
4
|
|
4
|
Do you currently have or have you ever had an infectious disease?
|
10
|
|
If yes, please describe.
|
─
|
|
5
|
Do you have a gastrointestinal disease or external/internal hemorrhoids or strictures
in the anal region?
|
14
|
|
i
|
If yes, please describe.
|
8
|
|
6
|
Have you been diagnosed with a metabolic disease (e. g. gout, diabetes) or a disease
involving a major organ (e. g., kidney, heart, vascular system, lung, liver, nervous
system)?
|
16
|
|
If yes, please describe.
|
6
|
|
7
|
Have you been diagnosed with other benign or malignant diseases that can affect kidney
function?
|
35
|
|
i
|
If yes, please describe.
|
─
|
|
8
|
Do you currently have or have you ever had thyroid disease?
|
15
|
|
i
|
If yes, please describe.
|
─
|
|
9
|
Have you ever undergone a CT or MRI scan or X-ray examination of the body region to
be examined now?
|
17
|
|
i
|
If yes, when (year), where (facility), which body region/organ?
|
83
|
|
ii
|
If yes, was contrast agent used?
|
28
|
|
iii
|
If yes, did you experience side effects (e. g. circulatory changes, shock, rash)?
|
22
|
|
iv
|
If yes, please describe.
|
─
|
|
10
|
Have you ever undergone an operation in the body region to be examined now?
|
17
|
|
i
|
If yes, please describe.
|
14
|
|
11
|
Are you claustrophobic (fear of tight or enclosed spaces) or are you prone to panic
attacks?
|
8
|
|
12
|
Additional questions for women: Could you be pregnant? Are you breastfeeding?
|
2
|
The following actions are automatically digitally logged with a time stamp. Assignment
of the form, opening by the patients, processing by the patient, completion by the
patient, opening by the physician, processing by the physician, completion by the
physician, signing by the patient, signing by the physician, time of generation of
the PDF/A document. Until completion by the physician, changes can be made to the
document and are provided with a corresponding time stamp. Whether the action was
performed in a patient or physician context is noted for every time stamp. Therefore,
there are two users, namely the patient and the physician. The software currently
does not have a feature for noting processing in a patient context by someone other
than the patient, e. g. a family member or employee. The patient provides a digital
biometric signature on the tablet to consent to examination. A signature field is
displayed for this purpose on the tablet at the end of the digital briefing and is
signed by both the physician and the patient using a special pen. In addition to the
signature, the pressure and angle of the pen are recorded and digitally stored. This
information is generally considered legally secure. Signing is only possible after
all open questions have been discussed with the physician. By signing, the patient
confirms his consent to (or refusal of) CT examination. This process is thus comparable
with the paper documents currently used for patient briefing and recording of the
medical history. Once the physician and patient have signed, further processing of
the document or manipulation of the data is no longer possible. The digital document
is archived with the responses to the medical history questions, the individual comments
of the physician, and the digital signature of the patient and physician including
the corresponding time stamps as a PDF/A document in the digital patient file. The
PDF/A document is initially temporarily stored on a central server in the IT department
and is then automatically assigned to the patient on the basis of the stored case
ID and patient ID in the digital archive used hospital-wide. Prior to implementation
of this internal solution, this process was checked for accuracy by employees in the
IT department and the central patient archive. At the same time, a copy of the patient
briefing documents is printed out on a local networked printer and is provided directly
to the patient. To ensure data protection in the case of loss or theft, data is not
stored on the device.
Data analysis
For this study performed in the period 3 – 9/2015, the data of 502 consecutive patients
briefed with the help of the E‑Consent Pro software for a diagnostic CT examination
was evaluated. A prerequisite for inclusion was mastery of the German language. Discussions
with patients receiving care or prior to CT-guided interventions were excluded from
the analysis. Further selection of the patient population based on disease spectrum
was not performed. In addition to emergency situations, many examination were performed
in our areas of specialization, i. e., in the framework of staging and cardiovascular
issues. Due to the organizational separation between radiology and neurophysiology,
neurophysiology issues were seen in only a few patients. Under the assumption that
younger patients have a higher affinity for tablet computers and thus have fewer reservations
and technical difficulties using tablets, patients were divided into three age groups.
Data analysis was performed separately for each group. The first group (A) was comprised
of 40 patients under the age of 30. The second group (B) included 220 patients between
30 and 60 years old. The last group (C) was comprised of 242 patients over the age
of 60.
The analysis was limited to the quantitative determination of three aspects:
-
What was the total patient briefing time from opening to signing?
-
How many open or unclear questions did the patient need to discuss with the physician?
-
What was the total time needed for discussion with the physician prior to diagnostic
CT examination?
The t-test was performed to check for significant differences. A p-value of less than
0.05 was statistically significant.
Results
The average age of the 502 patients was 58 ± 17 years. The histogram of the age groups
is shown in [Fig. 1]. The average age of groups A, B, and C was 21 ± 7, 49 ± 8 and 71 ± 7 years, respectively.
Fig. 1 Histogram of age groups. Group A: age < 30 years, group B: 30 – 60 years, group C: age > 60 years.
[Fig. 2] shows the total time needed for patient briefing as a function of the patient’s
age. The time needed for patient briefing was independent of patient age (increase = –2.99·10–5, R2 = 2.22·10–3).
Fig. 2 Total time needed for patient briefing as a function of the patient’s age.
The time needed for patient briefing was 19.2 ± 12.5, 21.4 ± 17.0 and 19.4 ± 14.8
minutes for the individual groups as shown in [Fig. 3]. There was no significant difference in the briefing times of all groups (p = 0.339).
Fig. 3 Total time required for patient briefing for age groups A, B and C. The dashes in the boxplots are the median values. The bars represent mean ± 2 standard
deviations. The points correspond to outliers.
The patient briefing included twelve questions. Depending on the responses to the
main questions, patients may be required to answer up to twelve additional secondary
questions. Of the 502 evaluated patients, 224 had open questions prior to the discussion
with the physician. Clarification was required particularly with respect to questions
as to whether an operation had already been performed in the body region to be examined
(83 patients) and regarding the regular use of medications (66 patients). The other
open questions comprised a percentage of less than 10 %. All patient briefing questions
are listed in the appendix. Patients with more than 10 open questions were not included
in the evaluation (33 patients) since it must be assumed that there was a fundamental
issue with comprehension. 32 of the 33 hospitalized patients had reduced alertness
and were unable to answer the questions independently. 1 of the 33 patients was young
with a newly diagnosed advanced-stage tumor. We interpreted her refusal to answer
the questions on the tablet as a coping mechanism.
The number of questions requiring discussion with the physician increased with the
patient's age. While patients in group A had an average of 1.9 ± 1.3 open questions,
the number of questions requiring clarification was 3.6 ± 3.9 in group B and 4.8 ± 5.3
in group C. The results of the questions to be discussed are shown in [Fig. 4]. A significant difference regarding the number of open or unclear questions was
not observed between the three groups (p = 0.051).
Fig. 4 Number of open or unclear questions for age groups A, B and C. The dashes in the boxplots are the median values. The bars represent mean ± 2 standard
deviations. The points correspond to outliers.
The time needed by the physician to answer or process open or unclear questions for
all groups is shown in [Fig. 5]. The corresponding averages for groups A, B and C were 1.5 ± 1.3, 1.7 ± 1.8 and
2.0 ± 2.2 minutes indicating a time requirement independent of patient age (p = 0.449).
Fig. 5 Total time needed for the processing of open questions and discussion with the physician
for age groups A, B and C. The dashes in the boxplots are the median values. The bars represent mean ± 2 standard
deviations. The points correspond to outliers.
Discussion
Although the performance of digital patient briefing prior to MRI examinations has
been evaluated in various studies [4]
[5], no corresponding data regarding digital patient briefing prior to CT examinations
has been published to date. In our opinion a decisive difference compared to MRI is
the higher rate of CT examinations due to the typically shorter examination time.
Particularly in the case of parallel operation of multiple CT units, it has been our
experience that the patient briefing process can represent a bottleneck, thus extending
wait times for patients and resulting in unit downtime. Therefore, optimization of
the patient briefing process could greatly improve work flows in computed tomography.
Consequently, we decided to conduct a pilot project to evaluate tablet-based digital
patient briefing in the area of computed tomography. The present study provides the
results of this project.
The total briefing time from assignment to legally secure signature was approximately
20 minutes on average and did not differ significantly between the three age groups
The total time for discussion with the physician including explanation of typical
and individual risks as well as clarification of open questions was less than 2 minutes
on average. Questions regarding previous operations and medications were most common.
Our data analysis showed a trend toward more open questions with increasing age although
the defined level of significance was just barely exceeded (p = 0.051). A different
age group categorization may have shown significant differences between the groups
regarding open questions.
At our institute, the time needed for paper-based patient briefing was determined
prior to the introduction of digital patient briefing on the basis of a sample of
100 patients. In concordance with the digital processes evaluated in this study, the
preceding analysis also included the time from arrival of the patient in the CT waiting
area to archiving of the patient briefing documents. The time needed for this was
approximately 39.8 minutes of active work time or up to 46.8 minutes in the case of
incomplete or incorrect patient briefing documents or technical problems during archiving.
Passive time during which documents were waiting to be retrieved by a patient archive
employee was not included in the time analysis. We expected an average time savings
of 6.5 minutes compared to the paper-based briefing process as a result of the automation
of the storage of briefing documents in the digital patient file. Thus, the tablet-based
technology presented here with a total briefing time of approx. 20 minutes is not
only significantly shorter than the total time for the paper-based method but is also
40 % shorter than the value determined in the time requirement analysis. The lower
personnel time requirement (medical employees, radiographers) and the potential elimination
of personnel costs in the patient archive result in a reduction in personnel costs
of approx. 20 %. In comparison, the one-time investment costs for the purchase of
tablets and digital pens are of minimal consequence. The highest investment costs
can be expected in the case of expansion of the WLAN network to include multiple access
points prior to establishing the digital briefing process.
Every patient received a copy of the patient briefing documents. Due to the option
not only to generate the PDF document but also to initiate printing of a copy via
the “air print” technology upon completion of the patient briefing process, we found
the process presented here to be feasible. Moreover, the printer was in the immediate
vicinity of the area in which patient briefing was performed so that the medical employees
did not have to walk far. However, in our experience, most patients do not want a
copy of the patient briefing documents. Therefore, we currently explicitly ask patients
prior to conclusion of the discussion with the physician if they want a copy and confirm
as applicable in a field provided on the digital briefing document for this purpose
that a copy was not desired. This elimination of some copies results in a further,
albeit minimal, cost savings.
We attributed the greater number of open questions with increasing patient age to
the fact that the underlying diseases are more complex and may affect multiple organ
systems. Such complex medical information may be more difficult for older people to
record so that more questions remain open or patients are unsure how to correctly
answer questions. However, this does not have a significant effect on the time needed
by the physician to clarify questions, and this value was comparable with the younger
age groups.
The briefing of underage patients was not given separate consideration in the present
study. Since the rule at our institute is to brief patients under the age of 16 years
in the presence of a legal guardian, it must be expected that some questions were
answered by the minor and some by the legal guardian. This cannot by definitively
clarified since the software only allows differentiation between patient/legal guardian/caregiver
on the one side and the physician on the other side. The software also cannot record
whether older patients received assistance from younger family members or non-medical
personnel. The extent to which these points affect the total patient briefing time,
the time for discussion with the physician, and the number of open questions remains
unclear. However, a similar problem regarding underage and older patients can probably
be expected in the case of paper-based patient briefing.
Following the digital patient briefing process, we surveyed 100 patients who had previously
participated in paper-based patient briefing for a diagnostic CT examination at least
once. 83 % of these patients preferred the digital process to the paper-based method.
Moreover, 62.5 % of medical employees and radiographers rated the digital process
as superior, which was largely due to the lower time requirement.
As a result of the time savings and the high acceptance of digital patient briefing
among patients and employees in combination with automated and legally secure archiving
that is largely free of errors like document loss, we decided to replace paper-based
patient briefing with the tablet-based digital process in computed tomography following
the pilot phase.
Clinical relevance
Digital patient briefing is accepted by patients of different age groups as well as
by employees and helps to optimize organizational processes in radiology with the
efficient use of personnel.
