Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02572115 |
| Other study ID # |
JFME001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
October 5, 2015 |
| Last updated |
December 21, 2017 |
| Start date |
September 4, 2017 |
| Est. completion date |
December 1, 2017 |
Study information
| Verified date |
September 2017 |
| Source |
University of Aarhus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this randomized controlled trial is to test the use of an emergency button
that allows patients to jump the telephone waiting line at the out-of-hours primary care in
two regions in Denmark if they perceive their illness as acute and severe.
Description:
Patients calling the Danish out-of-hours primary care service (OOH-PC; i.e. lægevagt) and
Medical Helpline 1813 (i.e. Akuttelefonen) queue up in the telephone waiting line. Ranging
from patients calling for acute illness such as chest pain to parents calling to ask if their
coughing child is well enough to go to day care the next day, they must all wait for their
turn to talk to the triage general practitioner (GP) or triage nurse. This Project is a part
of a PhD-project which is a composition of two different randomised controlled studies with
overlapping background. This registration with www.clinicaltrials.gov only concerns the
following study:
- Intervention to bypass the telephone queue in case of a perceived emergency: The
investigators implement an option for patients to bypass the telephone queue by pressing a
button if they perceive their illness as acute and severe.
Background:
Acute out-of-hours (OOH) care is an important part of health care and the point of entrance
into the health care system for many patients, who contact outside normal working hours (i.e.
4 pm to 8 am on weekdays, all weekends, and bank holidays). Patients with acute health
problems have several options to access the health care system, such as OOH-PC, 112-Emergency
Medical Communication Centre (112-EMCC), and Medical Helpline 1813. These settings have
complementary aims in delivering health care, but at the same time their patient population
is partly overlapping.
Primary care is often the first point of contact, also outside office hours. However, in the
Capital Region of Denmark patients call the Helpline 1813 which is answered by triage nurses
who have the option to forward the call to a doctor, to triage to a consultation at the
emergency department (ED) or another hospital department, to order a home visit, to forward
the call to 112-EMCC or to give telephone health advice. In the four other regions OOH-PC is
run by GPs, who answer and triage all telephone calls. They can triage to a telephone advice,
a clinic consultation, a home visit, or directly refer to the ED/hospital. Patients
contacting the OOH-PC or Helpline 1813 are put on hold and wait in a telephone queue if no GP
or nurse is available to answer their call.
The Danish acute care settings are intended to provide care to different patient groups
depending upon the nature and severity of the health problem. With the decision to contact a
specific setting, patients themselves choose the point of access to acute care, thus
influencing their care pathway. An `inappropriate´ choice may result in serious delay of
treatment or insufficient intensive care, if they for example contact primary care instead of
112-EMCC in life-threatening cases. On the contrary, over-use or -treatment is a potential
risk if calling 112-EMCC for minor problems.
At the moment, if a patient calls OOH-PC or Helpline 1813, he has to wait in line, even if
the health problem is experienced as highly urgent or life-threatening. The alternative to
waiting in line is calling 112-EMCC instead, as there is no possibility to bypass the
telephone waiting line. In the Netherlands this functionality is integrated in the telephone
system, meaning that patients who jump the waiting line are connected to the first available
telephone triage professional.
No information is available about the number of patients whose safety has been compromised
because of extensive waiting. The investigators also lack knowledge on the number of patients
who decide to contact another health care service, such as 112-EMCC, due to the waiting time
in OOH-PC and Helpline 1813. At the OOH-PC about 5% of patients estimate their condition as
potentially life-threatening and approximately 1% of all telephone contacts are directly
triaged to 112-EMCC. In the Central Denmark Region this accounts for approximately 7,000
patient contacts per year who may experience potential harm from a delay as a consequence of
the telephone queue.
Although it is not clear whether the absence of the possibility to jump the line is a problem
for patients, its presence may provide patients with a feeling of safety and reduce the level
of stress in medical situations which are experienced as distressing.
Aim:
To implement the jump-the-line option in OOH-PC and Medical Helpline 1813 to:
1. study the frequencies of patients jumping the line and the general characteristics of
these patients,
2. study the patients' reasons for jumping the line and their satisfaction with this
option,
3. evaluate the amount of jumps assessed as relevant by the triage GP/nurse
Methods
Design, setting and intervention:
The investigators conduct a randomised controlled trial (RCT) at OOH-PC in the Central
Denmark Region and Helpline 1813 in the Capital Region. The two settings are used so the
investigators can make a comparison of the usage of the jump-option in the two regions and
hopefully a well-founded recommendation regarding the intervention. At the moment, when
calling, patients are already routinely asked to press their CPR number at the telephone.
Hereafter, the patients will be randomized into two arms according to their date of birth
(even or uneven date in the month) which is part of the Social security number (Central
Person Register, CPR number).
For those in the intervention arm, the message at the answering machine will inform the
patient of the possibility to jump the waiting line by pressing '9'. By doing this their call
will be answered by the next available triage person. On the computer screen of the triage
person a message will appear, if the patient has used the jump option. Patients at the
control arm will get the normal message at the answering machine and will not get the
possibility to jump the line. If patients call several times during the study period they
will be randomized to the same arm every time, using the CPR number. If patients do not press
their CPR number, they will get the normal message at the answering machine without the
option to jump the line.
Data collection:
A questionnaire will pop-up on the PC for the triage GPs in the Central Region of Denmark and
triage nurses and doctors in the Capital Region for all patients who use the jump option.
This pop-up questionnaire contains questions about the medical and social relevance of
jumping the line, the degree of urgency, the reason for encounter (RFE) and the probable
diagnosis. The questionnaire is short and can be completed in less than a minute.
Furthermore, a similar questionnaire (without the question about the relevance for jumping
the line) will pop-up for the triage professionals for a random group of patients in the
intervention arm who did not jump the line and for a random group of patients belonging to
the control arm. This will enable the investigators to compare the three groups. This method
of collecting data from the GPs has been found feasible in earlier studies.
A patient questionnaire will be sent to a random group of patients who use the jump option.
Questions focus on the reason for using the jump option, patient satisfaction, and the effect
of the intervention on their feeling of safety, as well as relevant patient and contact
characteristics (e.g. RFE). Furthermore, questionnaires will be sent to a random group of
patients from the intervention arm who did not jump the line. Questions for this group focus
on the reason for not using the jump option, RFE, patient satisfaction, and the effect of the
intervention on their feeling of safety. Finally, a questionnaire will be sent to a random
group of patients in the control group, focusing on the RFE and patient satisfaction with the
current system.
As a part of the telephone message in the OOH-PC telephone, patients will be informed about
the ongoing study with the option not to participate in the study. The questionnaires are
planned to be sent in a few days after the contact by ordinary letter as well as by a message
to the patient's electronic mailbox required by the state (e-boks) with a link to an
electronic version of the questionnaire. If the patient is less than 14 years old, the
questionnaire will be addressed to the parents. Patients will only receive one questionnaire
in the study period although they may have several contacts.
Furthermore, the investigators collect information of all contacts to OOH-PC and Helpline
1813 in the study period the electronic patient record system of OOH-PC and Helpline 1813 can
provide: CPR number of the patient, date and time of contact, triage outcome (i.e. telephone
consultation, consultation, home visit or referral to ED or other hospital departments), use
of jump the line option, and waiting time in the telephone line at time of patient call to
the service. If the patient has chosen to jump the line, the investigators also collect the
length of waiting time at the time of the jump.
Study period and power calculation:
Based on the patient questionnaires: The investigators want to be able to detect a minimum
mean difference of 0.3 between jumpers and non-jumpers in the outcome measures regarding
satisfaction and feeling of safety. If the investigators assume that the sample standard
deviation is 1, significance level is 5%, power is 95% and given a mean of 3 the
investigators need a total of 580 answered patient questionnaires to be able to detect a
difference of 0.3 between the two groups. This means that, with a response rate from the
patients of 40%, the investigators have to send out 1450 questionnaires.
In 2013 the total number of contacts with OOH-PC in the Central Denmark Region was
approximately 660,000. An earlier study showed that approximately 80% of patients type in
their CPR number on their phone when calling the service. Numbers from the Netherlands show a
user rate of 3 % of their version of the option to jump the line. An estimated response rate
from the GPs of 70% gives a study period of approximately 1,6 months.
Based on number of jumps: In relation to the aim of frequency of jumping the line the
investigators want to determine the user rate. The investigators estimate a user rate of 3 %
and this gives them 7,800 users of the intervention in one year. In order to obtain
satisfactory power in the calculations of the usage of the jump option the investigators want
a 95%-confidence interval of +/- 2,2%. This means that the investigators need at least 1950
jumpers, which requires 3 months to complete the study.
In conclusion the investigators need approximately 3 months to complete the study if they
want satisfactory power regarding the frequency of jumps and patient satisfaction.
The investigators plan to conduct a pilot study with a running time of 1-2 weeks to give a
more precise estimate of the user rate in order to perform a more accurate power calculation
to define the length of the study period.
Analyses:
The investigators provide a descriptive analysis of the group of patients who jump the line,
the group who chose not to jump the line, and patients from the control group, along with
univariate analyses comparing the patients in the three groups (i.e. patient characteristics,
RFE, incentives). Descriptive analyses will be performed using Student's t-test for data
following a normal distribution, Mann-Whitney U-test for non-normally distributed data, and
chi-square test for categorical data. For the primary outcome measures patient satisfaction
and feeling of safety the investigators perform intention to treat analyses as wells as
analyses between subgroups. The association between relevant jumps and GP assessed level of
urgency and patient characteristics is explored by the use of multivariate binomial
regression taking clustering at GP level into account. The association between patients'
choosing to jump the line, satisfaction with having the option, and the reasons to do so, is
assessed using multivariate binomial regression models.
Perspective:
This study will provide knowledge on the feasibility and effects of implementing an option to
jump the telephone waiting line at OOH-PC and Helpline 1813, and it will be clarified whether
patients will use such an option appropriately. This information will be used to decide
whether this intervention should be implemented nationwide. The percentage of patients
potentially benefiting from this option to jump the line is expected to be relatively
limited, but as the total number of contacts with OOH-PC is extensive, the absolute number of
patients actually benefiting from this simple intervention is likely to be substantial.
Especially in the area of feeling safety the investigators hope to see a significant effect.
This intervention is robust and can be extended to other regions and settings easily.
Information about the decrease in waiting time for urgent cases could lead to stratification
of quality goals for different patient groups. Also a higher number of cases with acute
illness could be handled by the OOH-PC which could ease the pressure on 112-EMCC.
