Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02033915 |
| Other study ID # |
201107036RB |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
October 7, 2011 |
| Last updated |
January 9, 2014 |
| Start date |
October 2011 |
| Est. completion date |
July 2012 |
Study information
| Verified date |
January 2014 |
| Source |
National Taiwan University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Taiwan: Department of Health |
| Study type |
Interventional
|
Clinical Trial Summary
Suicide attempters or people with self-harm have a high percentage in seeking medical
services before and after their suicidal or self-harm behaviour compared to general
population. Studies revealed that apart from psychiatric services, they were more likely to
seek help from doctors of various units (e.g. emergency departments, general medicine,
medical-surgical units) across different healthcare systems (i.e. hospitals or district
clinics). Besides, suicide event was possibly heard on in-patients of psychiatric or
non-psychiatric units. People with self-harm experienced poor communication with healthcare
personnel, and they perceived staff's lacking knowledge about suicide as serious problems.
In Taiwan it was also found that emergency nurses and general practitioners were in need of
improving negative attitudes and enhancing knowledge towards suicidal behaviour. From the
point that nurses are the healthcare personnel that spend the most time with in-patients
compared to others in the hospital, suicide risk assessment training may enhance nurses'
attitudes and ability of risk awareness and assessment towards people with self-harm, which
may in turn significantly increase the identification rate of the high risk group for
suicide. Currently there is a lack of suicide training program as a reference for nursing
education in Taiwan. The study therefore aims to strengthen suicide risk assessment ability
among clinical nurses through interactive discussion groups. Using quasi-experimental design
with randomized cluster sampling strategy, a case vignettes will be used for suicide risk
assessment together with other measurements regarding suicide knowledge and attitudes for
both experiment and control groups before and after the training course.
Description:
Title:
The effectiveness of interactive discussion group intervention to improve nurses' abilities
of risk identification and assessment on people with suicide attempt or self-harm behavior
A.Background
Suicide has become an important issue in the public health and medical-related field in the
past decade and has also aroused the attention of government in Taiwan. It has been one of
the top ten cause of death since 1997 . The high percentage of people who act on suicide
idea in different age groups pose great challenge to healthcare personnel. Clinical workers
are first-line gatekeepers of patient health and safety. They are supposed to be willing to
care for people with suicide risk and can be equipped with the ability to identify patients
with suicide risk. However, the negative attitudes of medical workers towards people who
have suicide attempt and self-harm behavior may affect the patients' intention to seek
professional help and the nurses' quality of care for these people . At present, the
investigators have limited nursing curriculum related to the concept of and guidance for
suicide prevention and limited resources that guide nurses to do suicide risk assessment.
Few information about suicide process and suicide risks are available for nurses , which may
result in their inability to provide proper care for this group of people. If the
investigators can improve the ability of suicide risk identification of the nurses, the
investigators may promote nurses' confidence and change their attitudes in caring for such
patients. Also, nurses can learn how to empathize suicidal patients, intervene at early
stage of patients' hospitalization, and potentially build good nurse-patient relationship
with patients under high risk for suicide. Furthermore, the investigators can refer patients
to receive appropriate therapy and to provide adequate support to reduce their suicide
attempts. The investigators addressed the background and importance of this study in the
following sub-sections:
The importance of suicide prevention throughout the process of nursing education and
clinical training
People with deliberate self harm behavior are the high risk group for suicide, and the
prevalence of self-harm behavior is 10-30 times to suicide . Identification and assessment
of suicide risk is the main target of suicide prevention. However, there are only few
opportunities for nurses to acquire knowledge about suicide prevention in the process of
nursing education and training. For instance, in a Nursing Department of Medical college in
Northern Taiwan, there is only one class talking about related issue of suicide prevention
among all the Psychiatric Nursing lectures. In general, student nurses think they are
unfamiliar with this issue and unable to assess the patients' suicide risk. Clinical nurses
who have more chance to care for suicide high risk group, such as those in the Emergency
Department (ED) and psychiatric ward, may still have negative attitudes toward self-harm
behavior. Nurses regarded suicidal behavior as selfish, wasting of social or medical
expenses, or not worthy of showing sympathy. Moreover, they may think self-harm behavior as
a kind of controlling behavior, calling for attention, and difficult in caring or building
therapeutic relationship. These negative thinking and emotions are both less likely to
promote caring quality to patients with self-harm. It was found that psychiatric nurses
tended to use verbal communication, to inform doctors about patients' suicide risk, or to
give close observations to prevent self-harm act or to offer a safe environment in the
psychiatric ward. But there is a lack of concept of early prevention among clinical nurses,
irrespective those working in the psychiatric or medical-surgical wards. Patients who suffer
from chronic illness or in terminal stage of disease in medical wards might have more
suicide ideations. It might be helpful to promote the ability of suicide identification and
assessment among nurses to give better caring quality for the suicide high risk population.
Moreover, nurses in the ED are easily encountered with the high risk (i.e. people who had
suicide attempt or self-harm behavior before). There is still few research focusing on the
ability of suicide risk evaluation of nurses in the ED. It was suggested that training
courses can change the negative attitude of suicide for nurses who work in the ED, promote
their ability of suicide risk assessment, and enhance their confidence in facing these
patients.
The policy of suicide prevention and gatekeeper program are forming currently by the health
organization in Taiwan. Not only are the public playing the role of gatekeepers to indentify
suicide risk, clinical nurses should also know how to assess suicide risk. So far the
investigators have few courses about suicide risk assessment, and the investigators need
further research to develop a complete content of suicide evaluation, which can be used in
clinical training and nursing education. The investigators can provide a learning
environment based on interactive group, and this can help improve critical thinking and
problem solving skills. Also, using case vignette to design the discussion course
(case-based curriculum) can help the learners understand integrated knowledge content based
on clinical situation; its advantages include to promote the motivation of active learning,
to strengthen the analysis skills, to enhance decision making ability, or to cultivate
learners o how to correctly evaluate the effects on patients from social culture
perspectives. At the present, nursing education in Taiwan is focusing on critical thinging,
problem-solving, and decision making, and the use of group discussion can help reach the
above teaching goals.
The importance of patient safety in hospitals
It is important to keep patient safety in the medical environment, and it is also necessary
to provide quality of care. However, the issues of suicide and self-harm behavior have been
neglected in hospitals, and the investigators are lacking of effective preventive
interventions and policy. There are many topics related to patient safety in medical
environments, including mistakes happened during the process of giving medicine, falling,
environment safety. However, suicide behavior among inpatients has been posing the greatest
challenge to medical personnel. According to the Taiwan Patient-Safety Reporting System
(Taiwan Joint Commission on Hospital Accreditation, 2009), there were 1,613 accident events
of hospitalized patients in 2008. General wards are the mainly location of events, in the
categories of events, 12.0% is self-harm behavior. Although there are only 43 events of
suicide attempt, its consequence are the most serious compared to other patient safety
issues. Researches in the 1960s in western countries indicated that the death rate of
suicide among hospitalized patients are 0.06~5.66 per thousand. Even suicide is a rare
topic, the investigators cannot ignore its severity. To prevent suicide events, psychiatric
ward and general ward should put emphasis on the prevention, the education training and
communications between patients and nurses (Taiwan Joint Commission on Hospital
Accreditation, 2009). For general medical workers, they might underestimate the formation
and the effects of suicide or self-harm behavior. The investigators may reach the goal of
suicide prevention and treating for self-harm behavior appropriately if clinical nurses can
identify the high risk group of suicide effectively and follow the steps suggested in the
gatekeeper program.
The importance of suicide risk assessment
There is a remarkable percentage seeking for medical help among patients who harmed
themselves before committing suicide. These patients not only appeared in psychiatric
department, but also seek medical help in different medical settings. According to a
systemic literature review, people of self-harm behavior think they do not have good
communication with medical workers, and most medical workers do not have idea about what
self-harm behavior is either. This is a common problem in the medical system across
different departments. The investigators also understand that negative attitude or knowledge
do actually exist in the nurses of Emergency Department and doctors. Tzeng & Lipson (2005)
suggested that medical workers need to know the reasons of suicide or self-harm behavior and
the kind of interventions that may be helpful. Cognition and attitude training like this is
not usual in nursing education, but nurses, among the medical group, have relatively more
time to stay with patients. So strengthen the training of suicide evaluation and
identification can help us to know the potential group of high risk, and also provide social
support and medical connections to reduce the formation rate of suicide and self-harm
behavior.
The reasons why the investigators need to identify and assess suicide risk
To identify and evaluate the suicide risk is the first step in suicide prevention.
Evaluations for factors of suicide risk (such as major depression and high risk group of
suicide)is not often performed in clinical care, expect for the psychiatric care settings.
However, the process of help seeking behavior could happened in the following ways such as
self-disclosure of suicide idea and risk factors, or transferred by nurses in any department
and start to accept further treatment. In this process, help and social support from family
or friends can strengthen the intention to seek for help. Therefore, to identify the case
with potential risk is the key point to start suicide prevention. Although the investigators
don't have any research talking about suicide prevention policy in hospital now in the
world, the awareness and identification for group with high risk, risk assessment and
transfer are strongly recommended by many Western countries. Nurses can play the role of
gatekeeper of suicide prevention, and identify the suicide or self-harm behavior before it
occurs and transfer to the right association for further caring instead of providing
assessment and protective instructions after the event.
Based on the backgrounds, this research focuses on the ability of suicide risk
identification and evaluation of clinical nurses in a teaching hospital of Northern Taiwan.
And the investigators do evaluate the impact of interactive discussion group which promote
the identification ability for nurses. The investigators expect to find out patients with
high risk of suicide and provide appropriate interventions by improving the sensitivity of
first line clinical professionals.
B. Aims of the study
- To improve the ability of suicide risk identification and assessment on hospitalized
patients for clinical nurses
- To understand the impact of using the interactive discussion group to promote the
ability on suicide risk identification and evaluation for clinical nurses
- To provide evidence-based nursing education as a basis to practice the interactive
discussion group to promote nurses' ability on suicide risk identification and
evaluation
C. Methods
The study is a randomized controlled trial. The sample will be consisted of 120 people, with
half of them allocated to the intervention group and another half allocated to the control
group. Therefore, the sample will be distributed into experimental group and control group
equally and randomly. After receiving approval from the Ethical Review Committee, the
investigators will start recruiting people to attend the intervention, "interactive
discussion group" (IDG), the investigators aim to discuss the concept of suicide risk
identification and evaluation as well as investigate the impact of such an intervention. The
investigators have developed a standardized teaching program (the IDG and suicide gatekeeper
course for nurses) as our intervention. Moreover, before starting the intervention, the
investigators will have three focus groups in the pilot study in order to recruit clinical
nurses' perspectives on the issue of the study and their opinions of the study tool. Depends
on their opinions, the investigators will revise the teaching materials and assessment
tools, and evaluate the feasibility of putting the IDG into practice. Next, the experimental
group will take one suicide gatekeeper course and the IDG discussion twice, and the control
group takes one suicide gatekeeper course. The investigators will do the baseline
measurement and outcome measurement to evaluate the effects of intervention. The research
methods and rationale are described in details below.
The rationale of adopting the intervention of "interactive discussion group" (IDG)
Education training for nurses currently includes classroom teaching through speeches,
film/website teaching, group discussion and practice, and classroom teaching is most popular
one in nowadays. Materials the investigators use to teach suicide assessment such as
interactive website which provided by Taiwan Nurses Association and books are also available
for nurses for self-learning. Concerning the importance of discussion and evaluation of
suicide risk, and the realization of suicide risk based on a case vignette, also the
interactive learning between trainees and facilitators, the investigators choose using
interactive discussion group as our teaching policy, and via the randomized controlled trial
the investigators can evaluate the effect or research interventions.
Standardized procedure of the interactive discussion group
Researchers will take the interactive discussion group class for six times (8-10 persons
every time). During the 50-60 minutes, the facilitators will guide the trainees to
understand the case vignette and focus on the key issues to discuss, to improve the ability
of suicide risk identification and evaluation. Two research team workers are responsible for
the facilitators, and they are both experienced in suicide prevention and clinical works.
The two facilitators will guide the group in a comprehensive way and standardized maneuver.
The topic of discussion is focus on a suicide case, a 47-year-old man, who is now in
hospitalization of medical ward. In the content the investigators can find out there are
many messages and signs of major depression and suicide behavior. Through the discussion,
the investigators guide nurses to realize the suicide-related factors, and teach them to
identify/evaluate the suicide risk. 10 minutes before the group, the investigators ask the
trainees to read the case and answer the questions. In the next 30 minutes, the
investigators start problem discussion and use three simple, convenient tools: PHQ2,
simplified health scale, SAD PERSONS, to do the teaching of identification and evaluation of
suicide risk. In the last 10-15 minutes, the investigators go into a conclusion, do point
review and get feedback from trainees.
The Research team uses the standardized material course which is authorized by the Health
Department of Taiwan-"The Gatekeeper Training Program" to do our interventions. Facilitators
are trained to use the same material and ways to teach the experimental group and control
group in consistency. In this part, the investigators do not discuss the suicide case
vignette, so the investigators can divide this from the group which trained by interactive
discussion and therefore the investigators can evaluated the effect of using discussion
group in our training.
Research Tools
1. The baseline measurement 1-1 Information Assessment of basic demographic variable such
as age, sex, marriage, duration of practicing in nursing, nursing levels, working
experience of psychiatric wards, caring experience of person they know (friends,
colleague or neighbors) or patient who committed suicide or self-harm behavior before,
do they accept any training related to suicide prevention in the past year.
1-2 Suicide Case vignettes and risk assessment question Research team designed a case
discussion depends on clinical experiences and suicide cases they had cared before. The
investigators drafted some important questions to evaluate the ability of suicide risk
identification and evaluation of research samples (Nurses). 8 student nurses of
university went through this case discussion, and the investigators got a good result
of this pilot test. Student nurses all agreed the interactive discussion with teacher
and problem-based teaching can help them to grab the point of suicide prevention and
arouse their learning interest.
1-3 Assessment of the cognition and attitude to suicide behavior This scale is used in
the survey by Health Department of Taiwan which to understand the attitude and opinion
toward suicide and Psychiatric disease of randomized sample size in the population of
Taiwan. And the validity of this tool was already proved.
2. Assessment tools in the Interactive Discussion Group 2-1 Case vignette is the point in
our interactive discussion group, please read the details in .
2-2 PHQ PHQ was originally used to evaluate the health situation of general public in
community, and PHQ-9, a part of this scale, which used to evaluate the tendency of Major
Depression. And the content of PHQ-9 is correlated to the 9 diagnosis items with DSM IV.
Scholars modified a new vision of PHQ-2, and the reliability and validity is good on the
public of Taiwan (Sensitivity: 88.0%, Specificity: 81.9%) (Lu et al., 2010). Therefore the
investigators use the scale to train nurses to screen if there is possibility of Major
Depression in patients. The two questions are related to the symptoms of "depressed mood"
and "lost of interest".
2-3 Simplified Health Measurement Scale This scale is developed to test the general mental
health of the public, including five question as "do you feel nervous and anxious", "easily
to feel worrisome and angry", "feeling depressed and sad", "feeling of low self-esteem" and
"bad sleeping quality". Also, the investigators ask extra question as "do you have any
suicide idea". This reliability and validity was proved by Li et al.,(2003), and it's a
simple, convenient scale to screen out the potential depression tendency and suicide risk.
The goal the investigators use this scale in the research is to improve the recognitions of
nurses on Major Depression.
2-4 SAD PERSONS-check list of suicide risk This checklist was originally designed to screen
if a patient needs to be hospitalized by the Emergency Department staffs based on a 10-item
suicide risk screening sheet.
S - Sex: male A - Age( <19 or >45) D - Depressive symptoms P - Previous suicide
attempt/psychiatric care E- Excessive ethanol/drug use R- Rational thinking loss, sever
psychiatric symptoms as delusion, hallucination S - Separated/ divorce/drug use/widowed O -
Organized or serious attempt, who had severe and objective self-harm behavior before like
carbon monoxide poisoning, overdose medicine taking and need to be hospitalized…etc.
N - No social support, lack of family, friends, work and religion support S - Stated future
intent, clear plan including time, methods and location
Each item is scored one point, with two points weighing for items that are underlined.
Kripalani et al., (2010) suggested people who get five points or higher need to be
hospitalized and accept further therapy. The validation of the Chinese version of the scale
has been performed by a group of psychiatric researchers in Taiwan and is under drafting.
Data collection procedure
1. The target population and study sample The target population (i.e. clinical nurses) for
the study is defined to be from a variety of ward such as Hematology, Oncology, Stroke
and Rehabilitation where potential cases with high suicide risk may be identified. The
investigators hypothesise that nurses who work in these wards should understand more
about the concept of suicide prevention and suicide risk assessment. Therefore the
study will include all clinical nurses in these wards as the target population. The
sample size is calculated based on the suggestion in the literature, and the
investigators set the significant level data, α = 0.05, power = 0.80. Then the
investigators divide all study subjects into experimental group and control group
randomly, and use different interventions to examine the effect of research.
2. Pilot study
The investigators design focus group courses (three times) for clinical nurses to
understand their opinions and needs about the teaching materials of suicide risk
identification and assessment. Also, the investigators examine the possibility of
adding the interactive discussion group which suggested by group discussion. The
investigators choose 6-8 nurses each time out of the study samples randomly and
excluded who had already joined the focus group before. Location of the focus group is
on the independent discussion room in hospital. Meanwhile, nurses who joined focus
group will also be excluded in the later study samples (neither the experimental group
nor the control group).
3. The baseline measurement
The experimental group and control group will both be administered the baseline
measurement including the ability of suicide risk identification, attitude and
recognition toward suicide behavior, and the ability of suicide risk assessment (the
investigators use a case vignette and the SAD PERSONS check list). The goal of baseline
measurement is to evaluate the difference of demographic characteristics and
perceptions and attitude toward suicidal behaviour between the two research groups
before the intervention.
4. The outcome measure
The investigators will use the score of SAD PERSONS-check list as the outcome measure in
assessing the effect of our intervention. The reason of using this check list is because it
is a simple and convenient tool to screen suicide risk in clinical settings, and researches
have proofed its reliability and validity.
Statistical analysis
All statistic analysis of this research are based on the Intent-to-treat method, which
follow up participants who cannot finish the whole study process (i.e. drop out from the
study). The investigators still ask them to do the outcome measurement. All the data will be
count into the original groups to do further analysis in order to get a conservative
conclusion. Researchers will key-in the data the investigators will use SPSS 16.0 to do the
statistical analysis. The significant level will be set at 0.05. Main variables and methods
for analysis are listed below:
Independent variables
1. Demographic information: Basic demographic variable such as age, sex, marriage status,
nursing practice years (continuous variable); categorical variables such as nursing
levels recognized in the study hospital, working experience in psychiatric related
field, caring experience of suicidal persons of their acquaintances (friends, colleague
or neighbors) or patient who committed suicide or self-harm behavior before, training
experiences related to suicide prevention in the past year.
2. Variables in the baseline measurement: Attitude and cognition toward suicide
(continuous variable), the ability of suicide risk identification and assessment
(category variables), and SAD PERSONS-the check list of suicide risk (continuous
variable).
Outcome variables The ability to identify and evaluate the suicide risk, SAD PERSONS-the
check list of suicide risk (continuous variable), and case analysis 1(category variable)
Baseline comparison To make sure there is no difference at first among participants in this
research, the investigators will compare the characteristics and basic ability of suicide
risk. Independent t-test is used to deal with continuous variables, and Chi-square test is
used for category variables. However, whether there is significant difference or not, the
investigators will further analyze their suicide identification and assessment ability in
multivariate analysis.
Further analysis The investigators will compare the change in scores of the outcome, the
scale of "SAD PERSONS", as the continuous variables before and after the interventions. The
investigators will also analyze the frequency and associations of the items in baseline
measurement including the participants' working site, age, sex, education, duration of
nursing practice, trainings of suicide risk assessment, caring experience of suicide or
self-harm cases.
D. Predictable Difficulties and Solutions
1. Attendance and Participation of the interactive discussion group in Nurses According to
the different shifts of clinical nurses, before the investigators arrange the schedule
of interactive discussion group, the investigators will completely communicate with
chief manager of different department and get the support of hospital administration to
make sure that the investigators have an appropriate time for every member in the
group. Also, researcher will remind of every member one by one to elevate the
attendance and participation. Furthermore, all the time nurses spend on this training
will be count into the in-service education time to arouse enforce the motivation.
Besides, researcher will provide the research fee to every participant to promote the
participation interest.
2. Missing data in the questionnaire To prevent the missing data, the researchers will
join every discussion activity to examine if there is any problem for nurses to fill
out the questionnaire, and keyin the data individually to ensure its correctness.
Moreover, the research assistant will key in the data twice under surveilance of the
principle investigator during the whole procedure.
