Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05487482 |
| Other study ID # |
Safety Culture on Elderly Home |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 20, 2021 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Gadjah Mada University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: The elderly are a vulnerable group for health problems as they age. Safe care is
essential when caring for the elderly at home because adverse events can happen there, such
as falls, pressure ulcers, injuries, or dangers caused by medication errors. Safety culture
for the elderly at home needs to be developed so that they can avoid unexpected events. This
study aimed to develop the model for safety culture among the elderly called Aging Safe from
the Risk (ASRi) to improve the safety culture in elderly care at home.
Methods: This exploratory sequential mixed methods study will consist of three stages. Stage
1, a qualitative descriptive study, will be conducted to explore the perceptions of families,
nurses, and school administrators for the elderly regarding the safety of the elderly at
home. Data will be collected by interviews and focus group discussions. Stage II will involve
developing The ASRi model using the modified Delphi method. The list of elderly safety
culture indicators will be assessed by experts and then further developed into a model. In
stage III, a model test will be conducted with a non-equivalent control group using a
quasi-experimental design. The investigators will provide interventions in the form of
education and training to families regarding the safety culture for the elderly at home.
Findings: There is a crucial need for studies assessing the safety culture in elderly care by
empowering families at home to improve safety for the elderly. The results of this study will
help fill the knowledge gap in this research and can aid in developing public health policy
and programs for the elderly.
.
Description:
This study aims to obtain a model of elderly safety culture by involving families in
self-care at home to increase perceptions of safety culture and reduce adverse events at
home. The specific aims are:
1. Exploring the perceptions of families, healthcare providers, and elderly school
administrators regarding the safety of the elderly at home;
2. Develop the Ageing Safe from the Risk (ASRi) model of safety culture; and
3. Conducting trials of applying the ASRi model to improve the perception of the elderly
safety culture and reduce adverse events at home.
This protocol have been approval from the Medical and Health Research Ethics Committee of the
Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada-Dr. Sardjito General
Hospital with the number KE/FK/0632/EC/2021 on the date in 10 June 2021.
Study design This exploratory sequential mixed methods will include three stages, and the
quantitative design will be the most dominant in this research. Setting This study will be
conducted in Bandung, the capital city of West Java, Indonesia. Bandung has 30 subdistricts,
and there are 4 subdistricts that have elderly schools. Elderly schools in Bandung have 275
members and are managed by Elderly Friends. The elderly school model was established in 2019
developed by Indonesia Ramah Lansia (IRL) West Java. Activities at the Bandung Elderly School
include education about elderly health concerns and home visits by Elderly Friends to monitor
the health of the elderly at home.
Study stages and data collection Stage I (Qualitative Study) In the first stage, the
descriptive exploratory will be used to explore the perceptions of families, the elderly,
healthcare providers, and school administrators regarding the safety of the elderly at home.
Data collection will be conducted with in-depth interviews with the elderly and families and
focus group discussions (FGD) among the healthcare providers and elderly school managers
In-depth interviews will be conducted to obtain complete information about perceptions of
families and elderly about their safety, especially in four dimensions: the personal
dimensions including family values/beliefs about the safety of the elderly, understanding,
attitudes and family motivations towards the safety of the elderly; behavioral dimensions
including communication patterns, cooperation, family stress and burden; and environmental
dimensions including family efforts in creating a safe environment for the elderly. The
interview guides (shown in Appendix 1) which contain open-ended questions and probes to
explore the perceptions about safety in elderly care will be tested in pilot study. To
increase credibility, researchers will use data triangulation by also observing the
conditions of the elderly home. Furthermore, will also conduct interviews about the hopes and
needs of families related to the safety of the elderly at home. Data collection also will be
done among the elderly to obtain information about the experiences related to safety and
security and their expectations regarding their safety at home.
Interviews will be conducted face-to-face at participants' homes. Each in-depth interview and
FGD will take between 60-90 minutes. In-depth interviews will be terminated when there is no
additional information needed anymore (data saturation). In this pandemic period, the
invesitagors will apply health protocols when conducting interviews, by using masks,
maintaining safe distance, and ensuring the conditions of researchers and participants are in
good health. The FGDs will be conducted in two groups: with healthcare providers and with
administrators of elderly schools in four sub-district areas. FGDs will be held by the
agreements of the participants, whether offline or online.
Before the interviews, participants will provide their sociodemographic and related
information such as age, education, occupation and race. Information about this research will
be explained to all participants before they are required to sign an informed consent form.
All interviews will be conducted in Indonesian or Sundanese language and audio-recorded. All
data in Sundanese language will be translated into Indonesian.
Stage 2 (Quantitative Study) In the second stage, the investigators will conduct Delphi
methods with some modification (30) to find out indicator drafts that can be used to develop
the ASRi Model. Modifications from the implementation of Delphi will be in stage 1 when
researchers directly provide a list of indicators based on the results of the phase 1 study.
In addition, in stage two the panel discussions will be conducted online or offline depending
on the willingness of the experts. The Delphi methods modification will be done in two
rounds. In the first round of Delphi, the investigators will compile a list of statement
items that are indicators of the elderly safety culture at home based on the results of the
first stage. Informed consent will be obtained from all participants at the first round. The
investigators will contact the experts individually by phone or email to explain the purpose
of research and implementation of Delphi. Then, the experts will be asked to provide an
assessment of indicators in the safety culture of the elderly at home. The investigators will
allocate two weeks for Delphi experts to respond in the first round. Reminders will be sent
to participants one week before each round begins in order to maximize their participation.
Then, we will process and refine the findings according to the assessment of the Delphi first
round.
Next, the Delphi second round will do by conducting expert panel discussions. The
investigators will invite experts for discussions regarding the results of the first round of
Delphi. Discussions will be conducted both online and offline (hybrid). All indicators
resulting from the first round will be discussed in this expert panel. The results of the
second round of Delphi will be developed into the ASRi model of safety culture in the
elderly.
Stage 3 (Quantitative Study) The third stage, testing the model will be done by conducting a
quasi-experimental study with a non-equivalent control group using a pre-posttest design. The
intervention "Ageing Safe from the Risk" (ASRi) will consist of about 16 weeks. First, the
investigators will conduct training of trainers to nurses and elderly friends. They will be
given modules. At this stage, the investigators will also prepare for the control groups and
intervention groups. Selection of control and intervention groups based on geographical
locations.
Two research assistants, with minimum education of bachelor nursing, will conduct a survey
for pre-test measurements and make home visits in each groups. Previously, the investigators
will explain about filling out the questionnaire to the research assistants.
For the intervention groups, planning will be done to provide education and training.
Families will be given modules on Safety Culture in the Elderly. Materials provided about the
safety of the elderly include changes in the elderly, the concept of safety in the elderly,
the type of danger to the elderly, how to prevent harm in the elderly, the first handling in
case of accidents, and the role of the family in the efforts of elderly safety. The material
will be delivered by experts in elderly health and patient safety (professionals from health
centers, social services, and academics). In addition to education and training, families
will also receive home visits to check and monitoring the condition of the elderly at home
related to adverse events and the home environment. Measuring will be done every 2 weeks by
using a monitoring book.
In the control groups, activities as usual will be carried out by the elderly friends. After
16 weeks, researchers will evaluate perceptions of the elderly's safety culture at home and
adverse events at home.
STUDY POPULATION Participants Stage I (Qualitative study) The qualitative study aims to
explore the perceptions of family, elderly, healthcare providers, and administrators of
elderly schools about safety in the elderly. This study will conduct individual interviews
for family and the elderly, and FGD for healthcare providers and administrators of elderly
schools.
This study will include the elderly and their families who are members of the elderly schools
in Bandung, healthcare providers from the Public Health Centers, and administrators of
elderly schools in Bandung. The sampling technique will use purposive sampling and maximum
variation. Inclusion criteria for elderly are: living with family; level of independence are
independent, mild and moderate based on Barthel Index [31], no impaired cognitive function,
and communication.
Inclusion criteria for the family are: family members who live with the elderly and age at
least 18 years old or more. Inclusion criteria for healthcare providers are: minimum
education background of diploma with one year of work experience in caring for elderly.
Inclusion criteria for elderly school administrators are: manager of The Indonesia Ramah
Lansia (IRL) West Java who manages elderly schools in Bandung, and administrators of elderly
schools and active in managing elderly schools. There are four elderly schools in Bandung,
and each elderly school will involve two administrators.
Stage II (Quantitative study with Delphi method) Purpose of study is to develop the Ageing
Safe from the Risk (ASRi) model of safety culture. The subjects in this stage II study are
experts in elderly nursing, family nursing, patient safety, and stakeholders related to
elderly health programs. Criteria of experts in this study are: geriatric doctors with
experience caring for elderly at home; healthcare providers in elderly programs; elderly
school managers; managers of IRL West Java; lecturers in family nursing, gerontics and
patient safety; families who have experience caring for the elderly, and stakeholders from
social services and National Population and Family Planning Board.
Stage III (Quantitative study) The purpose of the study is to test the ASRi model in
improving perceptions of safety culture and decreasing adverse events in the elderly at home.
At this stage of the study, the population is the elderly and family members of the Bandung
City Elderly School in 2020. The sample in this study are the elderly and families who are
members of elderly schools in Bandung. Purposive sampling will be used to recruit the
samples. Inclusion criteria for the elderly are: living with family; have a history of
adverse events over the past one year such as falls, pressure ulcers, injuries, and problems
due to treatment; can communicate effectively, and have a level of dependence: independent,
mild, and moderate. Inclusion criteria for family are: taking care of the elderly directly,
can communicate effectively, and have a minimum age of 18 years. Withdrawal criteria: family
did not continue the study, elderly were hospitalized, and died during the study.
Sampling methods and sample size Stage I (Qualitative study) The sampling technique will use
purposive sampling. The investigators (AHS) will recruit participants for individual
interviewing in subdistrict Central Antapani, Sukajadi, Ujung Berung and Cinambo based on the
inclusion criteria. First, investigators will contact the Elderly Friends in each elderly
school to recruit for the participants. Then, the investigaot will contact the participants
and make an appointment. The number of participants suggested in qualitative studies is 4-10
participants for individual interviews. The number of participants will depend on the
saturation of data to be agreed upon by the team.
Meanwhile, the participants for FGDs will be recruited based on inclusion criteria. The
investigators will divide the two groups, namely the group of healthcare providers and
elderly school managers. For the healthcare providers group, investigators will visit four
Public Health Centers, then contact the nurses and managers in the elderly programs.
Meanwhile, for the elderly school administrators, the investigators will contact them by
WhatsApp chat group and make appointments. Each group consists of 4-12 participants.
Stage II (Quantitative study: Delphi methods modified) The sampling technique will use
purposive sampling based on inclusion criteria. There are no standards regarding the sample
size in Delphi studies. The sample size varies in many studies from 4 to 171 experts. A
minimum of 20 experts will be recruited to this Delphi study. Experts will be invited to
participate by the research team. They will be invited by email with a formal invitation to
become a part of the panel.
Stage III (Quantitative study: Quasi experiment) The sampling technique will use purposive
sampling. The sample count will be calculated based on previous studies, with the proportion
of adverse events in the control group as 31.43% and the intervention group as 53.33%. Based
on the proportions of previous studies, the researchers will calculate the number of samples
needed. Researchers will use a sample calculator, Sample Size Version 2.0, from the World
Health Organization (WHO) with Zα= 1,96 and Zβ = 0,84 and obtain 62 results for each group.
In anticipation of the possibility of respondents dropping out, 10% of the sample number to
62 + 10% = 68 family members. Furthermore, the researchers will divide the control and
intervention groups based on geographical locations so they are far apart from each other.
The control group and the intervention will not be allowed to have communication. The control
group is an elderly school in Ujung Berung and Cinambo sub-district, and the intervention
group is in Central Antapani and Sukajadi sub-districts.
Data analysis Stage I (Qualitative) The investigators will analyze the data with content
analysis guided by the total safety culture model. The investigators will read each
transcript and then determine the coding. Coding will be done by AHS and discussed with the
coauthor CE. Codes will be applied to raw data, and then grouped into categories to generate
themes. Consensus concerning the codes and themes among at least three investigators (AHS, CE
and PS) needs to be reached. Peer debriefing will be used to increase the credibility and the
reliability of the data. Confirmability will be enhanced by keeping an audit trail of the
documents.
Stage II (Quantitative study with Delphi method) Advance validity tests are conducted through
readability tests by experts based on the ratings given by experts. In the first round of
Delphi, the experts will be given a list of indicators that shape the dimensions of elderly
safety culture at home. The investigators will provide the essential indicators that are
developed for the model. Researchers will include a questionnaire to assess them by giving a
score of 1-9. A score of 1-3 means it does not matter, 4-6 means less important, and 7-9
means very important. This scoring will be done individually where the researchers will meet
the experts and explain the purpose of the study and provide a list of statements of
indicators of elderly safety culture. The experts can revise or add to the indicator by
filling in the response columns.
After obtaining the results of the first round Delphi, it will be continued with Delphi's
second round. Items which do not achieve consensus in Round 1, with items that need to be
revised and additional items will be discussed in Round 2.
The investigators will use median, minimum and maximum scores to analyze the data and will be
reported to panel members as feedback after each round. The assessment of Delphi Round 1 and
Round 2 will indicate if the item scored <7 it is considered not valid and > 7 the item is
valid.
Stage III (Quantitative) Data analysis will be conducted with univariate, bivariate and
multivariate analyses. The investigators will also perform normality and homogeneity tests
before determining parametric or non-parametric statistical tests. Tests of normality and
homogeneity are conducted to determine the equivalence between intervention and control
groups. Homogeneity tests will be performed by the Levene test. When the p-value is more
significant than alpha, the intervention and control groups can be inferred as equivalent or
homogeneous. The normality test will use Kolmogorov Smirnov tests.
Data security All individual data will be kept in privacy and all members of team will be
assured to data secrecy. The data collected from all work study will be anonymized and kept
in accordance with the appropriate data protection guidelines.
Outcomes Stage I (Qualitative) The outcome of qualitative research will describe the themes
about the safety in elderly related to the culture of safety in the elderly at home. The
emerging themes will be adapted to the theory of Total Safety Culture which consists of three
dimensions, including the personal, behavior and environmental dimensions.
Stage II (Quantitative) Based on the results of stage I, and the literature review, the
investigators will formulate potential indicators to rate by the experts using the Delphi
methods in stage II. The results of stage II, will be stated as indicators of elderly safety
cultures. The list of indicators then will be organized into models.
Stage III (Quantitative study) The assessment of the culture of the safety of the elderly at
home was developed from the results of a literature study on the instrumented assessment of
safety culture. Based on the results of the study, there is no instrument that assesses the
culture of elderly safety in the family, so we will make some modifications to the Nursing
Home Survey of Patient Safety Culture (NHSOPSC) issued by AHRQ . The NHSOPSC consists of 42
questions plus two outcome questions, using answers in the form of Likert scales ranging from
strongly agree, agree, neither agree or disagree, disagree, and strongly disagree. All items
with positive statements are given a score of 5 (Strongly agree), 4 (agree), 3 (neither agree
or disagree), 2 (disagree) and 1 (strongly disagree). Negative statements are scored as
follows: If there is an answer they do not know, then it is considered missing (not answered)
and will not be counted. Furthermore, the percentage score of 1-2 will be combined into a
negative response, a score of 3 is neutral and a score of 4-5 is a positive response. Each
dimension of the safety culture will be calculated on the average of the percentage of each
item in that dimension and only calculated for a positive response.
Adverse events will be measured by the type and frequency (no events, 1-2 events, >3 events)
experienced by the elderly at home before and after the model trial. Sociodemographic
information will be collected in the baseline assessment, including age, sex, educational
level, occupational, and relation with elderly.
Data management plans Interviews will be recorded, and all data will be transcribed verbatim
and managed using Opencode software 4.03 version. Data in the Sundanese language will be
translated into Bahasa Indonesian. Data will be entered into data collection sheets and
confidentially stored in ongoing computer database. For quantitative data, th einvestigators
will use SPSS release 22 (IBM Corp., Armonk, NY) administered by UGM. For qualitative study,
the investigators will report the study by Consolidated Criteria for Reporting Qualitative
Studies (COREQ) and the quantitative study will be reported by Strengthening the Reporting of
Observational Studies in Epidemiology (STROBE). For mixed methods study, the investigators
will reported by Good Reporting of a Mixed Methods Study (GRAMMS) .
Ethical considerations Investigators will inform respondents either verbally and in writing
about the objectives, methods, procedures and measurements during the study. They will also
be informed about ethical issues such as confidentiality, their right to ask any questions
during the study, and their right to withdraw at any time without consequence. To confirm
that all respondents have received appropriate information about the study and have agreed to
participate, all participants will be asked to sign a written consent form. This research
will be conducted using the approval from the Medical and Health Research Ethics Committee of
the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada with the number
KE/FK/0632/EC/2021.
