Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05421143 |
| Other study ID # |
2536702 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 29, 2022 |
| Est. completion date |
April 2027 |
Study information
| Verified date |
May 2024 |
| Source |
Oslo University College |
| Contact |
Malin O Syversen, Msc |
| Phone |
+4748126091 |
| Email |
m.o.syversen[@]farmasi.uio.no |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Multiple long term conditions entails various needs for complex medication treatment, which
is a huge clinical challenge considering medication interactions and disease-medication
interactions. It might affect quality of life, increase medical costs and needs, and cause
patients to live several years with disabilities and reduced functional level. Multiple long
term conditions is an important public health problem, since it is increasingly more common
as the population is getting older.
It is well documented that communication problems exist between sectors in the healthcare
system and that it creates an area of risk. There are many transfers that could be associated
with risk for errors, as when patients are discharged from the hospital and is being
transferred to the next level of care. When patients are discharged from the hospital, there
is a need for transfer of correct information regarding medications. Transition of care leads
to risk for medication discrepancies for the patients. Medication discrepancies are common
within primary care and studies show that up to 90% of patients have at least one medication
discrepancy in their lists. Different interventions have been tested to reduce medication
discrepancies, but the interventions do not eliminate the need for medication
reconciliations.
Higher patient satisfaction have been associated with improved patient safety, clinical
effectiveness, health outcomes, adherence and lower resource utilization. According to
Norwegian legislation, patients or users have a right to participate in the implementation of
healthcare services, e.g. the choice between available and justifiable forms of service,
examination methods and treatment methods. Person-centered care (PCC) is a concept that
shifts the focus away from the traditional biomedical model to personal choice by applying
shared decision-making. PCC reduce symptom burden, enhance patient activation, reduce
readmission rates and improve quality of life.
Obtaining knowledge about medication discrepancies and perceptions from patients, next of kin
and healthcare personnel (HCP) after the patient's hospital discharge could contribute to a
better success rate for future interventions and services. It is therefore of interest to
investigate which factors that are of importance for a successful seamless person-centered
intervention to optimize medication use across healthcare levels. To obtain knowledge about
medication discrepancies and perceptions, the study will include both quantitative and
qualitative methods, and be using a design thinking framework. The persons included will
represent a wide selection with respect to, among other things, age, gender, socio-economic
background, profession and diagnoses. The patients, next of kin and HCP will be included
after written, informed consent.
The aim of the project is to obtain knowledge about how the investigators can strengthen
patient's self-efficacy and improve the information flow when it comes to medications, in the
transition between the healthcare levels. To do so, the investigators need to identify
facilitators and barriers to achieve a seamless medication treatment based on the user's
needs. The results will form a basis for a new, improved intervention, which follow patients
during the hospital stay and further out in the primary healthcare. The aim of this project
is divided into the following parts:
- Investigate the frequency and type of medication discrepancies between the medication
list in the discharge summary and medication use after hospital stay, to identify risk
factors for which and why medication discrepancies occur in patients with multiple long
term conditions.
- Map the perceptions of patients with multiple long term conditions and next of kin
regarding medication use, shared decision-making and their opinions about previously
published interventions to improve medication use.
- Evaluate HCP's perceptions regarding elements in patients with multiple long term
conditions care that works well, what HCP believe do not work, with particular emphasis
on the treatment with medications and transfer of care. In addition, how this care could
be improved especially with the new intervention in mind.
- Using design thinking framework to create prototypes for a new intervention
Overall hypothesis for the project: Knowledge about medication discrepancies and perceptions
from patients, next of kin and HCP regarding barriers and facilitators for a seamless
medication treatment can contribute to an improved efficacy and implementation of the new,
improved intervention.
Description:
Our research group has previously completed the OPERA- and PERLE-studies, which explore the
effect of a pharmacist intervention at the hospital and medication communication at hospital
discharge from the patient perspective including the discharge process, respectively. The
results from the PERLE-study gives a wider understanding of the discharge process and how
patients experience medication communication at discharge. The results showed that every
patient experienced a unique discharge process and that communication between healthcare
personnel and patients was not sufficiently fostering patient empowerment and self-efficacy.
The OPERA-study found no significant effect of the in hospital intervention on time to
readmission or death within 12 months, but found a statistically significantly increased
overall survival. The intervention in the OPERA-study consisted of clinical pharmacist added
to the multidisciplinary treatment team working systematically according to the "Integrated
Medicines Management" (IMM). IMM was originally developed in Northern Ireland and refined in
Sweden. It is of importance to note that the model was used as without adaption to the
Norwegian context and taking into account the traditional role for clinical pharmacists in
Norwegian hospitals. This is especially related to the discharge process in which pharmacist
would not normally be included.
Even though the OPERA-study showed statistically significant increased overall survival, is
it desirable with a new intervention that fits better to the Norwegian context. Furthermore,
a study suggest that medication reconciliation, medication review and post-discharge
interventions should be performed all together as an integrated part of a multi-faceted
program for better outcomes, and not isolated. This leads to a demand for a new intervention
that extend beyond the hospital stay to achieve a seamless person-centered intervention to
optimize medication use across healthcare levels. In designing the new intervention, the
investigators need to obtain more knowledge about how to inform intervention development,
study design and planning with respect to the user's needs. This is important since it is
shown that patients are effective and willing contributors by supporting their own medication
safety at transfers in the healthcare system. When developing a complex intervention, it is
important to identify facilitators and barriers, e.g. to ensure that HCP involved in its
delivery find it suitable and not in conflict with their daily tasks.
This study will use a design thinking framework based on the Three I's developed by IDEO:
Inspiration, Ideation and Implementation. Inspiration focuses on learning how to better
understand people to create possibilities, ideation focuses on making sense of that the
investigators have heard to identify opportunities for design and generate ideas, and
implementation focuses on bringing the investigators solutions to life to maximize its
impact. This framework is a field guide to human-centered design as a way to apply design
techniques to social service and innovation sectors, such as healthcare. This study will
focus on the two first I's, namely the inspiration and ideation phase, whereas the third I,
the implementation phase, will be covered in future projects.
The inspiration phase will comprise the following methods:
- Literature search to identify previously published models which might be suitable
- A quantitative part that assesses the number and type of medication discrepancies after
hospital discharge by medication reconciliation
- A qualitative part in the form of semi-structured interviews and field notes including
patients, next of kin and HCP
The investigators will focus on learning how to better understand people, and will use some
of the aspects from the methodology of ethnography (38). Ethnographic research focuses on the
social aspect of the research object. Ethnography is a multidimensional research approach
covering a range of qualitative methods, including interviews and observations. Gathering
ethnographic data is often termed doing fieldwork, with the field referring to the specific
sites or locations where the data collection takes places. Using an ethnographic approach to
understand aspect of medication use after newly being discharged could provide new, important
insights to the field, both in theory development and to inform applied research projects.
The ideation phase will comprise the following methods:
The investigators will create personas and scenarios using the baseline understanding
gathered from the inspiration phase. The created personas and scenarios will be further
explored through workshops for prototyping. The workshops will aim to include relevant
stakeholders, e.g. end users, comprising patients, next of kin and healthcare professionals
(e.g. nurses, doctors and pharmacists), researchers and designers, together to work
collectively during the prototyping.
The ideation phase will lead into the implementation phase for further planning of the future
intervention.
Inspiration phase:
Literature search Before the inclusion starts, the investigators will perform a literature
search through relevant research in PubMed and Medline, using search terms such as
"patient-centered care", "person-centered care", "decision-making", "health communication",
"self-efficacy", "medication management", "medication instructions", "patient participation",
"patient preference", "patient transfer", "personal health records", "patient's drug list"
and "electronic patient record". This to identify previously published models for an
intervention.
Recruitment of study participants:
Participants to the quantitative and qualitative parts will be recruited simultaneously.
Patients admitted to the Internal medicines ward and Geriatric ward, Oslo University Hospital
(OUS), Ullevål, and a selection of their HCP and (if applicable) next of kin, will be
included. Employees at the wards will ask inpatients for permission for one of the data
collectors to inform and ask about participation in the study. This will take place close to
the patients discharge (1-3 days ahead). Participants will be enrolled at the hospital, after
written, informed consent. Consent from patients and next of kin will be obtained for
medication reconciliation and interviews by use of one consent form. Consent will be obtained
from HCP after their patient's enrollment in the study.
The data collection will take place face to face in the patient's home, HCP offices or other
suitable location (e.g. meeting room at the hospital), approximately 1-2 weeks after the
patients hospital discharge. A pilot study will be carried out during the spring 2022. The
inclusion of patients, next of kin and HCP to the main study will start in the autumn 2022
and continue until the different parts have reach their goal, and for the qualitative parts;
also have enough information power. The goal is to include patients, next of kin and HCP in
the period from August 2022-July 2024. To further enrich the data, some patients might be
selected for additional follow up interviews, after additional 3-4 weeks.
Number of persons to be included:
Quantitative study with medication reconciliation: The data collection will continue
consecutively until the goal of 150 patients is reached. If it is feasible, the investigators
will try to reach 200 patients. The investigators think 150-200 patients will give good
insight into different types of medication discrepancies, since studies have shown that up to
90% of patients have at least one medication discrepancy in primary care. The inclusion and
medication reconciliation will be done by the PhD-student together with master students in
pharmacy.
Qualitative semi-structured interviews with patients and next of kin: The data collection
will continue until the study have enough information power. This means that a selection of
patients from the quantitative study described above will be chosen purposively and step by
step along the way to ensure the informational strength in the selection. When possible, the
investigators will include next of kin in the interviews together with the patient. The
investigators aim to include around 20-30 patients, without counting in next of kin. For the
follow-up interviews, approximately 5-8 patients will be selected. The part will be
accomplished together with the quantitative part. Every new interview will be compared with
previous interviews to identify similarities and differences. Characteristics it is important
to ensure variability for; women and men, different ethnicities, education type, spread in
age, number of medications and help from next of kin/homecare nurses or not. It is also
important to ensure variability in number and type of medications and diagnoses. The
inclusion and interviews of patients will be done by the PhD-student and master students in
pharmacy.
Qualitative semi-structured interviews with HCP: The data collection will continue until the
study have enough information power. This means that HCP will be recruited purposively along
the quantitative study to ensure the informational strength in the selection. The
investigators aim to include around 15-20 HCP. The HCP recruited are involved in the patients
medication regime or management, this to ensure that HCP have knowledge about patients with
multiple long term conditions. Every new interview will be compared with previous interviews
to identify similarities and differences. Characteristics it is important to ensure
variability for; woman and men, physicians and homecare nurses, spread in age, years of
working experience, different ethnicities and number of medications the patients the HCP care
for use. The inclusion and interviews of HCP will be done by the PhD-student.
Training and piloting:
Medication reconciliation and interviews will be done by the PhD-student and master students
in pharmacy after receiving adequate training of clinical work. Training in medication
reconciliation will be performed in accordance with procedures from the Hospital Pharmacies
Enterprise, South-Eastern Norway, by an experienced clinical pharmacist. The procedure is
based on the IMM-model for clinical pharmacists.
Both the PhD-student and master students will receive training and supervision in
interviewing methodology from a researcher in the project group with strong competence in
qualitative methods. During the spring 2022, the PhD-student will complete a course in
qualitative research methods at the University of Oslo (UiO). The master students will
complete relevant research preparatory courses during spring 2022.
The study procedures and documents will be piloted to obtain input to their finalization,
e.g. the interview guide, and the practicability of the data collection tools. Inclusion of
patients to the pilot will continue until sufficient feedback has been obtained. The
inclusion to the pilot will follow the study criteria, as described above. If only minimal or
no changes to the documents are deemed necessary, persons included to the pilot might be
included in the study population described above. The pilot for all parts will start at the
same time, and be finished when all details are in order. The PhD-student will have
assistance from the research group for detailed design of the study during the pilot, and
assistance as needed during the study. Consent to participate in the pilot study will be
obtained as described above.
Instruments Quantitative study with medication reconciliation: The medication reconciliation
will describe medication discrepancies between the medication list in the discharge summary
and the actual medication use after hospital discharge. The medication discrepancies will be
explored in conversation with the patient or, if the patient agrees to this, next of kin or
other relevant information sources such as the GP or home-care nurse, to figure out why
medication discrepancies have occurred. This could for example be changes done by the GP
after hospital discharge. The medication reconciliation form from Hospital Pharmacies
Enterprise, South-Eastern Norway (attached) will be used to do this task in accordance to
their procedure for performing this (attached). The data will be analyzed consecutively to
ensure that all details is included. A digital tool has been developed for the data
collection in this study (attached).
Qualitative semi-structured interviews with patients and, if present, next of kin: The
interviews will focus on patients and next of kin perceptions regarding medication use,
shared decision-making when it comes to medications and their opinions about previously
published interventions. Open questions will primarily be used in the interviews adjusted to
each individual patient to explore different patient perspectives. The interview guide will
be divided into themes and contain some predefined overarching questions with examples of
possible probing questions. Furthermore, field notes will be taken to describe the setting,
issues observed with relevance to the administration of medications, persons present and time
consumption for the interviews. The interviews with patients and next of kin will focus on
the following:
- How patients experience being a medication user, what patients think work and what
patients think do not work. If something could be done to make medication use a more
pleasant (rather than coercive) experience
- How patients use and assesses the utility value of digital solutions
- Experienced factors of PCC during the hospital stay, at discharge and after discharge,
with a view to medication treatment
- Their opinions about previously published interventions with examples The interviews
will be audiotaped, when the patients and (if present) next of kin agrees to this. If
the patient does not consent to recording, notes will be taken. The interviewers will
transcribe consecutively to prevent memory-bias, and to ensure that all details and own
reflections comes with. The interviewers will read each other's transcripts and meet
regularly to ensure the quality of the interviews. Follow-up interviews will be informal
in nature, with no specific pre-defined interview guide.
Qualitative semi-structured interviews with HCP:
The interviews will focus on HCP's perceptions regarding factors, barriers and facilitators
in the care for patients with multiple long term conditions with importance for a new,
improved intervention. Open questions will primarily be used in the interviews adjusted to
each individual HCP to explore different perspectives. The interview guide will be divided
into themes and contain some predefined overarching questions with examples of possible
probing questions. Furthermore, field notes will be taken to describe the setting and time
consumption for the interviews.
The interviews with HCP will focus on the following:
- Factors in patients with multiple long term conditions medication treatment important
for the patient's self-efficacy as a user of medicines and for their quality of life,
both in a negative and positive direction, e.g. experience with patient empowerment and
PCC
- How the system could improve with focus on digital solutions
- Their opinions about previously published interventions with examples The interviews
will be audiotaped, when the HCP agrees to this. If the HCP does not consent, notes will
be taken. The PhD-student will transcribe consecutively to prevent memory-bias (42), and
to ensure that all details and own reflections comes with. The PhD-student will get help
from the research group to read the transcripts and meet regularly to brief and discuss
to ensure the quality of the interviews.
The main study for all parts will start at the same time, but the qualitative studies could
be finished earlier if the investigators reach the goal of patients or HCP earlier than the
goal in the quantitative study.
Data and measurement variables:
Demographic data and measurement variables will be retrieved from electronic patient record
or directly from the patients and next of kin. Following data will be registered as part of
inclusion about patients:
- Age
- Gender
- District in Oslo
- Profession
- Country of origin (if not Norwegian)
- Reason for admission
- Date for admission at the ward
- Multidose before admission (yes/no)
- Acute or elective admission
- Education level
- Cognitive function (if separate form has been filled in at the wards)
- Frailty scale (if separate form has been filled in at the wards)
- Assistance with medication administration before admission (manage themselves, manage
themselves with help from next of kin or manage themselves with help from homecare
nurses)
The following data will be collected as part of inclusion or interview about next of kin:
- Age
- Gender
- What kind of assistance next of kin give
- Education level
- Profession
- Relation to the patient
- How long next of kin have assisted the patient
The following data will be collected as part of inclusion or interview about HCP:
- Profession
- Age
- Gender
- Country of origin (if not Norwegian)
- Education level
- Years of working experience
- Years of working experience with patients with multiple long term conditions For
patients, next of kin or HCP who do not consent to participate in the study, gender,
age, role (patient, next of kin, HCP) and reason for refusal will be registered.
The following data will be collected consecutively after inclusion or at discharge for the
patients:
- Type of ward the patient are discharged from
- Patients discharge summary
- Date of discharge
- Discharged to which care-level
- Medication list in the discharge summary: number of medications, ATC-code (level 5),
medication name, dosage, formulation, regular/on demand use
- Diagnoses according to International Classification of Diseases (ICD) -10: Number and
type, as described in the patients discharge summary
- Multidose after discharge (yes/no)
- Assistance with medication administration after discharge (manage themselves, manage
themselves with help from next of kin or manage themselves with help from homecare
nurses).
The following data will be collected during medication reconciliation:
- Complete medication use after discharge: In this way, the investigators will be able to
count how many patients who has medication discrepancies and how many medication
discrepancies each individual patients have. Why (if any) medication discrepancies have
occurred.
- If the patient have assistance with medication administration: How much/type of help the
patient have
- Descriptive data: Date, description of the setting, issues observed with relevance to
the administration of medications, persons present and time consumption and information
sources used during medication reconciliation.
Field work journal, field notes and other documents:
As part of the data collection process a fieldwork journal will be written by the data
collectors. Here a narrative of the research process will be written down and form a basis
for reflecting on the process and as inspiration for the data analysis. In addition, field
notes will be written e.g. include impressions from the interviews, different kinds of
observations done during the interviews, notes from the interviews. Information will also be
collected from relevant documents, e.g. procedures from hospital and primary healthcare
services.
Analyses:
Quantitative study: Medication reconciliation. Medication discrepancies revealed during
medication reconciliation will be classified quantitatively, i.e. the proportion of patients
with medication discrepancies, number of medication discrepancies per patient and type of
medication discrepancies. In addition, the medication discrepancies will be categorized
according to reasons why medication discrepancies have occurred.
Qualitative interviews and fieldwork. During the whole data collection process, field notes
and fieldwork journal will be written by the data collectors. The interviews will be
audiotaped, and will then be transcribed word for word. The interviews together with the
field notes and journal will be analyzed inductively with inspiration from "content analysis"
and/or systematic text condensation. The interviewers cooperate in the analyses to ensure
quality, which means that the context is understood. Here also the field notes will be
important in assuring reflectiveness of the process. Furthermore, the analyzes will focus on
creating personas and scenarios for the ideation phase according to the design-thinking
framework.
Ideation phase:
Workshops will be held with between six to eight participants comprising patients, next of
kin, HCP (e.g. nurses, doctors and pharmacists), researchers and designers. Each workshop
group will be assigned a scenario/personas and asked to conduct early prototyping. The
prototyping will focus on supporting self-efficacy and transfer of medication information in
the scenario. The output from the workshops together with the results of the inspiration
phase, will be used by the research group to create models for the intervention. The created
models for the intervention will be sent out by e-mail to previous participants in the
inspiration- and ideation phases who are willing to contribute, for review and feedback.
Ethics The hypothesis of the project is that knowledge about medication discrepancies and
perceptions from patients, next of kin and HCP after discharge can contribute to a better
success rate for the new and improved intervention (29). Before the participants are included
in the study, the participants will receive written information about the project and can
decide for themselves whether they want to participate or not. It has been taken into account
that some patients might refuse to participate, as the patients might not want to be visited
by the study pharmacists, or that some might withdraw their consent. It will be acceptable
that patients consent only to participate in the part with medication reconciliation, this
can help to achieve our goal for this part of the study. Participants will be offered a small
gift at maximum value of 100 Norwegian kroner, which is considered to small to influence
their willingness to participate.
Information transfer when changing treatment level is a well known area of risk, and there is
a need for greater focus on and knowledge about risk factors for medication discrepancies and
perceptions of both patients, next of kin and HCP. The aim of the project is to form a basis
for an improved intervention, which follows patients with multiple long term conditions
during the hospital stay and through transition to the primary healthcare. This will be done
by investigating medication discrepancies and map perceptions of patients, next of kin and
HCP which, in both a positive and negative sense, are important for achieving seamless and
person centered medication treatment, after the patients are discharged from hospital. It is
expected that the results could give increased understanding that could contribute to a more
seamless and person centered medication treatment in the future intervention and further
development and improvement of healthcare services for patients.
Pharmacy students or the PhD-student, who are not affiliated with the internal medicines or
geriatric wards on a daily basis, will perform the medication reconciliation, interviews and
writing field notes. The pharmacy students and PhD-student are not involved in or have an
overview of the overall picture and assessments behind decisions made regarding medication
treatment. The pharmacy students and PhD-student have no active role in the treatment team
and participation in the study thus does not contribute to any risk or harm for the
participants beyond the time the participants spend on the medication reconciliation,
interviews and/or workshop. No invasive procedures will be performed. If the medication
reconciliation or interviews of the patients reveal critical discrepancies in the medication
management in the patient's home, this will be passed on to the homecare nurse or GP.
Privacy and information:
The patients will be included after written, informed consent, see attachments. The same
applies for HCP and next of kin. The attending physician determines whether the patients are
competent to consent in those cases where there is doubt about this. After consent is
obtained, the patient, next of kin or HCP will be given a study number. The included
participants can at any time withdraw their consent, without having to give any justification
for this. Registered data will be deleted if consent is withdrawn, as long as the data not
yet has been included in the analysis work. Participants will receive a copy of the consent
form. The signed consent forms will be kept in a locked filing cabinet in the project
manager's office at UiO, and separate from the collected study data. The code list that
connects patient identity to study number will be stored separately and secured from other
data. The code list will be deleted no later than 10.01.2027.
All collected data will be treated confidentially and stored on the research server of UiO,
Services for sensitive data (TSD). Data from medication reconciliation will be collected
using a self-developed web form and stored directly on TSD. The interviews will be recorded
on a Dictaphone and the audio files will be uploaded to TSD, immediately after the interview
has ended. The interviews will be transcribed on TSD. The audio file will be deleted after
the interview has been analyzed. Deidentified electronic research data will be processed
using Statistical Package for the Social Sciences (SPSS) (quantitative data) or using Nvivo
(qualitative data), on TSD.
The research project is approved by the Regional Committee for Medical and Health Research
Ethics (420920/REK south-eastern C). In accordance with procedures for research at UiO,
notification is sent and approved by the Norwegian Center for Research Data (NSD) (Ref.
919319).
