Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT04814576 |
Other study ID # |
CNCMM |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 26, 2021 |
Est. completion date |
April 30, 2022 |
Study information
Verified date |
March 2021 |
Source |
FIDMAG Germanes Hospitalàries |
Contact |
Ana Ventosa Ruiz |
Phone |
662385337 |
Email |
anaventosaruiz[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
OBJECTIVES: 1. To evaluate the impact of an intervention based on collaborative nursing care
in terms of the changes produced in the recovery process, in positive mental health and in
the nurse-patient therapeutic relationship among users of mental health day hospitals. To
explore the changes produced in the recovery process of users who receive collaborative
nursing care through the co-design and implementation of group activities.
DESIGN: A sequential and transformative mixed methods design is proposed.
METHODS. The study is structured in three phases. In phase one (baseline) and phase three
(follow-up), quantitative data will be collected from patients at a mental health day
hospitals based on a two-armed, parallel-design, non-randomized trial. In phase two, two
groups will be established: an intervention group (GI) in which the intervention based on
collaborative nursing care will be carried out through the co-design and implementation of
activities through Participatory Action Research, and a control group (CG) in which the usual
care dynamics will be continued. All the users of three mental health day hospitals who agree
to participate in the study will be studied consecutively until the necessary sample size is
reached. The outcomes used to evaluate the impact of the intervention will be the stage of
the recovery process, the quality of the therapeutic relationship and the patient's level of
positive mental health.
DISCUSSION: Very few collaborative nursing care interventions have been studied and shown to
be effective in the context of the paradigm shift toward recovery in mental health nursing.
IMPACT: Understanding the changes produced in the recovery process, as well as in the quality
of the therapeutic relationship and in the maintenance and/or increase of the levels of
positive mental health of people with mental health problems, can contribute to the design
and implementation of new methodologies to offer effective and person- centered care.
Description:
1. Aims A.evaluate the impact of a collaborative nursing care intervention through the
co-design and implementation of group activities, in mental health day hospital users,
in terms of the changes produced in the state of the recovery process, in the level of
positive mental health and in the level of therapeutic relationship with the nurse.
B. explore the changes produced in the recovery process of mental health day hospital
users who receive collaborative nursing care through the co-design and implementation of
group activities.
The research hypotheses to be tested in this study are:
A. day hospital users who receive an intervention based on collaborative nursing care
through the co-design and implementation of group activities will report improved
changes in: i) recovery status, ii) level of Positive Mental Health and iii) quality of
the therapeutic relationship at the end of the intervention, than users receiving usual
care.
B. the effects of the intervention based on collaborative nursing care through the
co-design and implementation of group activities on the changes in the level of recovery
are mediated by the changes produced in the quality of the therapeutic relationship and
the changes in the positive mental health of the users.
2. Design In order to meet the main objectives, a sequential and transformative mixed
methods design is proposed through three phases. On the one hand, in phases 1 and 3, a
two-armed, parallel-design, non-randomized trial is proposed. And in phase 2, the
intervention will be carried out based on collaborative nursing care through the
co-design and implementation of group activities using the qualitative Participatory
Action Research (PAR) method.
2.1. The Participatory-Action Research In order to carry out the intervention of
co-design and implementation of activities through collaborative nursing care, PAR is a
method that provides a suitable framework for implementation and evaluation, since it is
a method that makes it possible to extract knowledge in a democratic, cooperative,
transparent and effective way, as well as to intervene in changes in people's daily
lives. It is about unveiling the complexity of problems through dialogue and
collaboration, as well as acting as a tool to promote change . The PAR process is
considered open, holistic and egalitarian, i.e. it equates the researcher with those
being researched and requires collaboration between researcher and researched . In
general, the PAR consists of four stages that follow each other in a cyclical manner.
The cycle begins in the first stage, where a situation or problem is analyzed, and then
in the second stage the elements that facilitate its resolution and those that hinder it
are identified. Once these factors have been identified, a plan of action or change is
developed and implemented. Finally, the effect of this change will be evaluated, thus
completing the cycle. All these stages should be evaluated in a reflective manner to
improve the rationality, justification and understanding of the changes that occur in
the process. In other words, in this PAR process, theory and practice are combined,
bringing theoretical constructs into reality and analyzing them simultaneously. Among
the different PAR modalities, we will use the one described by Susman and Evered where a
process of constant cycles of action research takes place, since it is the one that best
adapts to the actual practice of care in the mental health day hospital.
3. Study setting and participants The scope of the study will be three adult mental health
day hospitals in the metropolitan area of Barcelona (Spain). The three centers belong to
the same institution and are part of the public mental health network of Catalonia.
These centers have the same management, and therefore develop the same care program. The
study population will be the users requiring treatment in the mental health day
hospitals included in the study.
Criteria for selection and recruitment of participants:
- The criteria for inclusion in the study of participating users will be: A) Users over 18
years of age of the selected day hospitals. B) Acceptance of the study conditions and
informed consent.
- The exclusion criteria for participating users will be: A) Hospital admission for a period
of less than one week. B) Physical or psychological conditions that do not allow
collaborative nursing care through co-design of group activities.
All persons who meet the inclusion and exclusion criteria and who agree to participate in the
study will be invited. Participants will be incorporated consecutively as they are
hospitalized in the three units that form part of the study. To calculate the sample size
necessary to have sufficient statistical power for the quantitative part and based on the
results of Lemos-Giráldez, accepting an alpha risk of 0.05 and a beta risk of 0.2 in a
bilateral contrast, 76 participants would be required in the first group receiving the
intervention and 76 in the second group, in order to detect a difference equal to or greater
than 5 units. It is assumed that the common standard deviation is 11 and the correlation
coefficient between the initial and final measurement is 0.6. A 20% loss-to-follow-up rate
was estimated.
4 Procedure, techniques and analysis for the qualitative part or intervention: 4.1 The
intervention Given the clinical practice conditions of the study, the intervention will be
carried out in the selected hospital using the Participatory Action Research method and will
be implemented through a cycle of four well-defined stages which will be repeated
continuously throughout the process . Thus, for each user who joins the study, a minimum of
one complete cycle will be performed before the user is discharged. The start of the cycle
will begin with stage 1 or diagnosis, which will be performed at the time of admission to the
day hospital. The nurse, through an individual semi-structured interview, will explore the
meaning for the user of the concept of recovery together with the individual perception of
the facilitating and limiting elements of this process. Subsequently, in the second stage or
planning stage, through a discussion group with other users, the meaning of recovery, as well
as its limitations and facilitators will be discussed collectively, whereby individual or
collective action plans will be shared by the users in order to work and improve their level
of recovery in stage 3 or the action stage. Once the action plan agreed upon by the users and
the nurse has been carried out, the cycle will conclude with stage 4 or evaluation, where an
individual intervention in the form of a semi-structured interview will be carried out again
to assess the recovery process.
4.2 Qualitative data collection techniques Semi-structured interview The conversation will be
recorded with the prior consent of the participant and then a written transcript will be
prepared, which requires validation by the user to avoid possible biases. The interview
should take place in a room, if possible without interruptions and with an approximate
duration of 40 minutes. The user will be given the possibility of ending the interview at any
time as desired. A script will be used to conduct the interview.
Focus groups These will also be recorded, thanks to the prior consent given by the users. A
weekly group will be held at the day hospital's facilities, during the day hospital's hours
of operation. It will last approximately 45 minutes. There will be the possibility of leaving
the group if the user wishes to do so. To carry out the group, a support script will be
followed.
Researcher's diary As a reflective tool and in order to monitor the research process, a field
diary written by the principal investigator will be kept.
4.3 Qualitative data analysis The qualitative content analysis method will be used. The data
obtained from both the focus groups and the interviews will be transcribed verbatim. Then,
once the authenticity of the transcripts has been verified by the participants (content
validation), the text will be broken down into descriptive codes assigned on the basis of
their purely semantic content. In a second stage, such codes will be grouped into more
analytical subcategories, in such a way that the initial codes are grouped according to the
meaning of the linguistic units and their combinations. This will lead to a third
hierarchical stage, where, taking into account the semantic analysis of the previous
subcategories, they will be categorized according to the objectives of the study. It is worth
mentioning that the data analysis will be performed by two researchers, jointly in the first
stage of data coding, and independently during the subsequent analytical process and again
together in the comparison of their results. The analysis of these data will be carried out
through the QRS Nvivo v12 program. It should be noted that data will be collected and
analyzed qualitatively until the moment when the team considers that no new meanings are
found and considers that data saturation has been reached.
3.4 Outcome measures, data collection procedure and data analysis for quantitative phases 4.1
Outcomes Primary outcome Changes in the users' recovery process will be evaluated with The
Stages of Recovery Instrument (STORI), validated in the Spanish population by Lemos-Giráldez.
It is a self-report questionnaire of 50 items grouped into 5 dimensions of 10 items. Each
dimension is related to one of the recovery processes (moratorium, awareness, preparation,
rebuilding and growth). The items are scored from 0 "not true at all at this time" to 5
"completely true at this time", resulting in a score for each stage, ranging from 0 to 50.
The participant is assigned to the stage with the highest score. The questionnaire has been
validated in the Spanish population, obtaining a Cronbach's alpha of 0.86 .
Secondary outcomes The quality of the therapeutic relationship between nurses and users will
be evaluated with the Working Alliance Inventory-Short (WAI-S) scale. The short version of
this scale contains 12 items, and each item is assessed by the health professional based on a
scale ranging from 1 (never) to 7 (always). The scoring range of the overall WAI-S is 12-84
points. The higher the score, the higher the therapeutic relationship. This questionnaire has
three dimensions: (i) bond: the bond between patient and nurse, which includes aspects such
as empathy, mutual trust and acceptance; (ii) objectives: the agreement between patient and
nurse on the goals of therapy (i.e. mutual acceptance of what the intervention aims to
achieve); and (iii) tasks or activities: the agreement between patient and nurse on the tasks
or activities to be carried out. The Spanish version of the WAI-S has good reliability and
validity, with a Cronbach alpha of 0.93 .
The level of positive mental health will be assessed with the Salud Mental Positiva (SMP)
scale (Positive Mental Health), developed and validated by Lluch which studies the level of
positive mental health, a concept previously developed by Jahoda. The scale consists of 39
scorable items, for which the lowest value is "always or almost always" and the highest value
is "never or almost never". The items belong to six dimensions (personal satisfaction,
prosocial attitude, self-control, autonomy, problem solving and self-actualization, and
interpersonal relationship skills). The questionnaire has shown adequate internal consistency
values in different populations with Cronbach's alpha values of 0.89 .
Other outcomes Sociodemographic variables were gathered, including age, sex, educational
level, employment status and marital status.
The clinical variables consisted of the main diagnosis described by ICD10 criteria, years of
evolution of the disorder, referral unit, number of previous admissions to mental health
facilities.
4.2 Data collection procedure Users who agree to participate in the study and have signed the
informed consent form, both in the case of the intervention and control groups, will be given
a form containing a questionnaire with sociodemographic and clinical data and the three
evaluation instruments by a member of the research team who is not directly involved in the
care of the users. Participants will not receive any information about their inclusion in the
intervention or control group. Each user will be assigned a participant code to ensure the
anonymity of the participating users. When the user is discharged, a person from the research
team will collect the follow-up data in the same way by means of a new form.
4.3 Quantitative data analysis The principal investigator will construct a database using the
IBM SPSS v25 program ECPHDSM, the data obtained from the forms will be incorporated into the
database by two members of the research team to minimize error. The analysis will focus on
the numerical differences obtained through the STORI, WAI-S and SMP questionnaires before and
after the intervention. In order to describe the characteristics of the participants and the
scores obtained on the scales, descriptive statistics will be used, using the arithmetic mean
and standard deviation for quantitative variables, and the frequency and percentage for
qualitative variables. The differences between the baseline scores obtained and the follow-up
assessment will be estimated thanks to the application of parametric tests (Student's t-test
in paired data) in the case of quantitative variables, first verifying the assumptions of
normality and homogeneity of their variances. When the opposite is true, nonparametric tests
will be used, using the Wilcoxon test for quantitative variables and Chi-square tests or
Fisher's exact test for qualitative variables. In addition, to analyze the impact of changes
on the dependent variable adjusted for the remainder of the secondary outcomes, multiple
linear regression models will be used. A significance level of p<0.05 will be considered.
5 Ethical considerations Authorization has been obtained from the management of the centers
and approval for the project has been granted by the Ethics Committee of the institution
where the study will be carried out. In relation to the current law on personal data
protection and guarantee of digital rights, the authorization of all users will be requested
for the public dissemination of the data, preserving the confidentiality and anonymity of
their identity at all times. This will be achieved by anonymizing the names or any sign of
identity by assigning a user code. All participants will be able to voluntarily withdraw from
the study at any time. For this reason, users will be given a sheet with all the precise
information about the study to be carried out and written consent will be requested.
6 Validity and reliability / Rigor To ensure the validity and rigor of the study, appropriate
strategies will be used for each phase of the research. In phases 1 and 3, the selection of
participants and recruitment of an appropriate sample size together with the validity and
reliability of the instruments used will guarantee validity and reliability. For phase 2,
reliability, authenticity and ethical criteria will be addressed. Within the framework of
reliability, the credibility of the study is based on the use of triangulation of techniques
and researchers. Likewise, the criterion of dependence will be obtained through the constant
auditing and transfer of external reports throughout the procedure. Likewise, the dynamics of
the process, which will involve a constant interaction between the realities of researchers
and participants, will provide authenticity to the data obtained. The treatment of
confidentiality, privacy and participant consent will guarantee the ethical rigor criteria of
the project. In addition, reflexivity, understood as a process of critically reflecting on
what is taking place during the research study, will be the key quality criterion upon which
the project will be based.