Psychosis Clinical Trial
Official title:
Person-Centered Psychosis Care: An Educational Intervention for Inpatient Staff
Schizophrenia is a major mental illness that presents in young adulthood and affects ~1% of
the population. Impact on affected persons life is often major and life expectancy is reduced
by ~20 years. Better and more effective care models are needed to increase health in these
persons. Person-centered care have been suggested to be one way to increase efficiency in
care delivery for patients with chronical and complex conditions. The impact of
person-centered care on a inpatient psychosis care setting is now being tested.
The purpose of this study is to test whether inpatient Person-centered psychosis care (PCPC)
can
1. increase patient empowerment
2. improve patient satisfaction
3. reduce the frequency of involuntary treatments
4. reduce the duration of inpatient care and
5. reduce overall ward burden
A further purpose is to qualitatively explore which components in this complex intervention
are experienced as facilitators or barriers to the achievement of good care, from both
patient, next-of-kin and staff perspectives.
Quantitative data is collected through questionnaires from patients (measuring empowerment,
care satisfaction and perceived health) before and after an educational intervention for
staff, along with ward level measures such as care burden, number of involuntary treatments
and length of stay on ward.
Qualitative interview is used to study experiences of patients, next-of-kin and staff.
Background
Schizophrenia is a major mental illness that presents in young adulthood. It affects
approximately 1% of the population and is a major cause of Disability-adjusted Life Years
worldwide. Besides impacting on the ability to independently carry out daily activities,
work/studies and interactions with family and community, the illness has a profound effect on
physical health. Diabetes and cardiovascular diseases are common complications and life
expectancy is reduced by as much as two decades. The long term nature of this complex illness
highlights the need for more effective, holistic care models. Increased patient involvement
is central, as it has been shown that patients' views of appropriate interventions often
differ from those of formal care providers.
Person-centered care (PCC) is recognized by the WHO as a valuable approach to the care of
chronic conditions. A basic assumption of person-centered care (PCC) is that healthcare must
recognize the patient as a person, with own knowledge, capacity and preferences along with
needs and problems. The PCC way to deal with illness and disease is to form a partnership
with the person and together form a plan of action to increase health (i.e. not only focus on
symptoms or signs of diagnosed disease) taking into account the person's context and
priorities. Previous studies show that persons with serious mental illness can and want to
participate in their own care and participation might increase adherence. Improved social
function and consumer satisfaction were demonstrated when a person-centered care approach,
Integrated Care (IC) was tested in a psychosis outpatient-based randomized controlled trial.
To the best of the authors knowledge, PCC has yet to be tested in an inpatient setting for
persons with severe mental illness. Favorable results have been demonstrated with regard to
both ward level and patient level outcomes from inpatient settings within somatic care.
Person-centered care in geriatric settings, which might share some common issues with
hospital care for persons with schizophrenia (decreased cognitive function, lack of insight,
compromised autonomy), have shown positive outcomes for QoL and agitation in patients and job
satisfaction for staff. Reviews show mixed results though. Thus, we wanted to evaluate an
intervention for inpatient psychiatric care for persons with schizophrenia and similar
psychoses. To this end, we developed Person-centered Psychosis Care (PCPC), a staff
educational intervention involving components of PCC as well as IC. Person Centered Psychosis
Care was defined as having four key elements; dialogue, building partnership, formulation and
documentation of a health plan, and early involvement of the patient's outpatient facility.
The latter means that the patient's outpatient-based social resource group can come into play
already during the inpatient stay.
Purpose
The purpose of this study is to test whether inpatient PCPC can
1. increase patient empowerment
2. improve patient satisfaction
3. reduce the frequency of involuntary treatments
4. reduce the duration of inpatient care and
5. reduce overall ward burden
A further purpose is to qualitatively explore which components in this complex
intervention are experienced as facilitators or barriers to the achievement of good
care, from both patient, next-of-kin and staff perspectives.
Methods
The study employs a simple "before and after" design. Quantitative data (patient-level,
ward-level) are collected pre- and post intervention on all four wards. Qualitative data
are provided through interviews with patients as well as focus groups with staff.
Data collection: Patient-level data All patients on any of the four wards who fulfill
study criteria during pre- and post-intervention periods will be asked to participate in
the study.
Anticipated number of participants: 50 pre intervention, 50 post intervention.Those who
accept will complete questionnaires at the clinic together with the interviewer. The
following outcomes will be measured:
- Empowerment will be measured with The Empowerment Scale. This scale is validated
and used internationally in studies involving persons with severe mental
ill-health. There are 28 questions; responses are given on a scale of 1 (agree
totally) to 4 (disagree totally).
- Patient satisfaction measured with the UKU-ConSat Rating Scale consists of 11 items
on different aspects of the care provided where response is given on a scale 1
(Very bad/negative/little) to 7 (very good/positive/much). The scale also includes
two VAS-like scales where an answer is marked on a 100 mm line to a question on
overall life experience (0=worst imaginable, 100=best imaginable).
Confounders including illness burden, functional ability, and overall health will be
quantified for each patient at discharge. Positive and negative symptom burden will be
rated with the Remission subscale of PANSS, consisting of 8 items reflecting core
symptoms of schizophrenia and functional ability will be determined using the GAF scale
and overall health with the EQ-5D. Ratings will be carried out by two nurses and one
psychologist.
After the completion of the scales, all participants are asked the following open-ended
questions:
1a) What are the most important things that have improved for you during your stay at
the hospital?
1b) What was the reason that you got better? 2a) What do you wish could improve for you
in the future, after your hospital stay? 2b) How could the health care sector help you
to achieve this?
At the end of the interview, participants are asked for permission for researchers to
contact them after discharge for invitation to a qualitative interview study. A
purposive selection of stabilized patients who accepted follow-up contact will be asked
if they would like to participate in an interview with a study nurse or psychologist.
The interview will focus on experiences of care during the inpatient stay and
patient-relevant endpoints will be explored. The sampling will aim at a heterogeneous
group with regard to gender, age, ethnicity, level of psychosocial function, involuntary
vs voluntary care.
Data collection: Next-of-kin A purposive sample of family members or other persons close
to the patient will be asked if they would like to participate in focus groups/an
interview. The selection of family members' for focus group interview will strive to
include next-of-kin of patients with varied backgrounds with regard to age, gender,
ethnic background, education level, living situation (do they live together with the
patient or not?) etc. The main focus for this focus group will be the identification of
positive and negative experiences in the care, discrimination, facilitators and barriers
for good care
Data collection: Staff experiences A purposive sample of staff were invited to
participate in focus group to collect experiences of the educational intervention and
implementation. Facilitators and barriers to implementation of PCPC will be in focus.
Staff were recruited through invitation via e-mail and posters on their wards. In a
second step section leaders at the wards asked persons who would be on duty on the days
of interview to participate. All focus groups are led by an experienced clinician with
research experience of qualitative studies. All interviews will be recorded and
transcribed verbatim.
Data collection: Ward level data Mean number of inpatient days, mean number of inpatient
days with compulsory care and mean number of involuntary treatment interventions
(involuntary injections, medical restraint) for pre- and post intervention periods will
be derived from the clinic's administrative database. Overall care burden is measured at
each ward with an instrument developed by the Psychosis Clinic for quality monitoring.
The instrument includes objective items (number of admissions and discharges, number of
involuntary treatments during the shift etc), followed by a subjective item on the
overall level of burden perceived during the shift. The form is filled out by one staff
member on each ward once a day according to clinical routine.
Data analysis: Quantitative data The main study question is whether the intervention is
associated with a change in the degree of empowerment experienced by persons who receive
hospital care due to psychosis. The secondary outcome measure is patient satisfaction at
discharge. Quantitative ratings before and after the care intervention will be compared
with standard statistical methods. Similarly, for the ward level analyses, wardwide
outcomes will be compared in wards before and after the implementation of the
intervention: mean number of inpatient days, mean number of inpatient days with
compulsory care, mean number of involuntary treatment interventions and overall ward
burden. Distribution of the variables to be studied will determine whether parametric or
non-parametric analyses are employed.
Data analysis: Qualitative data Free text responses to the open-ended questions at the
end of the quantitative interview (see patient level data above) as well as data from
individual patient interviews and focus group interviews with staff and next-of-kin will
be analyzed using content analysis and thematic analysis.
Ethics All participants (patients, next-of kin and staff) are given written and oral
information about the study, the voluntary participation, possibility to withdraw from
participation without having to give explanation. All will sign consent form before
participating in any study related task, a copy of signed consent is given participants.
The study was approved by the Regional Ethics Board in Gothenburg, Dnr. 773-13.
Time plan Data collection for the pre-intervention phase is completed (December 2014);
the educational intervention is completed (May 2015) and the implementation period will
end April 30, 2017. Focus group interviews with staff regarding the educational package
are now underway (2017). Audit to determine the level of PCPC implementation is
currently underway (April 2017), which will determine whether post-intervention data
collection could start. Complete data set should be available fall 2017.
Comment on project so far
This is a complex intervention involving action research and the study is registered
first after the completion of the educational intervention and on-ward implementation of
PCPC. The implementation process has been dynamic and varied at the four different wards
involved in the project. The duration of the implementation period was considerably
longer than anticipated. This is in part related to high staff turnover, serious lack of
psychiatrically trained RNs, as well as other barriers to implementation. Barriers have
slowly been overcome by changes in routines instigated from within the care staff (as
opposed to being imposed on staff from "above"). While the long implementation process
can be seen as a limitation, it's interactive nature can at the same time be construed
as a strength, as change from within can be expected to increase sustainable change.
A quantitative study was planned with questionnaires investigating consumer satisfaction
and care giver burden in next-of-kin but baseline collection resulted in too few
participants to continue that subproject.
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