Preventing and Approaching Crises for Frail Community-dwelling Patients Through Innovative Care (PRACTIC) - an Effectiveness Study
Phase: NA
Conditions: Frailty
Sponsor: Sykehuset Innlandet HF

27.11.23 
 
Study protocol  
Project title:  
Preventing and approaching crises for frail community-dwelling patients through innovative care 
(PRACTIC) - an effectiveness study 
Participatory action research in a cluster randomised controlled trial 
This protocol represents Work Package 2 (WP2) in the PRACTIC-study (Preventing and approaching 
crises for frail community-dwelling patients through innovative care). The PRACTIC-study consist of 
four work packages: 
 
WP1  
Characteristics of crises in frail patients receiving home-care services 
WP2  
Evaluation of the effect of an adapted version of the TIME model in the prevention 
and treatment of crises in frail community-dwelling people 
WP3  
Pre-specified process-evaluation of the intervention in the RCT 
WP4  
Administration and project coordination 
 
Abstract 
Background: 
Demographic changes, with an increasing number and proportion of older people with 
multimorbidity and frailty, will put more pressure on home care services in municipalities as well as 
on specialist health care. Frail multimorbid people receiving home care services are at risk of 
developing crisis often resulting in adverse events, coercive measures, and acute institutionalisation. 
Crises also pose increased demands and stress on the next of kin. There is a lack of evidence based 
interventions to prevent and resolve crises in community settings. Our hypothesis is that through 
interventions targeting the patients, the next of kin, the patients’ social context, and healthcare 
service, crises may be prevented and resolved. This project aims to test the effectiveness of an 
adapted version of a bio-psychosocial person centred model the Targeted Interdisciplinary Model for 
Evaluation and Treatment of Neuropsychiatric Symptoms, (TIME) to prevent and resolve crises for 
frail community-dwelling people receiving home care services. In addition, we will analyse factors 
associated with the effect of TIME, and we will explore the experiences the users have with the 
introduction of TIME in the services. 
 
Design/Methods: This is a participatory action research design (PAR) in a six-month cluster 
randomized controlled trial (RCT). The trial will be conducted in 30 municipalities including 150 frail 
community-dwelling participants receiving homecare services judged by the services to have 
imminent crises. Each municipality will be defined as a cluster and will be randomized to receive 
either the locally adapted TIME intervention (the intervention group) or care as usual (the control 
group). TIME is a manual-based, multicomponent programme that will include a rigorous assessment 
of the crises, one or more interdisciplinary case conferences and the testing and evaluation of 
customised treatment measures. Primary outcome: Difference in change between intervention and 
control group in individual goal achievement to resolve or reduce the challenges of the crises, 
between baseline and 3 months using the PRACTIC Goal Setting Interview (PGSI), which is inspired by 
the Bangor Goal Setting Interview (BGSI scale of 1–10). Secondary outcomes: Difference in change in 
the PGSI scale at 6 months, and in neuropsychiatric symptoms (NPS), quality of life, distress 

27.11.23 
 
perceived by professional careers and next of kin, and institutionalization at 3 and 6 months. For the 
exploration of the factors  associated with the effect of the intervention we will use multiple level 
regression analysis of the data from the RCT. To explore the experiences of the users of home care 
services with the intervention we will use qualitative in-depth interviews of dyads with 15 patients 
and next of kin who participated in the RCT. 
Trial registration: ClinicalTrials.gov identifier, ID: NCT05651659. Registered 15.12.22. 
Keywords: frailty, crises, home care services, community-dwelling people, behavioural and 
psychological symptoms of dementia (BPSD), psychosocial interventions, case conferences, 
participatory action research (PAR), randomized controlled trial (RCT), PRACTIC Goal Setting 
Interview (PGSI) 
 
Protocol  
Background  
Worldwide, the proportion and absolute number of older individuals are increasing dramatically. The 
population aged 60 and older is expected to double by 2050 worldwide, and the proportion of 
people receiving care at home has increased over the past ten years (1, 2). In Norway, approximately 
200,000 people are currently receiving home care services, while there are approximately 40,000 
beds in nursing homes (3). The majority of people would rather reside and receive care at their 
homes than in an institution (4). One of the main health and societal challenges for municipalities, 
now and in the future, is to offer high-quality health care services for a growing population of older 
people with complex needs due to frailty and multimorbidity (5). Patients may experience distress 
because they are unable to manage the situation at home, even though they may prefer to avoid 
institutionalization. The considerable distress experienced by informal caregivers revolves around the 
lack of sufficient support from home care services and the limited availability of nursing home places 
(6). Home care services can be described as a complex organization with various service components 
ranging from practical assistance in the home to the delivery of advanced medical treatment. To 
enable people to live safely at home, home care services are interdependent on other sectors, such 
as general practitioners (GPs), the hospital sector, primary health care workers, and social care (4, 7). 
 
There is a significant variation among patients receiving home care services in terms of functional 
abilities, age, living conditions, and chronic diseases (8). A considerable number of these patients 
have multiple chronic conditions, commonly referred to as multimorbidity (4). Estimates suggest that 
within the next twenty years, the population of elderly individuals with multimorbidity will double 
(9). The prevalence of frailty is estimated to be 11% among adults aged ≥65 years, increasing to 50% 
among those >80 years of age (10). Most frail individuals are multimorbid, but not all multimorbid 
individuals are frail (11). Frailty has been described as a state of physiological vulnerability with a 
reduced capacity to adapt and manage internal and external stressors (12). Studies have emphasized 
the relevance and utility of a biopsychosocial definition of frailty, including the terms physical frailty, 
psychological frailty, and social frailty. Social frailty is an important dimension of the frailty concept 
and makes people with low incomes, low educational levels, and low housing standards vulnerable to 
various adverse health outcomes. Combining these three dimensions into a multidimensional 
concept of frailty promotes the use of targeted multidomain interventions tailored to older adults’ 
frailty status (13, 14). 

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Definition of crisis 
People who are at an increased risk of developing crises are often frail. Crises are major stressors for 
patients, their next of kin, and the care staff and often lead to adverse events, acute 
institutionalisation and the use of coercion (15, 16). Crises can be described as ‘a process in which the 
stressors cause an imbalance requiring an immediate decision which leads to a desired outcome and 
therefore crisis resolution’ (15). In the Preventing and approaching crises for frail community-dwelling 
patients through innovative care (PRACTIC) study, we will operationalize this definition to describe 
crises in practice as “critical challenges and symptoms that demand immediate and new actions”. 
The challenges and symptoms that trigger and maintain crises are heterogeneous and vary between 
patients and may include depression, poor nutrition status, rejection of care, incontinence, 
neuropsychiatric symptoms (NPSs), and social isolation (12). The ‘Mind the Gap report’ from the 
Advisory Board of the Global Forum for Health Care Innovators states that 1–5% of community-
dwelling patients are high-risk patients and 15–35% are patients with an increasing risk. The 
literature on crises among patients receiving home care services has mainly explored the 
phenomenon in relation to people with dementia living at home (15, 16). 
 
The need for new multicomponent interventions possible to adapt to the local context  
One of the most demanding challenges for health care authorities and home care services is to 
develop and implement high-quality health care models for the growing population of frail 
community-dwelling patients (17). In addition to early recognition and response to clinical signs and 
symptoms, as recommended by the Norwegian Health Directorate, providing health care for this 
group of frail patients represents a change from a merely task-oriented service to a service that aims 
to assess the complex biopsychosocial character of frailty (18). There are large variations in the 
content and organization of Norwegian home care services, and research pertaining to these services 
has largely been descriptive, with a preponderance of qualitative studies (19, 20). There is a paucity 
of studies investigating the effectiveness of interventions (20). A study testing a structured follow-up 
program using a checklist for frail community-dwelling adults found no common perception among 
nurses or their leaders that the approach was useful to ensure high-quality health care (21). This 
finding supports the conclusion of a Cochrane Review in 2016 summarizing primary care 
interventions for patients with multimorbidity (22). The review revealed no clear positive 
improvements in clinical outcomes, health service use, medication adherence, patient-related health 
behaviours, health professional behaviours or costs. The authors concluded that to improve 
outcomes for people with multiple conditions, there is a need for new multicomponent 
interventions, targeting both the heterogeneity of patients and their multimorbidity. To our 
knowledge, no effectiveness study of interventions targeting heterogeneous groups of home-
dwelling patients with multimorbidity has been conducted in Norway. The proposed project will 
develop knowledge beyond the current state by also including the experimental testing of an 
intervention (20). 
 
Participatory action research (PAR) in combination with an RCT has been suggested as a design to 
enhance local adaptations of an intervention to the local context and needs (23, 24). There are 
multiple variations in the content and organization of Norwegian home care services, with various 
service components ranging from practical assistance in the home to the delivery of advanced 
medical treatment (19). The possibility of success for innovative interventions is probably higher if 
the interventions are not too complex, with no aim of changing the organization of health care 

27.11.23 
 
services (23, 25). A flexible complex intervention has been emphasized as an important factor for 
interventions to be effective and increasing their applicability (24, 26-28). According to Hawe et al. 
(24), it is the function and processes of the intervention that should be standardized, not the 
components in the intervention. Adaptation of the components should be performed both at the 
research project level and at the implementation level in municipalities (24). Using a PAR design will 
help to adapt the components of the intervention to these variations, thereby enhancing 
implementation in each municipality. As a part of the main PRACTIC study, a process evaluation study 
will be conducted in parallel with the RCT (29). This will ensure that these variations in the 
organization mentioned earlier and the necessary adaptations are accounted for. 
 
The TIME intervention 
TIME (Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms) 
is a Norwegian evidence-based model for problem-solving regarding neuropsychiatric symptoms 
(NPSs) in dementia and other mental diseases. The model is based on the theoretical frameworks of 
cognitive behavioral therapy (CBT) and person-centered care (PCC) (28). TIME has also been used in 
clinical practice for other complex issues, such as nutritional failure, multimorbidity, and general 
functional loss (30). It is a multicomponent interdisciplinary model consisting of three overlapping 
phases, which are the core components of the model. First is the assessment phase where the care 
staff and the physician collaborate in a comprehensive biopsychosocial assessment. The second 
phase is the reflection phase with interdisciplinary case conferences based on principles from 
cognitive behavioural therapy (the ABC method), where a customized treatment plan is developed. 
The ABC method from cognitive behavioral therapy is used as an analytic tool for the analyses of 
complex challenges in case conferences (31). The third phase is the action and evaluation phase, and 
each treatment measure in the plan is implemented and systematically evaluated. The TIME model is 
effective for treating NPSs in dementia and has been proven feasible in nursing homes (NHs) (28, 32). 
Our research centre has pilot tested the model in home care services (33). One of the assets of TIME 
is interdisciplinary case conferences, and interdisciplinarity is essential in the approach to a crisis. 
Based on the results from the pilot test, the inclusion criteria for the patients were broadened, and 
the content of the training for all employees was further developed (33). In addition, the schedule for 
the training and implementation was adapted to everyday routines for home care services. Further 
adaptation of the TIME model to home care services will be performed continuously at local project 
group meetings during the RCT in the intervention municipalities. 
 
A goal-oriented primary outcome 
To evaluate the effects of a biopsychosocial intervention to prevent and resolve crises in a 
heterogeneous population, there is a need for a goal-oriented outcome comprising this variability. 
The goal of the intervention and the outcome will necessarily vary from patient to patient (26). We 
have therefore translated and modified a validated individual goal-oriented interview (The Bangor 
Goal-Setting Interview, BGSI) (34) to establish a common primary outcome to be used in the RCT. The 
PRACTIC Goal Setting Interview (PGSI) is a Norwegian adapted version of the BGSI. In the PGSI, the 
individual goals set for each patient represent treatment and actions targeting the challenges and 
symptoms that trigger and maintain the patient’s crisis. The difference in goal achievement between 
the intervention and control groups, as further explained in the Methods section, defines our primary 
outcome. 
 

27.11.23 
 
Theoretical framework 
The study is based on a theoretical framework of complexity science and a biopsychosocial 
understanding of crises (35, 36). In this framework, frailty means that the frail patient is prone to 
instability caused by complex interactions among biological, psychological and social stressors (14, 
36). If this instability rises, it eventually culminates in the development of a crisis that, according to 
our description of crises, demands immediate and new actions. Describing frailty and crises as 
complex phenomena sets the stage for why interventions should be constructed and implemented as 
flexible complex interventions to be able to assess, prevent, and resolve crises (24). This also includes 
the choice of design and methods for testing the effectiveness of an intervention. 
 
Aims and research questions  
The primary purpose of this study is to test the effectiveness of an adapted version of a 
biopsychosocial person centred model (TIME) to prevent and resolve crises for frail community-
dwelling people receiving home care services. We have formulated the following research questions: 
 
RQ1: Can the TIME model adapted for home care service, prevent, and resolve crises in frail 
people receiving home care services? 
RQ2: Which participant characteristics or organizational factors are associated with the effect 
of the TIME model?  
RQ3: What are the experiences of the users of home care services on how crises were 
approached during the trial? 
 
Design and methods 
Study design 
For RQ1 we will use a participatory action research (PAR) design in a cluster randomized controlled 
trial (RCT) with two parallel groups: intervention municipalities (IMs) and control municipalities (CMs) 
(23, 37). Figure 1 shows a flow chart of the clusters and individuals through the phases of the trial 
based on the power calculation.  
PAR aims to ensure adaptation of the components of the intervention to the local context (23, 37). 
This will be done by establishing a local project team in each municipality consisting of two 
representatives from the research group and local participants (representatives of local managers, 
staff, and GPs). These groups will adapt the implementation process and the TIME model according 
to the cyclic Deming process: plan, do, check, act, and adjust (38). The implementation process will 
be adapted to the local context to fit with the organizational structure already established in home 
care services. For example, the content and time used for educational and training purposes can vary 
depending on the educational level and established educational arenas. These variations will be 
registered during the process. For the TIME model, the core components (functional) of the 
intervention (TIME) must be fixed, and other components can be adapted to the local context and 
the patients included. An assessment phase must be performed, but what to assess and the types of 
clinical scales to be used can vary (processes). Case conferences using the inductive cognitive ABC 
model for the analyses of crises must be conducted, but the timeframe and participants of these 
conferences will vary. The action and evaluation phase must be conducted, but the timeframe and 
types of actions and evaluations can vary. These adaptations of the model will be accurately mapped 
in each setting during the study, and this mapping will be a part of the process evaluation study in 
the PRACTIC study (29). In this trial, we will follow the recommendations from the CONSORT 

27.11.23 
 
statement for randomized trials of nonpharmacologic treatments (39). 
 
For RQ2 we will utilise an explorative design with multilevel regression analysis based on the 
participants’ characteristics from the RCT and organizational data including staff characteristics from 
the process evaluation study in WP3.  
For RQ3 we will use an explorative design with qualitative in-depth interviews of dyads with 15 
patients and next of kin who participated in the RCT. Qualitative methods provide contextual based 
knowledge about people’s experiences and how they interpret, understand and link meaning to 
events (40). The aim is to get a deeper understanding of how crises were approached during the trial 
as experienced by the users of the home care services in the intervention municipalities. Because the 
questions and topics of the interviews concern personal critical situations, individual interviews are 
perceived as the most appropriate method of collecting data.  
Settings and target population 
This study is part of the larger PRACTIC (Preventing and approaching crises for frail community-
dwelling patients through innovative care) study. The trial will include approximately 30 randomly 
selected municipalities and their home care services from all health care regions in Norway. From 
each region, a sample of small, medium, and large municipalities will be invited to participate. From 
those 30 included municipalities, 150 users of home care services and their next of kin will be invited 
to participate in the trial. The local project team will collaborate with the research team in the 
adaption of TIME to the local context during the trial. Specially trained nurses (see below, section: 
Control and intervention phases of the study) will support the research team in the recruitment of 
participants and the data collection. However, the care providers for the intervention will be the 
regular staff in the home care services.  
 
Inclusion criteria for patients are: (1) in need of home care services, (2) a score ≥5 on the Clinical 
Frailty Scale (indicating mild to severe frailty) (41), and (3) perceived by the home care service as 
being in an unstable situation with a high risk for acute institutionalisation or showing resistance to 
care. The only exclusion criterion is an expected short life expectancy (i.e., <4 weeks).  
Inclusion criteria for next of kin (for RQ3) are (1) being next of kin of a user of home care services 
who meets the above mentioned inclusion criteria (2) regular contact with the patient (i.e., at least 
once a week).  
 
Fig.1. The PRACTIC trial: Flowchart of the clusters and individuals throughout the phases of the trial  
 
RQ1 and RQ2 Sample size calculation based on the primary outcome 
The proposed sample of 150 participants is based on a power calculation with clusters of 
approximately five participants from each of the 30 municipalities. Based on a previous trial, a 
minimal clinical important average difference on the PGSI scale is set to 2 points between 
intervention and control group with a standard deviation (SD) for change of 2.83 in each group (40). 
To observe a statistically significant difference with a power of 80%, an intra-cluster (municipality) 
correlation coefficient (ICC) of 10% and an estimated attrition rate of 25% for the primary outcome at 
three months, we will need approximately 150 participants. We assume a high attrition rate since the 
participants are at high risk for acute institutionalisation (see inclusion criteria). 

27.11.23 
 
This trial must perform cluster randomisation, with the municipality as the cluster, for two main 
reasons. The intervention is a biopsychosocial intervention that involves the entire interdisciplinary 
team and staff in the home care services of the participating municipalities to optimize the approach 
towards a group of patients in the municipalities. In addition, without cluster randomisation, the 
study runs the risk of transmitting all or parts of the intervention model to the individual control 
patients in the same municipalities (42). The patients in the control group will receive care and 
treatment as usual, but they will probably also profit from the extra attention given by the home care 
services because of their participation in the RCT and because of the use of the measure for the 
primary outcome, the PGSI. In this way, we can isolate any effects on goal achievements to prevent 
or resolve crises to the main difference between IMs and CMs, i.e., the TIME intervention. 
 
RQ3 Selection of participants for the individual in-depth interviews  
For the interviews in RQ3, we will use a purposeful sample of approximately 15 dyads with 15 
patients and next of kin from the intervention municipalities in the RCT (43). To minimize selection 
bias in selecting the municipalities that will be represented in the interviews, we will select five of 
them randomly from the pool of the 15 municipalities which had received the intervention with TIME 
and recruit 3 participants from each of these municipalities (44). Local project nurses (see below in 
section Control and intervention phases of the study) in each municipality will inform eligible 
participants and their next of kin about the interviews and hand out written information, consent 
forms, and a franked envelope to be returned to the research team, if they consent to participate. 
Precautions will be taken to ensure that the members of the local project group that inform the users 
and their next of kin, do not have any care-relation to the participants. The researcher will send a 
short letter to the eligible participants after one week and invite them to contact the researchers or 
the local project group by phone if they have any questions. The aim is to ensure that the 
participants have received all necessary information needed to take a well-informed consent. Many 
potential participants will have difficulty understanding only written information due to mild 
cognitive impairment or impaired vision, and the researcher can provide additional oral information. 
The researcher will not require a replay regarding participation in the study at the time of this 
contact.  
 
Randomisation 
Municipalities will be randomly assigned to either the intervention group or the control group. A 
statistician will perform the randomisation procedure independently of the project management 
team and the municipalities. The project management team will provide the home care services in 
the municipalities with the randomisation and allocation results immediately following this 
procedure. The intervention will start with the educational sessions (described below) within one to 
two weeks after randomisation. 
 
 
Control and intervention phases of the study 
Education and training for the staff in intervention municipalities (IMs) and control municipalities 
(CMs) 
 
Depending on the size and organization of the home care services, approximately four project nurses 
from each organizational unit of the home care services in each IM and CM will be given special 

27.11.23 
 
responsibility in the trial. Before randomisation, these nurses will complete a one-day educational 
course on the procedures for the trial. Their main task will be to recruit participants according to the 
inclusion criteria, obtain written consent for participation, and facilitate the interviews for the 
assessments of the participants at baseline, three months, and six months. The manager of the home 
care services will select these nurses in the municipality based on the following criteria: health care 
professionals who work on a nearly full-time basis, have shown interest in professional development 
and have gained legitimacy with the rest of the staff. Thus, these health care professionals can be 
selected among registered nurses, auxiliary nurses, or members of other professional groups (e.g., 
social workers or occupational therapists) in home care services. 
 
After this coeducational session for both the IMs and CMs, the CMs will continue care and treatment 
as usual (CTAU). Care and treatment as usual will usually involve medication follow-up and medical 
procedures, personal care, dressing, and bathroom assistance. 
 
Specific education and training of staff in the IMs 
The staff in the IMs will complete four hours of lectures, training and role-play related to TIME. The 
educational program is aimed at as many employees as possible in the organization and provides 
basic knowledge about the TIME model. The education and training team will consist of eight 
specialist registered health care professionals in geriatrics or geriatric psychiatry and one physician 
with special competence in nursing home medicine. All members of the education and training team 
are familiar with TIME and have used the model for some years in real-world clinical settings. The 
lectures will be standardized according to the steps listed in the TIME manual. 
 
The leaders of the home care service in the IM will attend these lectures to ensure that these leaders 
provide support to the staff during the trial. We will also encourage the GPs in the municipalities to 
participate. Each staff member in the IM will be provided with the TIME manual, which describes the 
intervention step by step. They will also be given access to an educational film about TIME and to a 
website to support the intervention. The project nurses who participated in the coeducation for the 
inclusion criteria in each municipality in the IM will now hold a special responsibility for putting the 
model into practice based on the manual. These nurses will therefore receive three additional hours 
of education, training and role play about the different components of TIME and the implementation 
of the intervention. In the trial, they will be referred to as TIME administrators. Immediately after 
randomisation and allocation, the project management team will contact these TIME administrators 
via telephone and instruct them to begin to implement the intervention according to the TIME 
manual for the patients included in the trial. This telephone call is made from a few days up to one 
week before the education and training sessions are given. The TIME manual is available online.  
 
One specialist registered nurse from the education and training team will attend and supervise the 
TIME administrators’ first case conference on their first patient in their municipality. For the 
remainder of the intervention, and for the other patients included in the trial, the TIME 
administrators and the staff will carry out the intervention independently.  
 
Table 1. The assessment phase 
Table 2. Agenda and timeframe for the case conferences 
 

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Procedures for data collection 
Specially trained nurses (data assessors) from the project’s research centre who are not affiliated 
with the municipalities will, together with staff members in the home care services, assess patients’ 
baseline characteristics before randomisation. These data assessors will after randomisation be 
blinded to the randomisation result. They will assess the effect of the intervention via telephone by 
interviewing the participants, the next of kin and the staff members who know the patient best, at 
three months and six months after baseline assessments. All assessors are nurses with substantial 
experience and formal training on the use of the assessment scales. They will attend a one-day 
course on the use of the assessments scales before start of the trial. A description of the 
questionnaires, including data assessors, respondents and the time point(s) at which they are 
administered, is provided in Table 1. 
Baseline data and primary and secondary outcome measures  
The primary outcome of the trial is the difference in the change between the intervention and 
control groups in individual goal achievement to resolve or alleviate the challenges regarding crises 
between baseline and three months using the PGSI (scale of 1–10) (34). We chose this primary 
outcome because there is a need for a targeted outcome that comprises the variability in a 
heterogeneous population. It is very unlikely that a participant would be harmed due to participation 
in the RCT; therefore, it is not deemed necessary to have a harm outcome in the study. In the RCT, no 
new experimental treatments for the patients will be introduced, and care and all treatment actions 
will rely on recommended national care and treatment guidelines.  
 
The secondary outcomes are the differences in the change between the intervention and control 
groups in the PGSI scale at 6 months, in neuropsychiatric symptoms (NPSs) measured by the 
Neuropsychiatric Inventory (NPI-NH) (45), quality of life measured by the Quality of Life in Late-Stage 
Dementia scale (QUALID) (46, 47), distress perceived by the next of kin measured by the Relative 
Stress Scale (48), rejection of care measured by the Minimum Data Set (49), activities of daily living 
assessed with the Physical Self-Maintenance Scale (PSMS) (50), prescribed medications collected 
from the medical records (51), frailty measured with the Clinical Frailty Scale (CFS) (52), 
institutionalization at three and six months, and pain and discomfort assessed by the EQ-5D 
questionnaire (53) at six months. All these questionnaires have been proven to have acceptable 
validity and reliability. The trial will also collect data to be used as covariates in the RCT and to 
describe the sample of participants. These data will be collected with questionnaires answered by 
the staff in home care services: 
 
a) Age (covariate in the RCT), sex, level of education and employment status, marital status, 
living conditions (living alone or with someone) 
b) Hours a week and type of home care service 
c) Relation to next of kin (e.g., next of kin and how often they meet) 
d) Physical health measured with the General Medical Health Rating Scale (GMHR) (54) 
e) Cognitive function assessed by the Clinical Dementia Rating Scale (CDR) (55) (covariate in the 
RCT). 
 
 

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Table 3 Overview of the data collection in WP2 with primary and secondary outcome measures 
Data collected 
Interviewers 
 Respondents 
 
Baseline  
3 months  
6 months  
Characteristics of the 
participants 
 
 
 
 
 
 
Agea, gender, level of 
education and employment 
status, marital status and 
living conditions 
Data assessors from 
AFSb 
Staff members in the 
home care services 
 
 
X 
 
 
Hours a week and type of 
service from the home care 
service 
Data assessors from 
AFS 
Staff members in the 
home care services 
 
X 
 
 
Number of visits per day 
from the home care service 
Data assessors from 
AFS 
Staff members in the 
home care services 
 
X 
 
 
Relation to next of kin (e.g., 
next of kin and how often 
they meet) 
Data assessors from 
AFS 
Staff members in the 
home care services 
 
X 
 
 
Diseases (known diagnosis) 
Data assessors from 
AFS 
Staff members in the 
home care services 
 
X 
 
 
Frailty, measured with the 
Clinical Frailty Scale 
(CFS)c 
Data assessors from 
AFS 
Staff members in the 
home care services 
 
X 
 
 
X 
Physical health, measured 
with the General Medical 
Health Rating Scale 
(GMHR)d 
Data assessors from 
AFS 
Staff members in the 
home care services 
 
 
X 
 
 
Cognitive Function -  the 
Clinical Dementia Rating 
Scale (CDR)e 
Data assessors from 
AFS 
Staff members in the 
home care services 
 
X 
 
 
Primary outcome 
 
 
 
 
 
 
PRACTIC Goal Setting 
Interview (PGSI)f 
Data assessors from 
AFS 
Patient, next of kin 
and staff members in 
the home care 
services 
 
 
X 
 
 
X 
 
 
X 
Secondary outcomes 
 
 
 
 
 
 
Medication from medical 
records 
Data assessors from 
AFS 
Staff members in the 
home care services 
 
X 
 
X 
 
X 
Rejection of care - Minimal  
Data Set (MDS)g 
Data assessors from 
AFS 
Staff members in the 
home care services 
 
X 
 
X 
 
X 
Neuropsychiatric Inventory 
Nursing home version 
(NPI-NH)h 
Data assessors from 
AFS 
Staff members in the 
home care services 
 
X 
 
X 
 
X 
Activities of Daily Living -  
assessed with the Physical 
Self-Maintenance Scale 
(PSMS)i 
Data assessors from 
AFS 
Staff members in the 
home care services 
 
 
X 
 
 
X 
 
 
X 
The EQ-5D questionnairej, 
to evaluate pain and 
discomfort 
Data assessors from 
AFS 
Patient 
x 
 
X 
Quality of Life in Late 
Stage Dementia scale 
(QUALID)k 
Data assessors from 
AFS 
Staff members in the 
home care services 
 
X 
 
X 
 
X 
RSS (Relative Stress Scale)l 
Next of kin  
Data assessors from 
AFS 
next of kin 
 
X 
 
X 
 
X 
Notes: aAge is to be used as covariates in the RCT; bAFS = Research centre for Age-related Functional decline and disease; 
AFS, Innlandet Hospital Trust); cClinical Frailty Scale (CFS) (41); dGeneral Medical Health Rating Scale (GMHR) (54); eClinical 
Dementia Rating Scale (CDR) is to be used as covariates in the RCT (55); fPRACTIC Goal Setting Interview (PGSI) (56);  
gMinimal  Data Set (MDS) (57); hNeuropsychiatric Inventory (NPI-NH) (45); iPhysical Self-Maintenance Scale (PSMS) (50); jEQ-
5D questionnaire (53); kQuality of Life in Late Stage Dementia scale (QUALID) (46, 47); lRelative Stress Scale (48). 

27.11.23 
 
Data describing the municipalities and the organization of the home care services will be assessed in 
the process-evaluation study part (WP3) of the PRACTIC project. To capture the care providers’ 
adherence and fidelity to the adapted TIME model during the trial, members of the research team 
will contact one of the TIME administrators in each IM two times with two months interval during 
the trial to fill in a fidelity checklist with the four main components of TIME (i.e., the assessment 
phase, the performance of the case conferences, the actions taken and a systematic evaluations of 
these actions). This check-list will also capture any adaptions of the intervention and the TIME model 
done by the local project group. The checklist will be developed as a part of the PRACTIC process 
evaluation study in WP3.   
 
Data collection for the qualitative data (RQ3) 
The interviews will based on a semi-structured interview guide where the participants will be asked 
to reflect on two main themes (58): 1) their experiences on how their health and care challenges 
were approached and eventually resolved during the trial and 2) their experiences in participating in 
shared decision-making about their care with the home care services and their GP. These main 
themes will be developed upon during the interview with open-ended and exploratory questions. 
When other key themes emerge spontaneously during the interviews, time will be allotted to 
elaborate these themes. 
  
Data processing and statistical analysis of quantitative data for RQ1 and RQ2 
The data will be presented as frequencies and percentages for categorical and means (standard 
deviations) for the continuous variables. The normality of continuous variables will be assessed 
graphically. If necessary, skewed data will be transformed. Differences in the changes in outcomes 
between the intervention group and the control group will be assessed by a linear mixed model with 
fixed effects for time component and group and the interaction between the two. The analysis will 
be performed as an intention-to-treat analysis. A significant interaction will imply the differences in 
change between the groups. Random effects for patients nested within municipalities and slopes (if 
significant) will be included into the model. Individual time point contrasts will be derived within 
each group at each time point with the corresponding 95% confidence intervals and p-values. Linear 
mixed model correctly adjusts estimates for intra-cluster correlations as well as for intra-individual 
correlations due to repeated measurements in time. The model also handles unbalanced data by 
allowing inclusion of all available information, also from dropouts. The analyses for primary and 
secondary outcomes will be adjusted for baseline PGSI-scores, baseline severity of dementia (Clinical 
Dementia Rating), and age of the participants. 
 
For RQ2 the dependent variables will be the changes from baseline in primary or secondary 
outcomes that are statistically significant after the implementation of TIME. Independent variables 
will be participants characteristics from the RCT, and organizational data (staff characteristics and 
organizational data) assessed in the process evaluation study in WP3. 
 
Data analysis of qualitative data for RQ3 
For the analysis, thematic content analysis will be used. Thematic content analysis is a method with 
the purpose to identify, analyse, and report patterns and themes in qualitative data (59, 60). The aim 
is to provide a systematic description of both the manifest and latent content of the data, and in the 

27.11.23 
 
end to evolve new concepts and understanding of phenomena. Accordingly, our analysis will consist 
of four steps: (1) an overall impression obtained from repeated reading of the transcribed text; (2) 
identification of meaning units using coding and condensation of these meaning units. Coding will be 
effected by labelling related text elements, excised from the original text, and reassembled as 
meaning units in a new document; (3) abstraction of these units by grouping them into subthemes 
and then the subthemes into main themes; and (4) a summation of these subthemes and themes 
seen in the context of our research questions, existing theory or new theoretical formulations, if 
necessary (59). 
  
Ethical considerations 
The Data Protection Official, Innlandet Hospital Trust, has approved applications. The collected data 
from the sampled patients will be de-identified and stored on a secured research server at Innlandet 
Hospital Trust. Participants with the capacity to provide consent will be asked to give their written 
consent; assessment of such capacity will be performed by the local project nurses (RN) who have 
experience of doing such assessment. In addition, these RN will be given extra training by the 
research team, who has long clinical experience in preforming capacity assessment. For patients 
considered to lack the capacity to consent, the next of kin will be informed about the research and 
asked to provide consent on the patient’s behalf. The consent implies an understanding of what it 
means to participate in the RCT and the interviews and the ability to express an informed choice. 
Separate consents for participating in the RCT and the interviews will be obtained. It is very unlikely 
that a participant would be harmed because of participating in either the RCT or the interviews. In 
the RCT, no new experimental treatments for the patients will be introduced, and care and 
treatment actions will rely on recommended national care and treatment guidelines. The patients in 
the control group will receive care and treatment as usual but will probably also profit of the extra 
attention given by the services because of participating in an RCT. It is not possible to achieve 
blinding of the local home cares services for the recruitment process since it is the local home care 
services with the aforementioned local project nurses who will be responsible for the recruitment 
process based on the inclusion criteria (e.g., perceived by the home care service as being in an 
unstable situation). This will also be the case for the results of the allocation process (i.e., to the 
intervention or control group).  
 
For RQ3, both patients and their next of kin who are invited to participate in interviews will be asked 
to give their written consent. During the interview, the participants will be well taken care of by 
interviewers who have long clinical experience in working with people with cognitive impairment. If 
during the interview the patient indicates or signals that he/she wants to stop, the researcher will 
immediately end the interview. A patient who lacks understanding of what it means to participate in 
research but consents to participate in an interview will be given the opportunity to bring their next 
of kin to the interview. Even if some of the participants have cognitive impairment and lack of 
capacity to understand the concept of research, they may still have the capacity to understand and 
express relevant views on the services they receive. Hearing their experiences with crises and how it 
was handled by the service is therefore important. This is a patient group that is prone to crises, but 
also to neglect and probably poorer treatment from the service since they often have difficulty 
promoting their needs, preferences, and desires. This is an important reason why this group of 
patients should be included in both the RCT and the interview study with the common final aim to 
improve approaches towards crises. 

27.11.23 
 
 
Since the local project groups can consist of staff members from home care services, precautions will 
be taken to ensure that the members of the local project group that inform the users and their next 
of kin, don’t have any care-relation to the participants invited to participate in the interview study 
(RQ3). In this way the users of home care services and their next of kin should do not feel obliged to 
participate upon being informed about the project. Members of the local project groups will only 
share information about the project with users and hand out written information and consent forms. 
In this way, the members of the local project group will not know whether the users of home care 
services and their next of kin have consented to participate or not.  
 
Potential impact of the proposed research 
Due to the patients' multimorbidity, changes in home care services can hardly be introduced as 
standardized solutions based on single diagnoses but should be made through holistic approaches 
based on multimorbidity and functional impairments. The PRACTIC study will enhance innovation 
where health professionals, management, and users actively participate in the development of new 
knowledge and a new approach towards each patient and where this process is adapted to local 
structural conditions. The project is likely to enforce a systematic cooperation with the GPs, where 
diagnostic work-up and follow-up become one of the most important tasks. For the home care 
services, this means a cultural change from a mainly task-oriented service based on failure in 
activities of daily life, to an interdisciplinary assessment and follow-up service of functional 
impairment in the user group. If successful, the intervention can, based on the process evaluation 
study in WP3, easily be implemented in the healthcare services with minimal extra resources. 
Improving the approaches to crisis may reduce the use of specialist healthcare services. 
 
Project organization and collaboration 
This study is a part of the PRACTIC study: Preventing and approaching crises for frail community-
dwelling patients through innovative care. The project is owned by the Research Centre for Age-
Related Functional Decline and Disease (AFS), Innlandet Hospital Trust, Ottestad, Norway. The 
project manager of the PRACTIC study is PhD MD Sverre Bergh, research leader at AFS, who will, 
together with professor Øyvind Kirkevold (AFS), PhD MD Bjørn Lichtwarck (AFS) and PhD RN Janne 
Myhre (AFS) also be part of the research team in this project. The research group has extensive 
research experience in health care services for patients with complex care needs.  
 
The project has organized two reference groups, one with end-users (patients and next of kin) and 
one with staff from the home care services including GPs. The reference groups will meet with the 
central project group regularly during the project period. A steering group will be organized, 
consisting among others of stakeholders from municipalities and the county governor of Innlandet. 
The design of the project will enable close cooperation with end-users and stakeholders in the 
municipalities, through the establishment of local project groups in each municipality. 
 
Collaborators in the project 
Collaborating municipalities will recruit participants to the different sub-studies, organize local 
project groups, be active in the local adaptation and development of the TIME model, and 
participate in the reference groups. So far, four municipalities have signed an intentional 
agreement. The municipalities will contribute to the teaching of staff and data collection.  

27.11.23 
 
Hochschule fȕr Gesundheit (hsg) Bochum, University of Applied Sciences (Germany, Prof. Daniela 
Holle), has developed the case conference model WELCOME-IdA, similar to the TIME model, and 
published papers on a step-wedged cRCT and the process evaluation (61-63). They will contribute to 
the plan for the analyses, interpretation of the results, and writing of papers in WP2 and WP3.  
The Norwegian National Advisory Unit on Ageing and Health (Norway, Prof. Geir Selbæk), has 
extensive experience in performing research in municipality healthcare in Norway, including 
recruitment of participants from home care service. They will participate in all WPs, in the design of 
the study, recruitment of municipalities and participants, analysis and writing of papers.  
The Centre for Development of Institutional and Home care Services (USHT) Innlandet (PhD Irene 
Røen and Målfrid Schiager) has a network of collaborating municipalities in Innlandet county, and a 
network of USHTs in Norway. They will contribute to the design of the study, will recruit 30 
municipalities for the study, and will contribute to the organisation of the study and collaboration 
with the municipalities.  
Collaborating partners in the study will not have access to any of the data.  
 
Plan for activities 
Three papers will be published in international peer reviews open journals.  
In addition, results from this study will be presented by oral presentation at national and 
international congress.  
 
Time schedule 
PhD 75% position for four years 
01.06.22: Application to the Regional Committees for Medical and Health Research Ethics. 
Application to the The Data Protection Commissioner, Innlandet Hospital Trust.  
01.04.22 – 31.08.22: : Detailed planning of the project, recruitment of municipalities, signing 
agreements with municipalities and establishing local project groups in each municipalities. 
01.09.22 – 31.12.22: Educational sessions for the local project nurses in the home-care services 
designated to assist with the inclusion of patients and their next of kin.  
01.01.23 – 31.12.23: The RCT: Inclusion of participants, baseline measurements, randomisation and 
allocation procedures, start of intervention with educational sessions in IM, and follow-up data 
collection of outcomes after 3 and 6 months after baseline in IM and CM.  
01.01.24 – 30.06.24: In-depth interviews for RQ3. 
01.01.24 – 31.01.25: Analyses of data from the RCT (RQ1) and for RQ2, writing and submission of two 
papers.  
01.02.25 – 30.11.25: Analysis of interviews for RQ3, writing and submission of paper. 
01.08.25 – 31.03.26: Writing of thesis, dissertation, and dissemination. 
 
Abbreviations 
Declarations section 
Consent to publish 
Not applicable 
 
Competing interests 

27.11.23 
 
The authors declare that they have no competing interests. 
 
Authors’ contributions 
 
Availability of data and materials 
The datasets supporting the conclusions of this article are available on the website for the PRACTIC 
study. 
 
 
 
Funding and acknowledgments 
The study is funded in total by a grant from the Innlandet Hospital Trust (project number: 150667). 
 
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27.11.23 
 
Figure 1. The PRACTIC trial: Flowchart of the clusters and patients throughout the phases of the trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment meetings with home 
care services leaders and GPs 
from a list of 60 randomly 
selected municipalities (Ms) 
Cluster randomisation:  
30 Ms with 150 patients will be 
randomised 
Training of staff from the 30 Ms 
on inclusion procedures 
Inclusion criteria assessment of 
eligible patients in 30 Ms  
150 patients fulfil the inclusion 
criteria and consent to participate 
Visit I: Baseline assessment of 
150 patients 
15 control Ms, 75 patients 
allocated to control group 
Continue care and treatment as 
usual (CTAU) 
Visit II: Assessment after 3 
months   
Staff starts intervention with 
TIME based on the manual and 
receive 5 hours + 3 hours of 
education/training 
 
15 intervention Ms, 75 patients 
allocated to intervention group 
Visit III: Assessment of 56 
patients after 6 months  
Visit II: Assessment after 3 
months 
Visit III: Assessment of 56 
patients after 6 months  
Approximately 30 Ms agree to 
participate 
Anticipated 
loss to 
follow-up 19 
patients 
(25%) 
Anticipated 
loss to  
follow-up 19 
patients 
(25%) 

27.11.23 
 
Table 1. The assessment phase 
 
 
 
 
 
 
 
Checklist for the assessment phase
The following 
should  be 
performed:
PRACTIC Goal Setting Interview (PGSI)
Personal history and conversation with the person: what is the person's perspective? 
For example, "Who am I?"
Medical history: A summary
Somatic and psychological assessment and examination
ADL assessment: Activities of daily living
Nutritional screening 
Suspected 
conditions:
☐Yes ☐No If dementia is suspected, start a basic dementia assessment. In the case of 
known dementia, assess the degree of dementia.
☐Yes ☐No If pain is suspected, conduct a pain assessment.
☐Yes ☐No In the case of behavioral and psychological symptoms, map the 
symptoms.
☐Yes ☐No In case of nutritional difficulties, perform nutritional mapping.
☐Yes ☐No In case of acute confusion (delirium), map the synptoms and contact a 
doctor.
Agree upon a time and place for the case conference: TID administrator/manager

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Table 2. Agenda and timeframe for the case conferences 
 
Agenda for guided reflection meeting (case conference), approximately 1 hour 
Activity
Preparation: Convene a meeting and prepare a meeting room with a blackboard or 
similar facilities (projector, if available). Check that a flip pad and markers are 
available. As many as possible from the home care service staff should attend the 
conference. The leading registered nurse and the GP should attend the conference, if 
possible. 
1. Status Report: Personal history and main points from the patient’s medical record 
are presented, 10 min. Decide in advance who should prepare and present the 
patient’s personal history and the main points from the medical record.
2. Create a problem list, approximately 5 min.
3. Prioritize problems from the list, approximately 5 min.
4. Draw a five−column table on the whiteboard that includes facts – interpretations 
(thoughts) - emotions – actions – evaluation. 
5. Describe facts from the registration and assessment phase one problem at a time, 
approximately 10 min.
6. Suggest interpretations – guided discovery – discuss and reflect on the 
interpretations, approximately 10 min.
7. Describe any emotions experienced by the staff with interpretations by the staff, 
approximately 10 min.
8. Suggest SMART (Specific, Measurable, Achievable, Relevant, Time-bound) 
actions based on the interpretations and decide how and when to perform an 
evaluation of the actions, approximately 10 min.
9. Summarize interpretations and actions and close the meeting, approximately 5 
min.