A New Care Model for Patients With Complicated Multimorbidity A Cluster-randomised Pilot Study in General Practice, Municipalities, and Hospitals
Phase: NA
Conditions: Multimorbidity
Sponsor: Slagelse Hospital

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Official title: 
A new care model for patients with complicated multimorbidity. 
A cluster-randomised pilot study in general practice, municipalities, and 
hospitals  
 
NCT number: 
05406193 
 
Document date: 
May 23, 2022 
 
 
 

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Background 
The increasing prevalence of multimorbidity, defined as the coexistence of two or more chronic 
conditions in the same person [1], [2], is driven by the aging population and improved health 
technologies and represents a major challenge for healthcare systems. In the Capital Region of Denmark 
and Region Zealand, about 22% and 37% of the citizens aged 16 years and older suffer from 
multimorbidity [3], [4]. Around 10% of people with multimorbidity have complicated multimorbidity 
characterized by suffering from a symptom complex with several concomitant chronic conditions [5]. 
Researchers have proposed different definitions of complicated multimorbidity such as the severity of 
conditions, perception of illness, and more [6], [7]. Patients with complicated multimorbidity often have 
reduced health-related quality of life [8], [9], high treatment burden, polypharmacy, reduced ability to 
work, low employability, and increased mortality [5].  
Healthcare systems are designed to take care of patients with single conditions. 
Unfortunately, the organisation according to specialities causes problems for the provision of integrated 
care for patients with multimorbidity. Thus, care pathways are often fragmented, with multiple 
appointments, more frequent hospital admissions, ambulatory visits, and use of other healthcare. The 
underlying causes for fragmented care are associated with the lack of a clear division of responsibilities 
and insufficient coordination between healthcare organisations. This is aggravated by non-integrated 
economic incentives between general practice, municipalities, and hospitals as well as by IT systems 
that are not always compatible and different care- and leadership cultures. Disease management 
programs (DMPs) have been developed to support integrated care but these may not be adequate for 
patients with multiple conditions and lowered self-care ability, and adhering to multiple DMPs may 
result in too much medication, conflicting treatments, an overload of appointments, and fragmented 
health care [10]. Also, providing care to patients with multimorbidity in practices where the rate of 
patients with multimorbidity is high seems to increase risk of burnout among general practitioners (GPs) 
[11]. 
However, while the challenges are widely acknowledged [12] and there is some 
consensus about key components to improve care [13], knowledge of the most appropriate organisation 
of healthcare services to ensure patient-centred, high-quality integrated care for patients living with 
complicated multimorbidity is limited [14], [15].  
In Denmark, general practice is the key organisational setting in terms of offering people 
with complicated multimorbidity integrated, patient-centred care. General practice has responsibility 
for the continued and longitudinal care of all patients’ diseases. The approach is patient-centred and 
often includes collaboration with the families. A recent study showed that GPs provide chronic care to 
patients with multimorbidity, and those with low socioeconomic status, but service provision varied 
highly and more than expected across practices. Remarkably, GPs provided slightly fewer chronic care 
services than expected in practices where many patients with multimorbidity and low socioeconomic 
status were clustered, suggesting inverse care law mechanisms [16]. 
To improve care for patients with complicated multimorbidity in general practice, we 
developed a complex intervention model named, “patient-centred complex intervention in complicated 
multimorbidity (CIM)” [17]. The model was developed based on evidence from the Chronic Care 
Model [18], [19], models of care for multimorbidity [14], [15], [20], and results from our own research 
[3], [4]. Components of the CIM model included training of health professionals, a longer consultation 
time to facilitate patient-centred care [18], [19], [21] through the “overview consultation”, and reduction 
of control visits if appropriate. Further, integrated care was supported by a care coordinator, and shared 
patient information (individualized care plan) between organisations. The CIM model was tested in a 
feasibility study showing promising results regarding the implementation and acceptance of the CIM 
both by patients and healthcare professionals [17]. Based on the results from the feasibility study, and 
other national studies, the present project has developed an improved version of the CIM model named 

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the CIM2 model [17], [22]. The new CIM2 model includes improved training of healthcare 
professionals, strengthened identification of patients with complicated multimorbidity, adjustment of 
extended consultation according to the consultation model of DSAM, improved medical treatment, and 
strengthened integration of care services between healthcare organisations [17] [23]. 
The results from the first study of the CIM model [17] attracted the attention of 
policymakers in primary care, and the new collective agreement for general practice includes a plan to 
perform a large intervention project based on similar ideas and involving 600 GPs (hence labeled 
MM600 in the following). This has created a new critical potential for scaling up the elements from the 
CIM2 model at the national level. However, prior to large-scale implementation – and in accordance 
with the Medical Research Councils guidance on complex interventions [24] – the intervention must be 
pilot tested at a smaller scale in order to assess its functionality and effectiveness. For this purpose, we 
have designed the present pilot study named MM14 (since it includes 14 GPs). The MM14 pilot study 
will develop and strengthen the CIM2 model, and the results will be used to shape the MM600 national 
project. 
 
Aim of the pilot study  
The overall aim of this study is to evaluate important aspects of the “Complex intervention for patients 
with complicated multimorbidity model, version 2” (CIM2 model) in a pilot cluster-randomised 
controlled trial (RCT) before conducting a larger cluster RCT[25] being part of the research project 
described in the Agreement between PLO and Danish Regions 2022 (OK22).  
 
The evaluation of the pilot study has three main objectives [26]:  
 
1) To assess the acceptability, workability and value of the model as experienced by health professionals 
and patients. In particular, this includes:  
 
a) Assessing if and how the model supports patient-centred care as experienced by patients and 
professionals 
b) Assessing if and how the model supports integrated care between general practice, hospital, and 
municipality as experienced by patients and professionals 
c) Identifying important facilitators and barriers for implementing the model in practice. 
 
2) To assess the acceptability and feasibility of the cluster RCT study design and procedures;  
 
3) To assess and qualify the preliminary power calculations of the Patient Assessment of Chronic Illness 
Care (PACIC) questionnaire statistical estimates for the main RCT cluster study that is planned in the 
MM600 project. 
 
The results from the pilot study will be used to develop and strengthen the CIM2 model and the design 
of the MM600 project.  
 
Timeline  
The feasibility study took place in the years 2017-18 [17]. The pilot study (MM14), takes place in 2022-
2023 with a three months inclusion period and 12-month intervention period. The main RCT study 
(MM600) will take place in 2023-2024. 
 
 
Methods and design  

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Study principles and study design 
The pilot study includes 14 general practice clinics – seven will be allocated to CIM2-group and seven 
will be allocated to perform usual care. Each practice will include 25 patients with complicated 
multimorbidity, thus, in total 350 patients. At 6 and 12 month intervention period, the patients’ 
assessment of perceived patient-centred integrated care, health-related quality of life, and treatment 
burden will be measured in both groups (Figure 1).  
 
Figure 1. The flow diagram illustrates the structure of the RCT pilot “A new care model for patients with 
complicated multimorbidity – A cluster-randomised pilot study in general practice, municipalities, and 
hospitals”. Patient Assessment of Chronic Illness Care (PACIC), EuroQol-5 Domain (EQ-5D-5L), 
Multimorbidity Treatment Burden Questionnaire (MTBQ). 
 
 
 
Setting  
The study will be carried out in Region Zealand and the Capital Region of Denmark, in general practices 
in three municipalities, in close collaboration with healthcare centers in the municipalities and hospital 
medical departments hospitals. The general practices should have a minimum of 4,500 patients 
registered to make sure that the number of patients with complicated multimorbidity reaches the needed 
number of 25 patients per practice. In addition, the practice needs to be able to include a care coordinator 
a few hours per week for five months. The municipalities were selected based on the rank of 
sociodemographic groups (III and IV, lowest) as the prevalence of patients with complicated 
multimorbidity is higher and the patients are sicker from their multimorbidity. Moreover, the possible 
benefits of the CIM2 model are expected to be larger in patients from municipalities of these 
sociodemographic groups. 
  

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Randomization and blinding 
General practices in the designated municipalities are contacted with an invitation to participate in the 
study. If a general practice agrees to participate in the project, they will receive detailed study 
information. The 14 participating general practices will be randomised into either the intervention group 
providing care as described in the CIM2 model or the control group, providing usual care. The general 
practices will be randomly allocated, at an allocation rate of 1:1, by a computer program. To ensure 
concealment of allocation, a data manager from another organisation with no interest in the project will 
provide the information of the randomization to the general practice draw and will be responsible for a 
randomization list, which will be available to the investigator. Due to the nature of the study, the general 
practices and the patients cannot be blinded. 
Eligible patients 
The healthcare professionals in general practice identify eligible patients for the project. Identified 
patients receive oral and written information about the study from the care coordinator. Patients who 
agree to participate provide informed consent for participation in the study collected by the care 
coordinator. 
  
Inclusion criteria: 
The study group is patients with complicated multimorbidity in general practice that fulfil the 
fourinclusion criteria:  
1. Has more than one of the 3 common chronic diseases (diabetes,  chronic obstructive pulmonary, 
chronic heart conditions) [27].  
2. Has been hospitalised, or visited an outpatient clinic due to their chronic diseases during the 
previous year [17].  
3. Take at least five different prescription drugs assessed from the Shared Medicine Card 
recording (FMK, in Danish “Fælles Medicinkort”) in the general practice [28]. 
4. The GP or the nurse in the practise recognise the patient as a “demanding” patient with 
complicated multimorbidity that will benefit from an overview consultation.   
 
Exclusion criteria: 
Patients who cannot speak Danish, cannot give informed consent, for example, people with dementia, 
or who have a life expectancy of less than 12 months will be excluded. 
 
Definition of complicated multimorbidity: 
The patient has more than one of the 3 common chronic diseases (diabetes, chronic obstructive 
pulmonary, chronic heart conditions) [27], has been hospitalised, or visited an outpatient clinic due to 
their chronic diseases during the previous year [17], take at least five different prescription drugs 
assessed from the Shared Medicine Card recording (FMK, in Danish “Fælles Medicinkort”) in the 
general practice [28]. Lastly, some multimorbidity patients are more loosely defined by the GP or the 
nurse in the practice that recognise the patient as a “demanding” patient with complicated 
multimorbidity that will benefit from an overview consultation.   
 
 
Intervention 
Development of the CIM2 intervention 
The intervention elements in the CIM2 model have been inspired by the recommendations from the 
Medical Research Council guidance as described in the following four bullets [25] [24]. 
 

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Medical Research Council guidance for development of a complex intervention 
 
Identify and development of intervention: The project has undertaken a literature review in the field 
of organisation of care in multimorbidity to support the development of the intervention planned to 
be published in the autumn of 2021. The underlying development theory relies on the Chronic Care 
Model and uses methods as described for developing and evaluating complex interventions [25]. 
The interventions will be further developed based on information from participating researchers 
and health professionals.  
 
Assessment of the feasibility study and interventions: Assessment of the feasibility study and 
interventions has been reported previously [17].  
 
Implementation: the intervention is developed to impact everyday work in the general practice, in 
the municipality, and hospitals to a minimum. The GPs adopt a new type of consultation for a 
patient with complicated multimorbidity and both general practice, municipalities, and hospitals are 
part of the improved integrated care provision. Healthcare services and rehabilitation offered will 
remain within the already exciting guidelines. The GPs and hospitals are offered the opportunity 
for using cross-sectorial video conferences as described in the OK22 Agreement.   
 
Assessment of the complex intervention: This is described in the section “Evaluation” on page 4 in 
the project description. 
 
The intervention elements in the CIM2 model (Figure 2.) 
 
 
Training of healthcare professionals during a four-hour one-day course 
The training program is developed in collaboration with The Danish College of General Practitioners. 
Healthcare professionals from general practice, nurses and physiotherapists from the municipalities, 
and healthcare professionals from the out-patient clinics participate in a training program. Healthcare 
professionals from general practice will receive training in project content, and methods to recruit and 
include patients (including informed consent). Further, does the education program offer training in the 
collection of patient data comprising the use of REDCap software for patient questionnaires. 
For general practices allocated to the intervention group, the training also includes how to provide 
medical care for patients with complicated multimorbidity, case-based teaching, patient centred 
methods, structure and implementation of the extended overview consultation, and development of the 
care plan. Further, the training cover methods for improving collaboration and integration between 
general practice, the municipality, and the out-patient clinics using methods known from the national 
disease management programs. 
 
 
The extended overview consultation (in Danish “overblikskonsultation”) in general practice 
The patient intervention starts with an extended overview consultation, lasting 45 minutes, with the GP, 
the patient (and maybe a relative), and the care coordinator. The consultation is based on the guidance 
for a patient-centred overview status for patients with multimorbidity published by The Danish College 
of General Practitioners [29]. The aim is to get an overview of the patient’s conditions, problems, and 
needs. The patient’s goals, preferences, and needs are identified, and treatments of the patient’s various 
conditions are prioritized.  The GP decides who has the treatment responsibility for each condition. The 
patient’s resources for handling the chronic diseases are elicited, and if the patient is motivated, a 
referral to a relevant rehabilitation program in the municipality is planned [30]. The individual care plan 
is developed, covering planned activities in the three sectors that will take place within the 12-month 
intervention period. The GP will try to reduce the number of outpatient visits in the hospital or replace 

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outpatient visits with GP visits if the patient and the specialist agree. The GPs are reimbursed with 1.000 
DKK. for the extended overview consultations  
 
Figure 2. Central activities during the implementation and intervention phases of the study “Complex intervention 
for patients with complicated multimorbidity model version 2 (CIM2)” over time.  
 
 
 
 
The individual care plan 
The individual care plan includes 6 themes: [29] 1) Listing of important diagnoses, 2) Overview of the 
patient’s prescription drugs, 3) Prioritising the patients’ treatment goals (using shared decision-making), 
4) Development of a coordinated care plan with telephone follow-up and future visits, 5) Plan for 
potentially reducing the number of visits to hospital out-patient clinic for example by shifting hospital 
outpatient clinic visits to general practice, and 6) Referral to community-based rehabilitation. The care 
plan is printed for the patient. 
  
 
Care coordinator 
General practice coordinates the planned patient care between general practice, the municipality, and 
the hospital, and follow-up on the execution of planned healthcare activities. The care coordinator 
function might be undertaken by the GP or the nurse in the practice. The practice plans the division of 
responsibilities and tasks in the project between the GP and the nurse. 
 
 
Follow-up activities  
The follow-up activities include telephone calls to the patient by the care coordinator at relevant time 
intervals according to the severity of conditions and other important factors to follow up on planned 
activities with the patient. A second extended overview consultation takes place after 12 months.  
 
 
Integration of care elements 

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The individual care plan is shared electronically with the healthcare center in the municipality and with 
the outpatient clinics using the standard IT-communication tool provided by MedCom and a routinely 
used national standard in general practice, hospitals, and municipalities.  
The GPs and hospitals are offered the opportunity for using cross-sectorial video conferences to plan 
the patient pathway as described in the OK22. This means that the GP arranges the conference when 
there is a professional indication for the conference. The GPs’ participation in the videoconference is 
reimbursed.  
The health professionals in the municipality provide information to the GP when patients have finished 
a rehabilitation program.  
 
The control group – usual care  
Patients with a GP allocated to the control group will receive usual care. To reduce the possibility of 
the Hawthorne effect, patients are offered a routine consultation conversation with a focus on patients 
everyday life with the nurse in general practice.  
 
 
Evaluation and data collection 
The main evaluation objectives of the study will be addressed as follows: 
 
1) Assessing acceptability, workability and value for health professionals and patients  
This part of the evaluation will investigate how professionals and patients experience the model in terms 
of acceptability, workability and value. In particular the evaluation will assess whether the intervention 
supports patient-centred care and integrated care between general practice, hospital, and municipality. 
Also, this part of the evaluation will identify important facilitators and barriers for implementing the 
intervention in practice. These objectives will be achieved using a mix of qualitative and quantitative 
data.  
At the end of the intervention, qualitative semi-structured interviews are performed with health 
professionals and patients. The interviews will include GPs and practice nurses from the seven practices 
in the intervention group as well as a number of healthcare professionals from the municipalities and 
hospitals who become involved in the cross-sectorial collaboration with the practices in the intervention 
group. Additionally, 15 patients will be interviewed.  
The interviews will focus on the participants’ experiences with the extended overview consultation and 
with the collaborative cross-sectorial elements of the intervention (especially video conferences and 
sharing of patient data). The interview guides will be informed by Normalization Process Theory (NPT) 
– a widely used theory to study the implementation of complex interventions in health care [31]–[33]. 
Following NPT, the interviews with health professionals will explore how they make sense of the 
intervention, how they engage with its various elements, how they operationalize the intervention in 
practice, and how they assess the value of the intervention. The interviews with patients will explore 
how the patients have experienced their treatment trajectory in terms of coherence and understanding 
of health care needs in relation to their expectations to integrated care. Also, the interviews with 
professionals and patients will explore their perceptions of facilitators and barriers to patient-centred 
and integrated care as well as their suggestions for how care can be improved. The interviews are 
recorded, transcribed, and subsequently analysed by thematic analysis and NPT.   
Further, since the extended overview consultation is a key element in the intervention, video recordings 
of conducted intervention consultations are gathered and analysed to evaluate if the consultation 
supports the relational competencies of the GPs needed to ensure that the patients concerns and priorities 
are articulated and taken into account. A combination of interactional linguistics [34] and a 

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psychological interpretative framework [35] is used to analyse the relational aspects of the interactions. 
The video recordings will furthermore be used for evaluation in the conduction of video-stimulated 
recall interviews (VSRI) [36]. These interviews will elucidate how elements of the model affect the 
GPs’ ability to work with relational competence, to help reduce work burden and prevent burnout. The 
analysis conducted for this evaluation will consist of Conversation Analysis and a psychological 
interpretive framework [35]. 
To supplement the qualitative data on the delivery of the intervention, quantitative data will be 
generated from the REDCap data collecting program (e.g., number of consultations delivered, number 
of care plans prepared, and the extent of cross-sectorial communications). 
Based on the overall analysis, a proposal is prepared for the possible adjustments of the CIM2 model 
before the national trial. Subsequently, the results (including any adjustment proposals) are 
communicated to relevant stakeholders, who are given the opportunity to comment on the results, which 
may give rise to further adjustment to the CIM2 model before the national trial. 
 
2) Assessing the acceptability and feasibility of the cluster RCT study design and procedures 
The acceptability and feasibility of the study’s tools and procedures for randomisation, recruitment, and 
data collection will be assessed through qualitative interviews with health professionals and patients 
supplemented by quantitative data generated by the study (e.g., variations in the number of recruited 
patients and questionnaire response rates). Patient characteristics according to age, gender, chronic 
conditions, medication, and care plans will be presented to the general practitioners, nurse care 
managers, and specialists to validate whether the identified and recruited patients are the “right” patients 
in need of the CIM2 model and the inclusion criteria are relevant.  
Patient-reported questionnaire-data for Patient Assessment of Chronic Illness Care (PACIC), EuroQol-
5 Domain (EQ-5D-5L), and Multimorbidity Treatment Burden Questionnaire (MTBQ).will be 
collected by electronic links by the REDCap software provided to patients at baseline, at 6-month 
follow-up, and at 12-month follow-up. If patients do not have IT-support at home, they will receive the 
questionnaires on paper.   
The applicability of the following questionnaires will be evaluated from the completion rates of the 
questionnaires: 1) PACIC [37], [38], 2) EQ-5D-5L, and 3) MTBQ [39].  
 
3) Assessing and qualifying the preliminary power calculations of the PACIC questionnaire statistical 
estimates for the main RCT cluster study that is planned in the MM600 study 
Prior to the beginning of the pilot study, we performed a preliminary power calculation to get an 
understanding of the size of a future main RCT and whether this seemed realistic to use the PACIC 
questionnaire assessed from the statistical power of the questionnaire. To perform this power 
calculation, we made several assumptions. First, to our knowledge, no minimal important difference, 
which provides a ”measure of the smallest change in the patient-reported outcome of interest that 
patients perceive as important”, has been defined for the PACIC score. However, previous studies have 
reported a change in the PACIC score to be 0.36, to be clinically significant [39]. Hence, the power 
calculations are made towards detecting this difference between the two groups. Second, the power 
calculations take a potential Intraclass Correlation Coefficient (ICC) of 0.1 into account, which is an 
upper limit of values found through our literature search for similar studies [39]. Third, literature studies 
directed a choice of the total variation of 1. Fourth, we require that each clinic will recruit 25 patients 
and, with a random loss to follow up of 30%. From the stated assumptions, we base ourselves on the 
following random effects model for those not lost to follow up: 
𝑌𝑖= 𝛼𝐺𝑟𝑜𝑢𝑝(𝑖) + 𝑍𝐶𝑙𝑖𝑛𝑖𝑐(𝑖) + 𝜀𝑖, 𝑖= 1, … , 𝑛 

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where the variation of the random effect component 𝑍 reflects the ICC. Simulating the above model for 
10.000 times per choice of the number of clinics in each group, with individually evaluated random loss 
to follow up, yields a power of 78%, 84% for 6 and 7 clinics in each group, respectively, based on a 
two-sided test at the level 𝛼= 0.05. The uncertainty of these powers is found to be less than 1 
percentage point, using the binomial formula. Thus, to obtain a power of 80% for detecting the specified 
difference Δ from the random effects modeling, 7 clinics of 25 patients, i.e. 175 patients are needed in 
the intervention and control group.  
The results from the pilot study will strengthen the validity of the estimates and clarify assumptions 
used in the power calculation. In particular, the results will clarify the need for implementing an ICC in 
the analysis of the main RCT, and if so, provide the power calculations with an estimated ICC value 
adapted to local conditions. Furthermore, the results from the pilot study will help to ascertain if 25 
patients from each practice is a realistic number to include in the main RCT.  
 
Data obtained from national health registers 
Data from national and health registers is used for 1) assessment of the comparability of the intervention 
and control groups according to sociodemographic, chronic conditions, medicine, and 2) assessment of 
utilization for health-care services. 
From registries at Statistic Denmark, data on sociodemographic information in 2021 will be retrieved 
for both patients in the intervention and control group, using the unique 10-digital personal 
identification number (CPR number). We will use The Danish Civil Registration System [40] to obtain 
information on sex, age, and cohabitation. Educational level will be retrieved from The Danish 
Education Register [41]. Work marked affiliation will be obtained from the Employment Classification 
Module (AKM) [42], which contains information on economic and employment conditions. 
Information on utilization of health-care services, such as hospitalizations, bed days, emergency visits, 
out-patient visits, general practice visits, out-of-hours general practice visits, and specialist visits will 
be obtained from the Danish National Patient Registry (NPR) [43].  
 
 
Dissemination and maintaining of results 
The scientific dissemination will consist of the publication of several articles in scientific journals in 
open-access, high-quality international journals, and a PhD thesis. The results will be presented at 
national and international conferences as well as at a patient seminar, inviting both patients and relatives 
included in the study. In addition, the results will be presented to the regional-community coordinating 
committees in the regions regarding enhancing cross-sectorial collaboration and used to formulate 
recommendations for organisational cross-sectoral and cross-disciplinary collaboration on complicated 
multimorbidity – in general practice, municipalities, and hospitals. Furthermore, the newest agreement 
between the Danish Regions Salary and Rate Board (RTLN) and the Danish Organisation of General 
Practitioners (PLO) has stated that research results from extended consultations will be used to improve 
healthcare services for patients with complicated multimorbidity.  
 
Ethics and approvals  
The project was notified to the Danish Data Protection Agency (applied on the 12th of November 2020) 
and the National Committee on Health Research Ethics in Region Zealand has been notified of the 
project. According to Danish law, projects like this project do not need ethical approval from a Research 
Ethical Board (protocol no.: EMN-2020-37129). The project complies with the Declaration of Helsinki. 
The project is registered at ClinicalTrial.gov.  
 

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