The Hotspotters Project. Pursuing the Triple Aim in Hotspotters: Identification and Integrated Care
Phase: NA
Conditions: Complex Patient, Multimorbidity, Psychosocial Problem, Chronic Disease
Sponsor: Leiden University Medical Center

NL78646 / Pursuing the Triple Aim in Hotspotters 
The Hotspotters project 
 
 
 
 
 
 
 
 
 
 
 
 
Pursuing the Triple Aim in Hotspotters: 
identification and integrated care 
protocol Version 4.1, April 2023 
 
 
 

NL78646 / Pursuing the Triple Aim in Hotspotters 
The Hotspotters project 
 
 
 
PROTOCOL TITLE ‘Pursuing the Triple Aim in Hotspotters: identification and integrated 
care’ 
Protocol ID 
NL78646 
Short title 
The Hotspotters Project 
Version 
4.1 
Date 
04/2023 
Coordinating investigator/project 
leader 
K.A. Leming, MSc,  k.a.leming@lumc.nl 
V. Tiemes, MSc, v.tiemes@lumc.nl 
Principal investigator(s) (in 
Dutch: hoofdonderzoeker/ 
uitvoerder 
 
Dr. R.C. Vos, r.c.vos@lumc.nl  
Dr. M.A. Bruijnzeels, m.a.bruijnzeels@lumc.nl 
 
 
 
 
 
Sponsor (in Dutch: 
verrichter/opdrachtgever) 
LUMC afdeling public health and 
eerstelijnsgeneeskunde (PHEG) campus Den Haag, 
Turfmarkt 99, 2511 DV, Den Haag 
Tel: 070-8009500 
 
 
Subsidising party 
Nederlandse organisatie voor 
gezondheidsonderzoek en zorginnovatie (ZonMw) 
CZ 
Menzis 
Independent expert (s) 
Mw. Dr. Bertien Hart, huisarts en kaderhuisarts 
diabetes  
h.e.hart@umcutrecht.nl  

NL78646 / Pursuing the Triple Aim in Hotspotters 
The Hotspotters project 
 
 
 
PROTOCOL SIGNATURE SHEET 
 
Name 
Signature 
Date 
Sponsor or legal representative: 
 
 
 
Head of Department: 
LUMC 
 
 
Prof. M. E. Numans, 
afdelingshoofd PHEG 
 
 
 
 
 
 
Coordinating Investigator/Project 
leader/Principal Investigator: 
 
 
 
 
 
 
 
Dr. R.C. Vos,  
Principle investigator, Project 
leader 
r.c.vos@lumc.nl 
 
 
 
 
 
 

NL78646 / Pursuing the Triple Aim in Hotspotters 
The Hotspotters project 
 
 
 
TABLE OF CONTENTS  
 
1. 
INTRODUCTION AND RATIONALES ............................................................................ 8 
1. 
OBJECTIVES ................................................................................................................. 9 
3.   STUDY DESIGN ............................................................................................................11 
4. 
STUDY POPULATION ..................................................................................................13 
4.1 
Population (base) ...................................................................................................13 
4.2 
Inclusion criteria .....................................................................................................13 
4.3 
Exclusion criteria ....................................................................................................14 
4.4 
Sample size calculation ..........................................................................................14 
4.5 
Investigational treatment ........................................................................................14 
5. 
METHODS ....................................................................................................................16 
5.1 
Study parameters/endpoints ...................................................................................16 
5.1.1 
Main study parameter/endpoint .......................................................................16 
5.1.2 
Secondary study parameters: Patient experience of care ................................17 
5.1.3 
Secondary study parameter: Process evaluation .............................................18 
5.2 
Randomisation, blinding and treatment allocation ..................................................19 
5.3 
Study procedures ...................................................................................................19 
5.4 
Withdrawal of individual subjects ............................................................................21 
5.4.1 
Specific criteria for withdrawal .........................................................................21 
5.5 
Replacement of individual subjects after withdrawal ...............................................21 
5.6 
Follow-up of subjects withdrawn from treatment .....................................................21 
5.7 
Premature termination of the study .........................................................................21 
6. 
STATISTICAL ANALYSIS .............................................................................................22 
7. 
ETHICAL CONSIDERATIONS ......................................................................................24 
7.1 
Regulation statement .............................................................................................24 
7.2 
Recruitment and consent........................................................................................24 
7.3 
Benefits and risks assessment, group relatedness .................................................24 
7.4 
Incentives (if applicable) .........................................................................................25 
7.5 
Compensation for injury .........................................................................................25 
8. 
ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION .............................26 
8.1 
Handling and storage of data and documents ........................................................26 
8.2 
Monitoring and Quality Assurance ..........................................................................26 
8.3 
Amendments ..........................................................................................................26 
8.4 
Annual progress report ...........................................................................................26 
8.5 
Temporary halt and (prematurely) end of study report ............................................26 
8.6 
Public disclosure and publication policy ..................................................................27 
9. 
REFERENCES ..............................................................................................................28 

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LIST OF ABBREVIATIONS AND RELEVANT DEFINITIONS  
 
ABR 
General Assessment and Registration form (ABR form), the application 
form that is required for submission to the accredited Ethics Committee; 
in Dutch: Algemeen Beoordelings- en Registratieformulier (ABR-
formulier) 
AE 
Adverse Event 
AR 
Adverse Reaction 
CA 
Competent Authority 
CCMO 
Central Committee on Research Involving Human Subjects; in Dutch: 
Centrale Commissie Mensgebonden Onderzoek 
CV 
Curriculum Vitae 
DSMB 
Data Safety Monitoring Board 
EU 
European Union 
EudraCT European drug regulatory affairs Clinical Trials  
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation; in Dutch: Algemene Verordening 
Gegevensbescherming (AVG) 
IB 
Investigator’s Brochure 
IC 
Informed Consent 
IMP 
Investigational Medicinal Product  
IMPD 
Investigational Medicinal Product Dossier  
METC  
Medical research ethics committee (MREC); in Dutch: medisch-ethische 
toetsingscommissie (METC) 
(S)AE 
(Serious) Adverse Event  
SPC 
Summary of Product Characteristics; in Dutch: officiële 
productinformatie IB1-tekst 
Sponsor 
The sponsor is the party that commissions the organisation or 
performance of the research, for example a pharmaceutical 
company, academic hospital, scientific organisation or investigator. A 
party that provides funding for a study but does not commission it is not 
regarded as the sponsor, but referred to as a subsidising party. 
SUSAR  
Suspected Unexpected Serious Adverse Reaction 
UAVG 
Dutch Act on Implementation of the General Data Protection Regulation; 
in Dutch: Uitvoeringswet AVG 
WMO 
Medical Research Involving Human Subjects Act; in Dutch: Wet Medisch-
wetenschappelijk Onderzoek met Mensen 

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SUMMARY 
Rationale:  
People with complex problems on multiple life domains, so called ‘hotspotters’, receive 
fragmented care. This is difficult to manage by patients and care providers, leading to little 
effect of care and persistent unmet needs. The accumulation and complexity of problems 
often leads to high medical expenses. Next to their high medical spending levels, 
hotspotters´ experiences with the healthcare system are low as the healthcare system is not 
(yet) successful in dealing with their needs. Interventions aimed at the complex situation of 
hotspotters in our current healthcare system might benefit by applying a Triple Aim approach. 
This approach aims to simultaneously improve the individual experience of care, reduce the 
cost of care per capita and improve the health of populations by offering proactive integrated 
care. 
 
Objective:  
Is proactive integrated care costeffective and does it result in better patients experience than 
usual care after 12 months for patients with problems on multiple life domains? 
 
Main and secundary study parameters:  
This study will focus on measuring the changes in the following:  
1. Incremental cost-effectiveness from a societal perspective. Information on cost will be 
based on patient-reported data obtained by questionnaires supplied with data from the GP 
medical files (Huisarts informatie system, HIS) and CBSmicrodata. To assess the 
effectiveness the EQ-5D-5L will be used for determining quality of life. 
 
The secondary study parameters are: 
1. Insight into patients experience of care, quality of life, proactive coping, and self-
efficacy. This information will be gathered using interviews, focus groups and 
questionnaires (SF-12, UPCC, PAM-13 & Self-efficacy and Intentie itemlist).  
2. Process evaluation with the involved care professionals, including the integration 
level of care per GP-practice, the nature of the communication between healthcare 
provider and patient (HCCQ, OPTION5), and acceptability (AIM), appropriateness 
(IAM), feasibility (FIM) ,and perceived and experienced effectiveness of the 
intervention.  
 
Study design:  
A stepped-wedge cluster randomised controlled trial (RCT) design will be used  
This study will be performed in 20 general practices that do not yet offer proactive integrated 
care for hotspotters. Data on cost-effectiveness will be quantitatively assessed. Patient 
experience will be qualitatively assessed through focus groups and quantitative using 
validated questionnaires. Besides, the process will be both qualitatively and quantitatively 
evaluated using interviews or focusgroups, observations (audio recording)  with care 
professionals on common themes of process evaluatation and a validated questionnaire. 
 
Study population:  
In total 200 hotspotters will be included. Hotspotters are individuals with at least two incidents 
of acute care utilisation (defined as out-of-office GP consultations, acute psychiatric care, 
emergency department visits and unplanned admissions) during the past year, and problems 
on two out of three health domains (chronic somatic, mental and/or social problems) based 
on diagnosis (coded with the International Classification of Primary Care) or medication 

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(ATC) coding.  
 
Intervention: 
The proactive integrated care intervention that will be used consists of five steps: 
1. Active invitation of the patient from the practice. 
2. Consult of 45 minutes with a trained Practice Nurse Mental Health Care based on the 
Positive Health Methodology. 
3. Multidisciplinary team meeting based on the spider web with domain specific explanation 
to create a personalised care plan and assign a care coordinator to each patient. 
4. Execution of the personalised care plan and frequent pro-active contact between care 
coordinator and the patient. In the first 12 weeks there is a minimum of 3 contact moments, 
however more frequent contact is expected. The proactive nature of this contact is 
emphasized.  
5. Follow-up of the personalised care plan using clinical review and at least one 
multidisciplinary meeting. If needed, ad hoc additional meetings can be organised. 
 
 
Nature and extent of the burden and risks associated with participation, benefit and 
group relatedness:  
Participation in this study is expected to be low risk for the patients. However, both risks and 
benefits are associated with participation. 
Benefits include: Improved knowledge and insight. Participation might lead patients to have a 
better understanding of the factors that contribute to their overall well-being. This can be 
achieved with analysing the six life domains of the positive health conversation tool. This 
insight might result in appropriate interventions that meet the needs of the hotspotters.  
 
A potential risk that should be taken into account is temporary elevated stress. Hotspotters 
experience a combination of different problems which can make life more complex and 
challenging. The heightened emphasis, especially in the beginning, on the factors that 
contribute to their health and social problems could result in higher stress levels in some 
participants. 
 

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1. INTRODUCTION AND RATIONALES 
The term ‘hotspotters‘ was first introduced in Gawande’s landmark article (Gawande, 2011). 
He suggested that the accumulation of problems and high hospital costs were concentrated 
in certain areas (also defined as ‘hot spots’) in Camden, New Jersey. When looking at 
medical care data he noticed that there was a small group of people located in these areas, 
who accounted for most of the medical costs. It was revealed that one per cent of the 
hundred thousand people who used Camden’s medical facilities, accounted for thirty per cent 
of its costs (Gawande, 2011).  
 
These so called ‘hotspotters’ are defined as people who have complex problems on multiple 
life domains, treated with fragmented care which is difficult to manage by patients and care 
providers, leading to high medical costs, little effect of the care and persistent unmet needs. 
Next to their high medical spending levels, hotspotters experiences with the healthcare 
system are low as the healthcare system is not (yet) successful in dealing with their needs. 
Furthermore, this group places a lot of strain on healthcare professionals as their problems 
require a multidisciplinary supply of healthcare services, often in combination with social care 
and welfare (Wammes et al., 2017; Lee, Whitman, Vakharia, Taksler, & Rothberg, 2017). 
Various studies claim that the current healthcare system produces a lot of waste of resources 
in the hotspotters group (Lantz, 2020). Due to the lack of coordination and reactive character 
of the care, many healthcare providers dealing with these patients are confronted with acute 
situations that could be prevented. 
 
Currently in The Netherlands, the ad hoc care as usual approach is the standard when 
treating any patient, including hotspotters. This type of care is concentrated around the 
general practitioner (GP), home care, mental health and social care. Hotspotters’ problems 
have are multidimensional and addressed by an ad hoc network of care providers. A central 
caregiver or coordinator is often lacking. All these different care providers respond reactively 
on symptoms and problems presented by the patient, have their own perspective and treat 
the patient from their own treatment options. The various care providers are not stimulated to 
work proactively together.  
 
In a pilot study performed in Portland Oregon showed that in patients with overuse and 
having a chronic condition, mental problems and substance abuse, the spending was at least 
4 times higher than in a person with just a chronic condition. After a relatively simple 
intervention with health resilience workers the median number of ED visits was reduced from 
annually 9.3 to 6.2 and of hospital admissions from 2.0 to 1.3 (Bisognano & Kenney, 2012). 
Based on this experience, a pilot was done in 2017 in two healthcare centres in Zoetermeer. 
 
The pilot study in the Netherlands (Zoetermeer) concentrated on a group identified 
hotspotters. In the two healthcare centres twenty-five hotspotters with multiple problems 
were enrolled. These 25 patients received an extensive interview based on positive health 
methodology, followed by welfare-support according to the individual needs. The one year 
results of the pilot demonstrated that positive health based on the positive health-tool of 
Machteld Huber improved in the overall group from a mean score of 5.5 (1.5 sd) to 6.7 (1.1 
sd) (t= 7.33, p<0.01), which is 22% (Huber et al., 2011). Due to methodological study design 
issues (observational data with the regression to the mean effect in a group with extreme 
health care utilisation) the evidence remains promising, but not convincing. The small 

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number of RCTs performed showed mixed results (Iovan, Lantz, & Shapiro, 2018; Lantz, 
2020; Iovan, Lantz, Allan, & Abir, 2020). 
 
This intervention requires a different organization of care for complex patients. The 
integrated and proactive nature of the proposed approach for patients identified as 
hotspotters ensues an improved holistic approach. Since evidence for an integrated and 
proactive approach for hotspotters is not substantial yet, a proper cost-effectiveness study is 
needed to provide evidence if the approach is worth the effort. 
 
1. OBJECTIVES  
The primary goal of this study is to get insight in the cost-effectiveness after 12 months of 
working with a proactive, integrated (social) care approach in patients fitting our definition of 
a hotspotter. A hotspotter is a patient with problems on two out of three health domains 
(chronic somatic, psychiatric and/or social) and at least 2 acute care activities in the previous 
12 months. The medical data from 3 years prior to the start of the study will be used to 
analyse the costs and utilisation of care. This extended period used for data analysis was 
deliberately chosen to include a timeframe during and before the SARS-CoV-2 pandemic. 
Since it is yet unknown how the pandemic and it subsequent measures affected our 
population and their usage of care. 
 
Hypothesis: We hypothesise that after one year of working with a proactive approach of 
integrated care to improve the care for patients with problems on two out of three health 
domains (chronic somatic, psychic and/or social) and at least 2 acute care activities in the 
previous 12 months will result in reduction in volume and spending of acute care, 
improvement in experienced health and in patient experience.  
 
Research questions:  
Is proactive integrated care costeffective and result in better patients experience than usual 
care after 12 months for patients with problems on multiple life domains? 
 
Primary outcomes: Incremental cost-effectiveness from a societal perspective. Information 
on cost will be based on patient-reported data obtained by questionnaires supplied with data 
from the GP medical files (Huisarts informatie system, HIS) and trough CBS microdata. To 
assess the effectiveness the EQ-5D-5L will be used for determining quality of life. 
 
Secondary outcomes:  
Insight into patients experience of care:  
Insights into the experiences of care will be gathered during a focus group and information 
about self-efficay (PAM-13 and SE+IN itemlist), proactive coping (UPCC), and quality of life 
(SF-12) will be collected using questionnaires (Hibbard, Mahoney, Stockard, & Tusler, 2005; 
Bode, & de Ridder, 2008; Rurner-Bowker, & Hoque, 2014). A questionnaire on experience of 
care has been considered, but no validated and appropriate questionnaires for this 
population are available. Therefore, for insight and rich information on the experienced care 
the format of a  focus group was chosen.  
 
Process evaluation:  
A process evaluation of this study will be done simultaneously, as a process evaluation can 
provide valuable insight on the practicalities of the intervention.This information is useful for 

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future implementation of this intervention. Data on recruitment and reach of the population 
will be gathered during the inclusion of patiens in this study. Integration of care will be 
collacted by using the Integration Meter, patient satisfaction with care using a modified 
version of the NPS (Reichheld, 2003; Krol et al, 2015), and the nature of the communication 
between care professional and patient, will be assessed using a HCCQ questionnaire 
(Jochems, Duivenvoorden, van der Feltz-Cornelis, & van Dam, 2014; Czajkowska, Wang, 
Hall, Sewitch, & Körner, 2017) and an observation questionnaire (OPTION5) for shared 
decision making based on audio records. Furthermore, a questionnaire will be used 
combining the assessment of the acceptability (Acceptability of Intervention Measure - AIM), 
appropriateness (Intervention Appropriateness Measure - IAM), feasibility (Feasibility of 
Intervention Measure – FIM), and perceived and experienced effectiveness of the 
intervention (Weiner, Lewis, & Stanick, 2017) (see F1). 
 
Through focusgroups with the involved care professionals the following themes of process 
evaluation will be discussed:  
- Fidelity (the extend to which the intervention is executed conform protocol) 
- Dose delivered (the extend in which the intervention is offered) 
- Dose received (the extend in which the patient received the offered care) 
- Context (other factors not related to this protocol that might have an influence on the 
outcomes) 
- Satisfaction (the extend to which the care providers are satisfied with the intervention and 
procedures) 
 
 
 
 
 
 

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3.   STUDY DESIGN 
We will use a stepped-wedge randomised controlled trial (RCT) design (Hemming, Haines, 
Chilton, Girling ,& Lilford, 2015). This design involves random and sequential crossover of 
groups from control to intervention until all groups are exposed to the intervention. A stepped 
wedge cluster RCT is especially useful when the intervention is thought to do more good 
than harm (i.e.,when there is no equipoise). In that situation, it is unethical to withhold or 
withdraw the intervention from a proportion of the subjects as would occur in a parallel group 
or classic cluster RCT. Besides, it may be impossible to implement the intervention in half of 
all clusters simultaneously because of practical, logistical, or financial reasons, which is also 
the case in the current study with regard to the practical and logistical reasons. Then, the 
stepwise treatment implementation 
of the stepped wedge design offers a solution. Since all patients included in this study will be 
offered the intervention, which may contribute to limiting lost to follow-up  
 
The personalized approach, local collaborations with the social domain and organizational 
differences between general practices will result in nuanced differences in how our 
intervention will be applied. Besides, training the Positive Health methodology and the 
enhanced collaboration between domains most likely effects patients not-offered the 
intervention as well. Randomisation will therefore be done by cluster.  
 
 
This study will be performed in 20 general practices. Each practice will form one cluster. We 
aim to include an average of 10 patients per cluster. A GP or POH-GGZ can only participate 
in one cluster. The terms GP practice and cluster will be used alternatively and 
exchangeable form this point on, both referring to the given description.  
 
Each participating patient starts with a control period and will cross-over to the intervention 
period. The control period varies between 2 to 8 months. All patients from a GP practice 
cross-over at the same moment. Therefore the GP-practices are randomized into one of four 
groups. 
 
All clusters start to collect control data at the same time ( t=0). The 20 clusters will be divided 
into four groups evenly and each group will be randomly assigned one of four time points at 
which they will start to implement the proactive integrated care intervention. The first switch 
will be after 2 months (t=2). Every subsequent 2 months a next group of general practices 
will switch to the intervention mode until all groups have started the intervention. All groups 
will continue with the intervention as described in this protocol for a total of 12 months. After 
the 12 months of intervention, care will be delivered as usual. There is no objection if care 
providers and patients wish to maintain certain aspects of the intervention. All measurements 
and timepoints after the switch to the intervention falls under the intervention period. The 
total duration of this study comprises 22 months. This results in varying control period 
ranging from 2 to 8 months. The total of intervention and follow-up period vary from 14 to 20 
months. This time table is summarized in the following chart.  
In order to achieve more accurate answers from patients and in turn more reliable results, a 
member of the research team will administer the SF-12, and questionnaires on proactive 
coping (UPCC), and self-efficacy (PAM-13 and SE+IN) during a face to face interview, as 
these might require extra guidance when filling in. This will be done at three time points for 
each group (before the start of the intervention, at the end of the intervention, and two 
months after the intervention has ended). 
 
 
 
 
 

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Figure 1. This figure depicts the time schedule of this study. The EQ-5D-5L is administered 7 or 8 
times, depending on cluster, and is depicted as a square. The Care and Work questionnaire is 
depicted with an arrow. The questionnaires PAM, SE+IN, SF-12 and UPCC are administered thrice: at 
the start and end of intervention and two months after endig the intervention (star). The dot represents 
the HCCQ and adapted NPS at 6 months after the start of the intervention. Focus groups (triangle) are 
organised per cluster, after finishing the intervention.  
 
 

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4. STUDY POPULATION 
4.1 Population (base)  
The population consists of individuals that are registered patients at one of the participating 
GP practices and have at least two incidents of acute care utilisation during the past year. 
These individuals also have active problems on two of three domains (somatic, mental 
and/or social problems) based on diagnosis (coded with the International Classification of 
Primary Care) or medication (ATC) coding. The patients will be identified by analysing data 
from GP’s electronic medical records from the participating GP practises. 
 
An algorithm and the general practitioner both identify eligible patients. This results in two 
separate, possible overlapping, lists. The general practitioner makes an assessment of 
possible suitable patients. This list will be checked for in- and exclusion criteria. A 
combination of the Adjusted Clinical care Groups, a risk stratification tool, and a specifically 
designed algorithm (Girwar, Fiocco, Sutch, Numans, & Bruijnzeels, 2021; Girwar et al., 
2022).  -- that predicts high acute care utilisation in patients with problems on multiple life 
domains--   are used to identify eligible patients from routine care data. The 60 highest 
scoring patients are screened for the inclusion criteria. After that, the GP checks exclusion 
criteria. In order to run these tools a pseudonymised extraction of HIS-data will be done, 
including needed data on age, sex, ICPC-, and ATC-codes and number of recent GP-visits. 
The data-extraction will be performed in two modes depending on whether the GP practice is 
affiliated within a regional GP network. In practices that are not affiliated, the extraction will 
be performed  in the GP practice using a standalone computer. In practices that are affiliated 
data extraction will be performed via a thrusted third party (ELAN or RadboudUMC). 
 
Patients can be grouped in one of three categories: (1)eligible per GP-list and per algorithm, 
(2) eligible per GP list and (3) eligible per algorithm. We aim to equally include patients from 
the GP’s selection and the algorithm’s. The internal order of these lists are randomised. First, 
patients who appear on the list of both GP and algorithm are approached for study 
participation. Then, recruitment alternates between the GP-list and the algorithm list to 
acquire a 50/50 divide. Inclusion stops when there are no more patients to recruit, or when 
the GP practice reached their maximum number of inclusions.  
 
4.2 Inclusion criteria 
In order to be eligible to participate in this study, the following criteria must be met by the 
general practice and participating patients. 
 
GP practice: 
- 
There is a POH-GGZ available in the GP practice. 
- 
Planning of a multidisciplinairy meeting (MTM or MDO) is a possibility within the GP 
practice. 
- 
The GP practice is willing to work and share information with different care 
professionals in the recurring multidisciplinary meetings, to optimise the results of the 
intervention. 
- 
 

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Participants: 
- 
The patients are ≥ 18yrs 
- 
The patients are registered within one of the participating GP practices. 
- 
Patients with at least two acute care encounters in the past 12 months. Acute care 
encounter is defined as an encounter with out-of-hours GP service, emergency care, 
acute mental health care or unplanned hospital admittance. 
- 
Patients have problems registered in the GP Information system on at least two out of 
three of the following domains: somatic, mental or social. Somatic problems is having 
at least one ICPC code on the problem list. Mental problems is having at least one 
ICPC code from the “P”-chapter on either the problem list, as a reason for encounter, 
and/or having medication prescribed related to mental health problems. Social 
problems is having at least one ICPC code from the “Z”-chapter or as reason for 
encounter, and/or having medication prescribed related to social problems. 
 
4.3 Exclusion criteria 
For this study exclusion criteria are set for GP practices and for participating patients.  
 
Participants: 
- 
The patient is terminal. 
- 
The patient is living in a residential home. 
- 
The patient has dementia or a disability that prevents them from communicating 
effectively.The patient already has experience with the positive health tool. 
- 
The patient is not competent to make decisions concerning their health. This wil be 
assessed by the patient’s own general practitioner.  
- 
Veto of the GP 
 
Exclusion criteria for GP practices: 
- 
Veto of GP 
- 
The GP or POH-GGZ is already participating in this study in a different cluster. 
 
4.4 Sample size calculation 
 
Sample size calculation for a stepped wedge cluster RCT is performed using the formule of 
De Hoop et al (Woertman et al., 2013). The unadjusted sample size for a RCT was 
established on 380, 190 per arm, based on average one year Health Insurance Act spending 
of a mean of ca €22.494 (€24.585SD)(source Statistics Netherlands), with 80% power, 5% 
alpha, 2-sided Equality and 25% decrease. The design effect for this study is 0.54. This is 
based on 1 baseline measure, 4 steps, and ICC of 0.1, 10 patients per cluster and a lost to 
follow-up of 20%. This leads to a sample side of 204 patients. Rounded off, we willinclude 
200 patients divided over 20 clusters. 
 
 
TREATMENT OF SUBJECTS 
4.5 Investigational treatment 
The proactive integrated care intervention that will be used consists of five steps: 
1. Active invitation of the patient from the practice 

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2. Consult of 45 minutes with a trained Practice Nurse Mental Health Care based on 
the Positive Health Methodology. The outcome of this consultation is a spiderweb 
with an overview of current health status according to positive health methodology. 
3. Multidisciplinary Team meeting (MDO) based on the spider web with the domain 
specific explanation. In this MDO at least the mental health practice nurse, GP, 
social worker or community nurse are present. The patient is always invited. The 
outcome of this meeting is: (1) a personalised care plan; (2) appointment of one care 
coordinator and (3) a structured follow up plan (frequency and duration) of the 
progression of this patient’s problems. 
4. Execution of the personalised care plan. The care coordinator has frequent 
contact with the patient. A minimum of 3 consultations for the first 12 weeks is 
set, however more frequent consultation can be expected. The proactive 
nature of this contact is emphasized. A minimum of 4 consultations between 
patient an care coordinator is set. These minimum amount of consultation is 
deliberately set to take frequency of consultation as an outcome parameter. 
The proactive nature will be strongly endorsed, however implementation may 
differ according to the needs of each individual patient. Given the complex 
nature of the population the frequency of contact is expected to be higher in 
the majority.  
5. Follow-up of the personalised care plan. During the regular monthly meetings 
of the health and social care network the follow-up of the patients will be 
reviewed. Each patient will be discussed at least two times, but more often if 
necessary. In case the care plan is not followed correctly or it does not have 
the desired outcome, the patient and the care network will make the needed 
adjustments to the care plan.  
 
 
 
 
 

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5. METHODS 
5.1 Study parameters/endpoints 
5.1.1 Main study parameter/endpoint 
The main study parameter is incremental cost-effectiveness. To measure this outcome 
several data sources will be used and linked at the individual level.  
 
Costs and utilisation of care during the trial 
At the start of the study (t=0) and at the end (t=22) data on care usage and costs will be 
collected. Data on medical and acute care utilization for individual patients will be obtained 
from HIS and CBS microdata, supplemented with patient reported data. A selection of 
relevant (potential) costs for this population is made via expert opinion. The patient reported 
data consist only of data not available in HIS, for which questions were selected from the 
iPCQ, iMCQ and TiC-P questionnaires (See F1). Items with limited effect on cost of care 
which were not retrievable from HIS or microdata were excluded (See F1). 
 
These data will be translated into cost using standard cost prices from the Dutch guideline for 
economic evaluations. The datasets containing coded data will be stored on the I-Drive of the 
LUMC for a period of 15 years. This drive is secured and only accessible by the researchers. 
Baseline characteristics from patients as well as information collected from the 
questionnaires will also be securely stored in an online database, named CASTOR. 
 
Cost and utilisation of care previous to trial  
The medical data from 3 years prior to the start of the study will be used to analyse the costs 
and utilisation of care. This extended period used for data analysation was deliberately 
chosen to include a timeframe during and before the SARS-CoV-2 pandemic. It is yet 
unknown how the pandemic and it subsequent measures affected our population and their 
usage of care. 
 
Data on cost of care and care utilization prior to the start of the trial is retrieved from CBS 
microdata (Statistics Netherlands). Data from several sources are linked at a personal level 
by Statistics Netherlands in a secured remoted access environment. Data in the CBS 
microdata environment is secured by using a linkage key. All data in this environment is 
pseudonymized and data extraction is checked by Statistics Netherlands on traceability. By 
doing this, the privacy and linkage on individual level is secured. The proposed linkages in 
this proposal are in accordance with the General Data Protection Regulation (GDPR), as 
Statistics Netherlands is allowed by law to link data sets under strict disclosure condition 
(The European Parliament & the Council of the European Union, 2016).  
 
Quality of life 
The EQ-5D-L5 will be used to provide the quality of life measures in this study. This 
questionnaire is used to define health in terms of 5 dimensions: self-care, usual activities, 
mobility, anxiety/depression and pain/discomfort. It is also possible to define unique health 
states with this questionnaire, as each domain has five answer levels ranging from no 
problems to extreme problems (Versteegh et al., 2016). Besides being short and easy to 
comprehend, the questionnaireisalso validated. In addition, quality of life will also be 
assessed by using the validated SF-12 (12-items), including 8 dimensions, namely: bodily 

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pain, vitality (energy and fatigue), general mental health (psychological distress and well-
being), general health perceptions, limitations in physical activities because of health 
problems, limitations in social activities because of physical or emotional problems, 
limitations in usual role activities because of emotional problems, and limitations in usual role 
activities because of physical health problems (Turner-Bowker et al., 2014). 
 
The ‘cost and utilization and EQ-5D-L5 questionnaires will be filed in at 7 or 8 different 
timepoints, which will result in 7 or 8 measurements per participant Participants are asked if 
they prefer a questionnaire on paper per post or one per email (using Castor). After receiving 
the questionnaire participants have one week to fill out the questionnaire. If there is no 
respons, patients are called and offered an interview by phone on the questionnaire. The first 
interview will be done at the start of the study (t=0) Afterwards information for the 
questionnaires will be gathered 6 or 7 more times, see figure 1 in  §3 study design for an 
overview and timing of questionnaires. In order to achieve more reliable results, a member of 
the research team will administer the SF-12 and other secondary study parameter 
questionnaires that might require extra guidance, during a face to face interview at three time 
points (before the start of the intervention, at the end of the intervention, and three months 
after the intervention has ended). 
 
5.1.2 Secondary study parameters: Patient experience of care 
The secondary study parameter is insight into the patient experience of care. To assess their 
experience focus groups will be organized. A questionnaire on experience of care has been 
considered, but no appropriate and validated quesntiones for this population are avilible. 
Therefore, the format of a focus group was chosen. Focus groups will be organised at 4 
different timepoint (t=14, t=16, t=18 and t=20) and each focus group will consist of 6 to 12 
patients. For each timepoint several focus groups will be organised. The exact size of the 
group and number of organised groups, will dependent on the number of patients that 
choose to participate. Four main topics will be discussed, namely: care before the new 
approach, the new approach, the collaboration between the professionals and the 
experienced effects of the new approach (see F1). 
 
The presence of proactive coping skills will be quantitively measured with the Utrechtse 
Proactieve Coping Competentie lijst (UPCC). This is a 21-item questionnaire that measures 
self-rated proactive coping competences. The questionnaire has been validated in different 
adult dutch patient groups. (Bode et al., 2008) (see F1). 
 
Self-efficacy will be measured using two different instruments. The first is the validated 
Patient activation Measure (PAM-13). This is a 13-item instrument that measures self-
reported knowledge, skills and confidence in managing one’s health. With this instrument 
patients can be categorised in four levels of activation (Hibbard et al., 2005). The second 
questionnaire is the Self-efficacy and Intention itemlist (SE+IN Itemlist). This measures 
(action and maintenance) self-management self-efficacy, the intention to perform certain self-
management behaviors and the presence of certain self-management behaviors. This 
itemlist was specifically created for this study, as there aren’t any questionnaires that are 
geared towards understanding behavior change in this complex and heterogeneous group of 
patients. The itemlist consists of 22-items and was created using the Health Action Process 

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Approach (HAPA) model (to determine to constructs that need to be measured) (Schwarzer, 
2016), a combination of literature and conversations with care professionals (to determine 
relevant self-management behaviors that these patient seem to lack) and other 
questionnaires with elements of self-management self-efficacy (Ludman et al., 2013; 
Bodenheimer, Lorig, Holman, & Grumbach, 2002; Lorig, Halsted, & Holman, 2003). 
 
5.1.3 
Secondary study parameter: Process evaluation 
A process evaluation of this study will be done simultaneously, as a process evaluation can 
provide valuable insight on the practicalities of the intervention.This information is useful for 
future implementation of this intervention. Data on recruitment and reach of the population 
will be gathered during the inclusion of patiens in this study, and on shared decision making 
will during the intake and MDO.  
 
All involved care professionals in this study will be invited to participate in a focusgroup ( see 
E1 and F1). These focusgroups will be held at four different timepoints (t=14, t=16, t=18 and 
t=20).Through focusgroups with the involved care professionals the following themes of 
process evaluation will be discussed:  
- Fidelity ( the extend to which the intervention is executed conform protocol) 
- Dose delivered ( the extend in which the intervention is offered) 
- Dose received ( the extend in which the patient received the offered care) 
- Context (other factors not related to this protocol that might have an influence on the 
outcomes) 
- Satisfaction (the extend to which the care providers are satisfied with the intervention and 
procedures) 
 
During this study information of each GP practice will be gathered on the level of integration 
of care with the social and mental domain. This will be done using an adapted 
integratiemeter (Broesveld et al., 2016). The level of integration with the social, mental and 
somatic domain will be determinant based on an (minor) adapted version of the 
integratiemeter from Broesveld et al. (2016). The wording of this questionnaire has been very 
slightly altered to fit our population (see F1). 
 
Additionally, information about acceptability, feasibility, appropriateness ,and perceived and 
experienced effectiveness of the intervention will be gathered from care professionals from 
participating as well as non-participating practices. This will be done before the intervention 
starts and right after the intervention for each group of GP’s. Acceptability, appropriateness, 
and feasibility will be measured using the The Acceptability of Intervention Measure (AIM), 
Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) 
four-item measures of implementation outcomes that are often considered “leading 
indicators” of implementation success (Weiner et al., 2017; Proctor et al., 2011). 
The FIM, AIM, and IAM have been translated and backtranslated for this study. 
Perceived and experienced effectiveness of the intervention will be measured with one item 
(see F1). 
 
To assess the patients’ experiences with the intervention and their care coordinator an 
adjusted version of the Net Promotor Score (2 item questionnaire) will be administered 
(Reichheld, 2003). Furthermore, the patients’ perceptions of the degree to which their 

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healthcare provider is autonomy supportive will be assessed using the 6 item Health 
Care Climate Questionnaire (Jochems et al., 2014; Czaikowska et al., 2017) (see 
F1). Level of shared decision making will be based on audio recored which will be scored by 
two independed observers using the validated OPTION5 questionnaire. If a  participant is not 
comfortable with these recordings, the recorings may be skipped without further 
consequence for study participation. 
 
5.2 Randomisation, blinding and treatment allocation 
Randomisation happens twice in this study. First, clusters are randomised evenly into one of 
four group ( see chapter 3), which corresponds with duration of control period. Every 2 
months a new group will start with the intervention, until all groups have received the 
intervention. The first group will start 2 months after the start of the study. A specifically 
designed randomisation tool using Microsoft Excel is used. We randomise clusters en bloc.  
 
The second randomisation is to determine the order in which selected patients are 
approached. While identifying eligible patients, we end with a selection of patients who fall 
under 1 of 3 categories: (1)eligible per GP-list and per algorithm, (2) eligible per GP list and 
(3) eligible per algorithm. We aim to equally include patients from the GP’s selection and the 
algorithm’s. The internal order of these lists are randomized using a specifically designed 
randomisation tool using Microsoft Excel.  First, those who appear on the list of both GP and 
algorithm are approached for study participation. Then, recruitment alternates between the 
GP-list and the algorithm list to acquire a 50/50 divide. 
 
5.3 Study procedures 
The procedure with patients will go as following: 
- 
An algorithm and the general practitioner both identify eligible patients. This results in 
two separate, possible overlapping, lists. 
- 
Lists of patients are screened for inclusion criteria. 
- 
GP checks the list of patients, meeting inclusion criteria, for exclusion criteria. 
Patients can be grouped in one of three categories: (1)eligible per GP-list and per 
algorithm, (2) eligible per GP list and (3) eligible per algorithm. 
- 
Internal order of these lists are randomised. First, patients who appear on the list of 
both GP and algorithm are approached for study participation. Then, recruitment 
alternates between the GP-list and the algorithm list to acquire a 50/50 divide. 
- 
GP practice approached patient and ask permission/ consent for sharing the contact 
information with the researchers so they give them written and oral information about 
the study  
- 
Study information is sent per mail. 
- 
Phone call from researcher to answer questions and acquire informed consent.  
- 
Start control period.  
- 
Baseline questionnaire:The ‘cost and care utilization’ and EQ-5D-5L questionnaires 
will be sent out to participants to fill in at home.  
- 
Start of intervention period (including intake and MDO’s). 
- 
Questionnaires: Repetition of the ‘cost and care utilization’ and EQ-5D-5L 
questionnaires according to schedule as depicted in  §3 study design (7 or 8 
measurements per patient). Furthermore, four questionnaires (SF-12, UPCC, SE+IN 

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itemlist, and PAM-13) will be repeated three times (before the start of the intervention, 
at the end of the intervention and 2 months after the intervention has ended). The 
remaining two questionnaires (HCCQ and adapted NPS) will be administered once 
(at the end of the 6 month mark of the intervention). 
- 
All participants are invited to join a focus group 12 months after starting the 
intervention. Patients will first be informed about the focus group though the patient 
information form. When a group is near the end of the 12-month intervention period, 
all patients in this group will be approached by the researchers to confirm 
participation. The goal of the focus group is to obtain insight about the patients’ 
experience with the new approach. Participation is not obligatory.  
- 
As part of process evaluation all involved professionals (GP, POH-GGZ, social 
workers or other) will be invited to join a focusgroup on their experience with this 
proactive, integrated care approach and the audio records of the intake and MDO will 
be scored on the level of shared decision making by two independent observers.  
- 
Collection of data on: medical and acute care 20tilization, medical costs. (beginning 
and end of study).  
 
The following time investment will be asked from each patient: 
- 
10 minutes: invitation of the patient by the GP practice and sharing of information about 
the study with the patient. Permission to send information about the study, will be asked. 
- 
10 minutes: follow-up with patient about participation in the study. If the patient agrees to 
participate, an informed consent form will be send out.  
- 
170 minutes for the questionnaires: this consists of 4 timepoints of EQ-5D-5L and 
Care and work questionnaire (4x10min = 40min), two timepoints of psychological 
questionnaires(SF-12, PAM-13, SE+IN) with EQ-5D-5L and care and work ( 2x40min 
= 80min), once EQ-5D-5L with Care and Work and evaluative questionnaire (modified 
NPS, HCCQ) ( 1x 10min = 10 min) and once psychological questionnaires combined 
with EQ-5D-5L (1x40min = 40min). 
- 
45 minutes: first consultation based on the Positive Health Methodology. 
- 
60 minutes (2x30=60min): all patients are invited and stimulated to join the 
multidisciplinary meetings. Patients will be discussed at least at least 2 times during the 
12 month period. Additional ad hoc meeting is possible if necessary.  
- 
10-30 minutes (minimum of 4 times, thus combined total of 40-120 minutes): for the extra 
meetings that patients are going to have with their care coordinator, according to their 
personal care plan. 
- 
60 minutes: focus group focused on the patients their experience with the intervention. 
Each focus group will be 60 minutes and each patient will only be invited once. This will 
be done after they end the intervention. 
 
 
First three 
month period 
Total 12 
months period 
Total in study 
period 
POH-GGZ intake 
1x45 min 
1x 45 min 
1x45 minutes 
Multidisciplinary 
meeting 
1x30 min 
Minimum 2x 30 
Minimum 2x 30 
minutes 
Care coordinator 
Minimum of 3x,  
more frequent 
contact is 
Minimum of 4x 
in 12 months, 
however more 
Minimum of 4x in 
12 months 

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possible. 
Proactive nature 
of this contact is 
highlighted.  
frequent contact 
is expected. 
Proactive nature 
of contact is 
highlighted. 
Questionnaires 
 
 
170 minutes 
Focusgroup 
 
 
1x60 minutes 
 
 
During the 22 month study period, the following questionnaires will be sent out per mail, but 
in case of no respons done by interview (see F1): 
- 
EQ-5D-L5 (Versteegh et al., 2016). This will be filled in at a maximum of 8 different 
timepoints.  
- 
Selected questions from iMCQ, iPCQ and TiC-P. This will also be filled in at a 
maximum of 7 different timepoints. 
- 
HCCQ and modified NPS (Jochems et al., 2014; Czajkowska et al., 2017; Reichheld, 
2003; Krol et al, 2015). This will be filled in at 1 timepoint. 
 
The remaining questionnaires will be filled in during a face to face interview with the 
researcher or trained intern or research assistant (before the start of the intervention, at the 
end of the intervention and 2 months after the intervention has ended).  
 
5.4 Withdrawal of individual subjects 
Subjects can leave the study at any time for any reason if they wish to do so without any 
consequences. The investigator can decide to withdraw a subject from the study for urgent 
medical reasons. 
5.4.1 Specific criteria for withdrawal 
The participating patients have the option to revert back to care as usual, at any given time. 
The reason for withdrawal will be asked, however patients are not obliged to answer if they 
do not wish to share the reason.  
 
5.5 Replacement of individual subjects after withdrawal 
Patients that chose to withdrawal from the study, will not be replaced. 
 
5.6 Follow-up of subjects withdrawn from treatment 
When a participant choses to retract from of the study, data collection for that participant will 
stop. The data collected until the moment of withdrawal will be used when analysing the 
data, unless the patient specifically requests otherwise.  
 
5.7 Premature termination of the study 
This is not applicable to this study. There are no health risks associated with study. 

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6.  STATISTICAL ANALYSIS 
Before analysis, all data will be cleaned improving data quality.  
 
Quantitative data: 
We will conduct intention-to-treat and per protocol analysis. We will use multilevel 
generalized linear models with the patient as the first level to correct for the repeated 
measures. The GP-practice (or cluster) will be the second level, and the group in which the 
GP practice is randomized will be the third level. We will adjust for level of integration, 
neighbourhood,time from start of study (continuous; with an interaction between cluster and 
time so that each cluster had its own underlying time trend), and total time on the 
randomised intervention, with time before intervention given as zero (continuous). Based on 
ICPC-codes used to select eligible patients, we will explore if subgroups can be identified in 
mainly (chronic) somatic, mainly mental or mainly social problems. Furthermore, analyses/ 
results will be stratification for sex. The analysis of the implementation will be  descriptive. 
 
Cost-effectiveness analysis/budet impact analysis: 
The economic evaluation will consist of a trial-based cost-utility analysis (cost per QALY) with 
a time horizon of one year and a cost-utility analysis with a lifetime horizon (cost per QALY). 
Both analyses will be performed from a societal perspective. Next to this a Budget Impact 
Analysis will be performed according to the ISPOR Task Force principles. 
 
Qualitative data: 
Qualitative data will be collected through interviews or focus groups with care providers and 
patients and audiorecording. The interviews and focus groups will be conducted using a topic 
list based on experience of the pilot (protocol number NL8223-10216) and literature, to 
determine their satisfaction with the new approach.  
The collected qualitative data will be analysed using both an inductive and deductive 
approach. This will be done by first transcribing the data and doing a thematic content 
analysis. After this, the data will be put into an initial coding book and futher analysed until a 
final coding book is formed. The deductive analysis will be done using the positive health 
methodology. We will analyze whether positive health topics and techniques are being 
discussed and applied, as recommended by the methodology.   
The audiotapes will be scored by two independent obesrvers using the validated OPTION5 
questionnaire.  
 
 
6.1 AEs, SAEs and SUSARs 
6.1.1 Adverse events (AEs) 
Due to the high amount of expected (serious) adverse events caused by treatment of the 
patients as part of standard care, only study related (S)AE’s will be reported immediately. 
This means all (S)AE’s related to participation in this study protocol, meaning from filling 
in the questionnaires, will be reported. All other (S)AE’s will not be reported, as no patient 
benefit is expected from this. 
 

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The sponsor will report the intervention related (S)AEs through the web portal 
ToetsingOnline to the accredited METC that approved the protocol, within 7 days of first 
knowledge for SAEs that result in death or are life threatening followed by a period of 
maximum of 8 days to complete the initial preliminary report. All other SAEs will be 
reported within a period of maximum 15 days after the sponsor has first knowledge of the 
serious adverse events. 

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7. ETHICAL CONSIDERATIONS 
7.1 Regulation statement 
This study will be conducted according to the principles of the Declaration of Helsinki 
(version 7, oktober 2013) and in accordance with the Medical Research Involving Human 
Subjects Act (WMO) and other guidelines, regulations and Acts. 
 
This study does not invade the physical integrity of participants, but the extra care 
appointments and the frequent and personal questionnaires can be seen as an additional 
burden to the participants. Besides, this study investigates the effects of a new intervention. 
Therefore, we consider this study to be subject of the WMO.  
 
7.2 Recruitment and consent  
GP practices 
The GP-practices affiliated with RadboudUMC, SGZ or affiliated with Hadoks will be 
approached through internal communication. This study is submitted as a single center 
research in agreement with the METC-LDD on 14-11-2021. The department of Public Health 
and Primary Care takes responsibility for gathering and storing onderzoeksverklaring from 
each participating GP practice.  
 
Patients 
Identification and selection of eligible patients is done as described in chapter 4.1. Patients 
can be grouped in one of three categories: (1)eligible per GP-list and per algorithm, (2) 
eligible per GP list and (3) eligible per algorithm. We aim to equally include patients from the 
GP’s selection and the algorithm’s. The internal order of these lists are randomised. First, 
patients who appear on the list of both GP and algorithm are approached for study 
participation. Then, recruitment alternates between the GP-list and the algorithm list to 
acquire a 50/50 divide. Invitations stops when there are no more patients to recruit, or when 
the GP practice reached their maximum number of inclusions.  
The GP-practices reaches out to the patient using a script (E3). If patients consent, an 
information package sent including informed consent forms and a link to an information 
video. A week later the researchers call to answer questions and to acquire informed 
consent. In case of consent, patients sign the Patient Informed Consent forms twice and sent 
both to the researcher. After researcher signs, one copy is stored and one copy is sent back 
to the patient.  
 
7.3 Benefits and risks assessment, group relatedness 
Participation in this study is expected to be low risk for the patients. However, both risks and 
benefits are associated with participation. 
 
Benefits include: Improved knowledge and insight. Participation might lead patients to have a 
better understanding of the factors that contribute to their overall well-being. This can be 
achieved with analysing the six life domains of the positive health conversation tool. This 
insight might result in appropriate interventions that meet the needs of these patients.  
 
A potential risk that should be taken into account is temporary elevated stress. The patients 
participating in this study experience a combination of different problems which can make life 

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more complex and challenging. The heightened emphasis, especially in the beginning, on 
the factors that contribute to their health and social problems could result in higher stress 
levels in some participants. 
 
7.4 Incentives (if applicable) 
Participating GP-Practices will receive two compensations:  
1.  An hourly rate for time that the GP and POH-GGZ spend in mutlidisciplinairy meetings. A 
total amount of 1200 per GP practice is expected, but due to a pending application for 
financing the exact amount can not yet be stated 
2. A small one time fee of 150 euro.  
 
Each participant will receive a 15 euro VVV gift card for participating in the study. They will 
also be compensated for additional transportation costs from their home to the GP practice.  
 
7.5 Compensation for injury 
We ask the METC for dispensation of the insurance obligation, as participation in this study 
is without extra health risk. 
 

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8. ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION 
8.1 Handling and storage of data and documents 
 
Baseline characteristics from patients as well as information collected from the 
questionnaires will be securely stored in an online database, named CASTOR. Data on care 
utilisation according to the health Care Act (ZVW) from period before the start of the study, 
and data on care utilisation according to Social care Act (WMO) is available in the secured 
data environment from Statistics Netherlands (CBS), a Trusted Third Party (TTP). The 
dataset on medical care utilization and costs will be linked to Statistics Netherlands within 
their secured data environment by using a linkage key. By doing this the privacy and linkage 
on individual level are secured. The proposed linkages in this proposal are in accordance 
with the General Data Protection Regulation (GDPR) as Statistics Netherlands is allowed by 
law to link data sets under strict disclosure condition (The European Parliament & the 
Council of the European Union, 2016). The researchers only have access to patient data that 
has been securely coded (pseudonymised) by CBS. Datasets that include microdata from 
CBS will be analysed is a secured CBS environment.  
 
Quantitative data retrieved from HIS will be coded and stored on the I-Drive of the LUMC for 
a period of 15 years. This drive is secured and only accessible by the researchers.  
 
Audiorecordings are transcribed. Transcirpts will be stored on the secured I-drive of the 
LUMC for a period of 15 years. After transcription, audiorecordings will be deleted.  
 
8.2 Monitoring and Quality Assurance  
Monitoring of the study will be executed by (internal) monitors of the LUMC according to the 
monitor plan .The study will be conducted as described in this protocol. The principal 
investigators will be contacted when unforeseen events change the course of this study. 
 
8.3 Amendments  
All substantial amendments will be notified to the METC and to the competent authority. 
Non-substantial amendments will not be notified to the accredited METC and the competent 
authority, but will be recorded and filed by the sponsor.  
 
8.4 Annual progress report 
The sponsor/investigator will submit a summary of the progress of the trial to the accredited 
METC once a year. Information will be provided on the date of inclusion of the first subject, 
numbers of subjects included and numbers of subjects that have completed the trial, serious 
adverse events/ serious adverse reactions, other problems, and amendments.  
 
8.5 Temporary halt and (prematurely) end of study report 
The investigator/sponsor will notify the accredited METC of the end of the study within a 
period of 8 weeks. The end of this study is defined as the last group of patients finish their 12 
month intervention period. The sponsor will notify the METC immediately of a temporary halt 
of the study, including the reason of such an action.  
 
Within one year after the end of the study, the investigator/sponsor will submit a final study 

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report with the results of the study, including any publications/abstracts of the study, to the 
accredited METC and the Competent Authority.  
 
8.6 Public disclosure and publication policy 
An article containing the research outcomes will published in a peer reviewed journal.  
 
 

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9. REFERENCES 
 
1. Autoriteit persoonsgegevens: 
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3. Bisognano M, Kenney C. Pursuing the Triple Aim: Seven Innovators Show the Way to 
Better Care, Better Health, and Lower Costs. San Francisco: Jossey-Bass Publishers; 
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4. Bode C, Thoolen B, de Ridder D. Measuring proactive coping. Psychometric 
characteristics of the Utrecht Proactive Coping Competence scale (UPCC). Psychologie 
& Gezondheid. 2008; 36(2); 81–91. https://doi.org/10.1007/BF03077476  
5. Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient Self-management of Chronic 
Disease in Primary Care. JAMA. 2002;288(19):2469–2475. 
doi:10.1001/jama.288.19.2469 
6. Boesveld, I.C., Annegarn, A.M.A., IJsseldijk, J.M., VeldHuyzen, D.C., Winkel, L., Annot, 
F., Bruijnzeels, M. D., Franx, A., & Wiegers, T. A. Geïntegreerde geboortezorg 
Resultaten van de VSV-Integratiemeter, Nederlands Tijdschrift voor Obstetrie & 
Gynaecologie vol. 129, december 2016 
7. CBS: https://www.cbs.nl/en-gb/corporate/2018/21/cbs-is-ready-for-the-eu-gdpr 
8. Gawande A. The Hot Spotters: Can we lower medical costs by giving the neediest 
patients better care? New York Times, Medical Report. January 24, 2011.  
9. Girwar, S.M., Fiocco, M., Sutch, S. P., Numans, M. E., Bruijnzeels, M. A. Assessment of 
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records: a retrospective cross-sectional study, BMC Health Services 
Research volume 21, Article number: 217 (2021)  
10. Girwar et al April 2022; Identifying ‘Hotspotters’ Using the Adjusted Clinical Groups Risk 
Stratification Tool , accepted in American Journal of Managed Care 
11. Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster 
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