Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals Versus in General Practitioners in the Netherlands: Prospective Cohort Study Protocol
Conditions: Fractures, Bone, Dislocations
Sponsor: University Medical Center Groningen

 
 
 
 
 
 
 
 
 
Determinants of patient satisfaction in light trauma care 
in hospitals versus in general practitioners 
 
Patient satisfaction in treatment of non-complex fractures and dislocations  
in hospitals versus in general practitioners: a prospective cohort study 
 
05-05-2017 

ABR  61894   
 
Determinants of patient satisfaction in light trauma care in hospitals vs GP’s 
 
 
 
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PROTOCOL TITLE ‘Determinants of patient satisfaction in light trauma care in hospitals 
versus in general practitioners’ 
Protocol ID
ABR 61894
Short title
Determinants of patient satisfaction in light trauma 
care in hospitals versus in general practitioners 
Version
2.0
Date
05-05-2017
Coordinating 
investigator/project 
leader 
 
Tjitte Verbeek van Buuren, MD, PhD
Department of General Practice 
University Medical Center Groningen 
University of Groningen, Hanzeplein 1 (9713 GZ) 
PO Box 30001, 9700 RB Groningen, The Netherlands
tel: +31 6 12 43 73 33 
Email: T.Verbeek@umcg.nl 
Principal investigator(s) (in Dutch: 
hoofdonderzoeker/uitvoerder) 
 
Huibert Burger, MD, PhD
Associate Professor of Epidemiology 
Department of General Practice 
University Medical Center Groningen 
University of Groningen, Hanzeplein 1 (9713 GZ) 
PO Box 30001, 9700 RB Groningen, The Netherlands
tel: +31 50 36 16724 | mobile: +31 6 12 58 23 56  
Email: H.Burger@umcg.nl 
Sponsor
(in 
Dutch: 
verrichter/opdrachtgever) 
Zorgverzekeraar De Friesland
Harlingertrekweg 53 (8913 HR) 
Leeuwarden, The Netherlands 
tel: +31 58 29 13131 
Independent physician(s)
Btissame Massoudi, MD
Email: b.massoudi@umcg.nl 

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PROTOCOL SIGNATURE SHEET 
 
Name
Signature
Date
H. Burger,  
Associate professor of Epidemiology 
 
05-05-2017
T. Verbeek van Buuren, 
Postdoctoral researcher 
 
05-05-2017
 
 
 
 

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TABLE  OF CONTENTS 
 
1. 
INTRODUCTION AND RATIONALE ....................................................................................... 7 
2. 
OBJECTIVES...................................................................................................................... 8 
3. 
STUDY DESIGN ............................................................................................................ 9 
4. 
STUDY POPULATION ........................................................................................................10 
4.1 
Population (base) .....................................................................................................10 
4.2 
Inclusion criteria .......................................................................................................10 
4.3 
Exclusion criteria ......................................................................................................10 
4.4 
Sample size calculation .............................................................................................10 
5. 
TREATMENT OF SUBJECTS .................................................................................................11 
5.1 
Investigational product/treatment ..............................................................................11 
5.2 
Use of co-intervention ...............................................................................................11 
6. 
METHODS .......................................................................................................................12 
6.1 
Study parameters/endpoints .....................................................................................12 
6.1.1 
Main study parameter/endpoint ............................................................................12 
6.1.2 
Secondary study parameters/endpoints ..................................................................12 
6.1.3 
Other study parameters ........................................................................................13 
6.2 
Randomisation, blinding and treatment allocation .........................................................13 
6.3 
Study procedures .....................................................................................................13 
6.4 
Withdrawal of individual subjects ..............................................................................14 
6.5 
Follow-up of subjects withdrawn from treatment ...........................................................14 
7. 
SAFETY REPORTING .........................................................................................................15 
7.1 
Section 10 WMO event ............................................................................................15 
8. 
STATISTICAL ANALYSIS .....................................................................................................16 
8.1 
Primary analysis ......................................................................................................16 
8.2 
Secondary analyses .................................................................................................16 
8.3 
Cost-effectiveness ....................................................................................................16 
9. 
ETHICAL CONSIDERATIONS ......................................................................................17 
9.1 
Regulation statement ................................................................................................17 
9.2 
Recruitment and consent ............................................................................................17 
9.3 
Benefits and risks assessment, group relatedness ..........................................................17 
9.4 
Compensation for injury ............................................................................................17 
9.5 
Incentives ................................................................................................................17 
10. 
ADMINISTRATIVE ASPECTS AND PUBLICATION ................................................................18 
10.1 
Handling and storage of data and documents .............................................................18 
10.2 
Annual progress report .............................................................................................18 
10.3 
End of study report ..................................................................................................18 
10.4 
Public disclosure and publication policy .......................................................................18 

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SUMMARY 
 
Rationale: In the Netherlands, diagnostics and treatment of fractures and dislocations are 
generally organized in the secondary care setting. In contrast, since January 2017 the general 
practice ‘Zorgplein Lemmer’ provides equal care for patients with non-complex fractures or 
dislocations. In this practice, regular X-ray diagnostics are used, which are digitally transmitted 
to the radiologist. When a non-complex fracture or dislocation is diagnosed, the for this 
purpose well-trained general practitioner provides the patient with a splint or sling and 
provides follow-up consults in his practice. While light trauma care is provided in several 
general practices in the Netherlands and healthcare professionals in both the general practice 
and the hospital are very satisfied with this provided care, it is unknown what the patient 
satisfaction level is and which determinants affect this patient satisfaction. Nowadays, 
substitution of care from the secondary to the primary care setting is stimulated by the 
government and insurers and in that light we aim to study the patient satisfaction of light 
trauma care for non-complex fractures or dislocations in the primary care setting in comparison 
to the secondary care setting. When the general practitioners in our study obtain similar results 
as the nearby hospitals, light trauma care may be substituted nationwide and beyond. 
 
Objective: To assess patient satisfaction of light trauma care in the primary and secondary 
care setting. In addition, we aim to study demographic factors, treatment results, time 
consumption and costs to assess which determinants are responsible for the patient satisfaction. 
 
Study design: Observational cohort study including patients presenting at the X-ray facility in 
the general practice ‘Zorgplein Lemmer’ and patients presenting at the X-ray facility of the 
Antonius Hospital Sneek, with non-complex fractures or dislocations. 
 
Study population: 200 patients (≥12 years old) with fractures or dislocations which are non-
complex such that they can be treated in the primary care setting. This sample size will allow 
us to demonstrate effect sizes of 0.4 (small to medium) or over with 80% (beta 20%) power 
using a two-sided alpha of 0.05.  
 
Determinants: demographic factors (age, sex, comorbidity), nature of the trauma, treatment 
setting (in general practice or in the hospital, distance to treatment center), treatment results 
(functionality scores, complications, general health, quality of life), time consumption and costs.   
 
Main study parameters/endpoints:  

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Primary: 
- 
Patient satisfaction (questionnaires after 1, 6, and 12 weeks) 
 
Secondary: 
- 
General health (GHQ questionnaire), age, SES (after 1 week) 
- 
Complications (e.g. secondary dislocation and pain scores; questionnaire after 12 
weeks) 
- 
Physical function (questionnaire after 12 weeks) 
- 
Time consumption (questionnaires after 1, 6, and 12 weeks) 
- 
Costs (economic evaluation; questionnaire after 12 weeks). 
 
Nature and extent of the burden and risks associated with participation, benefit and group 
relatedness:  
Since this is an observational study using a limited number of questionnaires in patients who 
receive regular care, there is no risk associated with participating in this study. The burden for 
participating patients will very low because they will only be asked to fill in a few 
questionnaires, which take about one and a half hours in total to fill in. 
 
 

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1. INTRODUCTION AND RATIONALE 
In the Netherlands, diagnostics and treatment of bone fractures and dislocations are generally 
organized in the secondary care setting. When a fracture or dislocation is presumed, most 
general practitioners refer the patient to an X-ray facility in a nearby hospital. When the 
fracture or dislocation is confirmed, an emergency care doctor or trauma surgeon generally 
provides the treatment and follow-up. In contrast, since January 2017 the general practice 
‘Zorgplein Lemmer’ provides equal care for patients with non­complex fractures or dislocations. 
In this practice, regular X-ray diagnostics are used, which are digitally transmitted to the 
radiologist. When a non­complex fracture or dislocation (a so-called ‘light trauma’) is 
diagnosed, the for this purpose well-trained general practitioners provide the patient with the 
usual care (e.g. a splint or sling) and provides follow-up consults in his practice. While light 
trauma care is provided in several general practices in the Netherlands and healthcare 
professionals in both the general practice and the hospital are very satisfied with this provided 
care, it is unknown what the patient satisfaction level is and which determinants affect this 
patient satisfaction. Nowadays, substitution of care from the secondary to the primary care 
setting is stimulated by the government and insurers and in that light we aim to study the 
patient satisfaction of light trauma care for non­complex fractures or dislocations in the 
primary care setting in comparison to the secondary care setting. When the general 
practitioners in our study obtain similar results as the nearby hospitals, light trauma care may 
be substituted nationwide and beyond. 

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Determinants of patient satisfaction in light trauma care in hospitals vs GP’s 
 
 
 
 
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2. OBJECTIVES 
 
Primary Objective:  
To assess patient satisfaction of light trauma care in the primary and secondary care setting. 
 
Secondary Objective(s):  
In addition, we aim to study demographic factors, treatment results, time consumption and costs 
to assess which determinants are responsible for the patient satisfaction. 
 

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3. STUDY DESIGN 
This is an observational cohort study including patients presenting at the X-ray facility in the 
general practice Zorgplein Lemmer and patients presenting at the X-ray facility of the 
Antonius Hospital Sneek, with an X-ray confirmed diagnosis of a non­complex fracture or 
dislocation and planned to be treated in either the Zorgplein Lemmer or Antonius Hospital 
Sneek. Patients aged 11 years or younger, and/or presenting outside ordinary business hours 
are excluded, due to possible inclusion bias. After inclusion the follow-up questionnaires 
continue for 12 weeks. The total duration of the study is 18 months. 

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4. STUDY POPULATION 
 
4.1 Population (base)  
The base population consists of patients in the region around Lemmer and Sneek. 
 
4.2 Inclusion criteria 
Eligible patients must meet the following inclusion criteria: 
1. X-ray confirmed diagnosis of a non­complex fracture or dislocation, which can be 
treated in the primary care setting according to the treatment protocol. 
2. Ability of the patient or assigned representative to understand the content of the 
patient information/informed consent form. 
3. Signed and dated written informed consent. Parents of patients of age 12-17 must 
provide a signed and dated written informed consent as well.  
 
4.3 Exclusion criteria 
1. Age 11 years and younger. 
2. Patients presenting outside ordinary business hours. 
 
4.4 Sample size calculation 
The sample size calculation has been performed based on the difference in patient 
satisfaction. There was no literature available concerning patient satisfaction in trauma 
care in general practices or hospitals. Therefore, we based our sample size calculation on 
an estimated effect size. With a significance level of 5%, a power of 80% and equal 
treatment groups, a sample size of 200 patients (100 per group) was calculated. This 
sample size will allow us to demonstrate effect sizes of 0.4 (small to medium) or over.  
 

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5. TREATMENT OF SUBJECTS 
5.1 Investigational product/treatment 
Treatment in the general practice is identical to treatment in the hospital and is equal to the 
national 
guidelines. 
Those 
are 
described 
in 
the 
online 
treatment 
protocol 
‘Behandelprotocollen Lichte traumazorg in de eerste lijn’. This study has no impact on 
speed, choice, location or execution of diagnostics or treatment and thus is an observational 
study. 
 
5.2 Use of co-intervention  
Patients are allowed to ask treatment next to the treatment according to the treatment 
protocol. 
 

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6. METHODS 
 
6.1 Study parameters/endpoints 
6.1.1 Main study parameter/endpoint 
Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form 
(PSQ-18; 12 weeks after treatment). 
Marshall GN Hays RD. The Patient Satisfaction Questionnaire Short-Form 
(PSQ-18). Santa Monica, CA: RAND, 1994. 
 
6.1.2 Secondary study parameters/endpoints  
1. Patient satisfaction measured using the PSQ-18 (1 and 6 weeks after treatment). 
Marshall GN Hays RD. The Patient Satisfaction Questionnaire Short-Form 
(PSQ-18). Santa Monica, CA: RAND, 1994. 
2. Complications of treatment and pain scores (12 weeks after treatment). 
3. Physical functioning according to the 12-item World Health Organisation (WHO) 
Disability Assessment Schedule II (12 weeks after treatment). 
World Health Organization Disability Assessment Schedule II (WHO-DAS II) 
WHO, Geneva (2000) www.who.int/icidh/whodas/whodasversions/12int.pdf 
4. Limitations in functions of upper extremities (if applicable) according to the 
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire (12 weeks after 
treatment). 
Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity 
outcome measure: the DASH (disabilities of the arm, shoulder, and hand). Am J 
Ind Med, 29 (1996), pp. 602–608 
5. General health status according to the 12-item General Health Questionnaire 
(GHQ-12; 12 weeks after treatment). 
Goldberg, D. P. (1972). The Detection of Psychiatric Illness by Questionnaire. 
Maudsley Monograph No. 21. Oxford University Press: Oxford. 
6. Quality of life using the EQ5D questionnaire (12 weeks after treatment). 
Euroqol Group (1990) Euroqol—a new facility for the measurement of health-
related quality of life. Health Policy 16:199–208 
7. Time consumption (waiting time, treatment time, travelling time and distance; 1, 6, 
and 12 weeks after treatment). 
8. Costs (12 weeks after treatment). 

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6.1.3 Other study parameters 
Baseline data: age, gender, social economic status, location and severety of the 
trauma (1 week after treatment). 
 
 
6.2 Randomization, blinding and treatment allocation 
This is an observational cohort study, so randomization and blinding are not applicable. 
 
6.3 Study procedures 
Hospital 
Light trauma care (treatment of non-complex fractures and bone dislocations) is generally 
provided by emergency care doctors, under supervision of (trauma) surgeons. When a 
radiologist diagnoses a non­complex fracture or dislocation, the emergency care doctors 
clinically assess the patients, as well as evaluate the X-ray diagnosis. When the emergency 
care doctor agrees with the diagnosis he composes a treatment plan. When needed, he 
may assess a trauma surgeon for supervision. The treatment plan is presented to the patient 
and after approval the emergency care doctor treats the patient. The trauma surgeon 
provides follow-up consults in his outpatients’ clinic. Treatment, follow-up consults, all 
procedures and management are provided according to the standard of surgical care in 
the Antonius Hospital Sneek. 
 
General practice 
Zorgplein Lemmer is a general practice where regular general medical care is provided by 
three general practitioners, supported by nurse practitioners, nurses, and doctor's assistants. 
The Antonius Hospital Sneek equipped this general practice with a regular X-ray facility, 
which is operated by a radiographer who is employed by the hospital. Digital images are 
digitally transmitted to in the Antonius Hospital Sneek, where they are assessed by a 
radiologist. When a non­complex fracture or dislocation is diagnosed, one of the for this 
purpose well-trained general practitioners is asked to clinically assess the patient, as well 
as to evaluate the X-ray diagnosis. When the general practitioner agrees with the 
diagnosis and no contraindications for treatment in the general practice (e.g. severe 
divergent bone position, suspicion of damage to nerves, vessels or tendons) are indicated, 
the general practitioner composes a treatment plan according to the treatment protocol. 
When needed, the general practitioner telephonically assesses a trauma surgeon from the 
Antonius Hospital Sneek, who is able to assess the X-ray as well. The treatment plan is 
presented to the patient and after approval the general practitioner treats the patient. This 
general practitioner also provides follow-up consults in his practice. Treatment, follow-up 
consults, all procedures and management is provided according to the hospital’s standard 
of care. 
 
Any other treatment not specifically described in this investigation is performed according 
to the standard of surgical care in the Antonius Hospital Sneek. 

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Inclusion of participants 
The assessment of eligibility will be performed by participating general practitioners near 
Lemmer, who will approach each potential study patient and inquire about their interest 
and eligibility in participating in this study. Both the Zorgplein Lemmer as well as the 
Antonius Hospital Sneek will be informed and trained about the importance of recruiting 
consecutive patients. If the patient wishes to participate, a legally eligible member of the 
research team or staff will go through the informed consent process, explaining the purpose 
of the study, procedures, risk/benefits, alternatives to participation and data protection. 
Each patient choosing to participate will sign and date an informed consent form. Parents of 
participants of age 12-17 years old at the date of informed consent must provide a signed 
and dated written informed consent as well. A copy of the signed informed consent form(s) 
will be placed into the patient’s medical record and the investigator site file and one copy 
will be handed over to the patient. All patients with written informed consent will be 
allocated to a unique patient study number. The date of informed consent and the 
recruitment information is entered in the study database. All patients who commence 
treatment within the study are considered as enrolled and all enrolled patients should be 
followed up within the study, except if their study participation is prematurely terminated. 
All patients recruited in the Zorgplein Lemmer or Antonius Hospital Sneek are automatically 
allocated to the Zorgplein Lemmer and Antonius Hospital Sneek analysis group, 
respectively. 
 
6.4 Withdrawal of individual subjects 
Patients are allowed to withdrawal at any moment without consequences for their treatment 
plan or follow-up consultations. 
 
6.5 Follow-up of subjects withdrawn from treatment 
Patients are allowed to withdrawal at any moment without consequences for their treatment 
plan or follow-up consultations. 

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7. SAFETY REPORTING 
 
7.1 Section 10 WMO event 
In accordance to section 10, subsection 1, of the WMO, the investigator will inform the 
subjects and the reviewing accredited METC if anything occurs, on the basis of which it 
appears that the disadvantages of participation may be significantly greater than was 
foreseen in the research proposal.  The study will be suspended pending further review by 
the accredited METC, except insofar as suspension would jeopardize the subjects’ health. 
The investigator will take care that all subjects are kept informed.  
 

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8. STATISTICAL ANALYSIS 
 
All statistical tests will be performed blinded for treatment allocation. 
 
8.1 Primary analysis 
The primary analysis will be conducted using data from all enrolled patients. The reported 
patient satisfaction at 12 weeks after treatment will be reported at the patient level along 
with the 95% CIs according to both treatment groups. In addition, univariable and 
multivariable regression models will be used whereby the outcome will be the patient 
satisfaction related to the treatment. 
 
 
8.2 Secondary analyses 
Secondary analyses will be conducted using data from all enrolled patients. Initially, 
univariable statistical tests (eg, χ2 test or Fisher’s exact test for categorical variables; t test 
or Wilcoxon rank-sum test for continuous variables) will be used to evaluate differences in 
outcome scores between the two treatment groups. Subsequently, data will be analyzed 
using multivariable regression models to estimate differences in mean patient satisfaction 
scores using possible predictors (eg, complications, pain scores, physical functioning, EQ-5D, 
time consumption) between both treatment groups. 
 
 
8.3 Cost-effectiveness 
The proposed cost–utility analysis will use decision modeling and sensitivity analysis 
techniques to ensure the robustness of the study’s conclusions. Cost-effectiveness will be 
assessed using the incremental cost-effectiveness ratio, which is determined by calculating 
the difference in costs divided by the difference in QALYs between both treatment groups. 

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9. ETHICAL CONSIDERATIONS 
 
9.1 Regulation statement 
The study will be executed according to law (WMO). All data will be processed and saved 
anonymously. 
 
9.2 Recruitment and consent 
Patients have sufficient time (approximately several hours between the moment of referral 
by the general practitioner, the moment when the assessment of eligibility is performed by 
participating general practitioners near Lemmer, who will approach each potential study 
patient and inquire about their interest and eligibility in participating in this study and the 
moment of X-ray diagnostics and composing a treatment plan) to ask questions and to 
consider participation. Patient information, website and informed consent forms are easy-
to-read.  Patients are allowed to withdrawal at any moment without consequences for their 
treatment plan or follow-up consultations. 
 
9.3 Benefits and risks assessment, group relatedness 
This is an observational cohort study consisting of questionnaires, thus there are hardly any 
risks associated with participation in this study. The burden of patients is considered as low 
because the study only consists of questionnaires (in total about 1.5 hours). 
 
9.4 Compensation for injury 
Because all interventions in this study (the questionnaires) are non-invasive, there is no 
obligatory insurance for a liability insurance. 
 
9.5 Incentives 
Participants have no (extra) costs by participating in this study. There is no compensation 
for participation in this study. 

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10. ADMINISTRATIVE ASPECTS AND PUBLICATION 
 
10.1 Handling and storage of data and documents 
All data is processed anonymously. All participants are coded and blinded. 
 
10.2 Annual progress report 
At their request, the METC may receive an annual report stating inclusion of participants, 
questionnaires completed, and adverse events. 
 
10.3 End of study report 
Researchers will inform the METC about the end of the study within 8 weeks after the last 
inclusion. The end of the study is defined as the last inclusion. When the study is terminated 
beforehand, the researchers will inform the METC. 
Within a year after the end of the study the researchers will report the results of the study 
to the METC. 
 
10.4 Public disclosure and publication policy 
Publication(s) about this study will never contain personal data of individual participants.