Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals vs General Practitioners

Study Overview
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Brief Summary
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Treatment of fractures and dislocations are generally organized in the hospital setting. However, equal care for patients with non-complex fractures or dislocations may be provided in general practices. While substitution of trauma care from the secondary to the primary care setting is stimulated by the government and insurers, it is unknown what the patient satisfaction level is and which determinants affect this patient satisfaction. Therefore, the primary objective of this study is to determine the effect of treatment in a general practice on patient satisfaction compared to treatment in a hospital. The secondary objectives include assessments in quality of life, patient-reported outcomes and cost-effectiveness. Besides, results will be discussed using a small focus group consisting of patients (n=15 per group) and healthcare providers.

Official Title
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Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals Versus in General Practitioners in the Netherlands: Prospective Cohort Study Protocol

Conditions
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Fractures, Bone, Dislocations

Intervention / Treatment
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* Procedure: Standard trauma care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: X-ray confirmed diagnosis of a non-complex fracture or dislocation, which can be treated in the primary care setting according to the treatment protocol. Ability of the patient or assigned representative to understand the content of the patient information/informed consent form. Signed and dated written informed consent. Parents of patients of age 12-17 must provide a signed and dated written informed consent as well. Exclusion Criteria: Patients of age 11 years and younger. Patients presenting outside ordinary business hours.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General Practice<br>Hundred patients with an X-ray confirmed diagnosis of a non-complex fracture or dislocation and planned to be treated in the general practice Zorgplein Lemmer. | Procedure: Standard trauma care<br>* In both groups, all procedures and management will be done according to the hospital's standard of care.<br>|
| Hospital<br>Hundred patients with an X-ray confirmed diagnosis of a non-complex fracture or dislocation and planned to be treated in the Antonius Hospital Sneek. | Procedure: Standard trauma care<br>* In both groups, all procedures and management will be done according to the hospital's standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18) | 12 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18) | 1 week and 6 weeks after treatment | 
| Complications of treatment | Assessment of treatment complications | 12 weeks after treatment | 
| Pain score | Assessment of pain score using a visual-analogue scale (VAS) | 12 weeks after treatment | 
| Physical functioning | Physical functioning according to the 12-item World Health Organisation (WHO) Disability Assessment Schedule II | 12 weeks after treatment | 
| Limitations in functions of upper extremities (if applicable) | Limitations in functions of upper extremities according to the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire | 12 weeks after treatment | 
| General health status | General health status according to the General Health Questionnaire (GHQ) | 12 weeks after treatment | 
| Quality of life | Quality of life using the EuroQol (EQ5D) questionnaire | 12 weeks after treatment | 
| Time consumption | Time consumption (waiting time, treatment time, travelling time) | 1 week, 6 weeks, and 12 weeks after treatment | 
| Costs | Costs of treatment | 12 weeks after treatment |