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

Completed

• Conditions: Fractures, Bone; Dislocations
• Interventions: Procedure: Standard trauma care

• Registration Number: NCT03506958
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-25
• Study First Submitted: 2018-04-07
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-24
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-16
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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.

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Exclusion Criteria

• Patients of age 11 years and younger.
• Patients presenting outside ordinary business hours.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospital	Standard trauma care	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.
General Practice	Standard trauma care	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.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	12 weeks after treatment	Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

General Practice Zorgplein Lemmer; 🇳🇱 Lemmer, Friesland, Netherlands

Antonius Hospital Sneek; 🇳🇱 Sneek, Friesland, Netherlands