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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03506958
Other study ID # 20170277
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 25, 2017
Est. completion date October 1, 2020

Study information

Verified date May 2021
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Standard trauma care
In both groups, all procedures and management will be done according to the hospital's standard of care.

Locations

Country Name City State
Netherlands General Practice Zorgplein Lemmer Lemmer Friesland
Netherlands Antonius Hospital Sneek Sneek Friesland

Sponsors (3)

Lead Sponsor Collaborator
University Medical Center Groningen Antonius Hospital Sneek, Innovatiefonds De Friesland Zorgverzekeraar (DFZ)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient satisfaction Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18) 12 weeks after treatment
Secondary Patient satisfaction Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18) 1 week and 6 weeks after treatment
Secondary Complications of treatment Assessment of treatment complications 12 weeks after treatment
Secondary Pain score Assessment of pain score using a visual-analogue scale (VAS) 12 weeks after treatment
Secondary Physical functioning Physical functioning according to the 12-item World Health Organisation (WHO) Disability Assessment Schedule II 12 weeks after treatment
Secondary 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
Secondary General health status General health status according to the General Health Questionnaire (GHQ) 12 weeks after treatment
Secondary Quality of life Quality of life using the EuroQol (EQ5D) questionnaire 12 weeks after treatment
Secondary Time consumption Time consumption (waiting time, treatment time, travelling time) 1 week, 6 weeks, and 12 weeks after treatment
Secondary Costs Costs of treatment 12 weeks after treatment
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