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

Fractures, Bone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506958
• Other study ID #: 20170277
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Dislocations
• Fractures, Bone

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