Clinical trial NCT03506958: Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals vs General Practitioners
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures, Bone
Dislocations
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Antonius Hospital Sneek
name: Innovatiefonds De Friesland Zorgverzekeraar (DFZ)
First posted: 2018-04-24
Enrollment: 117
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Two hundred patients with an X-ray confirmed diagnosis of a non-complex fracture or dislocation and planned to be treated in either the general practice Zorgplein Lemmer or Antonius Hospital Sneek will be recruited, 100 per center.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient satisfaction
timeFrame: 12 weeks after treatment
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 1 week and 6 weeks after treatment
measure: Complications of treatment
timeFrame: 12 weeks after treatment
measure: Pain score
timeFrame: 12 weeks after treatment
measure: Physical functioning
timeFrame: 12 weeks after treatment
measure: Limitations in functions of upper extremities (if applicable)
timeFrame: 12 weeks after treatment
measure: General health status
timeFrame: 12 weeks after treatment
measure: Quality of life
timeFrame: 12 weeks after treatment
measure: Time consumption
timeFrame: 1 week, 6 weeks, and 12 weeks after treatment
measure: Costs
timeFrame: 12 weeks after treatment
Other outcomes:
Locations:
city: Lemmer
country: Netherlands
facility: General Practice Zorgplein Lemmer
state: Friesland
city: Sneek
country: Netherlands
facility: Antonius Hospital Sneek
state: Friesland
Study officials:
References:
citation: Verbeek T, Arentsen H, Breet EJ, Kuipers MM, Lubbert PHW, Burger H. Patient satisfaction in treatment of non-complex fractures and dislocations in general practice in the Netherlands: prospective cohort study protocol. BMJ Open. 2019 Feb 19;9(2):e025046. doi: 10.1136/bmjopen-2018-025046.