NCT03506958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

3 years

First QC Date

April 7, 2018

Last Update Submit

May 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)

    12 weeks after treatment

Secondary Outcomes (9)

  • Patient satisfaction

    1 week and 6 weeks after treatment

  • Complications of treatment

    12 weeks after treatment

  • Pain score

    12 weeks after treatment

  • Physical functioning

    12 weeks after treatment

  • Limitations in functions of upper extremities (if applicable)

    12 weeks after treatment

  • +4 more secondary outcomes

Study Arms (2)

General Practice

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

Hospital

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

Interventions

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

General PracticeHospital

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

General Practice Zorgplein Lemmer

Lemmer, Provincie Friesland, 8531EB, Netherlands

Location

Antonius Hospital Sneek

Sneek, Provincie Friesland, 8601 ZK, Netherlands

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Fractures, BoneJoint Dislocations

Condition Hierarchy (Ancestors)

Wounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doc researcher

Study Record Dates

First Submitted

April 7, 2018

First Posted

April 24, 2018

Study Start

September 25, 2017

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

May 19, 2021

Record last verified: 2021-05

Locations