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

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

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.

Study Overview

• Status: Completed
• Conditions: Fractures, Bone; Dislocations
• Intervention / Treatment: Procedure: Standard trauma care

• Study Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• Netherlands
  • Friesland
    • Lemmer, Friesland, Netherlands, 8531EB
      • General Practice Zorgplein Lemmer
    • Sneek, Friesland, Netherlands, 8601 ZK
      • Antonius Hospital Sneek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; In both groups, all procedures and management will be done according to the hospital's standard of 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; In both groups, all procedures and management will be done according to the hospital's standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)	12 weeks after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Antonius Hospital Sneek; Innovatiefonds De Friesland Zorgverzekeraar (DFZ)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: April 7, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 16, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Fractures, Bone; Joint Dislocations
• Other Study ID Numbers: 20170277

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No