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

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ClinicalTrials.gov Identifier: NCT03506958
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Collaborators:
Antonius Hospital Sneek
Innovatiefonds De Friesland Zorgverzekeraar (DFZ)
Information provided by (Responsible Party):
dr. T. Verbeek, University Medical Center Groningen

April 7, 2018
April 24, 2018
April 24, 2018
September 25, 2017
December 26, 2017   (Final data collection date for primary outcome measure)
Patient satisfaction [ Time Frame: 12 weeks after treatment ]
Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Same as current
No Changes Posted
  • Patient satisfaction [ Time Frame: 1 week and 6 weeks after treatment ]
    Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
  • Complications of treatment [ Time Frame: 12 weeks after treatment ]
    Assessment of treatment complications
  • Pain score [ Time Frame: 12 weeks after treatment ]
    Assessment of pain score using a visual-analogue scale (VAS)
  • Physical functioning [ Time Frame: 12 weeks after treatment ]
    Physical functioning according to the 12-item World Health Organisation (WHO) Disability Assessment Schedule II
  • Limitations in functions of upper extremities (if applicable) [ Time Frame: 12 weeks after treatment ]
    Limitations in functions of upper extremities according to the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
  • General health status [ Time Frame: 12 weeks after treatment ]
    General health status according to the General Health Questionnaire (GHQ)
  • Quality of life [ Time Frame: 12 weeks after treatment ]
    Quality of life using the EuroQol (EQ5D) questionnaire
  • Time consumption [ Time Frame: 1 week, 6 weeks, and 12 weeks after treatment ]
    Time consumption (waiting time, treatment time, travelling time)
  • Costs [ Time Frame: 12 weeks after treatment ]
    Costs of treatment
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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.
  • Fractures, Bone
  • Dislocations
Procedure: Standard trauma care
In both groups, all procedures and management will be done according to the hospital's standard of care.
  • 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.
    Intervention: 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.
    Intervention: Procedure: Standard trauma care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Same as current
February 28, 2019
December 26, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Older Adult)
No
Contact: Tjitte Verbeek, MD PhD +31503616724 t.verbeek@umcg.nl
Contact: Huibert Burger, MD PhD +31503616724 h.burger@umcg.nl
Netherlands
 
 
NCT03506958
20170277
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
dr. T. Verbeek, University Medical Center Groningen
University Medical Center Groningen
  • Antonius Hospital Sneek
  • Innovatiefonds De Friesland Zorgverzekeraar (DFZ)
Not Provided
University Medical Center Groningen
April 2018