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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

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.

Condition or disease Intervention/treatment
Fractures, Bone Dislocations Procedure: Standard trauma care

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : December 26, 2017
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 12 weeks after treatment ]
    Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 1 week and 6 weeks after treatment ]
    Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)

  2. Complications of treatment [ Time Frame: 12 weeks after treatment ]
    Assessment of treatment complications

  3. Pain score [ Time Frame: 12 weeks after treatment ]
    Assessment of pain score using a visual-analogue scale (VAS)

  4. Physical functioning [ Time Frame: 12 weeks after treatment ]
    Physical functioning according to the 12-item World Health Organisation (WHO) Disability Assessment Schedule II

  5. 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

  6. General health status [ Time Frame: 12 weeks after treatment ]
    General health status according to the General Health Questionnaire (GHQ)

  7. Quality of life [ Time Frame: 12 weeks after treatment ]
    Quality of life using the EuroQol (EQ5D) questionnaire

  8. Time consumption [ Time Frame: 1 week, 6 weeks, and 12 weeks after treatment ]
    Time consumption (waiting time, treatment time, travelling time)

  9. Costs [ Time Frame: 12 weeks after treatment ]
    Costs of treatment



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506958


Contacts
Contact: Tjitte Verbeek, MD PhD +31503616724 t.verbeek@umcg.nl
Contact: Huibert Burger, MD PhD +31503616724 h.burger@umcg.nl

Locations
Netherlands
General Practice Zorgplein Lemmer Recruiting
Lemmer, Friesland, Netherlands, 8531EB
Contact: Hans Arentsen, MD         
Antonius Hospital Sneek Recruiting
Sneek, Friesland, Netherlands, 8601 ZK
Contact: Machiel Kuipers, MD         
Sponsors and Collaborators
University Medical Center Groningen
Antonius Hospital Sneek
Innovatiefonds De Friesland Zorgverzekeraar (DFZ)
  Study Documents (Full-Text)

Documents provided by dr. T. Verbeek, University Medical Center Groningen:

Additional Information:
Responsible Party: dr. T. Verbeek, Post-doc researcher, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03506958     History of Changes
Other Study ID Numbers: 20170277
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fractures, Bone
Joint Dislocations
Wounds and Injuries
Bone Diseases
Musculoskeletal Diseases