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Completed

NCT Number: NCT03506958

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

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Practice Zorgplein Lemmer, Lemmer, Provincie Friesland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard trauma care

Procedure

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

Primary outcomes

  1. Patient satisfaction

    Time frame: 12 weeks after treatment

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Antonius Hospital Sneek
  • Innovatiefonds De Friesland Zorgverzekeraar (DFZ)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2018
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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