Fractures, BoneNCT03506958
Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals vs General Practitioners
An observational study of Fractures, Bone and Dislocations, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Fractures, Bone, Dislocations
- What is being tested?
- Standard trauma care
- Type of treatment
- Surgery or procedure
- How many people
- 117 participants
- Where
- 2 sitesNetherlands
- Study dates
- 25 Sep 2017to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients of age 11 years and younger.
- Patients presenting outside ordinary business hours.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
General Practice Zorgplein Lemmer
Lemmer, Provincie Friesland, 8531EB
Antonius Hospital Sneek
Sneek, Provincie Friesland, 8601 ZK
About this study
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
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.
- Conditions
- Fractures, Bone, Dislocations
- Being tested
- Standard trauma care
- Medical subject headings
- Fractures, Bone, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard trauma careProcedure or surgery
In both groups, all procedures and management will be done according to the hospital's standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard trauma care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Measured: 12 weeks after treatment
Secondary outcomes (9)
Patient satisfaction
Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Measured: 1 week and 6 weeks after treatment
Complications of treatment
Assessment of treatment complications
Measured: 12 weeks after treatment
Pain score
Assessment of pain score using a visual-analogue scale (VAS)
Measured: 12 weeks after treatment
Physical functioning
Physical functioning according to the 12-item World Health Organisation (WHO) Disability Assessment Schedule II
Measured: 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
Measured: 12 weeks after treatment
General health status
General health status according to the General Health Questionnaire (GHQ)
Measured: 12 weeks after treatment
Quality of life
Quality of life using the EuroQol (EQ5D) questionnaire
Measured: 12 weeks after treatment
Time consumption
Time consumption (waiting time, treatment time, travelling time)
Measured: 1 week, 6 weeks, and 12 weeks after treatment
Costs
Costs of treatment
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start25 Sep 2017
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Antonius Hospital Sneek, Innovatiefonds De Friesland Zorgverzekeraar (DFZ)
- Responsible party
- Principal investigator, dr. T. Verbeek, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506958
- Sponsor's protocol ID
- 20170277
- Status last verified
- May 2021
- First submitted
- 7 Apr 2018
- Last updated
- 19 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30782924
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03506958
- Acronym / sponsor ID
- 20170277
- Conditions
- Fractures, Bone, Dislocations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Antonius Hospital Sneek, Innovatiefonds De Friesland Zorgverzekeraar (DFZ)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Practice | – | Procedure: Standard trauma careHundred 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. |
| Hospital | – | Procedure: Standard trauma careHundred patients with an X-ray confirmed diagnosis of a non-complex fracture or dislocation and planned to be treated in the Antonius Hospital Sneek. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients of age 11 years and younger.
- Patients presenting outside ordinary business hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard trauma careIn both groups, all procedures and management will be done according to the hospital's standard of care. | Procedure or surgery | General Practice, Hospital |
Primary outcome
Patient satisfaction
Time frame: 12 weeks after treatment
Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
9 secondary outcomes
Patient satisfaction
Time frame: 1 week and 6 weeks after treatment
Complications of treatment
Time frame: 12 weeks after treatment
Pain score
Time frame: 12 weeks after treatment
Physical functioning
Time frame: 12 weeks after treatment
Limitations in functions of upper extremities (if applicable)
Time frame: 12 weeks after treatment
General health status
Time frame: 12 weeks after treatment
Quality of life
Time frame: 12 weeks after treatment
Time consumption
Time frame: 1 week, 6 weeks, and 12 weeks after treatment
Costs
Time frame: 12 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Derived from this study: PubMed 30782924Verbeek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, Bone and Dislocations, run by University Medical Center Groningen at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 12 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03506958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.