- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04700969
Onset PrevenTIon of Urinary Retention in Orthopaedic Nursing and Rehabilitation (OPTION)
Onset PrevenTIon of Urinary Retention in Orthopaedic Nursing and Rehabilitation, OPTION - a Knowledge Implementation Study on a Facilitation Strategy for Multi-professional Clinical Champion Teams
Urinary retention (UR) is a common problem in older people undergoing hip surgery. Untreated UR can lead to bladder distention and a permanent damage of the bladder, which can cause both physical and psychical suffering as well as increased costs for society. Even if national and international practice guidelines are in place for handling UR within the health care system, many fail to comply with them. Compliance to clinical practice guidelines are improved if different professions and managers collaborate as a team. In OPTION (Onset PrevenTIon of urinary retention in Orthopedic Nursing and rehabilitation) the investigators will coach multi-professional local facilitator teams in knowledge translation and implementation of UR practice as well as investigate the effects of such evidence-based practice in orthopedic nursing and rehabilitation.
Implementation of research-based knowledge in evidence-based practice within an organization is complex with several known interacting factors. In a health care system these factors can be the care context, knowledge (innovation) and how the organization facilitates such implementations. The implementation strategy of OPTION utilize established theories of facilitation of knowledge implementation considering evidence and context with focus on leadership. The intervention consists of seminars and systematic support for implementation of UR-guidelines OPTION combine studies of adherence to evidence based practice regarding UR for patients over 65 years old that has undergone hip surgery and the health economic aspects of it. OPTION also contribute with improvements and increased knowledge regarding strategies to implement evidence based health care that can be used in other areas than UR and hip surgeries.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Arvika, Sweden
- Sjukhuset Arvika
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Danderyd, Sweden
- Danderyds Sjukhus
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Eksjö, Sweden
- Höglandssjukhuset Eksjö
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Enköping, Sweden
- Enköpings lasarett
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Eskilstuna, Sweden
- Mälarsjukhuset
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Huddinge, Sweden
- Karolinska University Hospital, Huddinge
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Johanneshov, Sweden
- Capio Ortopediska Huset
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Karlskoga, Sweden
- Karlskoga Lasarett
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Motala, Sweden
- Capio Specialistvård Motala
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Norrköping, Sweden
- Vrinnevisjukhuset
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Norrtälje, Sweden
- Norrtälje Sjukhus
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Nyköping, Sweden
- Nyköpings lasarett
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Stockholm, Sweden
- Södersjukhuset
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Södertälje, Sweden
- Södertälje Sjukhus
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Torsby, Sweden
- Sjukhuset Torsby
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Västerås, Sweden
- Västmanlands sjukhus
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Örebro, Sweden
- Orebro University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria: Orthopaedic units in Sweden performing hip surgery. -
Exclusion Criteria: Orthopaedic units in Sweden not performing hip surgery
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A support program to facilitate implementation of EBP for postoperative urinary retention
12- month support program.
Multi-professional facilitator-teams will be supported by a 12-month support program including seminars and monthly supervision (e-discussion forum and group teleconferences) to develop an awareness of, and skills in facilitating implementation of evidence/EBP in clinical everyday care.
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A 12-month implementation support program for multi-professional internal facilitator teams
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No Intervention: Control-No support program
No support program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to UR guidelines in the care of patients undergoing hip surgery.
Time Frame: Change from base line to 1 year after the intervention
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Adherence to national urinary retention guidelines documented in the patients' medical record
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Change from base line to 1 year after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of hip surgery patients with UR
Time Frame: Change from base line to 1 year after the intervention
|
Number of hip surgery patients with UR documented in the patients' medical record
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Change from base line to 1 year after the intervention
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Patient participation
Time Frame: Change from base line to 1 year after the intervention
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The Patient Preferences for Patient Participation tool (The 4Ps)
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Change from base line to 1 year after the intervention
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Costs related to UR
Time Frame: Change from base line to 1 year after the intervention
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Costs for device and labour for bladder scanning and urinary catheterization
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Change from base line to 1 year after the intervention
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The IFs', staff's, and managers' experience of UR care
Time Frame: Change from base line to 1 year after the intervention
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Investigated with qualitative interviews
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Change from base line to 1 year after the intervention
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The IFs', staff's, and managers' experience of the facilitation program
Time Frame: 1 year after the intervention
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Investigated with qualitative interviews
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1 year after the intervention
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The experience of people undergoing hip surgery, regarding UR, UR care.
Time Frame: Change from base line to 1 year after the intervention
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Investigated with qualitative interviews
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Change from base line to 1 year after the intervention
|
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The impact of a knowledge translation support program on the peoples' experience of the above
Time Frame: Change from base line to 1 year after the intervention
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Investigated with qualitative interviews
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Change from base line to 1 year after the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Hälleberg Nyman, PHD, Örebro University, Sweden
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORU 2020/03330
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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