NCT04700969

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

17 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Dec 2020May 2027

Study Start

First participant enrolled

December 15, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Expected
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

5 years

First QC Date

December 23, 2020

Last Update Submit

March 18, 2025

Conditions

Keywords

OrthopedicsImplementationResearch utilization

Outcome Measures

Primary Outcomes (1)

  • Adherence to UR guidelines in the care of patients undergoing hip surgery.

    Adherence to national urinary retention guidelines documented in the patients' medical record

    Change from base line to 1 year after the intervention

Secondary Outcomes (7)

  • Number of hip surgery patients with UR

    Change from base line to 1 year after the intervention

  • Patient participation

    Change from base line to 1 year after the intervention

  • Costs related to UR

    Change from base line to 1 year after the intervention

  • The IFs', staff's, and managers' experience of UR care

    Change from base line to 1 year after the intervention

  • The IFs', staff's, and managers' experience of the facilitation program

    1 year after the intervention

  • +2 more secondary outcomes

Study Arms (2)

A support program to facilitate implementation of EBP for postoperative urinary retention

EXPERIMENTAL

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.

Other: : A support program to facilitate implementation of evidence-based practice for postoperative urinary retention

Control-No support program

NO INTERVENTION

No support program

Interventions

A 12-month implementation support program for multi-professional internal facilitator teams

A support program to facilitate implementation of EBP for postoperative urinary retention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Sjukhuset Arvika

Arvika, Sweden

Location

Danderyds sjukhus

Danderyd, Sweden

Location

Höglandssjukhuset Eksjö

Eksjö, Sweden

Location

Enköpings lasarett

Enköping, Sweden

Location

Mälarsjukhuset

Eskilstuna, Sweden

Location

Karolinska University Hospital, Huddinge

Huddinge, Sweden

Location

Capio Ortopediska huset

Johanneshov, Sweden

Location

Karlskoga Lasarett

Karlskoga, Sweden

Location

Capio Specialistvård Motala

Motala, Sweden

Location

Vrinnevisjukhuset

Norrköping, Sweden

Location

Norrtälje Sjukhus

Norrtälje, Sweden

Location

Nyköpings lasarett

Nyköping, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Södertälje sjukhus

Södertälje, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

Sjukhuset Torsby

Torsby, Sweden

Location

Västmanlands sjukhus

Västerås, Sweden

Location

Related Publications (3)

  • Winberg M, Fjordkvist E, Joelsson-Alm E, Carlfjord S, Nyman MH, Eldh AC. Contextual Factors Affecting Evidence-Based Practice in Orthopaedic Nursing and Rehabilitation: A Mixed Methods Study. J Adv Nurs. 2025 Jul 19. doi: 10.1111/jan.70098. Online ahead of print.

  • Fjordkvist E, Halleberg Nyman M, Winberg M, Joelsson-Alm E, Eldh AC. First-line managers' experience of guideline implementation in orthopaedic nursing and rehabilitation: a qualitative study. BMC Health Serv Res. 2024 Jul 31;24(1):871. doi: 10.1186/s12913-024-11353-w.

  • Eldh AC, Joelsson-Alm E, Wretenberg P, Halleberg-Nyman M. Onset PrevenTIon of urinary retention in Orthopaedic Nursing and rehabilitation, OPTION-a study protocol for a randomised trial by a multi-professional facilitator team and their first-line managers' implementation strategy. Implement Sci. 2021 Jun 26;16(1):65. doi: 10.1186/s13012-021-01135-x.

MeSH Terms

Conditions

Urinary RetentionHip Fractures

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Maria Hälleberg Nyman, PHD

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2020

First Posted

January 8, 2021

Study Start

December 15, 2020

Primary Completion

December 30, 2025

Study Completion (Estimated)

May 30, 2027

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations