Implementing a bladder bundle intervention in elderly patients undergoing hip fracture surgery

ISRCTN	ISRCTN17022695
DOI	https://doi.org/10.1186/ISRCTN17022695
ClinicalTrials.gov number	NCT02983136

Submission date: 07/12/2021
Registration date: 23/12/2021
Last edited: 07/07/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
A condition called urinary retention is also common after anesthesia, and can increase the likelihood of a urinary tract infection (UTI). Urinary retention means that the bladder does not fully empty during urination, leaving urine sitting in the bladder longer than is normal
Urinary retention and UTIs are common adverse events that can occur after surgery.
We aimed to test if an intervention aiming to improve healthcare workers' knowledge, attitude, and clinical practice related to patient safety measures, would affect bladder distension in elderly patients undergoing acute hip fracture surgery.

Who can participate?
Registered nurses and nurse assistants working in the units caring for elderly patients undergoing acute hip fracture surgery.

What does the study involve?
Health care worker (registered nurses and nurse assistants) education:
-Preventing bladder distension including the use of appropriate indications and removal plan. Timely bladder scan according to the national voiding monitoring schedule to detect urinary retention and residual urine.
-Infection prevention measures
-Refreshment of patient assessment tools related to evidence-based catheter indications.
-E-learning test (online education material, film (how to perform aseptic catheterisation on men and women, quiz and a simulation test with instructors).

What are the possible benefits and risks of participating?
Potential reduction in healthcare related adverse events in hip fracture patients.
Risks: none

Where is the study run from?
Institute of Health Care Sciences, Sahlgrenska Academy, University of Gothenburg (Sweden)

When is the study starting and how long is it expected to run for?
December 2016 to April 2020

Who is funding the study?
Göteborg University (Sweden)
University of Gothenburg Center for Person-Centred Care, GPCC (Sweden)
Landstingens Ömsesidiga Försäkringsbolag (Löf) (Sweden)

Who is the main contact?
Maria Frödin, maria.frodin@gu.se
Annette.erichsen.andersson@gu.se

Contact information

Ms Maria Frödin
Scientific

Gundas gata 124
Mölndal
431 51
Sweden

ORCID ID	0000-0003-2890-8769
Phone	+46 731802487
Email	maria.frodin@gu.se

Study information

Study design	Single centre longitudinal implementation intervention
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet.
Scientific title	Theory driven implementation intervention co-creation of innovations to reduce bladder distension and urinary tract infections in elderly patients undergoing hip fracture surgery
Study objectives	A theory driven implementation intervention based on organisational learning, culture, and dialogue might reduce the incidence of bladder distention in elderly patients undergoing acute hip-fracture surgery.
Ethics approval(s)	Approved 18/05/2018, Regional ethics review board (Box 401, SE 405 30 Gothenburg, +46 31-786 68 21), ref: 166-15 and amendment 327-17
Health condition(s) or problem(s) studied	Prevention of bladder distension in elderly patients undergoing acute hip-fracture surgery
Intervention	The implementation intervention addressed healthcare worker specific culture related to preventing bladder distension. The process consisted of: -A logic model with the pre-planning of the intervention to identify enablers and barriers and set out goals. -Selection of facilitators within the involved units. -Creating a safe place for learning (called learning labs) through dialogue -Co-creation of the nurse-driven protocol -Introducing the national residual monitoring schedule. Bladder scanning with a tighter time interval. -Educational meetings and learning in dialogue. -Feedback on patient outcome For evaluating the effect of the intervention on patient outcomes, data from the hospital’s quality registry was used.
Intervention type	Behavioural
Primary outcome measure	Bladder distension (yes/no). Measured over five years using patient records on patients admitted for acute hip-fracture surgery.
Secondary outcome measures	Weekly reviews of the nurse-driven urinary catheterisation protocol were performed by two of the facilitators to ensure correct indications and removal plan for catheter treatment. 1. Urinary catheter-associated infections during hospital stay, Yes/No. 2. Registered nurses documented indication, yes/no 3. Registered nurses documented removal plan, yes/no 4. Involving patient in the catheter utilization, yes/no 5. Consulting a colleague to ensure appropriate indication, yes/no 6. Physician documented indication, yes/no 7. Physician documented removal plan, yes/no
Overall study start date	05/12/2016
Completion date	30/04/2020

Eligibility

Participant type(s)	Health professional
Age group	Adult
Sex	Both
Target number of participants	400
Total final enrolment	400
Key inclusion criteria	Registered nurses and nurse assistants working in the emergency department, operating department, ortho-geriatric wards, postoperative care unit and intensive care unit
Key exclusion criteria	Registered nurses and nurse assistants caring for hip fracture patients in the orthopaedic ward.
Date of first enrolment	10/01/2018
Date of final enrolment	31/12/2018

Locations

Countries of recruitment

Sweden

Study participating centres

Mölndals hospital, Sahlgrenska university hospital, Sahlgrenska academy

Göteborgsvägen 31
Mölndal
SE, 4431 80 Mölndal
Sweden

Institute of Health Care Sciences, Sahlgrenska Academy, University of Gothenburg

Arvid Wallgrens backe 1
Gothenburg
SE, 413 46 Gothenburg
Sweden

Sponsor information

University of Gothenburg
University/education

Institute of Health Care Sciences
Sahlgrenska Academy
Arvid Wallgrens backe 1
Gothenburg
SE- 413 46
Sweden

Phone	+46 737250458
Email	annette.erichsen.andersson@gu.se
Website	http://gu.se
"ROR"	https://ror.org/01tm6cn81

Funders

Funder type

University/education

Centrum fÖr Personcentrerad Vård
Private sector organisation / Universities (academic only)

Alternative name(s): Centre for Person-centred Care, GPCC
Location: Sweden

Landstingets övergripande försäkringsbolag (LÖF)

No information available

Results and Publications

Intention to publish date	01/05/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Three planned publications in a high-impact peer-reviewed journal
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (maria.frodin@gu.se)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Interim results article	Experiences	04/01/2018	20/06/2022	Yes	No
Results article		12/10/2022	13/10/2022	Yes	No
Results article	Economic evaluation	03/07/2025	07/07/2025	Yes	No

Editorial Notes

07/07/2025: Publication reference added.
13/10/2022: Publication reference added.
20/06/2022: Publication reference added.
23/12/2021: Trial's existence confirmed by Regional ethics review board Gothenburg.