Implementing a bladder bundle intervention in elderly patients undergoing hip fracture surgery
| ISRCTN | ISRCTN17022695 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17022695 |
| ClinicalTrials.gov (NCT) | NCT02983136 |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Gothenburg |
| Funders | Centrum fÖr Personcentrerad Vård, Landstingets övergripande försäkringsbolag (LÖF) |
- 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
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
Scientific
Gundas gata 124
Mölndal
431 51
Sweden
 ORCID ID |
0000-0003-2890-8769 |
|---|---|
| Phone | +46 731802487 |
| maria.frodin@gu.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre longitudinal implementation intervention |
| Secondary study design | Non randomised study |
| Study type | Participant 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(s) | Bladder distension (yes/no). Measured over five years using patient records on patients admitted for acute hip-fracture surgery. |
| Key secondary outcome measure(s) | 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 |
| Completion date | 30/04/2020 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
Mölndal
SE, 4431 80 Mölndal
Sweden
Gothenburg
SE, 413 46 Gothenburg
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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? |
|---|---|---|---|---|---|
| Results article | 12/10/2022 | 13/10/2022 | Yes | No | |
| Results article | Economic evaluation | 03/07/2025 | 07/07/2025 | Yes | No |
| Interim results article | Experiences | 04/01/2018 | 20/06/2022 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
