Long-term effects of a strategy to reduce inappropriate use of catheters
| ISRCTN | ISRCTN18989217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18989217 |
- Submission date
- 07/02/2022
- Registration date
- 11/02/2022
- Last edited
- 08/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In the era of increasing healthcare costs, it is crucial to reduce low-value care with the aim of improving the quality and safety of care and lowering costs. One aspect of care that is routinely given but that may be necessary is the use of catheters.
A urinary catheter is a flexible tube used to empty the bladder and collect urine in a drainage bag.
A peripheral venous catheter is a catheter (small, flexible tube) placed into a peripheral vein for venous access to administer intravenous therapy such as medication fluids.
A multifaceted de-implementation strategy has proven to be effective in a trial called ‘Reduce Inappropriate use of CATheters’ (RICAT) in the Netherlands. However, knowledge about the sustainability of de-implementation strategies is lacking. The aim of this study is to investigate the long-term sustainability of the de-implementation strategy that was implemented three years ago during the RICAT-trial. Further, we aim to identify general factors that contribute to sustainable de-implementation through use of a qualitative interview study.
Who can participate?
Patients who are admitted to a medical, non-surgical, ward and who have a peripheral venous catheter (PVC) or urinary catheter on the days of data collection.
What does the study involve?
We will perform an observational quantitative study, in which we will prospectively include patients with a PVC or urinary catheter. For these patients, we will assess whether the medical indications for this catheter are appropriate on the days of data collection.
What are the possible benefits and risks of participating?
The results of this study will be used to further improve healthcare pathways regarding the appropriate use of catheters. The measurements do not influence patients’ care and treatment plans. Further, the burden on patients is limited. A research physician will screen patients for having a PVC or urinary catheter, after which relevant data regarding the medical indication of the catheter will be collected from the electronic patient record.
Where is the study run from?
Amsterdam UMC, location AMC (the Netherlands)
When is the study starting and how long is it expected to run for?
November 2021 to April 2023
Who is funding the study?
ZonMw (the Netherlands)
Who is the main contact?
Tessa van Horrik, t.m.vanhorrik@amsterdamumc.nl
Dr Eva Verkerkeva.verkerk@radboudumc.nl
Contact information
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
 ORCID ID |
0000-0002-3496-2203 |
|---|---|
| Phone | +31(0)205665992 |
| t.m.vanhorrik@amsterdamumc.nl |
Scientific
Kapittelweg 54
Nijmegen
6525 EP
Netherlands
| ORCID ID |
0000-0002-6596-6207 |
|---|---|
| Phone | +31(0)243616333 |
| eva.verkerk@radboudumc.nl |
Study information
| Study design | Mixed-methods design including an observational quantiative part and a qualitative interview study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Long-term sustainability of a de-implementation project to Reduce Inappropriate Use of CATheters |
| Study acronym | RICAT-2 |
| Study objectives | We hypothesized that we will measure a sustained reduction of inappropriate use of peripheral venous catheters (PVC) of 15%, similar to the results of the RICAT-trial. |
| Ethics approval(s) | On 07/01/2022, the Medical Ethics Review Committee of the Academic Medical Center Amsterdam confirmed that the Medical Research Involving Human Subjects Act (WMO) does not apply to this study and that official approval of this study by their committee is not required. Reference number W21_560#22.001 |
| Health condition(s) or problem(s) studied | For the quantitative part, adult patients with a PVC or urinary catheter that are admitted to a medical ward. For the qualitative part, healthcare workers from the medical wards, who participated in executing and maintaining the de-implementation strategy. |
| Intervention | We will perform a multicenter observational study to measure the percentage of inappropriate use of peripheral intravenous catheters (PVCs) and urinary catheters. In addition, we will perform a qualitative interview study to assess to what extent the de-implementation strategy is maintained, and what barriers and facilitators apply to maintaining the effect of the de-implementation strategy. Quantitative part: We will only collect data about the medical indication for the peripheral venous catheter or urinary catheter on the days of data collection. Qualitative part: We will hold a one-time focus group interview with the healthcare workers in each participating hospital. |
| Intervention type | Other |
| Primary outcome measure | Percentage of inappropriate use of PVCs on the days of data collection will be collected by a research physician or research student. These data will be collected from medical records in an electronic Good Clinical Practice-compliant database. Based on the information from the medical records, the research physician or research student will assess if the use is inappropriate. The following indications will be considered appropriate: a. Peripheral intravenous catheter • Delivery of peripherally compatible infusate (intravenous fluids and medications) at least once in 24 h • Injection of contrast fluids • Intravenous access for cardiac dysrhythmia • Transfusion of blood and blood products b. Urinary catheter • Accurate measurements of urinary output in patients who are critically ill when required for treatment • Acute urinary retention or bladder outlet obstruction (≥150 mL) • Assist in healing of open sacral or perineal wounds in patients with urinary incontinence • Continuous bladder irrigation for haematuria • Palliative care for patients who are terminally ill if needed • Patient requires prolonged immobilisation • Before or after surgery according to (local) protocol • Volume measurements of urine output for diagnostics (24 h urine), which cannot be assessed by other collection strategies |
| Secondary outcome measures | 1. Number of patients with more than one PVC with an inappropriate indication on the days of data collection measured as above. 2. Barriers and facilitators of the sustainability of the effect of the de-implementation strategy measured using the themes that will emerge from the results of the focus group interviews conducted at a single time point |
| Overall study start date | 01/11/2021 |
| Completion date | 30/04/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1254 patients |
| Total final enrolment | 1155 |
| Key inclusion criteria | 1. Adult patients admitted to internal medicine, gastroenterology, geriatric, oncology, and pulmonology wards, and non-surgical acute admission units who have a PVC or urinary catheter on the day of data collection, or 2. Healthcare workers (e.g., nurses, physicians) who are or who were responsible for maintaining the de-implementation strategy to reduce inappropriate use of catheters |
| Key exclusion criteria | 1. Patients who are admitted for an elective short stay, and patients who are terminally ill 2. Patients with chronic use of catheters, defined as having any type of catheter before hospital admission, and no new inserted catheter of any type |
| Date of first enrolment | 01/05/2022 |
| Date of final enrolment | 01/04/2023 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Amsterdam
1105 AZ
Netherlands
Amsterdam
1081 HV
Netherlands
Amsterdam
1034 CS
Netherlands
Hoorn
1624 NP
Netherlands
Almere
1315 RA
Netherlands
Sponsor information
Hospital/treatment centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31(0)205669111 |
|---|---|
| s.e.geerlings@amsterdamumc.nl | |
| Website | https://www.amsterdamumc.org/research/institutes/cancer-center-amsterdam.htm |
"ROR" |
https://ror.org/05grdyy37 |
Hospital/treatment centre
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands
| Phone | +31(0)243611111 |
|---|---|
| tijn.kool@radboudumc.nl | |
| Website | https://www.radboudumc.nl/EN/Pages/default.aspx |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | 30/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | All relevant results of the study will be disseminated through publications in peer-reviewed journals and presentations at relevant –scientific- conferences. No identifiable patient data will be disseminated. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 16/08/2024 | 08/11/2024 | Yes | No |
Editorial Notes
08/11/2024: Publication reference and total final enrolment were added.
09/11/2022: The following changes were made to the trial record and the plain English summary was updated accordingly:
1. The recruitment end date was changed from 01/12/2022 to 01/04/2023.
2. The overall trial end date was changed from 01/11/2022 to 30/04/2023.
3. The intention to publish date was changed from 01/11/2023 to 30/04/2024.
04/04/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/04/2022 to 01/05/2022.
2. The recruitment end date was changed from 01/11/2022 to 01/12/2022.
10/02/2022: Trial's existence confirmed by Amsterdam UMC.
