Contact information
Type
Scientific
Contact name
Dr Anna Ehrenberg
ORCID ID
http://orcid.org/0000-0002-3964-196X
Contact details
School of Education
Health and Social Studies
Dalarna University
Falun
79188
Sweden
+4623778472
aeh@du.se
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
Nil known
Study information
Scientific title
Reminder implementation for safety in child care - a cluster randomized controlled trial in paediatric care
Acronym
RISCC
Study hypothesis
The overall objective of this project is to evaluate the effects of implementing a clinical practice guideline for peripheral venous catheters in the format of reminders, integrated in the electronic patient record. Specifically we hypothesise:
1. That a cluster randomized intervention using electronic reminders in peadiatric care will reduce complications related to peripheral venous catheters in hospitalised children
2. That the electronic reminders will improve registered nurses adherence to the clinical guidelines for peripheral venous catheters.
In addition, the study aims to describe the relationship between registered nurses perceptions of work context and the outcomes of the intervention.
Ethics approval(s)
Regional Ethics Review Board in Uppsala, Sweden, 06/04/2009 and 01/12/2010, refs: 2008/107 and 2008/360
Study design
A single centre cluster randomized controlled study
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Study setting(s)
Hospital
Study type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
The study focus is on complications related to pheripheral venous catheters that are used for adminstration of medications and fluids in patients.
Intervention
1. Intervention arm: Reminders based on recommendations from clinical practice guidelines for peripheral venous catheters, integrated in the electronic patient record.
2. Control arm: Clinical practice guidelines available on the Intranet, following normal procedure for dissemination of guidelines.
Intervention type
Other
Primary outcome measure
Recorded occurrence of peripheral venous catheter-related complications at removal.
Secondary outcome measures
Registered nurses self-reported adherence to the clinical practice guideline recommendations for managing peripheral venous catheters.
Overall study start date
01/09/2008
Overall study end date
30/09/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
12 paediatric hospital wards, including neonatal and paediatric patients, with the same electronic patient record system.
1. Hospitalised Children, age 0 - 18 years, with peripheral venous catheters:
1.1. Inserted and documented in a template for peripheral venous catheters at baseline and after the intervention.
1.2. Only one peripheral venous catheter per patient was included.
Registered nurses at the 12 peadiatric wards:
1.3. Who had worked at one of the 12 wards at the time for data-collection.
Participant type(s)
Patient
Age group
Child
Lower age limit
0 Years
Upper age limit
18 Years
Sex
Both
Target number of participants
The sample included 12 wards at a peadiatric hospital. A sample size of 1213 peripheral venous catheters (patients), about 100 per unit, was calculated, that is 2426 peripheral venous catheters per cluster, both at baseline and at follow-up.
Total final enrolment
1562
Participant exclusion criteria
Peripheral venous catheters were excluded that:
1. Lacked complete recording of reasons for removal.
Registered nurses were excluded who during the data-collection periods:
1. Had only adminstrative duties
2. Were on parental leave
3. Sick leave,
4. Doing full time studies
Recruitment start date
01/10/2009
Recruitment end date
30/09/2011
Locations
Countries of recruitment
Sweden
Study participating centre
Astrid Lindgrens Children's Hospital, Karolinska University Hospital
-
Sweden
Sponsor information
Organisation
School of Education, Health and Social Studies
Sponsor details
Dalarna University
Falun
79188
Sweden
+4623778472
aeh@du.se
Sponsor type
University/education
Website
ROR
Funders
Funder type
University/education
Funder name
Health Care Sciences Postgraduate School, Karolinska Institutet
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Högskolan Dalarna
Alternative name(s)
Dalarna University, DU
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Sweden
Results and Publications
Publication and dissemination plan
The intention is to submit the paper to Implementation Science for publication. The paper will include the results on the effects of implementing a clinical practice guideline for peripheral venous catheters in the format of reminders integrated in the electronic patient record, on complications related to peripheral venous catheters in hospitalised children, and registered nurses adherence to the guidelines. The submission is planned during 2015.
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 27/01/2016 | 17/12/2020 | Yes | No |