Reminder implementation for safety in child care

ISRCTN	ISRCTN44819426
DOI	https://doi.org/10.1186/ISRCTN44819426

Submission date: 10/06/2015
Registration date: 23/06/2015
Last edited: 17/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Plain English summary under review

Contact information

Dr Anna Ehrenberg
Scientific

School of Education, Health and Social Studies, Dalarna University
Falun
79188
Sweden

ORCID ID	0000-0002-3964-196X
Phone	+4623778472
Email	aeh@du.se

Study information

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
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Reminder implementation for safety in child care - a cluster randomized controlled trial in paediatric care
Study acronym	RISCC
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	30/09/2011

Eligibility

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
Key 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.
Key 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
Date of first enrolment	01/10/2009
Date of final enrolment	30/09/2011

Locations

Countries of recruitment

Sweden

Study participating centre

Astrid Lindgrens Children's Hospital, Karolinska University Hospital

-
Sweden

Sponsor information

School of Education, Health and Social Studies
University/education

Dalarna University
Falun
79188
Sweden

Phone	+4623778472
Email	aeh@du.se
Website	http://www.du.se
"ROR"	https://ror.org/000hdh770

Funders

Funder type

University/education

Health Care Sciences Postgraduate School, Karolinska Institutet

No information available

Högskolan Dalarna
Government organisation / Local government

Alternative name(s): Dalarna University, DU
Location: Sweden

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	27/01/2016	17/12/2020	Yes	No

Editorial Notes

17/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.