Condition category
Circulatory System
Date applied
10/06/2015
Date assigned
23/06/2015
Last edited
22/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Plain English summary under review

Trial website

Contact information

Type

Scientific

Primary contact

Professor 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 number

ClinicalTrials.gov number

Protocol/serial number

N/A

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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/09/2008

Overall trial end date

30/09/2011

Reason abandoned

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

Patient

Age group

Child

Gender

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.

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

Trial 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

http://www.du.se

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

government non-federal

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

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes