Condition category
Not Applicable
Date applied
22/01/2020
Date assigned
19/03/2020
Last edited
19/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
One major challenge in healthcare today is for healthcare professionals to stay up to date on the newest and most reliable research knowledge. Another is to implement new knowledge into complex and busy healthcare settings. This is a threat to patients, as they rely on healthcare professionals to provide them the best possible care. One solution to this, is to educate healthcare professionals in Knowledge Translation (KT) to provide them with skills and tools to handle these challenges.
The IMPAKT intervention bundle aims to first work with healthcare professionals in nursing homes to identify their educational needs related to KT. Secondly, tailored to these needs, the researchers will provide an educational program that addresses these needs. Then finally, researchers will support the nursing homes in applying what they learnt.

Who can participate?
Public nursing homes in a large municipality in Norway were eligible for inclusion.

What does the study involve?
The researchers will randomly allocate nursing homes to two groups: one group that will receive the IMPAKT intervention bundle, and one group that receives nothing. Then, after a year, the researchers want to see if there is a difference in care provided in the nursing homes that received this bundle, compared to patients in the comparison group. Care will be assessed at patient level outcomes.

What are the possible benefits and risks of participating?
The potential benefits of participating in this study, includes an increased level of awareness and competencies to stay up to date on research knowledge among healthcare professionals. Moreover, if healthcare professionals in this study succeed with the implementation process during the study period, then a potential benefit is that this may be applied again to different problems. For patients, a potential benefit is they receive care in line with the most reliable research knowledge. In this case, nursing homes are implementing an early warning score, and another potential benefit for patients is a reduction in unnecessary transfer to acute care hospital, and maybe an increase in appropriate transfers.
Potential risks of participation is frustration in the staff, regarding inability either personally or organizationally to fulfil expectations of the educational program goals.

Where is the study run from?
The Western Norway University of Applied Sciences

When is the study starting and how long is it expected to run for?
January 2019 to October 2020

Who is funding the study?
1. The Research Council of Norway
2. Western Norway University of Applied Sciences (Norway)
3. The Municipality of Bergen, Division of Nursing Homes (Norway)

Who is the main contact?
Dr Birgitte Graverholt
Birgitte.Graverholt@hvl.no

Trial website

http://www.impakt.no (lay language) and https://app.cristin.no/projects/show.jsf?id=550905 (scientific)

Contact information

Type

Public

Primary contact

Dr Birgitte Graverholt

ORCID ID

http://orcid.org/0000-0002-1145-3801

Contact details

Sollien 62B
Bergen
5096
Norway
+47 55585800
bgra@hvl.no

Type

Scientific

Additional contact

Dr Birgitte Graverholt

ORCID ID

http://orcid.org/0000-0002-1145-3801

Contact details

Sollien 62B
Bergen
5096
Norway
+47 55585800
bgra@hvl.no

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Project ID 256569 (The Research Council of Norway)

Study information

Scientific title

The effectiveness of an integrated-KT intervention to implement NEWS2 in nursing homes

Acronym

IMPAKT

Study hypothesis

A tailored and integrated Knowledge Translation (KT) intervention works better than no intervention in implementing NEWS2 in nursing homes.

Ethics approval

1. Approved 23/09/2019, Regional Committees for Medical and Health Research Ethics (REC) - region South East (Gullhaugveien 1-3, N-0484 Oslo, Norway; +47 22845511; post@helseforskning.etikk.no), ref: 29321
2. Approved 09/12/2019, Norwegian Center for Research Data (Harald Hårfagres gate 29, N-5007 Bergen, Norway; +47 55582117; nsd@nsd.no ), ref: 594767

Study design

Single-blind interventional multicenter study using a cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Other

Patient information sheet

This study was exempted from informed consent. We have Public announcements in each of the or each of the 19 included nursing homes. Not available in web format, please use contact details to request details of this information.

Condition

Nursing home residents

Intervention

This intervention was developed in collaboration with staff and leaders in nursing homes to tailor the needs in nursing homes to implement NEWS2.

NEWS2 is the tool used for early identification of acute deterioration. The intervention arm involves the implementation of NEWS2 in nursing homes.

The paired cluster randomization process is done as follows: The eligible nursing homes at time of randomization are presented with size (number of beds) and type of beds (short-term versus long-term) to a statistician, who then pairs 20 nursing homes according to these factors. Within each pair, one nursing home is randomly allocated to the intervention arm, and the other to the control arm. The randomization sequence is generated using a random number generator function in IBM SPSS Statistics.

The IMPAKT intervention consists of two main and preset components, that will be developed and adapted according to the needs of practice development nurses (PDNs) and care staff in Nursing Homes (NHs). This is in line with the underlying integrated-knowledge translation (i-KT) approach, essentially aiming to engage end-users in the entire research process.

The first component is an educational component, addressing identified learning needs related to knowledge translation (KT). The second component is an implementation phase where PDNs in intervention NHs are expected to apply what they (and colleagues) learned in the first component, in planning and leading the implementation of a KT-project. Specifically, PDNs are expected to lead the implementation of National Early Warning Score (NEWS2), in their respective nursing homes, while applying the tools and competencies gained in the first component. During the implementation phase (second component), each of the intervention NHs are facilitated by researchers from distance.

Nursing homes from both arms participated in two development phases of the intervention, for each of the two intervention components. To develop the first component, interviews and observations took place, among stakeholders in the nursing homes. The idea of this development phase was to gain a clearer picture of the problems and educational needs related to implementing new knowledge in this setting and how the IMPAKT intervention may address them to reduce them. To develop the second component, a workshop was organized to gain an understanding of what clinical areas of practice nursing homes are struggling with, and where they believe there is potential for improvement. Based on the workshop, a list of potential areas to focus on in the implementation phase emerged, and was further integrated with the views of physicians and NH administration, before the decision to focus on NEWS2 for the KT-project was made.

Ahead of the educational component, a start-up meeting between each nursing intervention home’s Head of institution and PDN with the PI will be organized to provide information about the educational component, its aims and target participants. Each Head of Institution will have the choice to send as many additional participants as they can afford, other than the expected participation of their PDN.

The final aspect of the educational component is to write an action plan for the implementation of NEWS2 in each of the intervention nursing homes. The Action plan template is developed based on the steps of the knowledge-to-action model, namely to identify and document the practice gap, to identify stakeholders, adapt the NEWS2 to the specific context, identify barriers and facilitators and finally to suggest actions to prepare their nursing homes for the implementation endeavor. During the implementation phase, the intervention homes will be facilitated by regular meetings with researchers. Additional ad hoc adaptations may occur, according to the needs expressed by the PDNs.

The control NHs will not partake in any of the intervention components.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Degree of implementation of NEWS2. Data will be extracted from individual Electronic Patient Journals (EPJ). Monthly baseline measures with NEWS2 for eligible residents and the level of use of NEWS2 in clinical indication.

Secondary outcome measures

none

Overall trial start date

01/12/2018

Overall trial end date

31/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Inclusion happened at the level of institution. Public nursing homes in a large municipality in Norway were eligible for inclusion.

Participant type

Health professional

Age group

Mixed

Gender

Both

Target number of participants

14 nursing homes (7 per arm)

Participant exclusion criteria

1. Public nursing home conceptually different from the typical facilities (facility for independently living patients discharged extra early from hospital ("a bed on the way home from hospital")
2. Public nursing homes considered unfit to participate in this intervention (as decided by the Municipality's Division of Nursing Homes)

Recruitment start date

18/12/2018

Recruitment end date

10/01/2019

Locations

Countries of recruitment

Norway

Trial participating centre

Kolstihagen sykehjem
Kolstibotn 6
Bergen
5098
Norway

Trial participating centre

Øvsttunheimen sykehjem
Solåsen 42
Bergen
5223 Nesttun
Norway

Trial participating centre

Odinsvei bosenter og sykehjem
Odins veg 106
Bergen
5221 Nesttun
Norway

Trial participating centre

Søreide sykehjem
Grunnane 71
Bergen
5251 Søreidgrend
Norway

Trial participating centre

Hordnestunet sykehjem
Hordnesvegen 127
Bergen
5244 Fana
Norway

Trial participating centre

Frieda Fasmers Minne
Vadmyrveien 85
Bergen
5172 Loddefjord
Norway

Trial participating centre

Ladegården sykehjem
Ladegårdsveien 65
Bergen
50333 Bergen
Norway

Trial participating centre

Ulset sykehjem
Salhusvegen 20
Bergen
5131 Nyborg
Norway

Trial participating centre

Arna helseheim
Utløbakken 4
Bergen
5260 Indre Arna
Norway

Trial participating centre

Midtbygda sykehjem
Åsane senter 1
Bergen
5116 Ulset
Norway

Trial participating centre

Sentrumssykehjemmene ved Engensenteret
Teatergaten 43
Bergen
5010 Bergen
Norway

Trial participating centre

Åstveit sykehjem
Åstveitveien 1
Bergen
5106 Øvre Ervik
Norway

Trial participating centre

Fyllingsdalen sykehjem
Dag Hammarskjøldsvei 98
Bergen
5144 Fyllingsdalen
Norway

Trial participating centre

Lyngbøtunet Bo og servicesenter
Lyngbøveien 89
Bergen
5164 Laksevåg
Norway

Trial participating centre

Løvåsen sykehjem
Løvåsveien 26
Bergen
5145 Fyllingsdalen
Norway

Trial participating centre

Gullstøltunet sykehjem
Øvre Kråkenes 111
Bergen
5142 Bønes
Norway

Trial participating centre

Skjoldtunet sykehjem
Skjoldvegen 19
Bergen
5221 Nesttun
Norway

Trial participating centre

Slettemarken sykehjem
Adolph Bergs vei 33
Bergen
5089 Bergen
Norway

Trial participating centre

Fantoft omsorgssenter
Øvre Fantoftåsen 56A
Bergen
5072 Bergen
Norway

Sponsor information

Organisation

Western Norway University of Applied Sciences

Sponsor details

Høgskulen på Vestlandet
Postboks 7030
Bergen
5020
Norway
+47 55585800
post@hvl.no

Sponsor type

University/education

Website

https://www.hvl.no/en

Funders

Funder type

Research council

Funder name

Norges Forskningsråd

Alternative name(s)

Research Council of Norway, Forskningsrådet, Norwegian Research Council

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Norway

Funder name

Western Norway University of Applied Sciences

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Municipality of Bergen, Division of Nursing Homes

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Titles and plan for publication:
"Optimizing an integrated KT intervention: A qualitative formative study to capture KT needs in nursing homes", May 2020.
"The effectiveness of an integrated-KT intervention to implement NEWS2 in nursing homes", December 2020.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available. The reason is that we are collecting data from people with limited ability to consent and were exempted from the requirement of informed consent.

Intention to publish date

01/12/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/02/2020: Trial’s existence confirmed by The Research Council of Norway (Forskningsradet)