See the published version of this article at Implementation Science.
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Examining fidelity in the INFORM trial, a complex team-based behavioural intervention
Liane Ginsburg
York University
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4436-9198
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Implementation Science.
Background. Fidelity in complex behavioural interventions is underexplored. This study examines fidelity of the INFORM trial and explores the relationship between fidelity, study arm and the trial’s primary outcome – care aide involvement in formal team communications about resident care.
Methods. A concurrent process evaluation of implementation fidelity was conducted in 33 nursing homes in Western Canada (Alberta and British Columbia). Study participants were from 106 clinical care units clustered in 33 nursing homes randomized to the Basic and Enhanced Assisted Feedback arms of the INFORM trial.
Results. Fidelity of the INFORM intervention was moderate to high, with fidelity delivery and receipt higher than fidelity enactment for both study arms. Higher enactment teams experienced a significantly larger improvement in formal team communications between baseline and follow-up than lower enactment teams (F(1, 70) = 4.27, p = .042).
Conclusions. Overall fidelity enactment was associated with improvements in formal team communications, but study arm was not. This suggests that the intensity with which an intervention is offered and delivered may be less important than the intensity with which intervention participants enact the core components of an intervention. Greater attention to fidelity assessment and publication of fidelity results through studies such as this one is critical to improving the utility of published trials.
Keywords
Trial fidelity, process evaluation, nursing homes
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CURRENT STATUS: Published
Version 2
Posted 18 Aug, 2020
Published
On 16 Sep, 2020
No community comments so far
Editorial decision: Accept
On 29 Aug, 2020
Editor assigned
On 14 Aug, 2020
Submission checks complete
On 13 Aug, 2020
Editor invited
On 13 Aug, 2020
No comments provided
Editorial decision: Major revision
On 19 Jul, 2020
Review #2 received
Received 15 Jul, 2020
Reviewer #2 agreed
On 05 Jul, 2020
Review #1 received
Received 10 Jun, 2020
Reviewer #1 agreed
On 12 May, 2020
Reviewers invited
Invitations sent on 06 Apr, 2020
Editor assigned
On 19 Mar, 2020
First submitted
On 18 Mar, 2020
Submission checks complete
On 18 Mar, 2020
Editor invited
On 18 Mar, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Health Economics & Outcomes Research
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This preprint is under consideration at Implementation Science. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research
Examining fidelity in the INFORM trial, a complex team-based behavioural intervention
Liane Ginsburg
York University
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4436-9198
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 18 Aug, 2020
Published
On 16 Sep, 2020
No community comments so far
Editorial decision: Accept
On 29 Aug, 2020
Editor assigned
On 14 Aug, 2020
Submission checks complete
On 13 Aug, 2020
Editor invited
On 13 Aug, 2020
No comments provided
Editorial decision: Major revision
On 19 Jul, 2020
Review #2 received
Received 15 Jul, 2020
Reviewer #2 agreed
On 05 Jul, 2020
Review #1 received
Received 10 Jun, 2020
Reviewer #1 agreed
On 12 May, 2020
Reviewers invited
Invitations sent on 06 Apr, 2020
Editor assigned
On 19 Mar, 2020
First submitted
On 18 Mar, 2020
Submission checks complete
On 18 Mar, 2020
Editor invited
On 18 Mar, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Health Economics & Outcomes Research
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Implementation Science.
Background. Fidelity in complex behavioural interventions is underexplored. This study examines fidelity of the INFORM trial and explores the relationship between fidelity, study arm and the trial’s primary outcome – care aide involvement in formal team communications about resident care.
Methods. A concurrent process evaluation of implementation fidelity was conducted in 33 nursing homes in Western Canada (Alberta and British Columbia). Study participants were from 106 clinical care units clustered in 33 nursing homes randomized to the Basic and Enhanced Assisted Feedback arms of the INFORM trial.
Results. Fidelity of the INFORM intervention was moderate to high, with fidelity delivery and receipt higher than fidelity enactment for both study arms. Higher enactment teams experienced a significantly larger improvement in formal team communications between baseline and follow-up than lower enactment teams (F(1, 70) = 4.27, p = .042).
Conclusions. Overall fidelity enactment was associated with improvements in formal team communications, but study arm was not. This suggests that the intensity with which an intervention is offered and delivered may be less important than the intensity with which intervention participants enact the core components of an intervention. Greater attention to fidelity assessment and publication of fidelity results through studies such as this one is critical to improving the utility of published trials.
Figure 1