NCT04043468

Brief Summary

Audit and feedback (A\&F) aims to improve practices by providing professionals with a summary of their performance. A major limitation to its effectiveness is a persistent intention-action gap following the feedback that prevents the translation of planned actions into concrete changes in practice. In nursing, the lack of coordination within nursing teams contributes to this gap and therefore limits their capacity for action. The objective of this study is to evaluate the effects of an A\&F intervention enhanced with an action support component on the primary care nursing teams' capacity to improve performance compared to a standard A\&F intervention. A pragmatic cluster randomised controlled trial with analysis of implementation fidelity will be conducted. Four nursing organizations will receive standard A\&F, while the other four will receive A\&F with a support component. We will measure performance using clinical administrative data from an electronic database based on wound care episodes. Performance indicators will be measured 3 times: at the beginning of the study (T1), after 6 months (T2) and after 12 months (T3). The feedback meetings will take place between times 1 and 2, then between times 2 and 3. The intervention group will receive the support component in the form of structured focus groups in addition to the feedback meetings. Changes in rates of seven nursing-sensitive indicators (continuity, planning and adjusting of the treatment plan, initial assessment, education, frequency and number of consultations and duration of episodes) will be measured to evaluate the effects of A\&F on performance. The results are expected to inform of the effectiveness of A\&F in order to improve its design and deployment. The potential impact on the improvement of practices is significant, considering that wound care is one of the main conditions in primary care for which nursing staff have a high degree of autonomy.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 2, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2024

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

July 20, 2019

Last Update Submit

January 25, 2021

Conditions

Keywords

audit and feedbackprocess indicatorsquality

Outcome Measures

Primary Outcomes (7)

  • Continuity

    Percentage of care episodes in which at least 50 % of the consultations are provided by the same professional

    Change from baseline continuity at 6 and 12 months.

  • Planning and adjusting of the treatment plan

    Percentage of care episodes in which at least 75 % of the consultations are with an RN

    Change from baseline Planning and adjusting of the treatment plan at 6 and 12 months.

  • Education

    Percentage of care episodes in which at least one education session is provided

    Change from baseline Education at 6 and 12 months.

  • Initial assessment

    Percentage of care episodes in which a RN performs a wound assessment in the first consultation

    Change from baseline Initial assessment at 6 and 12 months.

  • Frequency

    Percentage of care episodes with no more than three consultations per week as of the second week

    Change from baseline Frequency at 6 and 12 months.

  • Duration

    Percentage of care episodes lasting 42 days or less

    Change from baseline Duration at 6 and 12 months.

  • Intensity

    Percentage of care episodes with no more than 22 consultations

    Change from baseline Intensity at 6 and 12 months.

Study Arms (2)

Improved A&F intervention

EXPERIMENTAL

Two feedback sessions and four structured focus groups

Other: Audit and feedback

Standard A&F intervention

ACTIVE COMPARATOR

Two feedback sessions

Other: Audit and feedback

Interventions

Audit and feedback (A\&F) is an intervention that aims to improve professionals practices by providing professionals with a summary of their performance over a period of time.

Improved A&F interventionStandard A&F intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Wound care episodes in palliative care will be excluded, as the indicators were selected for episodes of wound care with healing potential. Such episodes are identifiable by codes in the database.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2019

First Posted

August 2, 2019

Study Start

September 2, 2021

Primary Completion

September 2, 2023

Study Completion

September 2, 2024

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share