Nurse's RoleNCT04043468
Audit and Feedback Interventions With Primary Care Nursing Teams
A study testing Audit and feedback in people with Nurse's Role, run by CR-CSSS Champlain-Charles-Le Moyne.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role
- What is being tested?
- Audit and feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2021to 2 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion and exclusion criteria are at two levels: 1) primary care organizations and 2) wound care episodes that will be used to measure performance improvement. Nursing organizations that offer services seven days a week will be included so that they can measure all the selected indicators and use the I-CLSC software in their daily practice. Wound care episodes with a minimum duration of 7 days and an episode start during the measurement period will be included. These two criteria are applied in order to measure the seven indicators.
Who cannot join
- 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.
About this study
Official title: Effects of an Action Support Component in Audit and Feedback Interventions With Primary Care Nursing Teams: A Pragmatic Trial
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.
Read the detailed description
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. A\&F has 1) an audit phase, in which performance indicators are measured and 2) a feedback phase, in which the indicators are reported to the professionals to encourage reflexive practice and determine an action plan. Although its effectiveness has been demonstrated, it is widely accepted that this type of intervention is highly variable and that its design has considerable room for improvement. A major limitation to the effectiveness of A\&F is a persistent intention-action gap encounters by professionals following the feedback. This gap prevents the translation of planned actions into concrete changes in practice. In nursing, an aspect that contributes to this gap is a lack of coordination of actions within nursing teams, which limits their capacity for collective action.
Purpose and objectives: The purpose 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. This study has two specific objectives: 1) to measure the effects of the addition of structured focus groups during an enhanced A\&F intervention on the performance levels of the process and outcome indicators compared with the measured effects of standard A\&F intervention; and 2) to analyze the effects of the implementation fidelity of the standard and enhanced A\&F interventions on the effectiveness of A\&F.
Method: A pragmatic cluster randomised controlled trial with analysis of implementation fidelity will be conducted. Eight primary care nursing organizations will be included. Four of them will receive a standard A\&F intervention, while the remaining four will receive an AF intervention with a support component. Performance will be measured using clinical administrative data from an electronic database currently used to compile statistics on the services provided and the users of Local community service centers (CLSC) in Quebec. Performance will be measured from wound care episodes of patients who had a follow-up during the study period. Four process indicators (continuity, planning and adjusting of the treatment plan, initial assessment and education) and three outcome indicators (frequency and number of consultations and duration of episodes) sensitive to nursing care 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, twice between each of the time periods. Models of generalized estimating equations will be adjusted to analyze differences in performance in each group. An analysis of implementation fidelity will be conducted in parallel of the pragmatic trial using grids of observations in each of the settings
- Conditions
- Nurse's Role
- Being tested
- Audit and feedback
- Keywords
- audit and feedback, process indicators, quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit and feedbackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Improved A&F intervention | Experimental | Two feedback sessions and four structured focus groups Receives: Other: Audit and feedback |
| Standard A&F intervention | Active comparator | Two feedback sessions Receives: Other: Audit and feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuity
Percentage of care episodes in which at least 50 % of the consultations are provided by the same professional
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline Frequency at 6 and 12 months.
Duration
Percentage of care episodes lasting 42 days or less
Measured: Change from baseline Duration at 6 and 12 months.
Intensity
Percentage of care episodes with no more than 22 consultations
Measured: Change from baseline Intensity at 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start2 Sep 2021 (estimated)
- Primary completion2 Sep 2023 (estimated)
- Study completion2 Sep 2024 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CR-CSSS Champlain-Charles-Le Moyne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilie Dufour, CR-CSSS Champlain-Charles-Le Moyne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043468
- Sponsor's protocol ID
- CharlesLeMoyne
- Status last verified
- Jan 2021
- First submitted
- 20 Jul 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Action Support Component in Audit and Feedback Interventions With Primary Care Nursing Teams: A Pragmatic Trial
- ClinicalTrials.gov ID
- NCT04043468
- Acronym / sponsor ID
- CharlesLeMoyne
- Conditions
- Nurse's Role
- Keywords
- audit and feedback, process indicators, quality
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CR-CSSS Champlain-Charles-Le MoyneUniversity, hospital or other
- Study start
- 2 Sep 2021 (estimated)
- Primary completion
- 2 Sep 2023 (estimated)
- Study completion
- 2 Sep 2024 (estimated)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. A\&F has 1) an audit phase, in which performance indicators are measured and 2) a feedback phase, in which the indicators are reported to the professionals to encourage reflexive practice and determine an action plan. Although its effectiveness has been demonstrated, it is widely accepted that this type of intervention is highly variable and that its design has considerable room for improvement. A major limitation to the effectiveness of A\&F is a persistent intention-action gap encounters by professionals following the feedback. This gap prevents the translation of planned actions into concrete changes in practice. In nursing, an aspect that contributes to this gap is a lack of coordination of actions within nursing teams, which limits their capacity for collective action.
Purpose and objectives: The purpose 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. This study has two specific objectives: 1) to measure the effects of the addition of structured focus groups during an enhanced A\&F intervention on the performance levels of the process and outcome indicators compared with the measured effects of standard A\&F intervention; and 2) to analyze the effects of the implementation fidelity of the standard and enhanced A\&F interventions on the effectiveness of A\&F.
Method: A pragmatic cluster randomised controlled trial with analysis of implementation fidelity will be conducted. Eight primary care nursing organizations will be included. Four of them will receive a standard A\&F intervention, while the remaining four will receive an AF intervention with a support component. Performance will be measured using clinical administrative data from an electronic database currently used to compile statistics on the services provided and the users of Local community service centers (CLSC) in Quebec. Performance will be measured from wound care episodes of patients who had a follow-up during the study period. Four process indicators (continuity, planning and adjusting of the treatment plan, initial assessment and education) and three outcome indicators (frequency and number of consultations and duration of episodes) sensitive to nursing care 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, twice between each of the time periods. Models of generalized estimating equations will be adjusted to analyze differences in performance in each group. An analysis of implementation fidelity will be conducted in parallel of the pragmatic trial using grids of observations in each of the settings
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Improved A&F intervention | Experimental | Other: Audit and feedbackTwo feedback sessions and four structured focus groups |
| Standard A&F intervention | Active comparator | Other: Audit and feedbackTwo feedback sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion and exclusion criteria are at two levels: 1) primary care organizations and 2) wound care episodes that will be used to measure performance improvement. Nursing organizations that offer services seven days a week will be included so that they can measure all the selected indicators and use the I-CLSC software in their daily practice. Wound care episodes with a minimum duration of 7 days and an episode start during the measurement period will be included. These two criteria are applied in order to measure the seven indicators.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audit and feedbackAudit 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. | Other | Improved A&F intervention, Standard A&F intervention |
Primary outcome
Continuity
Time frame: Change from baseline continuity at 6 and 12 months.
Percentage of care episodes in which at least 50 % of the consultations are provided by the same professional
Planning and adjusting of the treatment plan
Time frame: Change from baseline Planning and adjusting of the treatment plan at 6 and 12 months.
Percentage of care episodes in which at least 75 % of the consultations are with an RN
Education
Time frame: Change from baseline Education at 6 and 12 months.
Percentage of care episodes in which at least one education session is provided
Initial assessment
Time frame: Change from baseline Initial assessment at 6 and 12 months.
Percentage of care episodes in which a RN performs a wound assessment in the first consultation
Frequency
Time frame: Change from baseline Frequency at 6 and 12 months.
Percentage of care episodes with no more than three consultations per week as of the second week
Duration
Time frame: Change from baseline Duration at 6 and 12 months.
Percentage of care episodes lasting 42 days or less
Intensity
Time frame: Change from baseline Intensity at 6 and 12 months.
Percentage of care episodes with no more than 22 consultations
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Audit and feedback in people with Nurse's Role, run by CR-CSSS Champlain-Charles-Le Moyne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuity (time frame: Change from baseline continuity at 6 and 12 months.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.