Effective Feedback to Improve Primary Care Prescribing Safety

NCT ID: NCT01602705

Last Updated: 2014-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-10-31

Brief Summary

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We hypothesise that feedback and feedback + psychology informed intervention delivered to primary care medical practices will reduce high-risk prescribing to patients compared to a simple educational intervention alone. The specific objectives are :

1. To test the effectiveness of the two EFIPPS feedback arms in reducing the specified primary outcome of a composite measure of high-risk antipsychotic, non-steroidal anti-inflammatory drug, and antiplatelet drug prescribing
2. To test the effectiveness of the two EFIPPS feedback arms in reducing the specified secondary outcomes of the six individual measures constituting the composite
3. To assess the cost-effectiveness of the intervention

Detailed Description

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High risk prescribing is the use of drugs which carry significant risk to patients. Such prescribing is not always inappropriate but does require regular review to ensure that the balance of risk and benefit in individuals is appropriate. High risk prescribing is common and varies widely between practices, and there is evidence that intensive interventions (for example, pharmacist led medication review) can reduce rates of high risk prescribing. The aim of this study is to test whether a simpler and therefore cheaper feedback intervention can reduce high risk prescribing. The study is a three arm cluster randomised trial with primary care medical practices as the unit of randomisation and outcomes measured at patient level using routinely held prescribing for individual patients. The trial will compare two forms of feedback of practice rates of high risk prescribing with usual care. Usual care matches existing NHS working practice. The first active arm will receive quarterly feedback. The second active arm will receive the same feedback plus a health psychology informed intervention designed to promote response to feedback embedded in the feedback.

Conditions

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Complications of Surgical and Medical Care: General Terms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual care

Group Type PLACEBO_COMPARATOR

Usual care

Intervention Type OTHER

Practices in the usual care arm receive a one-off educational newsletter and support for searching for patients in their electronic health record in the form of downloadable searches

Usual care + feedback of practice performance

Group Type ACTIVE_COMPARATOR

Feedback of Performance

Intervention Type OTHER

Usual care (educational newsletter and support for searching) plus quarterly feedback of practice rates of high risk prescribing compared to a benchmark of the upper quartile of all practices in the year before

Usual care + feedback + health psychology intervention

Group Type ACTIVE_COMPARATOR

Feedback of Performance + Health Psychology Informed Intervention

Intervention Type OTHER

Usual care (educational newsletter + support for searching) plus quarterly feedback plus health psychology informed intervention (persuasive communication and action planning) embedded in feedback

Interventions

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Usual care

Practices in the usual care arm receive a one-off educational newsletter and support for searching for patients in their electronic health record in the form of downloadable searches

Intervention Type OTHER

Feedback of Performance

Usual care (educational newsletter and support for searching) plus quarterly feedback of practice rates of high risk prescribing compared to a benchmark of the upper quartile of all practices in the year before

Intervention Type OTHER

Feedback of Performance + Health Psychology Informed Intervention

Usual care (educational newsletter + support for searching) plus quarterly feedback plus health psychology informed intervention (persuasive communication and action planning) embedded in feedback

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* General medical practices in NHS Ayrshire and Arran, NHS Lanarkshire and NHS Lothian

Exclusion Criteria

* Practices with \<250 registered patients
* Practices with \<93% of scripts in the new PIS data warehouse having a unique patient identifier (the Community Health Index \[CHI\] number)
* Practices which were formed after 1st January 2011
* Practices which cease to exist during the trial
* Practices which merge during the trial, where the merging practices were originally in different arms of the trial
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chief Scientist Office of the Scottish Government

OTHER_GOV

Sponsor Role collaborator

University of Strathclyde

OTHER

Sponsor Role collaborator

Information Services Division, NHS Scotland

UNKNOWN

Sponsor Role collaborator

University of Dundee

OTHER

Sponsor Role lead

Responsible Party

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Bruce Guthrie

Professor of Primary Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce Guthrie

Role: PRINCIPAL_INVESTIGATOR

Professor of Primary Care

Locations

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NHS National Services Scotland

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Guthrie B, Treweek S, Petrie D, Barnett K, Ritchie LD, Robertson C, Bennie M. Protocol for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study: a cluster randomised controlled trial using ePrescribing data. BMJ Open. 2012 Dec 13;2(6):e002359. doi: 10.1136/bmjopen-2012-002359. Print 2012.

Reference Type RESULT
PMID: 23242239 (View on PubMed)

Guthrie B, Kavanagh K, Robertson C, Barnett K, Treweek S, Petrie D, Ritchie L, Bennie M. Data feedback and behavioural change intervention to improve primary care prescribing safety (EFIPPS): multicentre, three arm, cluster randomised controlled trial. BMJ. 2016 Aug 18;354:i4079. doi: 10.1136/bmj.i4079.

Reference Type DERIVED
PMID: 27540041 (View on PubMed)

Barnett KN, Bennie M, Treweek S, Robertson C, Petrie DJ, Ritchie LD, Guthrie B. Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) a pragmatic three-arm cluster randomised trial: designing the intervention (ClinicalTrials.gov registration NCT01602705). Implement Sci. 2014 Oct 11;9:133. doi: 10.1186/s13012-014-0133-9.

Reference Type DERIVED
PMID: 25304255 (View on PubMed)

Related Links

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Other Identifiers

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2010PS06

Identifier Type: -

Identifier Source: org_study_id

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