Complications of Surgical and Medical Care: General TermsEFIPPSNCT01602705
Effective Feedback to Improve Primary Care Prescribing Safety
A study testing Feedback of Performance and Feedback of Performance + Health Psychology Informed Intervention in people with Complications of Surgical and Medical Care: General Terms, run by University of Dundee at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complications of Surgical and Medical Care: General Terms
- What is being tested?
- Feedback of Performance and Feedback of Performance + Health Psychology Informed Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Oct 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- General medical practices in NHS Ayrshire and Arran, NHS Lanarkshire and NHS Lothian
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS): a Randomised Controlled Trial Using ePrescribing Data
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 :
- 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
- To test the effectiveness of the two EFIPPS feedback arms in reducing the specified secondary outcomes of the six individual measures constituting the composite
- To assess the cost-effectiveness of the intervention
Read the detailed description
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.
- Being tested
- Usual care, Feedback of Performance, Feedback of Performance + Health Psychology Informed Intervention
- Keywords
- Feedback (NOT MESH), Medication errors, Medication review, Inappropriate medication, Randomised controlled trial, Primary Health Care, Family Practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
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
Feedback of PerformanceOther
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
Feedback of Performance + Health Psychology Informed InterventionOther
Usual care (educational newsletter + support for searching) plus quarterly feedback plus health psychology informed intervention (persuasive communication and action planning) embedded in feedback
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Placebo comparator | Not described Receives: Other: Usual care |
| Usual care + feedback of practice performance | Active comparator | Not described Receives: Other: Feedback of Performance |
| Usual care + feedback + health psychology intervention | Active comparator | Not described Receives: Other: Feedback of Performance + Health Psychology Informed Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of proportion of patients at risk of an adverse event from specified prescribing.
The primary outcome is a composite of six high-risk prescribing measures relating to antipsychotic, non-steroidal anti-inflammatory and antiplatelet drug use. It is defined as the proportion of patients particularly at risk of an adverse event from the specified prescribing, who receives one or more high risk prescriptions. A composite is reasonable because each of the underlying indicators is based on evidence of harm and has been judged valid in one or more formal consensus studies, so the composite is a coherent measure of 'high-risk prescribing'.
Measured: Change in proportion of patients prescribed a high risk drug between baseline and 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complications of Surgical and Medical Care: General TermsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government, University of Strathclyde, Information Services Division, NHS Scotland
- Responsible party
- Principal investigator, Bruce Guthrie, University of Dundee
- Investigators
- Bruce Guthrie, Principal investigator, Professor of Primary Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602705
- Sponsor's protocol ID
- 2010PS06
- Acronym
- EFIPPS
- Status last verified
- Oct 2014
- First submitted
- 17 May 2012
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23242239Guthrie 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.
PubMed 27540041Barnett 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.
PubMed 25304255
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS): a Randomised Controlled Trial Using ePrescribing Data
- ClinicalTrials.gov ID
- NCT01602705
- Acronym / sponsor ID
- EFIPPS / 2010PS06
- Keywords
- Feedback (NOT MESH), Medication errors, Medication review, Inappropriate medication, Randomised controlled trial, Primary Health Care, Family Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government, University of Strathclyde, Information Services Division, NHS Scotland
- Study start
- Jun 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 21 May 2012 (estimated)
- 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.
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 :
- 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
- To test the effectiveness of the two EFIPPS feedback arms in reducing the specified secondary outcomes of the six individual measures constituting the composite
- To assess the cost-effectiveness of the intervention
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | Placebo comparator | Other: Usual care |
| Usual care + feedback of practice performance | Active comparator | Other: Feedback of Performance |
| Usual care + feedback + health psychology intervention | Active comparator | Other: Feedback of Performance + Health Psychology Informed Intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- General medical practices in NHS Ayrshire and Arran, NHS Lanarkshire and NHS Lothian
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Usual carePractices 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 | Other | Usual care |
| Feedback of PerformanceUsual 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 | Other | Usual care + feedback of practice performance |
| Feedback of Performance + Health Psychology Informed InterventionUsual care (educational newsletter + support for searching) plus quarterly feedback plus health psychology informed intervention (persuasive communication and action planning) embedded in feedback | Other | Usual care + feedback + health psychology intervention |
Primary outcome
Composite measure of proportion of patients at risk of an adverse event from specified prescribing.
Time frame: Change in proportion of patients prescribed a high risk drug between baseline and 12 months after the intervention
The primary outcome is a composite of six high-risk prescribing measures relating to antipsychotic, non-steroidal anti-inflammatory and antiplatelet drug use. It is defined as the proportion of patients particularly at risk of an adverse event from the specified prescribing, who receives one or more high risk prescriptions. A composite is reasonable because each of the underlying indicators is based on evidence of harm and has been judged valid in one or more formal consensus studies, so the composite is a coherent measure of 'high-risk prescribing'.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
- Results publication: PubMed 23242239Guthrie 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.
- Derived from this study: PubMed 27540041Guthrie 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.
- Derived from this study: PubMed 25304255Barnett 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.
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.
Bruce Guthrie principal investigator
Professor of Primary Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback of Performance and Feedback of Performance + Health Psychology Informed Intervention in people with Complications of Surgical and Medical Care: General Terms, run by University of Dundee at 1 site in United Kingdom.
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 5 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: finished, as of the sponsor's last update on 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite measure of proportion of patients at risk of an adverse event from specified prescribing. (time frame: Change in proportion of patients prescribed a high risk drug between baseline and 12 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01602705, which also lists 3 linked publications.
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 7 Oct 2014.