Status: Planned
First registered on:
15/07/2016
Last updated on:
04/02/2020
1. Study identification
EU PAS Register NumberEUPAS14111
Official titleImpact of Optimum Patient Care’s clinical review service
Study title acronymImpact of OPC
Study typeObservational study
Brief description of the studyHistorical cohort study evaluating the impact of a remote annual asthma clinical review service on high risk asthma patients in a UK primary care setting. Optimum Patient Care (OPC) is a social enterprise company whose aim is to improve patient outcomes in respiratory medicine through continuous audit and feedback to practices at a practice and individual patient level. OPC offers a free and unique remote clinical review service to support management of patients in primary care, using the company’s bespoke software tools. OPC provides practices with patient-specific reports including suggestions for interventions in accord with current asthma guidelines. These recommendations include identification of patients at high-risk of exacerbations and of patients who are seemingly on inappropriate medication and require urgent attention.
The purpose of this study is to evaluate, for the first time, the impact that OPC’s review service has on patients’ primary care utilisation, treatment and asthma exacerbation frequency. The analysis will focus on patients who are deemed high risk based on their exacerbation history.
The data extracted from practices by OPC enters their service database and is used to create patient-specific recommendations to the practice. It is also anonymized for use in respiratory research. This database, cleared of all patient identifiable information, is called the Optimum Patient Care Research Database (OPCRD) and will be used in this study.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research groupResearch in Real Life Ltd
Organisation/affiliationOPRI Pte Ltd
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/03/2016
Start date of data collection01/08/2016
Start date of data analysis01/09/2016
Date of interim report, if expected
Date of final study report26/02/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherOptimum Patient Care100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name David
First name Price
Address line 15 Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)6582822594
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name David
First name Price
Address line 15 Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)6582822594
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Asthma
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects50000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
The main objective of the study is to analyze the impact of the asthma review service on asthma exacerbations. This will be achieved by first comparing the number of exacerbations within the review cohort prior to post index, then between the review and control cohort.
Are there primary outcomes?Yes
The primary objective of the study is to analyze the impact of the asthma review service on asthma exacerbations. This will be achieved by first comparing the number of exacerbations within the review cohort prior to post index, then between the review and control cohort.
Are there secondary outcomes?Yes
To compare the number of asthma-related primary care consultations, prescription changes, and hospitalisations in the year prior and post the index date in the review cohort (within-group analysis) and between the review cohort and control cohort (between-group analysis).
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
OPCRD data extraction methods extract the patient’s entire electronic health record whilst at their current practice, enabling retrospective analysis.
15. Data analysis plan
Please provide a brief summary of the analysis method
This study will use a cluster matched strategy in which each practice in the review cohort will be matched to a practice in the control cohort. Multivariable mixed effects Poisson regression models will be used to analyze the change in asthma exacerbations within and between the review and control groups. For the within-group analysis, the follow-up indicator variable will be used to determine if the rate of exacerbations changed from baseline to follow-up for the review group. Incidence rate ratios (IRRs), 95% confidence intervals and p-values will be reported.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
