Study Background
What is Hypertension?
Resource Information
Patient Resources
National DNA repository
Recruitment Procedures
Acknowledgements
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Genome Screen Results
Investigators
Nursing and Scientific Teams
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Standard operating procedure
MRC GP Framework No: 013D
1. Introduction
The MRC GP Framework is a well established group of GP surgeries
who are willing to take part or who have previously taken part
in medical research studies. Unlike other GP practices they
usually have a designated room in which subjects for studies
can be seen. The majority of subjects for this study will be
recruited from MRC GP practices. However, subjects from other
sources may be included; e.g. other practices or clinics.
2. Responsibilities
Research nurses trained in the procedure are responsible for
establishing contact with MRC practices, AFTER they have had
confirmation from the Nurse Co-ordinator which practices are
willing to take part. The Nurse Co-ordinator will inform you
fortnightly of which MRC practices can be approached and you
should not contact any MRC practices independently until given
clearance.
3. Equipment
None
4. Method
- The
Nurse Co-ordinator will inform the nurses at each centre fortnightly,
which MRC practices are available in that area. Only MRC practices
on that list which have positively responded should be approached.
- Subjects
can be recruited from Non-MRC practices and hypertension clinics
if they meet the study entry criteria. · After you have received
the list of MRC practices in your area, select the practices
you wish to visit first. Telephone the surgery and speak to
the Doctor who expressed a desire for his/her surgery to be
involved.
- Explain
the implications of the study for their practice, these include:
- A
receptionist/practice nurse from the practice to search
their database for a list of hypertensive patients.
- If
the practice has EMIS/GPAS databases, Instruct the receptionist
to use the inclusion/exclusion parameters of the study
to select patients. This is helpful as it can reduce a
blanket screen of hypertensive subjects, to a sophisticated
search of subjects who meet the inclusion criteria. Examples
of criteria to be selected against are diabetes, renal
disease and BMI greater than 30.
- Ensure
to discuss the inclusion/exclusion criteria with the reception
staff, so they are aware of its importance. A selected
search reduces both time spent searching through returned
questionnaires for potential subjects, as well as saving
money on postage.
- Explain
how the study differs from others they may have been involved
with, that is two designated BRIGHT study nurses in their
area will be taking all the phenotypic measurements and
screening the subjects at their practice (at a time of
their convenience), instead of the MRC practice nurse.
- The
MRC practice nurse participation in the study, will involve
her/him to look at selected patient notes for diagnosing
blood pressure readings. The BRIGHT study nurses will
liase with the practice nurse on which notes need to be
searched.
- The
MRC practice should keep a record of the time spent by
the reception staff compiling the database search and
the practice nurse looking at selected notes (indicated
by the BRIGHT study nurse). The MRC GP Framework will
reimburse this time at a rate of £5/hr Reception staff
and £14/hr Practice nurse. All bills should be itemised
with the exact time spent and sent to the MRC GP Framework,
based at Northwick Park Hospital, Harrow, Middlesex.
- Send
a protocol to the GP which lists all the requirements of the
study, including the inclusion/exclusion criteria. This should
also state that the study has central ethical clearance. However,
should they need local research ethics approval that should
be sought prior to commencing the study at that particular
practice.
- Ensure
to explain to the GP the format following the return of the
postal questionnaire.
- Ensure
the practice manager is aware of the requirements of the study
and ask when it is convenient to use the practice in order
to screen families.
- Ensure
ALL the reception staff are aware of the study, incase subjects
misread the questionnaire and spontaneously arrive at the
surgery to donate a blood sample.
- After
speaking to the practice nurse and receptionists confirm in
writing the details of the study and what is required of their
surgery.
- Ensure
all the surgeries you are using have a contact number to give
potential subject's who may have misread the questionnaire.
- When
working at each MRC practice comply with the local rules and
co-operate with the practice staff on convenient times to
screen subjects at their practice.
5.
Additional Information
None
6.
Reference Documents
None.
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