INTEGRATE.

Trial name or title	INTEGRATE Study: A pragmatic cluster randomised controlled trial of an integrated general practice and pharmacy‐based intervention to promote the prescription and use of appropriate preventive medications among individuals at high cardiovascular risk
Methods	Cluster‐randomized control, open‐label, parallel‐assignment
Participants	All adult patients (18 years) attending the GP will be potentially be eligible to receive the HealthTracker intervention. All adult patients who are recommended for the component medications according to current guidelines are eligible to be prescribed the polypill therapy. All adult patients attending the paired pharmacy with a new prescription for a CVD prevention medication will be eligible to receive the pharmacy intervention
Interventions	The integrated intervention comprises the following three elements: (1) HealthTracker, (2) availability of the Polypills and (3) Pharmacy Adherence Support Service (PASS) ** Eight CVD polypills will be available and they are: Name: PolyPill Hydroirb; components: hydrochlorothiazide (12.5 mg) + irbesartan (150 mg) + atorvastatin (40 mg) Name: PolyPill Hydroirb Asp; components: hydrochlorothiazide (12.5 mg) + irbesartan (150 mg) + atorvastatin (40 mg) + 100 mg aspirin Name: PolyPill Amloirb; components: amlodipine (5 mg) + irbesartan (150 mg) + atorvastatin (40 mg) Name: PolyPill Amloirb Asp; components: amlodipine (5 mg) + irbesartan (150 mg) + atorvastatin (40 mg) + aspirin (100 mg) Name: PolyPill Perindap; components: perindopril (4 mg) + indapamide (1.25 mg) + atorvastatin (40 mg) Name: PolyPill Perindap Asp; components: perindopril (4 mg) + indapamide (1.25 mg) + atorvastatin (40 mg) + aspirin (100 mg) Name: PolyPill Peramlo; components: perindopril (4 mg) + amlodipine (5 mg) + atorvastatin (40 mg) Name: PolyPill Peramlo Asp; components: perindopril (4 mg) + amlodipine (5 mg) + atorvastatin (40 mg) + aspirin (100 mg)
Outcomes	Primary Outcomes Proportion of high‐risk participants who were not on full treatment at baseline achieving recommended target (i) BP and (ii) LDL‐C target levels, at the end of the study. This is a composite primary outcome. These levels will be extracted from the general practice software systems using a general practice data auditing tool known as Clinical Audit Tool (CAT). Data is de‐identified prior to extraction Secondary Outcomes Proportion of high‐risk participants who were not on full treatment at baseline achieving recommended target BP levels at study end Proportion of under‐treated high‐risk participants achieving recommended BP or LDL‐C targets. Note: not composite. Data will be extracted from the general practice software systems using CAT. Under‐treated includes participants at high risk of a CV event, not on full treatment at baseline. Full treatment: at least 1 BP‐lowering drug and a statin for participants without established CVD; for those with CVD, full treatment will additionally require at least 1 antiplatelet drug Proportion of all high‐risk participants achieving BP and LDL‐C targets. Data will be extracted from the general practice software systems using CAT. Proportion of participants achieving BP and LDL‐C targets and prescribed antiplatelet (if relevant). Data will be extracted from the general practice software systems using CAT Risk factor measurement and mean levels. Data will be extracted from the general practice software systems using CAT. Risk factor measurement is calculated by HealthTracker Treatment intensity in high‐risk participants. Proportion of high‐risk participants who receive a dose escalation or addition to their prescribed medication during the intervention period. De‐identified data will be extracted from the general practice software systems using CAT Polypill prescriptions ‐ will be assessed from the number of consent forms signed for the polypill and the supply of polypills Participation in pharmacy adherence support programmes. Will be assessed from the number of consent forms for the PASS Proportion of non‐high risk participants receiving either BP lowering or statin and or anti‐platelet therapy (looking at all the therapies individually and combined)
Starting date	1 March 2016
Contact information	Prof Anushka Patel, apatel@georgeinstitute.org
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