Intervention proposed for Intervention proposed for the gaps of clinical target the gaps of clinical target

in hypertensionin hypertension

Stéphane Rinfret, MD, MSc, FRCPCStéphane Rinfret, MD, MSc, FRCPCCardiologist and epidemiologistCardiologist and epidemiologist

Centre hospitalier de l’Université de Centre hospitalier de l’Université de MontréalMontréal

HOW CAN I MAKE A DIFFERENCE IN HYPERTENSION MANAGEMENT?

A MULTIDISCIPLINARY SYMPOSIUM FOR HEALTH CARE PROFESSIONALS

October 19th 2007CHUQ – Pavillon Hôtel-Dieu de Québec

Disclosures

• S Rinfret received grant support and consulting fees from Pfizer Canada

In Canada in 2005

• 91% of the 22 million medical visits for hypertension were done in primary care

• 70,7 million prescriptions for antihypertensive agents were carried out in 2005

• In constant increase since 2001

– IMS Health, Canada (2006)

The importance of hypertension in primary care

• In Québec, in 2005– Close to one million people were

affected• 15% of the population over the age of 12• 43% of people 65 and over

– Statistics Canada, The Canadian Community Health Survey (CCHS), 2005

• Out of all the chronic health problems in primary care– Hypertension is the most frequent

The importance of hypertension in primary care

Hypertension in the World

Marques-Vidal P et Tuomilehto J. J Hum Hypertens 1997;11:213–220.

% of hypertension0 5 10 15 20 25 30 350 5 10 15 20 25 30 35

Germany

Australia

Scotland

Egypt

Finland

Taïwan

Spain

Canada

United-States

India

China

Men Women Both

Hypertension remains the principal cause of death in the world-wide population

Smoking

Hypercholesterolemia

Insufficient weight

Unprotected sex

Low intake of fruits and vegetables

Elevated BMI

Lack of physical activity

Alcoholism

Contaminated water, poor sanitation and hygiene

# of Deaths (millions)

High Blood Pressure

0 1 2 3 4 5 6 7

Developping countries

Developped countries

21%21%

Hypertension that has been treated but remains uncontrolled

22%22%

13%13% 9%9% Hypertensionand diabetes

43%43%

Undiagnosed hypertension

Hypertension in Canada

22% of Canadian adults between the ages of 18 to 70 are hypertensive

Joffres MR, Hamet P, MacLean DR , Gilbert JL, Fodor G. Distribution of Blood Pressure and Hypertension in Canada and the United

States. AmJ Hypertens 2001; 14: 1099 –1105

Hypertension that has been diagnosed but neither treated nor controlled

Hypertension that has been treated and controlled

Question Yes NoDo Not Know or Refused

Are HBP and hypertension the same ? 55 29 16Is HBP a serious health concern ? 30 68 2Has your BP been measured ? 99,9 0,1 ,,,,,Ever had HBP ? 46 53 1Does the top number indicate HBP ? 27 43 30If you had HBP, do you still have it 59 36 5Do you know your BP ? 54 ,,,,, 46Do you have BP monitoring equipment at home ? 33 67 ,,,,,If you've never had HBP, are you likely to as your age ? 14 64 22Is HBP an inevitable part of aging ? 19 71 10Does HBP usually have no physical symptoms ? 42 49 9Is stressfull life the main cause of HBP ? 46 45 9

Knowledge and attitudes towards hypertension

Arch Intern Med 2003 ; 163: 681-7

Uncontrolled hypertension*(% of the total number of hypertensive patients between the ages of 35 and 64)*Uncontrolled hypertension is defined as BP ≥140/90 mmHg

0 20 40 60 80 100

Spain

Switzerland

Germany

Italy

England

Canada

USA

Hypertension remains uncontrolled in the vast majority of hypertensive patients (BP≥140/90 mmHg)

Wolf-Maier K, et al. 2004

ARB vs. BB vs. CCB vs. ACEI vs. Diur

Multiple antihypertensive agents are needed to achieve target BP

AASK TAM <92

Target BP(mmHg)

UKPDS TAD <85

ABCD TAD <75

MDRD TAM <92

HOT TAD <80

Trial

Average number of anti-hypertensive agents needed to attain the target BP

IDNT TAS/TAD 135/851 2 3 4

Bakris GL, et al. 2000; Lewis EJ, et al. 2001

UKPDS = United Kingdom Prospective Diabetes StudyABCD = Appropriate Blood Pressure Control in DiabetesMDRD = Modification of Diet in Renal DiseaseHOT = Hypertension Optimal TreatmentIDNT = Irbesartan Diabetic Nephropathy TrialAASK = African American Intervention Study of Kidney Disease

The pressure measurements taken at the beginning (B) and during the treatment (T) are indicated for each trial. The dashed horizontal lines represent the target pressure measurements for the treatments according to international guidelines.

Mancia G, Grassi G. J Hypertens 2002;20:1461-64.

Effects of an antihypertensive treatment on the BPS and BPD of patients with HTN - main trials

http://www.arloandjanis.com/briskwalk.htm

Hypertension in primary care

Hypertension is one of the most frequent problems in primary careFirst Stange, et al 1998Second Rosser, NAPCRG, 2002

Of 8 486 visits in primary care clinic of la Cité de la Santé HT is the first Dx in 8% of

the visits (MT Lussier, personal communication)

• Patients followed in primary care– 2 to 6 visits/year

– 10 minutes/visit

– 2,3 health problems/visit

• Stange et al,1998

• Lussier et al, 1999

Hypertension in primary care

• During the visits, when precdribing CV medications, there is little discussion on:– adherence (4,5%) – difficulties in adhering to the

drug regimen (3,8%)– proposed solutions (1,1%)– the effects of non

compliance (3,0%)

Richard, Lussier 2002

Hypertension in primary care

Drug adherence is a complex phenomenon HT is asymptomatic

Non-adherence : one of the main difficulties of the practice Beaulieu et Leclere, 1993

Few tools to support adherence In between visits, patients are left

by themselves…

Hypertension in primary care

Economic impact of non-compliance

Sokol et al Medical Care • Volume 43, Number 6, June 2005

•HMO plan covered patients •US•06/97 to 06/99•7981 patients with HTN

« The principal problem in the treatment of the diseases today is the lack of adherance that the

patients have to the pharmalogical treatments »

(AHA 2004)

Study RCT IT Feedback to heath

prof

ABPM Significant reduction in

BP?Hamet P et al Exp Clin Cardiol 2002; 7 (4): 165-172 No

Borenstein JE Pharmacotherapy 2003; 23(2):209-216.

Yes

McPherson CPet al, Am J Manag Care 2002: 8(6):543-55

Yes

Okamoto MP; Nakahiro RK. Pharmacotherapy 2001; 21(11):1337-44

Yes

Friedman RH et al AJH 1996:9:285-92 Yes

Rogers MAM et al Ann Intern Med 2001;134:1024-1032

Yes

Rudd P et al Am J Hypertens. 2004; 17(10):921-7

Yes, active intervention

LOYAL ?

Multidisciplinary intervention studies

The Impact of a The Impact of a Multidisciplinary, Information Multidisciplinary, Information

Technology Supported Program Technology Supported Program on Blood Pressure Control in on Blood Pressure Control in

Primary Care (The Loyal Study)Primary Care (The Loyal Study)S Rinfret, M-T Lussier, F Duhamel,

S Cossette, L Lalonde, A Peirce, C Tremblay, F Ali, M-C Guertin,

J LeLorier, J Turgeon and P Hamet

 Late Breaking and Featured Clinical Trial Session

October 24th, 2007

Funding and Funding and DisclosuresDisclosures

Funding• Sponsored by Pfizer Canada• Supplementary support by

– CIHR Rx&D RCT grant (with Pfizer Canada)

– Fonds de la recherche en santé du Québec

BackgroundBackground

• Although the positive effects of optimal blood pressure (BP) control on morbidity and mortality have been clearly established, the majority of hypertensive patients are inadequately controlled.

• We hypothesized that a multidisciplinary, information technology (IT) supported program empowering patients to be responsible for monitoring their BP and adherence and facilitating communication between physicians, pharmacists, nurses and patients would have a positive impact on BP levels.

Study Design & Study Design & MethodologyMethodology

Design type RCT with PROBE design (Prospective, Randomized, Open label, Blinded Endpoints) ClinicalTrials.gov NCT00374829; ISRCTN Register, ISRCTN75436659

Enrolment period

May 2004 to February 2007

Follow-up 12 months

Recruitment sites

• 22 Family Physicians • 8 community primary care clinics Laval, Canada• 32 pharmacies

Inclusion criteria

• Consenting male and female patients > 18 years of age • Mean 24 hour BP >130/80 and mean daytime values >135/85mm Hg

Exclusion criteria

• Patients unlikely to complete study or • With chronic atrial fibrillation or• Pregnant or • Participating in another clinical trial

Visit 1Study Enrolment & Baseline ABPM (-1 to -7 days)

Intervention group (n=250)Computerised telephone-based

reminder and BP monitoring system

Control group (n=250)Usual care

Randomization1:1

Trial DesignTrial Design

Usual Care & FU visitsThroughout Study

Randomization was stratified according to: a) newly diagnosed and untreated hypertension vs. treated and

uncontrolled hypertensionb) presence or absence of current pharmacological treatment

for concomitant disease(s)

Visit 2ABPM return, Randomizatio

n(day 0)

Study EndABPM

(365 days +21 days)

FinalVisit

Intervention groupIntervention group

Usual care +1. Log book2. BP monitor 3. Access to an IT-based telephone

BP and adherence monitoring system

4. Facilitated communication between physicians, pharmacists, nurses and patients

Patient provide the system, using voice recognition technology, with : Weekly BP measures Self reported adherence System supports the patients in order to improve adherence: Daily reminders to take the medication Reminders to refill or renew the medication

E-mail alerts to the nurse about: Drug adherence Blood pressure

Nurse intervention with the patient, or with the physician

Download of pharmacy data into the system

Pharmacist can intervene Monthly reports

To physicians on BP And adherence

LOYAL multidisciplinary

intervention

How did the IT system How did the IT system work?work?

• The system collected data from patients via telephone and pharmacy data electronically and provided nurses, pharmacists and physicians monthly reports on patients’ BP levels and adherence.

• The system alerted nurses by e-mail if BP targets were not achieved or in the event of non-adherence.

• Nurses then contacted patients, provided counseling and/or referred patients to their physician as appropriate following a pre-determined algorithm.

Primary Efficacy Primary Efficacy EndpointEndpoint

Mean change (Δ) in the mean 24-hour systolic and diastolic BP between baseline and 12 months, measured using ambulatory BP monitoring (ABPM)

Secondary Efficacy Secondary Efficacy EndpointsEndpoints

1. Δ daytime SBP and DBP ABPM 2. Δ nocturnal SBP and DBP ABPM3. Δ office SBP and DBP4. Proportion of subjects who achieve BP

target5. Drug adherence, by continuous

medication availability (CMA)6. Drug adherence by gaps in medication

availability (CMG)7. Medication changes8. Number of anti-hypertensive agents

Challenges of a clinical trial

• Collaboration between the academic sector and the realities of primary care

• Many IT suppliers in the pharmacies• Non-scientific considerations

– Pontential to drive the patients towards a particular chain of pharmacies

– Expectations of the different partners

Practical issues

• Operation costs• Impact on QOL (“Big Brother”

effect?)• LOYAL patient = motivated patient,

more compliant (?)• Implementation – GMF?

« La maladie ne se guérit point en prononçant le nom du médicament,

mais en prenant le médicament. »

-SankaraExtrait de Viveka Chudamani

« Le médicament reste le principal symbole de la puissance du médecin.

»

-Denis Jaffe Extrait de La guérison est en soi

« La non-observance lui rappelle sa grande faiblesse ! »

 Late Breaking and Featured Clinical Trial Session

October 24th, 2007