Viva-Voce Presentation Viva-Voce Presentation 20112011

CRP Study 2008-2010

Date: 21st April 2011Time: 3.00pmVenue: USM

ASSESSMENT OF ECONOMIC, CLINICAL AND HUMANISTIC OUTCOMES OF PATIENTS WITH ACUTE CORONARY

SYNDROME IN THE CARDIAC REHABILITATION PROGRAM

 Mr. Lawrence Anak Anchah, 700713-13-5325 (Principal

Investigator)

Research Area: (FCA 701/ 48), Cardiovascular Pharmacy, Reference No under NIH KKM: MRG-2007-11

Main Supervisor:

Professor Dr. Mohamed Izham Bin Mohamed Ibrahim

Co-Supervisor:

1. Assoc. Prof. Dr. Mohd Azmi Ahmad Hassali

2. Professor Dr. Yahaya Hassan

Field Supervisor and Co-Principal Investigator:

Professor Dr. Sim Kui HianMBBS(Hons)(Monash), FRACP, FACC, FCSANZ , FSCAI, FESC, FAPSIC, FAsCC, FCAPSC, FAHA, FAMM, FNHAM ,Head, Dept of Cardiology & Head, Clinical Research Centre (CRC), Sarawak General Hospital, MALAYSIA. Adjunct Professor, Faculty of Medicine & Health Sciences, University Malaysia Sarawak (UNIMAS)

Background The World Health Organization (WHO) defines cardiac rehabilitation as1 :

Cardiac rehabilitation uses a multidisciplinary team approach toward

lifestyle modification with the thought that optimal outcomes are achieved

when rehabilitative strategies are combined

“the sum of activities* required to ensure patients the best possible physical,

mental and social conditions so that they may resume and maintain as

normal a place as possible in the community.”

* Activities includes: medical evaluation, prescribed exercise, patient education and counseling

World Health Organization. Needs and action priorities in cardiac rehabilitation and secondary prevention in patients with CHD. Geneva: WHO regional Office for Europe, 1993

National Heart Foundation of Australia & Australian Cardiac Rehabilitation Association. Recommended Framework for Cardiac Rehabilitation ’04

General Phases in Cardiac RehabilitationPhase I - Inpatient Program

begins soon after a cardiac events – CCU/CTW/Gen Med end when the patient is ready to go home low-level exercise and education for the patient and family.

Phase II - Outpatient Hospital-based > 4 weeks after discharge dietitians, social workers, pharmacists, clinicians & others emphasizes monitored exercise education and lifestyle management.

Phase III - Community-based health facilities maintenance program

Phase IV - Community-based community centre

American Association of Cardiovascular & Pulmonary Rehabilitation. AACVPR Cardiac Rehabilitation Resource Manual (2006). USA, Human Kinetics, Library of Congress. Web site: http://www.humakinetics.com/

Outline of CRP

Phase I, Stage I CRP (First assessment)

2004 Perth Royal Hospital, WA What we have learned from

others and improve it.

Phase I CRP Cardiac Care Unit, Sarawak

General Hospital Ward rounding Pharmacist will identify

those who needs counseling Stage I in drug

counseling Orientation to treatment

plan

04/12/235th Biennial Meeting on

Cardiopulmonary Bypass6

Phase I, Stage II CRP (CTW)

Bed side counselling regarding the evidence based medication

Our target: IHD, UA, post MI, post PTCA, post CABG, HF and on warfarin

Concomitant diseases/problems therapy (hyperlipidaemia, gout, DM, HPT, peripheral vessel disease, chronic AF….)

Stenting (DES and BMS), double antiplatelets

Medication and disease Medication adherence Self purchase (plavix), cardiprin RF Smoking cessation advise

Phase I, Stage IIIBed side and discharge counselling

Preparation for Rx Screening and filling Medication discharge sheet

(name, dose, frequency, duration, side effect, important notes)

Counseling session and documentation in BHT CP1, 2 and 3

Phase II CRPGroup counseling (The ideal)

Talks in different languages Different in

knowledge/educational levels Limitation

More than one pharmacist Coordination with colleagues

Problem Statements

CRP mostly in outpatient setting. Many reasons (short LOS, high BOR, put emphasis on exercise-based CRP) (Taylor et al., 2004)

No much involvement of pharmacist in CRP (Wenger, 2008)

Only 5 hospitals are doing well structured CRP phase II with pharmacist involvement in Malaysia.

No known study was done of clinical services provided by pharmacist in phase I CRP (3 stages of phase I).

The impact of the early attempt of rehabilitation in phase I were poorly emphasized by previous studies (AACVPR, 1999 & 2006). The interpretations were poorly defined (Bethell et al., 2001)

The cost effectiveness and humanistic outcomes studies in phase I and short course phase II of CRP are lacking in our local setting.

Study Objectives

1. To measures the quality of life outcomes in patients who undergo

variety of interventions after the post acute coronary syndrome

(ACS).

2. To evaluate the cost-effectiveness of cardiac rehabilitation

program.

3. To evaluate the clinical outcomes of modified phase I and short

course of phase II cardiac rehabilitation.

METHODOLOGY

Measurement for Interventional Outcomes

A patient perspective: quantitative surveys such as health status, work performance, symptom burden, and satisfaction.

Health status can be measured using disease specific or general instruments

General instrument measuring health-related quality of life (HRQoL)

patients’ perceptions of health status

the preference-based weights

calculate QALYs (Tradeoff in incremental costs and gains in health)

Examples: SF-36, EQ-5D

Brazier, J. E., Dixon, S., & Ratcliffe, J. (2009). The role of patient preferences in cost-effectiveness analysis: a conflict of values? PharmacoEconomics, 27(9), 705-712.

Van Stel, H., & Buskens, E. (2006). Comparison of the SF-6D and the EQ-5D in patients with coronary heart disease. Health and Quality of Life Outcomes, 4(1), 20

Methodology: Data collection

Approved by MREC, MOH. Written informed consent was obtained

Design & Setting: ACS cases on January 2008 to Dec 2009 An interview (one to one) session while patients on admission. In-patient intensive cardiac care unit (CCU) and the cardiothoracic ward

(CTW) at Sarawak General Hospital, east Malaysia.

Inclusion Criteria: Consented for the trial No other chronic comorbidities Below 75 years old. Able to talk in Bahasa and English and local dialect STEMI, NSTEMI and UA

"nonequivalent" because in this design we do not explicitly control the assignment and the groups were nonequivalent

CCRPCONTROL MCRP

Inpatient

Outpatient

SF-36

SF-6D

Utility Score

EQ-5D

Utility Score

A Comparison of Preference-based from EQ-5D and SF-36

SF-6D program in SPSS by Sheffield University ScHARR

Estimating a preference-based index from the SF-6D

Statistical Analysis

Minimal Clinically Important Difference (MCID) to indentify clinical significant of HRQoL outcomes. Population Norms Comparison as Anchor-Based Methods to

Determine Changes Analysing Paired Data as Distribution-based Approach to Determine

Changes

Manual by using SF-36, range of MID is 2 -20 points and depending to sample size. Walters and Brazier, 2003

SPSS 16 Paired t-test for continuous dependent One-way ANOVA and post-hoc test for 3 groups over time

RESULTS

Screening and Recruitment process from Jan-Dec 2008

At baseline there were no difference in demographic, socioeconomic

background, or physical characteristic data

Clinical & Physical Characteristic

Overall improvement compare to baseline Poor in physical components & emotional components

Baseline vs. Malaysian Norms by Azman et al., (2003) * Six months assessment

* Azman A.B., Sararaks S., Rugayah B., Low L.L., Azian A.A., Geeta S., Tiew C.T. (2003). Quality of life of the Malaysian general population: Results from a postal survey using the SF-36. Med J Malaysia, 58(5):694-711

Several dimensions of HRQOL measures were found improved in MCRP. BP, GH. VT and MH All methods showed improvement but MCRP was the best

Baseline 12-months assessment

NnotMCRP

Minimal Clinically Important Difference (MCID)

MCID is used to report the success rate (proportion of patients improved or in an acceptable state) in trial arms.

"the smallest difference in score in the domain of interest which patients perceive as beneficial and which would cause clinicians to consider a change in patient's management". (Crosby et al., 2003; Jaeschke et al., 1989; Fayers & Machin, 2007).

The minimal clinically important difference (MCID) : the patient acceptable symptom state (PASS) cut-offs dichotomizing continuous values improved or not improved

0.5 SD = mean change of the small change (rated by patients on global rating scale) Norman et al., 2003

0.5 SD vs. standardized response mean (Example 0.3 for SF-6D) Walters and Brazier., 2003

Manual by using SF-36, range of MID is 20 points and depending to sample size (20 and more per group)

Tubach, F., Giraudeau, B., & Ravaud, P. (2009). The variability in minimal clinically important difference and patient acceptable symptomatic state values did not have an impact on treatment effect estimates. Journal of Clinical Epidemiology, 62(7), 725-728.

Mean Differences after 12 months follow up (MCID of 20 points)

MCRP CCRP control

r = 0.805, p<0.01

ICER = Incremental cost annually / Incremental Utility Score How much it cost (unit per health benefit)?

A well control of therapeutic INR and PTT in MCRP during admission even though with a high number of usage of double antiplatelet/ fibrinolytic /thrombolytic /anticoagulation (SK, rTPA, LMWH, Heparin, Warfarin)

MCRP group

Bar chart of compliance score for 6- and 12-month follow-up

Morisky Medication Adherence Score in the control was much higher than the MCRP and the CCRP participants

Self reporting 4 items MMAS

Individual and combined outcome measures of the primary end point at 12 months follow-up in the three groups

control group has recorded the highest clinical events rate in this clinical trial

Discussion

This study demonstrates post ACS population with SF-36 may aid in the further development and health economic evaluation of CRP.

The domains in HRQoL of post ACS patients differ significantly in physical (PCS) and mental (MCS) scores compare with the Malaysian norms.

1.Modified Cardiac rehabilitation have improved quality of life of patients after long period of time in Physical Functioning (PF), Role of Physical (RP), Social Functioning (SF), and Role of Emotional (RE), that clinically difficult to assess with conventional metrics or surrogate makers

2.General findings that cardiac rehabilitation program have improved both PCS in Body Pain and MCS of Social Functioning

3.Without any cardiac rehabilitation for post ACS patients will cause a poor clinical care treatments, poor improvement in quality of life and poor clinical outcomes.

CONCLUSION

Humanistic Findings:

1.Phase I CRP bring advantage to improve QoL up to a year follow-up.

Economic Findings:

2.The impact of clinical pharmacist services had improved the annual treatment costs despite of intense interventions given.

3.Although ICER of MCRP more costly but the tradeoff on the other outcomes (QoL, survival rates, clinical outcomes) will give overall benefits.

4.MCRP is a cost effective program that should be implemented in all hospitals.

Clinical Findings:

5.MCRP model: Clinically have improved- Better monitoring of pre and post bleeding/coagulation therapy. Optimization of evidence based medicines (EBM) and Greater usage of EBM on admission and discharge. Reduction in MACE Improvement of cholesterol levels

Limitation Patients that most of them are literate, able to speak

English/Malay/Dayak and at city locality.

Limited funding.

Short duration of follow-up for QALY study. Though i)constant proportional trade-off ii) risk neutrality or utility function is linear across life-years & iii) independence of preference for health & life expectancy.

No “disease-specific questionnaire” that measures CAD.

Defaulters, incomplete data set and high dropout rate in control (54.8%)

Strength Of This Study

Non-specific questionnaires that can derive a preference based score.

Full economic evaluation (CUA & ICER) and pharmacoeconomic study for the health economic evaluation and health policy decision-making.

Clinical pharmacy service in cardiology has a clinical impact, add-on quality of care and economic values.

The model’s results are robust in wide range of parameters (health state, utility values, event rates, clinical outcomes and costs)

Suggestion for future research:

1. Study on society perspective and issues which is emphasized on direct and indirect cost bear by the patients.

2. Multicenter research (Cardiology Centres: PGH, QEH, SAGH, IJN)

3. More investigators, unlimited funding.

4. Recommendation of Improvement in Cardiac Rehabilitation:

More time spent in phase I cardiac rehabilitation, in term of;

1. Patient Education on drug –disease counseling

2. Medication adherence & understanding

3. More emphasize the intensive counseling and motivation by

clinical pharmacists.

4. GCP Guideline for CRP in Malaysia

Recommendations

Implementation of basic pharmacist-based cardiac rehabilitation program in phase I and phase II should be applied, enforced and practiced in all MOH hospital settings. MCRP can easily implemented in all hospitals and it is highly cost-effective program

Every patients with uncomplicated ACS should be recruited for CRP. MCRP provides a high quality rehabilitation outcomes for cardiovascular patients.

Incremental Cost Effectiveness Ratio (ICER) of modified cardiac rehabilitation program is very minimum in term of operational cost for clinical pharmacy services.

References American Association of Cardiovascular & Pulmonary Rehabilitation. AACVPR Cardiac

Rehabilitation Resource Manual (2006). USA, Human Kinetics, Library of Congress. Fairclough, D.L. (2002). Design and Analysis of Quality of Life Studies in Clinical Trials.

Interdisciplinary Statistics (Chapman and Hall/CRC). A CRC Press Company, Florida. Goble, A.J., & Worcester, M.U.C. (1999). Best Practice Guidelines for Cardiac Rehabilitation

and Secondary Preventation. Department of Human Services Publication, Victoria, Australia. pp 144-161.

Ware J.E., Snow K.K., Kosinski M., Gandek B. (1993). SF-36 Health Survey Manual and Interpretation Guide. Boston, MA: New England Medical Centre, The Health Institute, 1993

Balady, G. J., Ades, P. A., Comoss, P., Limacher, M., Pina, I. L., Southard, D., et al. (2000). Core Components of Cardiac Rehabilitation/Secondary Prevention Programs : A Statement for Healthcare Professionals From the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation Writing Group. Circulation, 102(9), 1069-1073.

Brazier, J., Roberts, J., Platts, M., & Zoellner, Y. (2005). Estimating a preference-based index for a menopause specific health quality of life questionnaire. Health and Quality of Life Outcomes, 3(1), 13.

Drummond, M. F., Aguiar-Ibanez, R., & Nixon, J. (2006). Economic evaluation. Singapore Med J, 47(6), 456-461.

Jacobson, N. S., & Truax, P. (1991). Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult ClinPsychol, 59(1), 12-19.

Kaboli, P. J., Hoth, A. B., McClimon, B. J., &Schnipper, J. L. (2006). Clinical pharmacists and inpatient medical care: a systematic review. Arch Intern Med, 166(9), 955-964.

THANK YOU Sarawak General HospitalSarawak General Hospital

It is not the number that count, but the heart….