Michael Mills MD CCFP FCFP Barbara Bell MD CCFP FCFP et al.

3. A Primary Care Cardiovascular Risk Reduction Clinic, More Effective and Not More Expensive: A Randomized Clinical Trial Michael Mills MD CCFP FCFP Barbara Bell MD CCFP FCFP et al.

4. Acknowledgements • The 634 patients who participated • The Staff at the Caroline Medical Group • Jo-Anne Lucas, Reg. N.

5. Background • Cardiovascular disease management programs improve processes of care such as prescription of drugs and risk factor profiles, in patients with cardiovascular disease (McAlister et al. 2001) • Cardiovascular disease treatment should focus on overall risk profile of patients • Randomized Clinical Trials of cardiovascular disease management programs have not shown statistically significant decreases in over all risk scores (Ketola et al. 2001) • Prospective cost analysis of cardiovascular disease programs are unavailable

6. Study questions • Determine the effectiveness of a CaRR (Cardiovascular Risk Reduction) Clinic and nurse phone intervention over usual care • Establish which patients with which characteristics benefited most from the three types of care • Determine the associated direct and indirect costs of each intervention

7. Methods

8. Design Consenting patients with Cardiovascular Disease risks or events Randomize CaRR clinic Nurse Phone Usual Care Assess the change in Cardiovascular Disease Risk score, risk factors, psychosocial factors, & costs after 1 year

9. Inclusion criteria • Patients with Cardiovascular Disease risk issues or events • Patients who were English speaking, 18 years of age or older, who were not residing in a nursing home and were mentally competent

10. Intervention 1 CaRR clinic patients attended 10 encounters over 53 weeks with a doctor or nurse CaRR clinic focused on • Reviewing disease status, lab results, medication lists • Linkage with health services • Motivational health counseling • Patient education

11. Intervention 2 Nurse phone patients received 10 phone calls over 53 weeks Nurse phone intervention focused on • Review lifestyle goals 3 Usual care patients attended Caroline Medical Group HSO at their discretion

12. Collecting outcomes • Telephone interview by one of seven trained interviewers blind to group assignment • Electronic database collection of initial psychosocial measures • Clinical Assessment by study nurse • Outcomes collected at baseline and 1 year

13. Outcome Measures • CVD risk score • Health and Social Service Utilization • Self-Efficacy • Social Support (PRQ85-Part2) • Montgomery Asberg Depression Rating • Indices of Coping Responses

14. Results

15. Characteristics of patients • Average age 65 years old • 49% male • 79% live in a house • 94% working • 77% have live in help • 95% feel they have adequate income • Average years of education 14

16. Adverse Events 108 78 69 χ2=9.812, p=0.007

17. Retention of patients Total identified 1913 Refusals 480 Ineligible 333 Not Needed 259 Total consenting 841 Refusals 43 Not Located 145 Baseline CaRR clinic 215 Nurse Phone 216 Usual Care 222 Lost to f/u 4 Lost to f/u 10 Lost to f/u 5 CaRR Intervention 211 Nurse Phone 206 Usual Care 217 Year 1 Overall Drop Out Rate…3%

18. Risk Factors Smoking LVH Present 23.4 22.7 20.5 20.5 18.4 Percent 16.2 Percent 4.7 6.3 5.5 4.4 2.4 3.7 n=210 n=204 n=213 n=210 n=204 n=213 Hyperglycemic 28.9 29.1 26.8 23.4 21.3 22.8 Percent n=210 n=204 n=213

19. Risk Factors LDL 2 Total Cholesterol 1 5.0 5.0 4.8 5.0 4.8 4.7 2.9 2.8 2.8 2.5 2.6 2.6 n=210 n=204 n=213 n=210 n=204 n=213 HDL • ANOVA F=3.29, p=0.038; Tukey HSD CRR-Usual care p<0.031 • ANOVA F=5.16, p=0.006; Tukey HSD CRR-Usual care p=0.006 1.4 1.5 1.6 1.5 1.5 1.4 n=210 n=204 n=213

20. Risk Factors Systolic BP Diastolic BP 3 139.5 139.7 140.6 79.8 79.2 79.9 131.8 73.9 75.4 76.0 128.2 130.7 mmHg mmHg n=210 n=204 n=213 n=210 n=204 n=213 BMI 27.8 27.9 27.7 28.1 28.6 28.5 3. ANOVA F=4.36, p=0.013; Tukey HSD CRR-Nurse p=0.029, CRR-Usual care p=0.029 n=210 n=204 n=213

21. CVD Risk Score CVD Present CVD Absent Percent Percent 8.7 8.7 8.4 7.8 5.9 6.7 11.2 14.0 12.3 11.4 9.1 9.7 n=83 n=76 n=77 n=127 n=128 n=136

22. Psychosocial Variables • MADRS – no statistically significant differences found between groups • Personal Resource – no statistically significant differences found between groups • Indices of Coping – no statistically significant differences found between groups • Self Efficacy – CaRR group significantly better in Managing Disease, Doing Chores, Social Recreational Activities

23. Total Direct Costs 1956 1928 1862 Canadian $ n=210 n=204 n=213

24. Total Indirect Costs 501 312 Canadian $ 94 n=210 n=204 n=213

25. Hospital Admissions 27 25 21 n=210 n=204 n=213

26. Anticipated/Unanticipated Outcomes of Service Interventions for Allocative Decision Making (Birch and Gafni, 1996) Effects Increased Same Reduced 1 2 3 Increased 4 5 6 Same 7 8 9 Reduced “Cost / Effective” Reduced benefit which releases resources for other purposes Expenditures for Resources Consumed “Win / Win” Unambiguous improvements in economic efficiency Producing more/same benefit at the same or lower expenditure Economic efficiency unaffected by introduction of this program

27. Conclusions • Risk factor scores showed improvement with a CaRR clinic in primary care • Risk score improved in all groups • Patients in CaRR clinic with CVD and low Problem Solving improved the most • CaRR clinic no more expensive • Longer follow-up needed to determine if risk scores can be reduced and costs can be maintained or further reduced