Care manager to control cardiovascular risk factors in primary care: the Raffaello cluster randomized trial.
OBJECTIVE
This cluster randomized trial evaluated the efficacy of a disease and care management (D&CM) model in cardiovascular (CVD) prevention in primary care.


RESULTS
Eligible subjects had ≥ 1 among: blood pressure ≥ 140/90 mmHg; glycated hemoglobin ≥ 7%; LDL-cholesterol ≥ 160 or ≥ 100 mg/dL (primary or secondary prevention, respectively); BMI ≥ 30; current smoking. The D&CM intervention included a teamwork including nurses as care managers for the implementation of tailored care plans. Control group was allocated to usual-care. The main outcome was the proportion of subjects achieving recommended clinical targets for ≥ 1 of uncontrolled CVD risk factors at 12-month. During 2008-2009 we enrolled 920 subjects in the Abruzzo/Marche regions, Italy. Following the exclusion of L'Aquila due to 2009 earthquake, final analyses included 762 subjects. The primary outcome was achieved by 39.1% (95%CI: 34.2-44.2) and 25.2% (95%CI: 20.9-29.9) of subjects in the intervention and usual-care group, respectively (p < 0.001). The D&CM intervention significantly increased the proportion of subjects who achieved clinical targets for both diabetes and hypertension, with no differences in hypercholesterolemia, smoking status and obesity.


CONCLUSIONS
The D&CM intervention was effective in controlling cardiovascular risk factors, in particular hypertension and diabetes. Numbers needed to treat were small. Such intervention may deserve further consideration in clinical practice.


BACKGROUND
ACTRN12611000813987.
Clinical Governance Area, Regional Healthcare Agency of Marche Region, Ancona, Italy.
A
A
Deales
Clinical Governance Area, Regional Healthcare Agency of Marche Region, Ancona, Italy.
M
M
Fratini
Department of Internal Medicine and Public Health, University of L'Aquila, L'Aquila, Italy.
S
S
Romano
Polytechnic University of Marche, Ancona, Italy.
A
A
Rappelli
Department of Internal Medicine and Public Health, University of L'Aquila, L'Aquila, Italy.
M
M
Penco
Department of Cardiovascular Diseases, University Hospital Umberto I, Ancona, Italy.
G Piero
GP
Perna
Health District of Jesi, Italy.
G
G
Beccaceci
Health District of Francavilla, Chieti, Italy.
R
R
Borgia
Primary Care Practice of L'Aquila, Italy.
W
W
Palumbo
Primary Care Practice of Ancona, Italy.
M
M
Magi
Diabetes Care Center Madonna del Soccorso Hospital, San Benedetto del Tronto, Italy.
G
G
Vespasiani
Polytechnic University of Marche, Ancona, Italy.
M
M
Bronzini
Alliance Development & Health Solutions Manager, Pfizer, Italy.
A
A
Musilli
Department of Medicine and Aging Sciences, University "G. d'Annunzio" of Chieti, Italy.
M
M
Nocciolini
Department of Medicine and Aging Sciences, University "G. d'Annunzio" of Chieti, Italy; Clinical Research Center, Ce.S.I., University "G. d'Annunzio" Foundation, Chieti, Italy.
A
A
Mezzetti
Department of Medicine and Aging Sciences, University "G. d'Annunzio" of Chieti, Italy. Electronic address: lmanzoli@post.harvard.edu.
L
L
Manzoli
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001794:Blood Pressure; D015992:Body Mass Index; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D008078:Cholesterol, LDL / Q000097:blood; D016000:Cluster Analysis; D019468:Disease Management; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood; D006973:Hypertension / Q000097:blood; D007558:Italy; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011320:Primary Health Care; D012307:Risk Factors; D016896:Treatment Outcome
D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin
Cardiovascular diseases; Cardiovascular prevention; Care management; Cluster randomized trial; Primary care