EAL

MNT: RDN in Medical Team (2015)

Citation:

Musacchio N, Lovagnini Scher A, Giancaterini A, et al. Impact of a chronic care model based on patient empowerment on the management of Type 2 diabetes: effects of the SINERGIA programme. Diabet Med J Br Diabet Assoc. 2011; 28 (6): 724-730. doi:10.1111/j.1464-5491.2011.03253.x.

PubMed ID: 21294769

Study Design:

Prospective Cohort Study

Class:

B - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To document the impact of the first two years of SINERGIA on clinical outcomes of patients and routine practice in the clinic
To evaluate if the desired targets reached by the specialist were maintained in the long-term, while reducing the number of face-to-face encounters with the diabetologist.

Inclusion Criteria:

Patients referred to the diabetes clinic for at least one year prior to starting the SINERGIA model program
Patients with type 2 diabetes mellitus (T2DM) who have reached stabilization in their disease or therapy (i.e., steady HbA1c level at up to 7.0%), without need for therapy changes
Have the ability to follow the educational program.

Exclusion Criteria:

None specifically stated beyond not meeting inclusion criteria.

Description of Study Protocol:

Recruitment

Not described, beyond a patient requests referral to a diabetes outpatient clinic from their primary general practitioner.

Design

Before-and-after study in which baseline values were collected one year prior to the start of the SINERGIA model program and evaluated one year after completion
The SINERGIA model is described below.

Intervention
The SINGERIA model is used in the management of patients with T2DM who have reached diabetes stabilization. The SINGERIA provider team includes three diabetologists, two nurses and one dietitian. The goal is to empower the patients through an individualized approach to treatment. There are four components to the model:

Education of the diabetological team: The team uses patient medical records and discusses objectives, strategies and tools for use with patients. Standardized data collection was implemented.
First visit: Diabetologist conducts a comprehensive exam and establishes the care map. Patients are actively involved.
Empowerment: Other healthcare professionals (including nurse and dietitian) take charge to educate the patient on self-monitoring glucose, management of an emergency, lifestyle, nutrition, food care, meaning of lab results and regular monitoring of microvascular complications. Again, patients are actively involved in goal-setting and self-monitoring strategies.
Follow-up visits: Patients follow-up with a nurse and dietitian to review the patients' glycemic diary and monitory variables. During this time, patients can contact the care team through a telemedicine system.

Statistical Analysis

Indicators were calculated as averages of all values available in the two study periods (pre and post) for a robust estimate
Generalized hierarchical linear regression models for repeated measures were used
A spatial-power structure was used to accound for within-individual correlations and non-uniformity of visit schedules for different subjects
Indicator results were reported as estimated mean change with standard error or percentage and 95% confidence interval
Two-tailed tests with P-value set at <0.05
SAS software (v. 9.1) was used.

Data Collection Summary:

Timing of Measurements

Baseline: Average of outcome data in the one year prior to start of program
One year: Average of outcome data in the year following completion of the program.

Dependent Variables

BMI
HbA1c
Blood pressure
Lipid panel: Total cholesterol, LDL-C, HDL-C, triglcyerides
Demographic data (i.e., age, sex, diabetes duration, tobacco use)
Percentage use of anti-diabetic agents, insulin, lipid-lowering drugs, antihyertensive agents and patients with micro- or macro-albuminia.

Independent Variables

Time (pre and post change).

Control Variables

None noted.

Description of Actual Data Sample:

Initial N: 1,004 (54% male)
Attrition (final N): 1,004 (0% attrition)
Age: Mean, 66.6±9.5 years
Ethnicity: Unknown
Other relevant demographics: Not stated.

Anthropometrics

BMI: 16% in the healthy BMI range; 17% with BMI between 25.1kg/m² and 27kg/m²; 67% with BMI over 27kg/m²
Smokers: 13%
Diabetes duration: 10% had T2DM for less than one year; 64% had a duration over five years.

Location
Italy.

Summary of Results:

Key Findings

Favorable Outcome Percentage of Patients	Pre	Post	One Year Change
HbA1c≤7.0%	32.7%	45.8%	+13% (P<0.001)
LDL-C<100mg/dL	39.7%	47.3%	+7.6% (P<0.001)
BP≤130/85mmHg	24.7%	23.5%	-1.2% (P=0.29)

Unfavorable Outcome Percentage of Patients	Pre	Post	One Year Change
HbA1c≥9.0%	10.5%	4.3%	-6.2% (P<0.001)
LDL-C≥130mg/dL	26.6%	19.7%	-6.9% (P<0.001)
BP≥140/90mmHg	62.1%	58.5%	-3.6% (P=0.006)

Other Findings

Percentage treated with insulin (5.2% to 5.9%), two or more antihypertensive agents (37.1 to 37.8%) and lipid-lowering drugs (46.5 to 48.4%) remained unchanged (non-significant change).

Author Conclusion:

Signs of SINGERIA model effectiveness were represented by benefits in CVD risk factors and were depicted in patient adherence without increases in pharmacological use or additional diabetolgist appointments.

Funding Source:

Reviewer Comments:

Author highlighted limitations

Observational study of weaker design than RCT
No direct measure of empowerment
Cost-effectiveness analysis not performed.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		N/A
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	N/A
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	N/A
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	No
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	No
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		N/A
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	Yes
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		N/A
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	No
	7.7.	Were the measurements conducted consistently across groups?	N/A
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	???
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes