EAL

MNT: RDN in Medical Team (2015)

Citation:

Martin OJ, Wu WC, Taveira TH, Eaton CB, Sharma SC. Multidisciplinary group behavioral and pharmacologic intervention for cardiac risk reduction in diabetes: A pilot study. Diabetes Educ. 2007; 33(1): 118-127.

PubMed ID: 17272798

Study Design:

Retrospective Cohort Study

Class:

B - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To evaluate the effectiveness of a multidisciplinary team providing both education and medication management in a group setting for cardiac risk reduction in patients with diabetes mellitus.

Inclusion Criteria:

Entry into the MEDIC program consisted of type 1 or type 2 diabetes in patients referred by their primary care provider on an as-needed basis to aid in the management of cardiac risk factors.

Exclusion Criteria:

Patients were excluded if they had difficulty attending group sessions.

Description of Study Protocol:

Recruitment

The electronic medical records of patients with diabetes who participated in group behavioral and pharmacologic interventions for cardiac risk reduction during May to October, 2002 at the Providence VA Medical Center were reviewed.

Design

Retrospective cohort study.

Intervention (if applicable)

The MEDIC intervention included participation from a registered nurse educator, a Registered Dietitian, and two clinical pharmacists with local and national certifications in patient assessment, diabetes and lipid management
Veterans with diabetes mellitus attended the weekly sessions of a diabetes education and intervention program directed by pharmacists for one month
Two groups of 15 to 20 patients received four 1.5-hour diabetes self-management education classes provided by a multidisciplinary team consisting of a pharmacist (leader), nurse educator, dietitian, physical therapist and social worker and four one-hour group medication adjustment sessions provided by the pharmacist
Pharmacists followed medication adjustment algorithms for blood pressure, diabetes and cholesterol management previously developed in collaboration with physician specialists in the field
Patients were given report cards, pedometers, scales, glucometers and sphygmomanometers.

Statistical Analysis

Continuous variables were expressed as mean ± standard deviation and categorical variables as percentages
A paired sample T-test was used to compare values at baseline and after the MEDIC intervention based on an intention-to-treat principle
Chi-square testing was used to compare percentages of patients who achieved the ACC/AHA and ADA guidelines recommended goals for the major cardiovascular risk factors at baseline and after the MEDIC intervention
To detect the apparent effect of MEDIC on achieving guideline recommended goals, the above analyses were repeated excluding those patients who were at target goals for individual risk factors at baseline
The change in BMI was reanalyzed in those patients with a baseline BMI more than 30kg/m².

Data Collection Summary:

Timing of Measurements

Baseline and three months after intervention data were collected.

Dependent Variables

Glycosylated hemoglobin A1C
Systolic and diastolic blood pressure
Lipid profile
BMI
Medical history of hypertension, dyslipidemia or diabetes was based on self-report, chart documentation or active usage of antihypertensive, lipid-lowering or antidiabetic agents.

Independent Variables

MEDIC program.

Description of Actual Data Sample:

Initial N: 41 veterans with diabetes mellitus, 97.6% male
Attrition (final N): 36 patients attended all four sessions (87.8%), and five patients attended three sessions
Age: Mean age 66.1±11.7 years.

Ethnicity

80.5% Caucasian
12.2% African American
4.9% Hispanic

Other Relevant Demographics

97.6% had type 2 diabetes mellitus.

Location

Providence, Rhode Island.

Summary of Results:

Risk Factors Before and After MEDIC Intervention in All Patients (N=41)

Variables	Before MEDIC	After MEDIC	Average Change	P-Value
A1C, %	8.5±2.2	7.0±1.2	-1.5±1.0	<0.01
Systolic blood pressure, mm Hg	134±19	131±17	-3±2	0.54
Diastolic blood pressure, mm Hg	77±12	72±12	-5±0	0.04
LDL-cholesterol, mg per dL (mmol per L)	105.4±41.4 (2.7±1.1)	95.0±33.0 (2.5±0.8)	-10.4±8.4 (-0.3±0.2)	0.21
BMI, kg/m²	31.2±6.2	30.7±6.1	-0.5±0.1	0.69

Other Findings

All parameters improved after the intervention, with significant reductions in A1C (-1.5±1.0%) and diastolic blood pressure (-5mm Hg).

Reductions were further accentuated when baseline values were abnormal, with significant improvement in A1C (-2.0%±0.5%), systolic blood pressure (-14±3mm Hg), and diastolic blood pressure (-13±3mm Hg).

The average number of medications increased from 1.7±1.2 at baseline to 1.9±1.3 after the MEDIC intervention for antihypertensive agents, from 1.2±0.8 to 1.4±0.9 for oral antidiabetic agents and from 1.3±0.7 to 1.5±0.5 for insulin regimens.

Author Conclusion:

The MEDIC program, a short-term, combined behavioral and pharmacologic intervention delivered by a team of non-physician providers, improved cardiovascular risk factors in patients with diabetes mellitus. Short-term multidisciplinary group behavioral and pharmacologic intervention programs may be effective in improving cardiac risk factors in patients with diabetes.

Funding Source:

University/Hospital:

Providence VA Medical Center, VA Merit Review Award in Health Services Research and Development

Reviewer Comments:

Small cohort size consisting primarily of males. Authors note the following limitations:

As with all retrospective analyses, it might be flawed with selection bias and the results might not be applicable to all patients with diabetes
The study sample was small and the applicability of the results in a large population remained questionable
Formal health care cost assessment was 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?		???
	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?	N/A
	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?	???
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?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	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%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	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?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	N/A
	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.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	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?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	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?	N/A
	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?		Yes
	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?	Yes
	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)?	Yes
	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?	No
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