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To conduct a cost analysis and cost-effectiveness study of MNT provided by RDs in a RCT comparing basic nutrition care (BC) with practice guidelines nutrition care (PGN) (Franz MJ, etal. J Am Diet Assoc. 1995; 95:1009-1017).

• Type 2 diabetes mellitus
• 38 - 78 years of age
• Free of serious complications or comorbidities

• Diabetes complications:  gastroparesis, renal disease
• Recent heart attacks or strokes
• Other acute illnesses, such as cancer or surgery, in the last 4 weeks
• Illnesses requiring corticosteroid therapy

Recruitment

Clinic patients were recruited from clinics in Minneapolis, Florida and Colorado

Design

Cost-effectiveness study

Intervention:

1. Randomized Controlled Trial:
   • basic care: 1 RD visit
   • practice guidelines nutrition care: >=3 RD visits
2. Cost-effectiveness analysis: cost per patient = (total cost for nutrition care/ number of patients served)
   • laboratory tests
   • educational materials
   • overhead
   • RD & support staff time for 0-3 visits; time spent with the patient + planning, documentation, team conferences
   • potential cost savings, e.g. MNT reduce or postpone the use of diabetes medications
3. Cost-effectiveness analysis process:
   • definition: measures the costs and outcomes of programs or services provided; consequences are measured in terms of a concrete desired health outcome.
   • objective: to compare >=2 means of achieving a desired outcome in terms of efficiency of dollar cost per unit of outcome.
   • calculation: costs are in dollar terms and outcomes are in natural units. Cost-effectiveness ratio = ($) cost/ unit of outcome (BC) compared to alternative: ($) cost/unit of outcome(PGC)

Blinding Used (if applicable):  none mentioned

Statistical Analysis:

The cost-effectiveness of PCG compared with BC was calculated using per-patient costs and glycemic outcomes for the 6 months of the study.  Cost effectiveness ratios are expressed as cost per unit of improvement in glycemic control (either fasting plasma glucose or HbA1C).  Net cost effectiveness ratios included the effects of cost savings due to therapy changes.  Cost savings were subtracted from per patient costs to obtain net per patient costs.  Sensitivity analysis was performed for 2 key input factors that showed the greatest effect on ratios:  dietitian salary and inclusion of an extra laboratory test.  Cost effectiveness ratios were also calculated for varying levels of outcome using the 95% confidence interval for amount of change from baseline to 6 months for fasting plasma glucose level.

Timing of Measurements

Data collected at baseline, 3 and 6 months.

Dependent Variables:

The impact of MNT after 6 months on:

1. Clinical outcomes:
   • fasting plasma glucose
   • HbA1c
2. Costs (direct health care)

Independent Variables:

Cost of nutrition care component of diabetes care:

• Dietitian and support staff time; for every 3 hours of time spent in patient care, 1 hour was added to account for related activities such as planning, documenting, attending team conferences
• Required laboratory tests (market price)
• Educational materials given to patients
• Overhead costs, calculated by considering the indirect cost rate (expressed as a percentage of personnel salaried) of each clinic site
• Reduction in cost of medications, assuming that the change in therapy would be maintained for 12 months

Control Variables: 

Initial N:  179 adults

Attrition (Final N):  Cost-effectiveness analysis based on 179 adults taken from a subsample of individuals completing a larger study.

Age:  38 - 78 years

Ethnicity:  81 - 92% white

Other relevant demographics:  67 - 75% college educated or higher

Anthropometrics:  BMI 33 +/- 6.9

Location:  Study conducted in outpatient diabetes centers in 3 states (Minnesota, Florida, Colorado) from 1992-1993.  Control group from primary care physician practices in Minneapolis.

Changes in Fasting Plasma Glucose over 6 month study period:

BC - 0.4+2.7 Mmol/L

PGC - 1.1+21.8 Mmol/L

Patients taken off medications and costs prorated over 12 months:

Subjects Cost Savings

	N	Cost Savings
BC	9	$3.13
PGC	7	$31.49

Each unit of change in fasting plasma glucose from entry to the 6-month follow-up can be achieved with an investment of $5.75 by implementing BC or of $5.84 by implementing PGC.

When net costs were considered (Per-patient costs – cost savings due to therapy changes) cost-effectiveness ratios were:

•  BC: $5.32
• PGC: $4.20

These findings suggest that experienced dietitians with a reasonable investment of resources can deliver individualized nutrition interventions.

Cost-effectiveness is enhanced when dietitians are engaged in active decision-making about intervention alternatives based on the patient’s needs.

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This study demonstrated that MNT provided for patients with type 2 diabetes mellitus could reduce the cost of care for patients by decreasing the need for diabetes medications.