Low Indexes of Metabolism - Information to Teams (LIMIT)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether alerting primary care providers by email about low values of BMI, HbA1c% or cholesterol will affect treatment and improve overall survival and other health indexes of people older than 75 years.

Detailed Description
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Scientific background Interventions aimed to ameliorate malnutrition are important for elderly health and include dietary counseling and discontinuing unnecessary medicines. Emailing an alert regarding low BMI was found to improve dietary counseling numbers. Correlation between death and HbA1c% is U-shaped, with increased mortality under a 6.5% level in patients taking two anti-diabetic medicines. Sending an email alert regarding an over-tight control of diabetes was followed by a reduction in mortality. Death and cholesterol correlation is also U-shaped, with increased mortality and morbidity under 160 mg%. The investigator found no interventional study for this situation. Objectives To check whether alerting the primary care providers by email, about low values of BMI, HbA1c% or cholesterol will affect treatment and improve health indexes of people older than 75 years. Working hypotheses During a year, and relative to the control group, intervention emails may result in the following: A decrease in mortality. An increase in dietary counseling percentage and a decrease in prescribing anti-diabetic and cholesterol-lowering medicines. A decrease in medical expenses and in other morbidity indexes. Type of research and methods of data collection This randomized controlled trial will be conducted entirely through the existing computer system. The participants (patients) will be assigned to the two Arms/Groups Intervention Email and Control. It has three separate interventions: a. Alerting about a significant drop in BMI. b. Alerting about a low HbA1c% level in patients taking anti-diabetics. c. Alerting about a low cholesterol level in patients taking cholesterol-lowering medicines. The alerts will be sent to the primary clinicians. Method(s) of data analysis Differences between intervention groups and control groups will be analyzed using Chi-square test (or Fishers' exact test) for categorical variables and using T-test (or Two-sample Wilcoxon test) for continuous variables. Uniqueness and relevance Health service policy regarding signs of malnutrition and excessive medicinal treatment needs a relevant scientific knowledge base. Nutritional counseling and revision of medicinal treatment may dramatically affect health. This research deals with questions that have no commercial interest, but are important to the public.

Official Title
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Sending Advisory Electronic Mail to Primary Care Staff, Addressing Low Metabolic Measures: Assessing the Health Outcomes for Patients Above Age 75

Conditions
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Weight Loss, Thinness, Malnutrition

Intervention / Treatment
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* Other: Email


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All found by computerized search in the data base of Clalit Health Services North and South districts: 1. A drop in BMI of 2 Kg/m^2 or more during previous two years AND BMI less than 23 Kg/m^2 AND No dietitian counseling during previous year OR 2. Last HbA1c% level of 6.5% or less AND dispensing anti-diabetic medicines during previous 2 months OR 3. Last total cholesterol less than 160 mg/dL AND dispensing cholesterol-lowering medicines during previous 2 months Exclusion Criteria: Patients whose their primary doctor and nurse email address is unobtainable For criterion 3: Patients diagnosed to have had a myocardial infarction, an ischemic heart disease, a transient ischemic attack or an ischemic stroke.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Email<br>An email is sent, alerting the primary care providers about low values of BMI, HbA1c% or cholesterol and advising to consider appropriate dietary and medical revision. | Other: Email<br>* Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.<br>* Other names: Dry Counseling;|
| No Intervention: Control<br>No email is sent. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death From Any Cause | Impact on overall-survival | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on Evaluation Rate | Percentage of patients evaluated by a nurse and counseled by a dietitian | 1 year | 
| Impact on Medical Costs | Medical expenses to the medical insurer, including hospitalizations, consultations, examinations, devices and medicines. | 1 year | 
| Impact on a Composite Measure of Medical Treatment | A composite measure of doses of prescribed anti-diabetic and cholesterol-lowering medicines - According to relevant alert by email. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypocholesterolemia, Frail Elderly, Aged, Aged, 80 and over, Cholesterol, Clinical Laboratory Information Systems, Hemoglobin A, Glycosylated, diet therapy, Anticholesteremic Agents, Health Services for the Aged, Hypoglycemic Agents, Hypoglycemia