Low Indexes of Metabolism - Information to Teams (LIMIT) (LIMIT)

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

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.

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.

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

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.

Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.

Medical expenses to the medical insurer, including hospitalizations, consultations, examinations, devices and medicines.

A composite measure of doses of prescribed anti-diabetic and cholesterol-lowering medicines - According to relevant alert by email.

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.

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request to email nir.tsabar@clalit.org.il. Shared data will not include exact dates, exact lab results or any data that might expose the identity of patients. Also, commercial data such as drug brands or costs may not be shared.

Flegal KM, Kit BK, Orpana H, Graubard BI. Association of all-cause mortality with overweight and obesity using standard body mass index categories: a systematic review and meta-analysis. JAMA. 2013 Jan 2;309(1):71-82. doi: 10.1001/jama.2012.113905.

Giovannelli J, Coevoet V, Vasseur C, Gheysens A, Basse B, Houyengah F. How can screening for malnutrition among hospitalized patients be improved? An automatic e-mail alert system when admitting previously malnourished patients. Clin Nutr. 2015 Oct;34(5):868-73. doi: 10.1016/j.clnu.2014.09.008. Epub 2014 Sep 18.

Iribarren C, Reed DM, Chen R, Yano K, Dwyer JH. Low serum cholesterol and mortality. Which is the cause and which is the effect? Circulation. 1995 Nov 1;92(9):2396-403. doi: 10.1161/01.cir.92.9.2396.

Currie CJ, Peters JR, Tynan A, Evans M, Heine RJ, Bracco OL, Zagar T, Poole CD. Survival as a function of HbA(1c) in people with type 2 diabetes: a retrospective cohort study. Lancet. 2010 Feb 6;375(9713):481-9. doi: 10.1016/S0140-6736(09)61969-3. Epub 2010 Jan 26.

Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. A Randomized Trial of Alerting to Low Glycated Hemoglobin Level in Older Adults: Results of the Low Indexes of Metabolism Intervention Trial B (LIMIT-B). J Am Med Dir Assoc. 2020 Feb;21(2):277-280.e3. doi: 10.1016/j.jamda.2019.08.004. Epub 2019 Oct 3.

Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. A Randomized Trial of Alerting to Hypocholesterolemia Results of the Low Indexes of Metabolism Intervention Trial-C (LIMIT-C). J Am Med Dir Assoc. 2020 Mar;21(3):410-414. doi: 10.1016/j.jamda.2019.08.018. Epub 2019 Oct 12.

Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. Randomized trial results of alerting primary clinicians to severe weight loss among older adults in the Low Indexes of Metabolism Intervention Trial part A. Geriatr Gerontol Int. 2020 Apr;20(4):329-335. doi: 10.1111/ggi.13888. Epub 2020 Feb 16.

Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. The low indexes of metabolism intervention trial (LIMIT): design and baseline data of a randomized controlled clinical trial to evaluate how alerting primary care teams to low metabolic values, could affect the health of patients aged 75 or older. BMC Health Serv Res. 2018 Jan 5;18(1):4. doi: 10.1186/s12913-017-2812-0.