Low Indexes of Metabolism - Information to Teams (LIMIT)

Weight Loss Clinical Trial

— LIMIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476578
• Other study ID #: 0023-15-COM
• Secondary ID: ?/2015/49METABOL
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: November 2016

Study information

• Verified date: March 2020
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8584
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Thinness
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clalit Health Services

References & Publications (7)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Ass — View Citation

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 Geron — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death From Any Cause	Impact on overall-survival	1 year
Secondary	Impact on Evaluation Rate	Percentage of patients evaluated by a nurse and counseled by a dietitian	1 year
Secondary	Impact on Medical Costs	Medical expenses to the medical insurer, including hospitalizations, consultations, examinations, devices and medicines.	1 year
Secondary	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

External Links

•   Israel National Program for Quality Indicators in Community Healthcare