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

March 28, 2020 updated by: Dr. Nir Tsabar, Clalit Health Services

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

8584

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Email
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
Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.
Other Names:
  • "Dry Counseling"
No Intervention: Control
No email is sent.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clalit Health Services

Investigators

  • Principal Investigator: Nir Tsabar, MD/PhD, ClalitHS North District Principal Geriatrist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimate)

June 19, 2015

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

March 28, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0023-15-COM (Registry Identifier: Clalit Health Organization Community Division)
  • ר/2015/49 (Other Grant/Funding Number: The Israel National Institute for Health Policy Research)
  • METABOL_EMAIL (Other Identifier: Clalit Health Organization North District Research Group)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After publishing the results in a peer reviewed journal.

IPD Sharing Access Criteria

Any clinical researcher; Any ethically approved clinical research

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Study Data/Documents

  1. Study Protocol
    Information comments: LIMIT HEBREW PROTOCOL Version 3 (Final)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malnutrition

Clinical Trials on Email

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe