Low Indexes of Metabolism - Information to Teams (LIMIT)

• Sponsor: Clalit Health Services (Other)
• Overall Status: Completed
• CT.gov ID: NCT02476578
• Collaborator: (none)
• Enrollment: 8,584
• Arms: 2
• Duration (Months): 13

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss; Thinness; Malnutrition	Other: Email	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 8584 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sending Advisory Electronic Mail to Primary Care Staff, Addressing Low Metabolic Measures: Assessing the Health Outcomes for Patients Above Age 75
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Death From Any Cause [1 year]

   Impact on overall-survival

Secondary Outcome Measures

1. Impact on Evaluation Rate [1 year]

   Percentage of patients evaluated by a nurse and counseled by a dietitian

2. Impact on Medical Costs [1 year]

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

3. Impact on a Composite Measure of Medical Treatment [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 75 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

• 1. Last HbA1c% level of 6.5% or less AND

• dispensing anti-diabetic medicines during previous 2 months

• OR

• 1. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Clalit Health Services

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan: APPROVED STUDY PROTOCOL, TRANSLATED FROM HEBREW - Oct 13, 2015

More Information

Additional Information:

• Israel National Program for Quality Indicators in Community Healthcare

Publications

• 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.
• 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.
• 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.

• Responsible Party: Dr. Nir Tsabar, North District Principal Geriatrician, Clalit Health Services
• ClinicalTrials.gov Identifier: NCT02476578
• Other Study ID Numbers: 0023-15-COM; ר/2015/49; METABOL_EMAIL; 0023-15-COM
• First Posted: Jun 19, 2015
• Last Update Posted: Apr 9, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Dr. Nir Tsabar, North District Principal Geriatrician, Clalit Health Services: 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
• Additional relevant MeSH terms: Malnutrition; Weight Loss; Thinness

Study Results

Participant Flow

Pre-assignment Detail	Some of the participants may fit more than one criterion, as explained in the Eligibility section. Hence 7 subgroups are created: A) Fit only alert 1. B) Fit only alert 2. C) Fit only alert 3. D) Fit both alert 1. and alert 2. E) Fit both alert 1. and alert 3. F) Fit both alert 2. and alert 3. G) Fit all alerts: 1. , 2. and 3.

Arm/Group Title	Intervention Email	Control
Arm/Group Description	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. Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.	No email is sent.
Period Title: Overall Study
STARTED	4310	4274
Died Before Email Was Sent	35	43
Left Before End of Trial	6	13
COMPLETED	4269	4218
NOT COMPLETED	41	56

Baseline Characteristics

Arm/Group Title	Intervention Email	Control	Total
Arm/Group Description	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. Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.	No email is sent.	Total of all reporting groups
Overall Participants	4269	4218	8487
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	80.6 (4.7)	80.8 (4.9)	80.7 (4.8)
Sex: Female, Male (Count of Participants)
Female	2484 58.2%	2445 58%	4929 58.1%
Male	1785 41.8%	1773 42%	3558 41.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Israel	4269 100%	4218 100%	8487 100%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.7 (5.9)	28.8 (5.9)	28.8 (5.9)
HbA1c% Mean (Standard Deviation) (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	6.51 (1.05)	6.46 (1.00)	6.49 (1.02)
Total Cholesterol Mean (Standard Deviation) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	154.61 (33.88)	154.23 (33.60)	154.42 (33.74)

Outcome Measures

1. Primary Outcome

Title	Death From Any Cause
Description	Impact on overall-survival
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Email	Control
Arm/Group Description	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. Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.	No email is sent.
Measure Participants	4269	4218
Count of Participants [Participants]	285 6.7%	245 5.8%

2. Secondary Outcome

Title	Impact on Evaluation Rate
Description	Percentage of patients evaluated by a nurse and counseled by a dietitian
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Email	Control
Arm/Group Description	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. Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.	No email is sent.
Measure Participants	4269	4218
Count of Participants [Participants]	3387 79.3%	3337 79.1%

3. Secondary Outcome

Title	Impact on Medical Costs
Description	Medical expenses to the medical insurer, including hospitalizations, consultations, examinations, devices and medicines.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Intervention Email	Control
Arm/Group Description	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. Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.	No email is sent.
Measure Participants	0	0

4. Secondary Outcome

Title	Impact on a Composite Measure of Medical Treatment
Description	A composite measure of doses of prescribed anti-diabetic and cholesterol-lowering medicines - According to relevant alert by email.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Data were not collected.

Arm/Group Title	Intervention Email	Control
Arm/Group Description	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. Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.	No email is sent.
Measure Participants	0	0

Adverse Events

Time Frame	Adverse event data were collected for 1 year
Adverse Event Reporting Description	Primary physicians and nurses who were recipients of the trial e-mail alert, were asked to report any adverse event to the principal investigator. No such report was received.
Arm/Group Title	Intervention Email		Control
Arm/Group Description	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. Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.		No email is sent.
All Cause Mortality
	Intervention Email		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	285/4269 (6.7%)		245/4218 (5.8%)
Serious Adverse Events
	Intervention Email		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4269 (0%)		0/4218 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Email		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4269 (0%)		0/4218 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.