Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 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 | |
| 0023-15-COM | Registry Identifier | Clalit Health Organization Community Division |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Email | Experimental | 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. |
|
| Control | No Intervention | No email is sent. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other | Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death From Any Cause | Impact on overall-survival | 1 year |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nir Tsabar, MD/PhD | ClalitHS North District Principal Geriatrist | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23280227 | Background | 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. | |
| 25277380 | Background | 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. |
| Label | URL |
|---|---|
| Israel National Program for Quality Indicators in Community Healthcare | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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.
After publishing the results in a peer reviewed journal.
Any clinical researcher; Any ethically approved clinical research
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider. |
| FG001 | Control | No email is sent. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Years old on 9.2015 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Death From Any Cause | Impact on overall-survival | Posted | Count of Participants | Participants | 1 year |
|
Adverse event data were collected for 1 year
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nir Tsabar | CLALIT HEALTH SERVICES | +97246049512 | NIR.TSABAR@CLALIT.ORG.IL |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: APPROVED STUDY PROTOCOL, TRANSLATED FROM HEBREW | Oct 13, 2015 | Feb 2, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D013851 | Thinness |
| D044342 | Malnutrition |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| 7586337 | Background | 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. |
| 20110121 | Background | 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. |
| 31588026 | Result | 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. |
| 31610995 | Result | 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. |
| 32064727 | Result | 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. |
| 29301522 | Derived | 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. |
LIMIT HEBREW PROTOCOL Version 3 (Final) |
| BG001 |
| Control |
No email is sent. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| HbA1c% Mean (Standard Deviation) | Baseline HbA1c% in known for all participants in groups B,D,F,G. However, it is known only for some participants in groups A,C,E. (See: Eligibility section) | Mean | Standard Deviation | % |
|
| Total Cholesterol Mean (Standard Deviation) | Baseline Cholesterol is known for all participants in groups C,E,F,G. However, it is known only for some participants in groups A,B,D. See: Eligibility section. | Mean | Standard Deviation | mg/dL |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Impact on Evaluation Rate | Percentage of patients evaluated by a nurse and counseled by a dietitian | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Impact on Medical Costs | Medical expenses to the medical insurer, including hospitalizations, consultations, examinations, devices and medicines. | Data were not collected | Posted | 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. | Data were not collected. | Posted | 1 year |
|
|
| 285 |
| 4,269 |
| 0 |
| 4,269 |
| 0 |
| 4,269 |
| EG001 | Control | No email is sent. | 245 | 4,218 | 0 | 4,218 | 0 | 4,218 |
Not provided
Not provided
Not provided
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |