Weight Loss Clinical Trial
Official title:
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.
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