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CTRI Number  CTRI/2020/01/022852 [Registered on: 17/01/2020] Trial Registered Prospectively
Last Modified On: 07/01/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Trial 
Public Title of Study
Modification(s)  
STOPP /START Criteria and Beers Criteria for use of medicines in elderly  
Scientific Title of Study
Modification(s)  
Usefulness of STOPP /START Criteria and Beers Criteria for prescribing in geriatric patients in a tertiary heath care Center, Raipur, Central India. 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR YOGENDRA KECHE 
Address  ROOM NO.2215 DEPT OF PHARMACOLOGY GE ROAD TATIBANDH AIIMS RAIPUR

Raipur
CHHATTISGARH
492099
India 
Phone  08818882119  
Fax    
Email  drynkeche@gmail.com  
 
Details Contact Person
Scientific Query
 
Name  DR YOGENDRA KECHE 
Address  ROOM NO.2215 DEPT OF PHARMACOLOGY GE ROAD TATIBANDH AIIMS RAIPUR

Raipur
CHHATTISGARH
492099
India 
Phone  08818882119  
Fax    
Email  drynkeche@gmail.com  
 
Details Contact Person
Public Query
 
Name  DR YOGENDRA KECHE 
Address  ROOM NO.2215 DEPT OF PHARMACOLOGY GE ROAD TATIBANDH AIIMS RAIPUR

Raipur
CHHATTISGARH
492099
India 
Phone  08818882119  
Fax    
Email  drynkeche@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences GE Road Tatibandh Raipur CG 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  GE ROAD OPPO GURUDWARA TATIBANDH RAIPUR 
Type of Sponsor  Other [Autonomous Central Government Institute - Institute of National Importance] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Yogendra Keche  All India Institute of Medical Sciences Raipur  Department of Medicine and Department of Pharmacology Room No 2215 2nd floor College Building Gate 5 GE Road Tatibandh Raipur Chhattisgarh 492099
Raipur
 
08818882119

drynkeche@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee All India Institute of Medical Sciences Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Other problems related to medicalfacilities and other health care 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Age : 65 and above
Sex: Male/Female
OPD patients of Medicine/ Geriatric Department.
Patient who is taking 2 or more drugs
 
 
ExclusionCriteria 
Details  Age less than 65 years
Patient on single drug
Severely ill patients
Not willing to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Percentage of patients requiring change in prescription as per STOPP/START and Beers Criteria at 1st follow up and at the end of 1 month.
2. Percentage of patients had benefitted clinically and had improved quality of life at the end of one month.
 
1.Percentage of patients requiring change in prescription as per STOPP/START and Beers Criteria at 1st follow up and at the end of 1 month.
2. Percentage of patients had benefitted clinically and had improved quality of life at the end of one month.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Percentage patients requiring ≥ 5 drugs drug at baseline, 1st follow up & at the end of 1 month.
2. Percentage of patients not fulfilling STOPP/START criteria, but require change of therapy or continuation of existing therapy.
 
1.Percentage patients requiring ≥ 5 drugs drug at baseline, 1st follow up & at the end of 1 month.
2. Percentage of patients not fulfilling STOPP/START criteria, but require change of therapy or continuation of existing therapy.
 
 
Target Sample Size   Total Sample Size="241"
Sample Size from India="241" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/01/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
NIL 
Brief Summary
Modification(s)  

Introduction:

Traditionally -over 65  is considered as "elderly“. Elderly Suffer from or having chances of Alzheimer’s disease, Parkinson’s disease, Vascular dementia,  stroke, Visual impairment, cataracts and macular degeneration, Atherosclerosis, coronary heart disease, heart failure, Diabetes, Arthritis, osteoporosis, and fractures, Cancer, Incontinence. Hence ,Needed more number of drugs for the treatment. There are changes in responses to some drugs  with advanced age and also the drug usage patterns changed due increase in number of drugs. Many diseases ,nutritional problems and reduced financial resources lead to reduced dosing compliance in elderly.1

There are several pharmacokinetic and pharmacodynamics changes that occur in geriatric patients.

a.   There is age related decrease in  renal function.  Blood urea nitrogen (BUN) and serum creatinine levels are markers for renal function.  BUN  gives idea about concentration of urea in blood, much of this is obtained from ingested protein. Malnourished old person does not consume more protein hence no more increase in BUN in elderly . Serum Creatinine is produced by muscles .As muscle mass decreases, there is no enough production of creatinine to reflect changes in renal function. Hence, normally appearing bun and creatinine level in elderly under estimate degree of renal failure. Dosing recommendations is done by the Cockcroft-Gault formula in elderly patient.  This formula can be applied for the  ages 40 – 80 years. For women, the result should be multiplied by 0.85 (because of reduced muscle mass).2,3

b.   Aging process in elderly leads to decreased liver mass and decreased hepatic blood flow and reduced hepatic metabolism  ( up to 25% ) .Regional blood flow to liver at 65 years is reduced by 40-45% at the age of 25 years.7 Reduced  clearance of drug depend on hepatic metabolism and hepatic blood flow (1st pass effect). Hence, metabolism of the drugs like Verapamil, Lidocaine and labetalol is afftected as depend hepatic blood flow.8

e.    Elderly are more "sensitive" to the action of many drugs. These changes in results are due to altered pharmacokinetics or diminished homeostatic responses. Elderly are more sensitive to some sedative-hypnotics and analgesics. There is decrease in responsiveness to adrenoceptor agonists. Certain homeostatic control  - blunted with the advanced age in elderly. .Physiologic alterations in response is seen in elderly. Average blood pressure goes up with age. Incidence of symptomatic orthostatic hypotension increased. 2-hour PP blood glucose increased by about 1 mg/dL for each year of age above 50.Temperature regulation is also impaired, and hypothermia in poorly tolerated in the elderly.1,9,10,11

f.      Major changes with the aging process are: eg, forgetting to take one’s pill related to  cognitive changes associated with vascular or other pathology. Economic stresses due to reduced income and increased expenses due to illness. Most important change is loss of a spouse.1

Drug like antihistaminics, hypnotics, hidden contents in Herbal drugs) can cause  incontinence, confusion, fatigue, depression, and many times these symptoms are attributed to disease condition. Gingko cause bleeding when used with Aspirin. These problems can be modified by appropriate diagnosis and therapeutic actions.1  There is need for high index of suspicion for drug induced illness in elderly.  Any symptoms in an elderly patient may be a drug side effect until proved otherwise.1

Aim of drug therapy elderly is 1. to improve QOL in elderly  and  2. to prolong the life span. Hence there is need for the intelligent use of drugs  and recognize practical obstacles for the compliance of drug treatment. Drug therapy has considerable potential for both helpful and harmful effects in elderly: Maintain balance.1

Hence for prescription of drugs in elderly there role of careful drug history and analyzing the prescription for rationality of the medication in elderly patient. Disease to be treated may be drug-induced.1

Principals of prescription in elderly mention that  there should be high index of suspicion for drug reactions & interactions and know the other drugs the elderly patient is being taking.1

By knowing the drug taken by elderly we can simplify regimen as much as possible when multiple drugs are prescribed and can reduce the number the drugs taken by the elderly person.1

The American Geriatric Society updated Beers criteria for potentially inappropriate medication use in older adults. The criteria are intended for use in all ambulatory, acute, and institutionalized settings of care for populations aged 65 and older in the United States, with the exception of hospice and palliative care. Consumers, researchers, pharmacy benefits managers, regulators, and policymakers also widely use the AGS Beers Criteria. The intentions of the criteria are to: improve medication selection; educate clinicians and patients; reduce adverse drug events; and serve as a tool for evaluating quality of care, cost, and patterns of drug use of older adults.12

 

 Polypharmacy and inappropriate prescribing are well known risk factors for adverse drug reactions (ADRs), which commonly cause adverse clinical outcomes in older people.13

 The recently published NICE guidance on Medicines Optimisation14 recommends using a screening tool – for example the STOPP/START tool in older people – to identify potential medicines-related patient safety incidents for those on multiple medicines or with long term conditions. NHS Wirral Clinical Commissioning Group had given START/STOP tool to support medication review in elderly person.15  Also O’Mahony et al. 16  also updated their tool STOPP/ START Criteria in 2015. This tool had shown previously that there is reduction in adverse drug events and average length of hospital when it was used within 72 hours of hospitalization. STOPP/START tool will determine the rate of underutilization of drugs if any as it recommend the use of drug for certain condition. This requirement of drug may be different in Indian scenario. This tool will be used in this study.

 With this background, we want to conduct this study in elderly person to find out usefulness of these tool in improving prescription and reducing adverse drug reactions to medication also to check for recommendation of drug in elderly persons.

 Primary objective:

To find out the usefulness of STOPP/START and Beers Criteria for prescribing in elderly in a tertiary care center in Central India.

Primary end points to achieve primary objective:

1.Percentage of  patients requiring change in prescription as per STOPP/START and Beers Criteria at 1st follow up and at the end of 1 month.

2. Percentage of patients  had benefitted clinically and had improved quality of life at the end of one month.

Secondary objective:  

1.To analyse the prescription in elderly person as per WHO prescription evaluation indicator.

2. If any deviation from drug used apart from the criteria then identify the reasons as per need of clinical condition for that particular patient.

Secondary end points to evaluate the prescription:

1.Percentage patients requiring ≥ 5 drugs drug at baseline, 1st follow up & at the end of 1 month.

2. Percentage of patients not fulfilling STOPP/START criteria, but require change of therapy or continuation of existing therapy.

Study Methodology:

Study design: Longitudinal observational study

 Selection of study participation and study procedure:

 Patient attending medicine/geriatric OPD and fulfilling inclusion and exclusion criteria will be recruited for this study. Informed written consent (Annexure II) will be obtained from each of the study participant. Patient will be given information about the study and study procedure with the help of patient information sheet (Annexure II). Information collected will be recorded in case record form cum questionnaire (Annexure III).

Information to be collected in Questionnaire cum case record form:

Demography, Education, occupation, family history, diagnosis for which visited hospital, dietary history, history of chronic illnesses with medication, history of constipation, peptic ulcer disease, history consumption of herbal medications, OTC medications, clinical finding (Weight, Height, Blood pressure, Pulse), laboratory findings (LFT, KFT, Lipid profile, Blood sugar,etc) if available and revised creatinine clearance will be calculated from available creatinine clearance by Cochcroft Gault formula, list of drugs prescribed with dose and frequency of drug administration, information about ADRs to previously prescribed drugs.

Also the quality of life will be assessed with the help of Health Related Quality of Life (HRQOL) -14 measures (Annexure IV), Center for disease control and Prevention (CDC).20

Cockcroft –Gault Formula=  (140-age) X (body weight in Kg)

                                                    Serum creatinine X 72   

                                              

Review with STOPP/ START Criteria and Beers Criteria:

Information collected from prescription and elderly person above 65 years will be reviewed and analysed with the help of STOPP/START4 and Beers Criteria1 for appropriateness in the Department of Pharmacology. If any change in drug therapy needed in the form of drug stop/start and change of the drugs will be discussed with treating physician. If physician agrees for the change of medication as per present clinical condition of the patient that will be advised to patient after giving full information to the patient by the physician.

Follow up after change of the therapy:

If change in therapy agreed by treating physician, patient will be called for 1st  follow up after 7 days for the changes in treatment and after 1 month to evaluate the effect of the changed therapy with the help of structured questionnaire.

 

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