Medication Misuse and Dependence Among Elderly

Study Overview
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Brief Summary
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The project focuses on investigating problematic medication use, especially overuse of potentially addictive drugs among the elderly. The investigators aim firstly to develop and validate instruments for detecting and describing behavioral aspects and consequences of dependence on, and misuse of, prescription medication among elderly. In addition to evaluating diagnostic utility of screening instruments, the investigators aim to identify and report characteristics, risk factors and consequences of medication misuse and dependence among the elderly.

Detailed Description
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Elderly represent a particularly vulnerable group with many contributing factors including age-related multifactorial morbidity, cognitive function, polypharmacy, dependence and multiple prescribers with suboptimal communication. Centrally active pain killers and sedative/hypnotic medications give increased risk of addiction, adverse drug events, reduced physical and/or cognitive function. The project comprises diagnostic accuracy, descriptive screening, cross-sectional and case-control studies, with aims to: i) assess diagnostic utility of instruments for elderly patients; ii) describe risk factors for medication misuse and dependence; iii) describe consequences of the use of centrally active medications among elderly compared to a control population. Moreover, the investigators aim to examine the association between medication misuse and changes in cognitive function, focusing on deficits in specific domains of cognition. An additional aim is to explore the possibility of dissociating such cognitive changes from other causes of mild cognitive impairment (MCI) associated with development of dementia.

Official Title
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Medication Misuse and Dependence in Elderly Patients

Conditions
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Mild Cognitive Impairment, Elderly, Substance-Related Disorders

Intervention / Treatment
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* Diagnostic Test: Substance misuse screening
* Diagnostic Test: EQ-5D
* Diagnostic Test: Impulsivity screening
* Diagnostic Test: Cognitive screening
* Diagnostic Test: Functional tests
* Diagnostic Test: Cognistat
* Diagnostic Test: Neuropsychological profiling
* Other: Clinical interview
* Other: Medication use
* Other: Comorbidity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to geriatric or Neurology dept of hospital during inclusion time Exclusion Criteria: MMSE < 21, diagnosis of pre-existing severe depression or psychotic disease, pre-existing dementia diagnosis, new pain requiring start-up of central pain killers not previously used, Palliative treatment. Insufficient Norwegian language Serious visual disturbance and hearing impairment Strongly reduced general health precluding partcipation in interview and questionnaires

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Users<br>Elderly patients who use prescription benzodiazepines/Z-hypnotics or opiates Clinical interview, Substance misuse screening, EuroQol five dimensional health-related quality of life questionnaires (EQ-5D), Impulsivity screening, Cognitive screening, Functional tests, Cognistat Neurobehavioural cognitive status examination (Cognistat), Neuropsychological profiling, Medication use, Comorbidity | Diagnostic Test: Substance misuse screening<br>* Diagnostic and Statistical manual of mental disorders, version 4 (DSM-IV)/MINI-international Neuropsychiatric interview (MINI interview) for Diagnostics of dependence, additional questions for DSM-V classification, severity of dependence scale (SDS)<br>Diagnostic Test: EQ-5D<br>* Health related Quality of life<br>Diagnostic Test: Impulsivity screening<br>* Barratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test<br>Diagnostic Test: Cognitive screening<br>* Minimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test<br>Diagnostic Test: Functional tests<br>* Timed up and go (TUG), Single leg balancing test (SLB)<br>Diagnostic Test: Cognistat<br>* Assessment of cognitive domains<br>Diagnostic Test: Neuropsychological profiling<br>* Controlled Oral Word Association Test, Categorical fluency tests, Wechsler Adult Intelligence Scale, Color-Word Interference Test (CWIT) from the Delis-Kaplan Executive Function test<br>Other: Clinical interview<br>* Interview for sociodemographics, utilisation of health care, economic varables, The De Jong Gierveld Loneliness Scale<br>Other: Medication use<br>* Detailed screen of used medications, interactions, side effects in electronic patient registry<br>Other: Comorbidity<br>* Charlson comorbidity index and Cumulated illness rating scale (CIRS) based on electronic patient registry<br>|
| Non-users<br>Age and gender matched controls not using the above Clinical interview, Substance misuse screening, EuroQol five dimensional health-related quality of life questionnaires (EQ-5D), Impulsivity screening, Cognitive screening, Functional tests, Cognistat Neurobehavioural cognitive status examination (Cognistat), Neuropsychological profiling, Medication use, Comorbidity | Diagnostic Test: Substance misuse screening<br>* Diagnostic and Statistical manual of mental disorders, version 4 (DSM-IV)/MINI-international Neuropsychiatric interview (MINI interview) for Diagnostics of dependence, additional questions for DSM-V classification, severity of dependence scale (SDS)<br>Diagnostic Test: EQ-5D<br>* Health related Quality of life<br>Diagnostic Test: Impulsivity screening<br>* Barratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test<br>Diagnostic Test: Cognitive screening<br>* Minimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test<br>Diagnostic Test: Functional tests<br>* Timed up and go (TUG), Single leg balancing test (SLB)<br>Diagnostic Test: Cognistat<br>* Assessment of cognitive domains<br>Diagnostic Test: Neuropsychological profiling<br>* Controlled Oral Word Association Test, Categorical fluency tests, Wechsler Adult Intelligence Scale, Color-Word Interference Test (CWIT) from the Delis-Kaplan Executive Function test<br>Other: Clinical interview<br>* Interview for sociodemographics, utilisation of health care, economic varables, The De Jong Gierveld Loneliness Scale<br>Other: Medication use<br>* Detailed screen of used medications, interactions, side effects in electronic patient registry<br>Other: Comorbidity<br>* Charlson comorbidity index and Cumulated illness rating scale (CIRS) based on electronic patient registry<br>|
| Screening group<br>Patients over 65 admitted to hospital as in-patients Clinical interview, Substance misuse screening, EuroQol five dimensional health-related quality of life questionnaires (EQ-5D), Impulsivity screening, Cognitive screening, Functional tests, Medication use, Comorbidity | Diagnostic Test: Substance misuse screening<br>* Diagnostic and Statistical manual of mental disorders, version 4 (DSM-IV)/MINI-international Neuropsychiatric interview (MINI interview) for Diagnostics of dependence, additional questions for DSM-V classification, severity of dependence scale (SDS)<br>Diagnostic Test: EQ-5D<br>* Health related Quality of life<br>Diagnostic Test: Impulsivity screening<br>* Barratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test<br>Diagnostic Test: Cognitive screening<br>* Minimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test<br>Diagnostic Test: Functional tests<br>* Timed up and go (TUG), Single leg balancing test (SLB)<br>Other: Clinical interview<br>* Interview for sociodemographics, utilisation of health care, economic varables, The De Jong Gierveld Loneliness Scale<br>Other: Medication use<br>* Detailed screen of used medications, interactions, side effects in electronic patient registry<br>Other: Comorbidity<br>* Charlson comorbidity index and Cumulated illness rating scale (CIRS) based on electronic patient registry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dependence y/n | DSM-IV defined substance dependence assessed by MINI interview | Within 2 weeks of admission | 
| Medication misuse y/n | Use of any of: opiates/benzodiazepine/Z-hypnotics >5 days per week for >3 months | Past year prior to in-hospital stay (data collected within 2 weeks of admission) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MCI - Mild cognitive impairment | Defined by MMSE < 26 | Within 2 weeks of admission | 
| MMSE | Numerical score of cognitive function | Within 2 weeks of admission | 
| COGNISTAT | Cognitive profile | Within 2 weeks of admission | 
| EQ-5D | Quality of life | Within 2 weeks of admission | 
| BIS-11 | Impulsivity score | Within 2 weeks of admission | 
| BIS/BAS score | Behavioura inhibition/activation score | Within 2 weeks of admission | 
| TUG | Functional test score (time in secs) | Within 2 weeks of admission | 
| SLB | Functional test score (time in secs) | Within 2 weeks of admission | 
| Neuropsychological profiles | Tests as listed | Within 2 weeks of admission | 
| Use of addictive medication y/n | Prescription use of any of the following: opiates, benzodiazepines, Z-hypnotics | Within 2 weeks of admission | 
| No of days of use of defined addictive medications/month | No. days of use of any of the following: opiates, benzodiazepines, Z-hypnotics | Within 2 weeks of admission | 
| No. of possible side effects | No. possible side effects of any of the following: opiates, benzodiazepines, Z-hypnotics | Within 2 weeks of admission | 
| No. of possible serious interactions | No. possible serious interactions of any of the following: opiates, benzodiazepines, Z-hypnotics | Within 2 weeks of admission | 
| No.of inappropriate medications for elderly at admission | No.of inappropriate medications as defined by NORGEP criteria (Norwegian general practice criteria) | Within 2 weeks of admission | 
| No.of inappropriate medications for elderly during in-hospital stay | No.of inappropriate medications as defined by NORGEP criteria | Within 2 weeks of admission | 
| No.of inappropriate medications for elderly at discharge | No.of inappropriate medications as defined by NORGEP criteria | Within 2 weeks of admission | 
| No.of inappropriate medications for elderly at admission | No.of inappropriate medications as defined by STOPP criteria (Screening tool of older patients prescriptions) | Within 2 weeks of admission | 
| No.of inappropriate medications for elderly during in-hospital stay | No.of inappropriate medications as defined by STOPP criteria | Within 2 weeks of admission | 
| No.of inappropriate medications for elderly at discharge | No.of inappropriate medications as defined by STOPP criteria | Within 2 weeks (index stay may in some cases be somewhat longer) | 
| Substance use disorder | DSM-IV criteria assessed through additional questions to MINI interview | Within 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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addiction, cognition, impulsivity, neuropsychology, prescription drug misuse, dependence