Medication Misuse and Dependence Among Elderly

Medication Misuse and Dependence in Elderly Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Substance-Related Disorders; Mild Cognitive Impairment; Elderly
• Intervention / Treatment: 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

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• Norway
  • Lørenskog, Norway
    • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All admitted elderly 65-90 years of age are screened, for case-control age and gender-matched pairs of Users and non-users will in addition be examined in depth with neuropsychological tests

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Users; 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; 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); Diagnostic test: EQ-5D; Health related Quality of life; Diagnostic test: Impulsivity screening; Barratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test; Diagnostic test: Cognitive screening; Minimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test; Diagnostic test: Functional tests; Timed up and go (TUG), Single leg balancing test (SLB); Diagnostic test: Cognistat; Assessment of cognitive domains; Diagnostic test: Neuropsychological profiling; Controlled Oral Word Association Test, Categorical fluency tests, Wechsler Adult Intelligence Scale, Color-Word Interference Test (CWIT) from the Delis-Kaplan Executive Function test; Other: Clinical interview; Interview for sociodemographics, utilisation of health care, economic varables, The De Jong Gierveld Loneliness Scale; Other: Medication use; Detailed screen of used medications, interactions, side effects in electronic patient registry; Other: Comorbidity; Charlson comorbidity index and Cumulated illness rating scale (CIRS) based on electronic patient registry
Non-users; 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; 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); Diagnostic test: EQ-5D; Health related Quality of life; Diagnostic test: Impulsivity screening; Barratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test; Diagnostic test: Cognitive screening; Minimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test; Diagnostic test: Functional tests; Timed up and go (TUG), Single leg balancing test (SLB); Diagnostic test: Cognistat; Assessment of cognitive domains; Diagnostic test: Neuropsychological profiling; Controlled Oral Word Association Test, Categorical fluency tests, Wechsler Adult Intelligence Scale, Color-Word Interference Test (CWIT) from the Delis-Kaplan Executive Function test; Other: Clinical interview; Interview for sociodemographics, utilisation of health care, economic varables, The De Jong Gierveld Loneliness Scale; Other: Medication use; Detailed screen of used medications, interactions, side effects in electronic patient registry; Other: Comorbidity; Charlson comorbidity index and Cumulated illness rating scale (CIRS) based on electronic patient registry
Screening group; 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; 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); Diagnostic test: EQ-5D; Health related Quality of life; Diagnostic test: Impulsivity screening; Barratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test; Diagnostic test: Cognitive screening; Minimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test; Diagnostic test: Functional tests; Timed up and go (TUG), Single leg balancing test (SLB); Other: Clinical interview; Interview for sociodemographics, utilisation of health care, economic varables, The De Jong Gierveld Loneliness Scale; Other: Medication use; Detailed screen of used medications, interactions, side effects in electronic patient registry; Other: Comorbidity; Charlson comorbidity index and Cumulated illness rating scale (CIRS) based on electronic patient registry

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Crude mortality from patient registry data	2 years
Mortality	Crude mortality from patient registry data	5 years
Readmission rate	Number of readmissions after index admission	5 years
Total readmission days	Total number of readmission days	5 years

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: King's College London; University of Oslo
• Investigators: Study Director: Jorunn Rugkåsa, PhD, Coordinator of overall research program

Publications and helpful links

General Publications

• Siddiqui TG, Bjelkaroy MT, Cheng S, Kristoffersen ES, Grambaite R, Lundqvist C. The effect of cognitive function and central nervous system depressant use on mortality-A prospective observational study of previously hospitalised older patients. PLoS One. 2022 Mar 3;17(3):e0263024. doi: 10.1371/journal.pone.0263024. eCollection 2022.
• Bjelkaroy MT, Cheng S, Siddiqui TG, Benth JS, Grambaite R, Kristoffersen ES, Lundqvist C. The association between pain and central nervous system depressing medication among hospitalised Norwegian older adults. Scand J Pain. 2021 Dec 16;22(3):483-493. doi: 10.1515/sjpain-2021-0120. Print 2022 Jul 26.
• Siddiqui TG, Cheng S, Gossop M, Kristoffersen ES, Grambaite R, Lundqvist C. Association between prescribed central nervous system depressant drugs, comorbidity and cognition among hospitalised older patients: a cross-sectional study. BMJ Open. 2020 Jul 27;10(7):e038432. doi: 10.1136/bmjopen-2020-038432.
• Cheng S, Siddiqui TG, Gossop M, Kristoffersen ES, Lundqvist C. Sociodemographic, clinical and pharmacological profiles of medication misuse and dependence in hospitalised older patients in Norway: a prospective cross-sectional study. BMJ Open. 2019 Sep 5;9(9):e031483. doi: 10.1136/bmjopen-2019-031483.
• Cheng S, Siddiqui TG, Gossop M, Kristoffersen ES, Lundqvist C. The Severity of Dependence Scale detects medication misuse and dependence among hospitalized older patients. BMC Geriatr. 2019 Jun 24;19(1):174. doi: 10.1186/s12877-019-1182-3.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Actual): February 1, 2021
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: addiction; cognition; neuropsychology; dependence; impulsivity; prescription drug misuse
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Neurocognitive Disorders; Cognition Disorders; Substance-Related Disorders; Cognitive Dysfunction
• Other Study ID Numbers: NRC256431WP2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No