Clinical trial NCT03162081: Medication Misuse and Dependence Among Elderly
Official title: Medication Misuse and Dependence in Elderly Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mild Cognitive Impairment
Elderly
Substance-Related Disorders
Keywords: addiction
cognition
impulsivity
neuropsychology
prescription drug misuse
dependence
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: King's College London
name: University of Oslo
First posted: 2017-05-22
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dependence y/n
timeFrame: Within 2 weeks of admission
measure: Medication misuse y/n
timeFrame: Past year prior to in-hospital stay (data collected within 2 weeks of admission)
Secondary outcomes:
measure: MCI - Mild cognitive impairment
timeFrame: Within 2 weeks of admission
measure: MMSE
timeFrame: Within 2 weeks of admission
measure: COGNISTAT
timeFrame: Within 2 weeks of admission
measure: EQ-5D
timeFrame: Within 2 weeks of admission
measure: BIS-11
timeFrame: Within 2 weeks of admission
measure: BIS/BAS score
timeFrame: Within 2 weeks of admission
measure: TUG
timeFrame: Within 2 weeks of admission
measure: SLB
timeFrame: Within 2 weeks of admission
measure: Neuropsychological profiles
timeFrame: Within 2 weeks of admission
measure: Use of addictive medication y/n
timeFrame: Within 2 weeks of admission
measure: No of days of use of defined addictive medications/month
timeFrame: Within 2 weeks of admission
measure: No. of possible side effects
timeFrame: Within 2 weeks of admission
measure: No. of possible serious interactions
timeFrame: Within 2 weeks of admission
measure: No.of inappropriate medications for elderly at admission
timeFrame: Within 2 weeks of admission
measure: No.of inappropriate medications for elderly during in-hospital stay
timeFrame: Within 2 weeks of admission
measure: No.of inappropriate medications for elderly at discharge
timeFrame: Within 2 weeks of admission
measure: No.of inappropriate medications for elderly at admission
timeFrame: Within 2 weeks of admission
measure: No.of inappropriate medications for elderly during in-hospital stay
timeFrame: Within 2 weeks of admission
measure: No.of inappropriate medications for elderly at discharge
timeFrame: Within 2 weeks (index stay may in some cases be somewhat longer)
measure: Substance use disorder
timeFrame: Within 2 weeks
Other outcomes:
measure: Mortality
timeFrame: 2 years
measure: Mortality
timeFrame: 5 years
measure: Readmission rate
timeFrame: 5 years
measure: Total readmission days
timeFrame: 5 years
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: Coordinator of overall research program
name: Jorunn Rugkåsa, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.