Drug-Related Side Effects and Adverse Reactions Clinical Trial
— ASPIREOfficial title:
The Effect of a trAnSitional Pharmacist Intervention in geRiatric Inpatients on Hospitals Visits After dischargE (ASPIRE): a Randomized Controlled Trial
NCT number | NCT04617340 |
Other study ID # | S64758 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 25, 2021 |
Est. completion date | November 2024 |
A randomized controlled trial will be performed in geriatric inpatients to investigate the impact of a multifaceted clinical pharmacy intervention on health related outcomes.
Status | Recruiting |
Enrollment | 828 |
Est. completion date | November 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients admitted to one of the study wards under supervision of a geriatrician - A written informed consent by the patient or his/her representative - Discharged from the hospital Exclusion Criteria: - Admitted for a maximum of one day - Unable to understand Dutch - Being in a palliative stage as stated in their medical record with active withdrawal of drug therapy - Patients being discharged to another ward within the same hospital or to another hospital |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
Van der Linden L, Hias J, Walgraeve K, Flamaing J, Tournoy J, Spriet I. Clinical Pharmacy Services in Older Inpatients: An Evidence-Based Review. Drugs Aging. 2020 Mar;37(3):161-174. doi: 10.1007/s40266-019-00733-1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to all-cause unplanned hospital visit after discharge. | An unplanned hospital visit is defined as an unplanned hospital admission or an emergency department visit | up to six months after discharge | |
Secondary | General practitioners contacts | Number of general practitioners contacts | Up to six months after discharge | |
Secondary | Mortality | Death date | Up to six months after discharge | |
Secondary | Other types of hospital visits | Number of planned hospital admissions, number of emergency department visits, number of unplanned hospital admissions | Up to six months after discharge | |
Secondary | Drug-related readmissions | Number of drug related readmissions | Up to six months after discharge | |
Secondary | Fall incidents | Number of falls | Up to one month after discharge | |
Secondary | Patient reported drug related problems | Number of drug related problems | Up to one month after discharge | |
Secondary | Change in Quality of life | five-level version of the EuroQol five-dimensional (EQ5D) descriptive system (EQ-5D-5L) questionnaire. values will be tranformed using a value set to a score from 0 - 1 (a higher score indicating a better quality of life) | on admission, one month after discharge and six months after discharge | |
Secondary | Differences in pain | Numeric Rating Scale (NRS score) once a week (min 0 - max 10), a higher score indicating more pain | Up to one month after discharge | |
Secondary | Medications | Number of medications | On admission, at discharge and one month after discharge | |
Secondary | Medication adherence | BAASIS tool | On admission and one month after discharge | |
Secondary | Potentially inappropriate medications | RASP tool | On admission, at discharge and one month after discharge | |
Secondary | Cost-effectiveness | Healthcare related costs and Medicine productivity costs | Up to six months after discharge |
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