Clinical trial NCT03671629: Clinical Pharmacist Intervention to Reduce Drug-related Readmissions Among Older People
Official title: Involving Clinical Pharmacists in Transitional Care to Reduce Drug-related Readmissions Among the Elderly - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug Use
Keywords: Clinical pharmacist
Elderly
Adherence
Drug-related readmission
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 700
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This randomized controlled trial primarily investigates if a clinical pharmacist intervention can reduce drug-related readmissions among patients \>75 years. The intervention targets the transfer between hospital and primary care. In brief, the intervention includes medical chart reviews and patient interviews during a period of 180 days.

Detailed description: At discharge from the hospital, patients that meet the inclusion criteria are offered to participate in the study. At this point the investigators will also gather baseline data through questionnaires on self-reported adherence (MARS-5) and quality of life (EQ-5D). The participants are randomized to the different study arms according to a stratified procedure based on their cognitive function.

The intervention group will have their charts reviewed every second week and be contacted by the clinical pharmacist through phone within 7 and after 30 and 60 days respectively to discuss their medications. If possible drug-related problems are suspected during the interviews that cannot be solved immediately, the physician is contacted.

Both groups have a follow-up time of 30 and 180 days. After 30 and 180 days, the patients will once again report adherence and quality of life. All other data can be gathered from the medical charts.

Eligibility criteria: Inclusion Criteria:

* Living at home
* Acutely admitted
* Registered at one of ten pre-specified primary care health centers

Exclusion Criteria:

* Patients unable to communicate or who do not speak Swedish
* Patients scheduled for palliative care
* Patients admitted due to intoxication by alcohol or drug (non prescription)

Primary outcomes:
measure: Time from discharge to first drug-related readmission
timeFrame: 180 days
Secondary outcomes:
measure: Time from discharge to first drug-related readmission
timeFrame: 30 days
measure: Frequency of drug-related readmissions
timeFrame: 30 and 180 days
measure: Time from discharge to first drug-related readmission - subgroups with/without heart failure
timeFrame: 30 and 180 days
measure: Time from discharge to first drug-related readmission - subgroups with/without cognitive impairment
timeFrame: 30 and 180 days
measure: Frequency of drug-related readmissions - subgroups with/without cognitive impairment
timeFrame: 30 and 180 days
measure: Frequency of drug-related readmissions - subgroups with/without heart failure
timeFrame: 30 and 180 days
measure: Time from discharge to first all-cause hospital visit
timeFrame: 30 and 180 days
measure: Frequency of all-cause hospital visits
timeFrame: 30 and 180 days
measure: Self-reported adherence
timeFrame: 30 and 180 days
measure: Self assessed quality of life: EQ-5D-questionnaire
timeFrame: 30 and 180 days
measure: Health economics
timeFrame: 180 days
measure: Medication appropriateness
timeFrame: 180 days
measure: Mortality
timeFrame: 30 and 180 days
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Medical Centre, University Hospital of Umeå
Study officials:
affiliation: Umeå University
name: Maria Gustafsson, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kindstedt J, Svahn S, Sjolander M, Glader EL, Lovheim H, Gustafsson M. Investigating the effect of clinical pharmacist intervention in transitions of care on drug-related hospital readmissions among the elderly: study protocol for a randomised controlled trial. BMJ Open. 2020 Apr 27;10(4):e036650. doi: 10.1136/bmjopen-2019-036650.