Pharmacist Intervention to Reduce Drug-related Readmissions Among the Elderly

Study Overview
=================
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.

Official Title
-----------------
Involving Clinical Pharmacists in Transitional Care to Reduce Drug-related Readmissions Among the Elderly - a Randomized Controlled Trial

Conditions
-----------------
Drug Use

Intervention / Treatment
-----------------
* Other: Enhanced clinical pharmacist service


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>In addition to a standard medication review at the hospital, this group also receives an enhanced clinical pharmacist service during 180 days after discharge from the hospital. | Other: Enhanced clinical pharmacist service<br>* The intervention includes regular medical chart reviews, multiple patient interviews and, if needed, collaboration with the primary care physician.<br>|
| No Intervention: Control group<br>This group receives standard care, which might include a medication review at the hospital. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from discharge to first drug-related readmission | Survival analysis with drug-related readmission as endpoint | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from discharge to first drug-related readmission | Survival analysis with drug-related readmission as endpoint | 30 days | 
| Frequency of drug-related readmissions | Difference in total number of drug-related readmissions | 30 and 180 days | 
| Time from discharge to first drug-related readmission - subgroups with/without heart failure | Survival analysis among patients with/without heart failure | 30 and 180 days | 
| Time from discharge to first drug-related readmission - subgroups with/without cognitive impairment | Survival analysis among patients with/without cognitive impairment | 30 and 180 days | 
| Frequency of drug-related readmissions - subgroups with/without cognitive impairment | Subgroup analysis among patients with/without cognitive impairment | 30 and 180 days | 
| Frequency of drug-related readmissions - subgroups with/without heart failure | Subgroup analysis among patients with/without heart failure | 30 and 180 days | 
| Time from discharge to first all-cause hospital visit | Survival analysis with readmission or visit to the emergency department as endpoint | 30 and 180 days | 
| Frequency of all-cause hospital visits | Difference in total number of readmissions and visits to the emergency department | 30 and 180 days | 
| Self-reported adherence | Adherence to medications reported through MARS-5 ( Medication Adherence Rating Scale) and Swedish Prescribed Drug Register | 30 and 180 days | 
| Self assessed quality of life: EQ-5D-questionnaire | Health-related quality of life reported through the EQ-5D-questionnaire | 30 and 180 days | 
| Health economics | Cost for visits for (drug-related) readmissions and to visits to the Emergency Department compared between patients in the control group and intervention group. | 180 days | 
| Medication appropriateness | Medication appropriateness using the implicit Medication Appropriateness Index (MAI) and explicit tools in the form of the quality indicators published by the Swedish National Board of Health and Welfare and The European Union (EU)(7)-PIM list | 180 days | 
| Mortality | Survival analysis with death as endpoint | 30 and 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical pharmacist, Elderly, Adherence, Drug-related readmission