Clinical trial NCT02648243: Impact of a Pharmacist-delivered Discharge and Follow-up Intervention for Patients With Acute Coronary Syndromes in Qatar
Official title: Impact of a Pharmacist-delivered Discharge and Follow-up Intervention for Patients With Acute Coronary Syndromes in Qatar: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndromes
Keywords: Qatar
Acute Coronary Syndrome
Pharmacist
Medication burden
Mortality
Readmission
Adherence
Impact
Lead sponsor: Qatar University
Sponsor class: OTHER
Collaborators: name: Hamad Medical Corporation
name: Weill Cornell Medical College in Qatar
First posted: 2016-01-07
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In Qatar, cardiovascular diseases (CVD) have become the leading cause of morbidity and mortality over the past two decades. Between 1991 and 2010, a total of 16,736 patients were admitted with ACS (Acute Coronary Syndrome) in Qatar. Despite the use of percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), and pharmacological agents to acutely reduce vascular risk, ACS patients are at high risk of having further cardiovascular events. Consequently, secondary cardiovascular risk reduction therapy is needed for all CAD (Coronary Artery Disease) patients. Clinical practice guidelines recommend that following ACS, patients should receive indefinite treatment with aspirin, a beta blocker, an angiotensin converting enzyme inhibitor (ACEI) or alternatively angiotensin II receptor blocker (ARB) and a statin. Less than 80% of ACS patients in Qatar use this quadruple combination after discharge. This creates a significant opportunity for pharmacists to improve CVD management and outcomes in Qatar. Nothing is known about the impact of Qatar clinical pharmacists as direct patient-care team members at discharge and post-discharge on the short-term and long-term outcomes of ACS patients. The proposed study is aimed to determine this impact. The investigators hypothesize that a clinical pharmacist-delivered intervention consisting of medication reconciliation and counseling at discharge and tailored follow-up post-discharge will decrease hospital readmissions, emergency department (ED) visits and all-cause mortality at 3 month, 6 months and 12 months after hospital discharge when compared with control arm and pharmacist delivered intervention at discharge only among ACS patients. The investigators also hypothesize that the effect of the intervention will increase patients' adherence to evidence-based secondary prevention medications for CAD (Coronary Artery Disease), and patient satisfaction with pharmacy services. Besides, this intervention will reduce the treatment burden on patients.

Detailed description: Nothing is known about the impact of Qatar clinical pharmacists as direct patient-care team members at discharge and post-discharge on the short-term and long-term outcomes of patients with ACS at Heart Hospital in Qatar. This research project aims to determine this.

The investigators hypothesize that a clinical pharmacist-delivered intervention consisting of medication reconciliation and counseling at discharge and tailored follow-up post-discharge will decrease hospital readmissions, emergency department (ED) visits and all-cause mortality at 3 months, 6 months and 12 months after hospital discharge when compared with control arm and pharmacist delivered intervention at discharge only among ACS patients. The investigators also hypothesize that the effect of the intervention will increase patients' adherence to evidence-based secondary prevention medications for CAD, and patient satisfaction with pharmacy services. besides, this intervention will reduce the treatment burden on patients.

Study objectives:

1. To evaluate the effectiveness of clinical pharmacist-delivered intervention at discharge and tailored follow-up post-discharge on decreasing hospital readmissions, ED visits and mortality in ACS patients.
2. To evaluate the effectiveness of the intervention on improving patient adherence to evidence-based secondary prevention CAD medications.
3. To study the effect of the intervention on reducing the burden of treatment on patients.
4. To assess the effect of the intervention on increasing patient satisfaction with pharmacy services at Heart Hospital in Qatar.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Admitted to and discharged from any nonsurgical cardiology service at Heart Hospital with a diagnosis of ACS in the period from September 2015 to February 2016.

Exclusion Criteria:

* Severe visual impairment
* Severe hearing impairment
* Inability to communicate in English or Arabic
* Mental or psychiatric illness
* Delirium or severe dementia
* Cognitive impairment
* Incomprehensible speech
* Planned discharge to a location other than home (e.g. long-term care facility, nursing home, other medicine units etc.)
* Plan for coronary artery bypass graft (CABG) surgery during hospitalization
* Plan to leave Qatar in the next 12 months
* A terminal illness with a high likelihood of death in the next 12 months.

Primary outcomes:
measure: All-cause hospitalizations and cardiac-related hospital readmissions
timeFrame: 3 months post discharge
measure: All-cause hospitalizations and cardiac-related hospital readmissions
timeFrame: 6 months post discharge
measure: All-cause hospitalizations and cardiac-related hospital readmissions
timeFrame: 12 months post discharge
Secondary outcomes:
measure: All-cause mortality including cardiac-related mortality
timeFrame: 3 months, 6 months, and 12 months post discharge
measure: ED visits including cardiac-related ED visits
timeFrame: 3 months, 6 months, and 12 months post discharge
measure: Patient adherence to evidence-based secondary prevention medications for CAD
timeFrame: 3 months, 6 months, and 12 months post discharge
measure: Burden of medications
timeFrame: 3 months, 6 months, and 12 months post discharge
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Dr. Maguy El Hajj
Study officials:
References:
citation: Zidan A, Awaisu A, Kheir N, Mahfoud Z, Kaddoura R, AlYafei S, El Hajj MS. Impact of a pharmacist-delivered discharge and follow-up intervention for patients with acute coronary syndromes in Qatar: a study protocol for a randomised controlled trial. BMJ Open. 2016 Nov 18;6(11):e012141. doi: 10.1136/bmjopen-2016-012141.