Impact of a Pharmacist-delivered Discharge and Follow-up Intervention for Patients With Acute Coronary Syndromes in Qatar

NCT02648243 | Completed DMC

• 1 other identifier: Qatar U
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndromes

Keywords

Qatar; Acute Coronary Syndrome; Pharmacist; Medication burden; Mortality; Readmission; Adherence; Impact

Outcome Measures

Primary Outcomes (3)

• All-cause hospitalizations and cardiac-related hospital readmissions

  This will be measured by the number (%) of hospital readmissions including hospitalizations for cardiac events, including coronary events, exacerbation of heart failure or arrhythmia. Coronary events will be defined as ACS, percutaneous coronary intervention, and/or coronary artery bypass graft. This outcome will be assessed by checking the Heart Hospital (HH) and Hamad Medical Corporation (HMC) medical records

  3 months post discharge

• All-cause hospitalizations and cardiac-related hospital readmissions

  This will be measured by the number (%) of hospital readmissions including hospitalizations for cardiac events, including coronary events, exacerbation of heart failure or arrhythmia. Coronary events will be defined as ACS, percutaneous coronary intervention, and/or coronary artery bypass graft. This outcome will be assessed by checking the Heart Hospital (HH) and Hamad Medical Corporation (HMC) medical records

  6 months post discharge

• All-cause hospitalizations and cardiac-related hospital readmissions

  This will be measured by the number (%) of hospital readmissions including hospitalizations for cardiac events, including coronary events, exacerbation of heart failure or arrhythmia. Coronary events will be defined as ACS, percutaneous coronary intervention, and/or coronary artery bypass graft. This outcome will be assessed by checking the Heart Hospital (HH) and Hamad Medical Corporation (HMC) medical records

  12 months post discharge

Secondary Outcomes (4)

• All-cause mortality including cardiac-related mortality

  3 months, 6 months, and 12 months post discharge

• ED visits including cardiac-related ED visits

  3 months, 6 months, and 12 months post discharge

• Patient adherence to evidence-based secondary prevention medications for CAD

  3 months, 6 months, and 12 months post discharge

• Burden of medications

  3 months, 6 months, and 12 months post discharge

Study Arms (3)

Control

NO INTERVENTION

Patients will receive routine discharge instructions and medication information by the nurses and treating physicians at hospital discharge: Patients will not have any contact with the clinical pharmacists.

Pharmacist delivered usual care at discharge

NO INTERVENTION

Patients will receive the usual counseling at discharge by the clinical pharmacists.

structured intervention at discharge and tailored follow up

EXPERIMENTAL

The pharmacist will deliver a structured personalized discharge intervention in addition to 2 follow-up session (around 30 minutes each session) at 4 weeks of discharge and 8 weeks of discharge.

Behavioral: Structured intervention at discharge and tailored follow up post discharge

Interventions

Structured intervention at discharge and tailored follow up post discharge BEHAVIORAL

At discharge, pharmacist-delivered personalized intervention would include the following (30-60 minutes session): The pharmacist will perform medication reconciliation and will check the appropriateness and accuracy of discharge medications. - Other potential interventions that could be done by the pharmacist include in addition to medication initiation: dose and/or frequency optimization, changing ACEI with ARB if necessary, changing to another statin if needed, identification of inappropriate or duplicated therapy, etc. The pharmacist will ensure that a follow-up plan for medication monitoring after discharge is communicated to the patient. The pharmacist will also provide a tailored and thorough counseling to the patient. In addition to the pharmacist delivered intervention at discharge (as described above), the study pharmacist will schedule 2 follow-up sessions (30-60 minutes each session) with the patients at 4 weeks of discharge and at 8 weeks of discharge.

structured intervention at discharge and tailored follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qatar University: lead
• Hamad Medical Corporation: collaborator
• Weill Cornell Medical College in Qatar: collaborator

Study Sites (1)

Dr. Maguy El Hajj

Doha, 2713, Qatar

Location

Related Publications (2)

• El Hajj MS, Kaddoura R, Abu Yousef SEA, Orabi B, Awaisu A, AlYafei S, Shami R, Mahfoud ZR. Effectiveness of a structured pharmacist-delivered intervention for patients post-acute coronary syndromes on all-cause hospitalizations and cardiac-related hospital readmissions: a prospective quasi-experimental study. Int J Clin Pharm. 2023 Jun;45(3):630-640. doi: 10.1007/s11096-023-01538-4. Epub 2023 Feb 16.

  PMID: 36795303 DERIVED

• 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.

  PMID: 27864247 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Tooth, Impacted

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Maguy El Hajj

Study Record Dates

• First Submitted: January 3, 2016
• First Posted: January 7, 2016
• Study Start: March 1, 2016
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

QA (1)