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

NCT ID: NCT02648243

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 373 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2019-12-30

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.

Conditions

Acute Coronary Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pharmacist delivered usual care at discharge

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

structured intervention at discharge and tailored follow up

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.

Group Type: EXPERIMENTAL

Structured intervention at discharge and tailored follow up post discharge

Intervention Type: 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.

Interventions

Structured intervention at discharge and tailored follow up post discharge

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Weill Cornell Medical College in Qatar

OTHER

Sponsor Role: collaborator

Qatar University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Maguy El Hajj

Dr. Maguy El Hajj

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dr. Maguy El Hajj

Doha, , Qatar

Countries

Qatar

References

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.

Reference Type: DERIVED

PMID: 36795303 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27864247 (View on PubMed)

Other Identifiers

Qatar U

Identifier Type: -

Identifier Source: org_study_id