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

Primary Purpose

Acute Coronary Syndromes

Status
Completed
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Structured intervention at discharge and tailored follow up post discharge
Sponsored by
Qatar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Coronary Syndromes focused on measuring Qatar, Acute Coronary Syndrome, Pharmacist, Medication burden, Mortality, Readmission, Adherence, Impact

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr. Maguy El Hajj

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Experimental

Arm Label

Control

Pharmacist delivered usual care at discharge

structured intervention at discharge and tailored follow up

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

All-cause mortality including cardiac-related mortality
This outcome will be measured by the number (%) of deaths. It will be assessed by checking HH and HMC medical records during the designated follow-up periods. •
ED visits including cardiac-related ED visits
This outcome will be measured by the number (%) of ED visits. The outcome will be assessed by checking HH and HMC medical records
Patient adherence to evidence-based secondary prevention medications for CAD
Adherence will be measured from the refill records as well as by asking the patients to list the medications they are currently taking and by using the ARMS tool
Burden of medications
will be assessed using a questionnaire that will be adapted from a validated and translated questionnaire.

Full Information

First Posted
January 3, 2016
Last Updated
March 9, 2021
Sponsor
Qatar University
Collaborators
Hamad Medical Corporation, Weill Cornell Medical College in Qatar
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1. Study Identification

Unique Protocol Identification Number
NCT02648243
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qatar University
Collaborators
Hamad Medical Corporation, Weill Cornell Medical College in Qatar

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. To evaluate the effectiveness of the intervention on improving patient adherence to evidence-based secondary prevention CAD medications. To study the effect of the intervention on reducing the burden of treatment on patients. To assess the effect of the intervention on increasing patient satisfaction with pharmacy services at Heart Hospital in Qatar.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes
Keywords
Qatar, Acute Coronary Syndrome, Pharmacist, Medication burden, Mortality, Readmission, Adherence, Impact

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
373 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Pharmacist delivered usual care at discharge
Arm Type
No Intervention
Arm Description
Patients will receive the usual counseling at discharge by the clinical pharmacists.
Arm Title
structured intervention at discharge and tailored follow up
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Structured intervention at discharge and tailored follow up post discharge
Intervention Description
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.
Primary Outcome Measure Information:
Title
All-cause hospitalizations and cardiac-related hospital readmissions
Description
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
Time Frame
3 months post discharge
Title
All-cause hospitalizations and cardiac-related hospital readmissions
Description
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
Time Frame
6 months post discharge
Title
All-cause hospitalizations and cardiac-related hospital readmissions
Description
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
Time Frame
12 months post discharge
Secondary Outcome Measure Information:
Title
All-cause mortality including cardiac-related mortality
Description
This outcome will be measured by the number (%) of deaths. It will be assessed by checking HH and HMC medical records during the designated follow-up periods. •
Time Frame
3 months, 6 months, and 12 months post discharge
Title
ED visits including cardiac-related ED visits
Description
This outcome will be measured by the number (%) of ED visits. The outcome will be assessed by checking HH and HMC medical records
Time Frame
3 months, 6 months, and 12 months post discharge
Title
Patient adherence to evidence-based secondary prevention medications for CAD
Description
Adherence will be measured from the refill records as well as by asking the patients to list the medications they are currently taking and by using the ARMS tool
Time Frame
3 months, 6 months, and 12 months post discharge
Title
Burden of medications
Description
will be assessed using a questionnaire that will be adapted from a validated and translated questionnaire.
Time Frame
3 months, 6 months, and 12 months post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Dr. Maguy El Hajj
City
Doha
ZIP/Postal Code
2713
Country
Qatar

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
27864247
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.
Results Reference
derived

Learn more about this trial

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

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