Acute Coronary SyndromesNCT02648243
Impact of a Pharmacist-delivered Discharge and Follow-up Intervention for Patients With Acute Coronary Syndromes in Qatar
A study testing Structured intervention at discharge and tailored follow up post discharge in people with Acute Coronary Syndromes, run by Qatar University at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- Structured intervention at discharge and tailored follow up post discharge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 373 participants
- Where
- 1 siteQatar
- Study dates
- 1 Mar 2016to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe visual impairment
- Severe hearing impairment
- Inability to communicate in English or Arabic
- Mental or psychiatric illness
- Delirium or severe dementia
- Cognitive impairment
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Pharmacist-delivered Discharge and Follow-up Intervention for Patients With Acute Coronary Syndromes in Qatar: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Acute Coronary Syndromes
- Being tested
- Structured intervention at discharge and tailored follow up post discharge
- Keywords
- Qatar, Acute Coronary Syndrome, Pharmacist, Medication burden, Mortality, Readmission, Adherence, Impact
- Medical subject headings
- Acute Coronary Syndrome, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured intervention at discharge and tailored follow up post dischargeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Structured intervention at discharge and tailored follow up post discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 12 months post discharge
Secondary outcomes (4)
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. •
Measured: 3 months, 6 months, and 12 months post discharge
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
Measured: 3 months, 6 months, and 12 months post discharge
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
Measured: 3 months, 6 months, and 12 months post discharge
Burden of medications
will be assessed using a questionnaire that will be adapted from a validated and translated questionnaire.
Measured: 3 months, 6 months, and 12 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start1 Mar 2016
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qatar University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamad Medical Corporation, Weill Cornell Medical College in Qatar
- Responsible party
- Principal investigator, Dr. Maguy El Hajj, Qatar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648243
- Sponsor's protocol ID
- Qatar U
- Status last verified
- Mar 2021
- First submitted
- 3 Jan 2016
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 36795303Zidan 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.
PubMed 27864247
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pharmacist-delivered Discharge and Follow-up Intervention for Patients With Acute Coronary Syndromes in Qatar: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02648243
- Acronym / sponsor ID
- Qatar U
- Conditions
- Acute Coronary Syndromes
- Keywords
- Qatar, Acute Coronary Syndrome, Pharmacist, Medication burden, Mortality, Readmission, Adherence, Impact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Qatar UniversityUniversity, hospital or other
- Collaborators
- Hamad Medical Corporation, Weill Cornell Medical College in Qatar
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Structured intervention at discharge and tailored follow up post dischargeThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- Severe visual impairment
- Severe hearing impairment
- Inability to communicate in English or Arabic
- Mental or psychiatric illness
- Delirium or severe dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured intervention at discharge and tailored follow up post dischargeAt 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. | Behavioural | structured intervention at discharge and tailored follow up |
Primary outcome
All-cause hospitalizations and cardiac-related hospital readmissions
Time frame: 3 months post discharge
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
Time frame: 6 months post discharge
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
Time frame: 12 months post discharge
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
4 secondary outcomes
All-cause mortality including cardiac-related mortality
Time frame: 3 months, 6 months, and 12 months post discharge
ED visits including cardiac-related ED visits
Time frame: 3 months, 6 months, and 12 months post discharge
Patient adherence to evidence-based secondary prevention medications for CAD
Time frame: 3 months, 6 months, and 12 months post discharge
Burden of medications
Time frame: 3 months, 6 months, and 12 months post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 36795303El 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.
- Derived from this study: PubMed 27864247Zidan 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured intervention at discharge and tailored follow up post discharge in people with Acute Coronary Syndromes, run by Qatar University at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause hospitalizations and cardiac-related hospital readmissions (time frame: 3 months post discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02648243, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.