Chronic DiseaseNCT02888782
Optimizing Medication Therapy for Patients Recently Discharged From Hospital
A study testing Pharmacist Consultation in people with Chronic Disease, run by Memorial University of Newfoundland at 2 sites in Canada.
Trial summary
Patients who are discharged from hospital can be overwhelmed when they suddenly have to manage new conditions or medications. These changes can be particularly difficult for people on many medications or with multiple health conditions. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Pharmacist Consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 2 sitesCanada
- Study dates
- 8 Dec 2016to 29 Jun 2018
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years of age or older
- Admitted to a General Medicine ward
- Take 5 or more chronic medications
Who cannot join
- Discharge to a long term care facility
- Life expectancy less than 3 months
- Have entered palliative care
- Cognitive impairment (unless a responsible caregiver can provide consent and assist in participation)
- Non-English speaking
- Unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Health Sciences Center
St. John's, Newfoundland and Labrador
St. Clares Mercy Hospital
St. John's, Newfoundland and Labrador
About this study
Official title: Optimizing Medication Therapy Outcomes for Complex Patients Transitioning From Acute to Primary Care
Patients who are discharged from hospital can be overwhelmed when they suddenly have to manage new conditions or medications. These changes can be particularly difficult for people on many medications or with multiple health conditions. There is a real risk that this will lead to emergency room visits, hospital readmission, and even death. In addition to endangering patients, these adverse events are very costly to the healthcare system. The good news is that these events can be preventable if patients receive care that is better coordinated.
Patient-oriented research will be conducted to determine if a pharmacist-led medication therapy management service can improve health outcomes of 'medically complex' patients transitioning from acute to primary care in Newfoundland and Labrador (NL). This a more comprehensive service than their community pharmacist would normally provide. The program will use a new Pharmacist Clinic service to provide care and support which does not currently exist for patients in NL after they leave hospital. After discharge, patients will be randomly divided into two groups: one group will receive care as usual from their doctor; the other group will have their medications assessed by a clinic pharmacist within one week of hospital discharge along with their usual care from their doctor. The two groups will be compared to determine whether specialized pharmacist services after hospital discharge is satisfactory to patients/providers, improves patient health, and reduces emergency room visits, hospital readmissions, and repeat trips to the doctor. If successful, this project will help ensure that patients are taking the right medications in the right way, improving individual health and making better use of healthcare system resources.
- Conditions
- Chronic Disease
- Being tested
- Pharmacist Consultation
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist ConsultationOther
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Consultation | Experimental | Meet with pharmacist for consultation in addition to regular physician follow up Receives: Other: Pharmacist Consultation |
| Control | No intervention | Receive regular physician follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Hospital Utilization Rate
A composite score of hospital readmission rate and ER visits
Measured: 30 days post discharge
Secondary outcomes (12)
Number of Emergency Room Visits
Measured: 30 days post discharge
Number of Emergency Room Visits
Measured: 60 days post discharge
Number of Emergency Room Visits
Measured: 90 days post discharge
Rehospitalization Rate
Measured: 30 days post discharge
Rehospitalization Rate
Measured: 60 days post discharge
Rehospitalization Rate
Measured: 90 days post discharge
Mortality Rate
Measured: 30 days post discharge
Mortality Rate
Measured: 60 days post discharge
Mortality Rate
Measured: 90 days post discharge
Frequency of Family Physician Visits
Measured: 30 days post discharge
Frequency of Family Physician Visits
Measured: 60 days post discharge
Frequency of Family Physician Visits
Measured: 90 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start8 Dec 2016
- Primary completion30 Apr 2018
- Study completion29 Jun 2018
Why it stopped: Program Restructured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Kelly, Memorial University of Newfoundland
- Investigators
- Deborah Kelly, PharmD, Principal investigator, Memorial Univeristy of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888782
- Sponsor's protocol ID
- HREB-2016.221
- Status last verified
- Oct 2018
- First submitted
- 25 Aug 2016
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Medication Therapy Outcomes for Complex Patients Transitioning From Acute to Primary Care
- ClinicalTrials.gov ID
- NCT02888782
- Acronym / sponsor ID
- HREB-2016.221
- Conditions
- Chronic Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Program Restructured
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 5 Sep 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.
Patients who are discharged from hospital can be overwhelmed when they suddenly have to manage new conditions or medications. These changes can be particularly difficult for people on many medications or with multiple health conditions. There is a real risk that this will lead to emergency room visits, hospital readmission, and even death. In addition to endangering patients, these adverse events are very costly to the healthcare system. The good news is that these events can be preventable if patients receive care that is better coordinated.
Patient-oriented research will be conducted to determine if a pharmacist-led medication therapy management service can improve health outcomes of 'medically complex' patients transitioning from acute to primary care in Newfoundland and Labrador (NL). This a more comprehensive service than their community pharmacist would normally provide. The program will use a new Pharmacist Clinic service to provide care and support which does not currently exist for patients in NL after they leave hospital. After discharge, patients will be randomly divided into two groups: one group will receive care as usual from their doctor; the other group will have their medications assessed by a clinic pharmacist within one week of hospital discharge along with their usual care from their doctor. The two groups will be compared to determine whether specialized pharmacist services after hospital discharge is satisfactory to patients/providers, improves patient health, and reduces emergency room visits, hospital readmissions, and repeat trips to the doctor. If successful, this project will help ensure that patients are taking the right medications in the right way, improving individual health and making better use of healthcare system resources.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Consultation | Experimental | Other: Pharmacist ConsultationMeet with pharmacist for consultation in addition to regular physician follow up |
| Control | No intervention | –Receive regular physician follow up |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50 years of age or older
- Admitted to a General Medicine ward
- Take 5 or more chronic medications
Key exclusion criteria (6 listed)
- Discharge to a long term care facility
- Life expectancy less than 3 months
- Have entered palliative care
- Cognitive impairment (unless a responsible caregiver can provide consent and assist in participation)
- Non-English speaking
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 |
|---|---|---|
| Pharmacist Consultation | Other | Pharmacist Consultation |
Primary outcome
Composite Hospital Utilization Rate
Time frame: 30 days post discharge
A composite score of hospital readmission rate and ER visits
12 secondary outcomes
Number of Emergency Room Visits
Time frame: 30 days post discharge
Number of Emergency Room Visits
Time frame: 60 days post discharge
Number of Emergency Room Visits
Time frame: 90 days post discharge
Rehospitalization Rate
Time frame: 30 days post discharge
Rehospitalization Rate
Time frame: 60 days post discharge
Rehospitalization Rate
Time frame: 90 days post discharge
Mortality Rate
Time frame: 30 days post discharge
Mortality Rate
Time frame: 60 days post discharge
Mortality Rate
Time frame: 90 days post discharge
Frequency of Family Physician Visits
Time frame: 30 days post discharge
Frequency of Family Physician Visits
Time frame: 60 days post discharge
Frequency of Family Physician Visits
Time frame: 90 days post discharge
Results and safety
The study was stopped early (reason given: Program Restructured). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Deborah Kelly, PharmD principal investigator
Memorial Univeristy of Newfoundland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist Consultation in people with Chronic Disease, run by Memorial University of Newfoundland at 2 sites in Canada.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 was stopped early (reason given: Program Restructured). Results are not available in the source record.
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?
Composite Hospital Utilization Rate (time frame: 30 days post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2018.