Pulmonary Disease, Chronic ObstructivePhase 2/3NCT02047448
Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model
A Phase 2/3 study testing Pharmacist Counseling in people with Pulmonary Disease, Chronic Obstructive and Heart Failure, run by Wilkes University at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine if medication adherence is improved by a transitional care pharmacy practice model designed to integrate hospital and community pharmacists in the care and education of patients with heart failure or COPD who are discharged from a community hospital to home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Heart Failure
- What is being tested?
- Pharmacist Counseling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 28 Apr 2017
- Phase
- Phase 2/3
- 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
- admitted to hospital with a primary or secondary diagnosis of heart failure or COPD
- anticipated eventual discharge to home
- agreeable to participate in monthly counseling sessions (if randomized to intervention group) from a participating community pharmacist
Who cannot join
- presence of cognitive impairment or dementia that would significantly prevent effective patient education and counseling
- non English-speaking
- anticipated discharge to a long-term care or skilled nursing facility on a permanent basis
- permanent long-term care facility residents
- surgical patients
- hospice patients
- patients who die within 30 days of initial study hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study is to determine if medication adherence is improved by a transitional care pharmacy practice model designed to integrate hospital and community pharmacists in the care and education of patients with heart failure or COPD who are discharged from a community hospital to home. The hospital and community pharmacists will collaborate with each other, the patient, and other practitioners including the primary care physician, nurse, and case manager to prevent and correct medication-related problems and attempt to improve patient outcomes especially during the error-prone transition from hospital to home.
- Being tested
- Pharmacist Counseling
- Keywords
- transition of care, care transitions, readmission, medication, adherence, medication management, medication reconciliation, patient counseling, pharmacist
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist CounselingProcedure or surgery
The hospital pharmacist will meet with the patient and complete medication reconciliation, assess the patient's understanding of the medications, and identify medication-related problems. The hospital pharmacist will complete a pharmacist discharge care plan and a copy will be sent to the participating community pharmacist. The patients will be scheduled for the first meeting with their community pharmacist within 1 week of hospital discharge. The community pharmacist will interview the patient about their general health and any current symptoms of heart failure or COPD, identify any additional medication-related problems, follow-up on any issues as described in the pharmacist discharge care plan, and provide patient education. The patients will then meet with their community pharmacist for counseling and patient education at monthly intervals for 6 months following hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will receive the current standard of care including medication reconciliation during hospitalization performed by a nurse or physician and education about discharge medications provided by the inpatient nurse. There will not be a pharmacist discharge care plan developed for this group. The patients will not be required to choose a participating community pharmacist and no counseling and education appointments will be scheduled. Any medication-related problems identified by the pharmacists and will be communicated as appropriate and resolved as is the standard of care. Any other interaction between the patient and their pharmacist will be according to the current standard of care. |
| Pharmacist Counseling | Experimental | The hospital pharmacist will meet with the patient and complete medication reconciliation, assess the patient's understanding of the medications, and identify medication-related problems. The hospital pharmacist will complete a pharmacist discharge care plan and a copy will be sent to the participating community pharmacist. The patients will be scheduled for the first meeting with their community pharmacist within 1 week of hospital discharge. The community pharmacist will interview the patient about their general health and any current symptoms of heart failure or COPD, identify any additional medication-related problems, follow-up on any issues as described in the pharmacist discharge care plan, and provide patient education. The patients will then meet with their community pharmacist for counseling and patient education at monthly intervals for 6 months following hospital discharge. Receives: Procedure: Pharmacist Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
The primary endpoint will be medication adherence as measured by the Proportion of Days Covered (PDC) calculation. This is calculated by dividing the total days' supply dispensed by 180 days. Medications considered in this calculation will include those used for the treatment of heart failure or COPD and known to improve outcomes. The composite PDC will be an average of the individual PDC for each drug class.
Measured: 6 months
Secondary outcomes (3)
Medication related problems
Actual or potential medication-related problems (MRP) that are identified by the hospital and participating community pharmacists will be categorized based on an MRP classification tool.
Measured: 6 months
Patient Satisfaction
The Care Transitions Measure (CTM-3) is a validated survey to assess the patient's satisfaction with the quality of transitional care during hospitalization and will be completed by the patient following hospital discharge. The patient's satisfaction with the services provided by the community pharmacies will be assessed with the Consumer Experience with Pharmacy Services survey (© Pharmacy Quality Alliance).
Measured: 6 months
Hospital readmissions or ED visits
Hospital readmissions are defined as an unplanned and overnight admission to the hospital
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2014
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilkes University
- Sponsor type
- University, hospital or other
- Collaborators
- Moses Taylor Hospital Foundation, Commonwealth Health, Community Pharmacy Foundation
- Responsible party
- Principal investigator, Judith L. Kristeller, Wilkes University
- Investigators
- Judith Kristeller, PharmD, Principal investigator, Wilkes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047448
- Sponsor's protocol ID
- CPF
- Status last verified
- Apr 2017
- First submitted
- 24 Jan 2014
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model
- ClinicalTrials.gov ID
- NCT02047448
- Acronym / sponsor ID
- CPF
- Keywords
- transition of care, care transitions, readmission, medication, adherence, medication management, medication reconciliation, patient counseling
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Wilkes UniversityUniversity, hospital or other
- Collaborators
- Moses Taylor Hospital Foundation, Commonwealth Health, Community Pharmacy Foundation
- Study start
- Jan 2014
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 28 Jan 2014 (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.
The purpose of this pilot study is to determine if medication adherence is improved by a transitional care pharmacy practice model designed to integrate hospital and community pharmacists in the care and education of patients with heart failure or COPD who are discharged from a community hospital to home. The hospital and community pharmacists will collaborate with each other, the patient, and other practitioners including the primary care physician, nurse, and case manager to prevent and correct medication-related problems and attempt to improve patient outcomes especially during the error-prone transition from hospital to home.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will receive the current standard of care including medication reconciliation during hospitalization performed by a nurse or physician and education about discharge medications provided by the inpatient nurse. There will not be a pharmacist discharge care plan developed for this group. The patients will not be required to choose a participating community pharmacist and no counseling and education appointments will be scheduled. Any medication-related problems identified by the pharmacists and will be communicated as appropriate and resolved as is the standard of care. Any other interaction between the patient and their pharmacist will be according to the current standard of care. |
| Pharmacist Counseling | Experimental | Procedure: Pharmacist CounselingThe hospital pharmacist will meet with the patient and complete medication reconciliation, assess the patient's understanding of the medications, and identify medication-related problems. The hospital pharmacist will complete a pharmacist discharge care plan and a copy will be sent to the participating community pharmacist. The patients will be scheduled for the first meeting with their community pharmacist within 1 week of hospital discharge. The community pharmacist will interview the patient about their general health and any current symptoms of heart failure or COPD, identify any additional medication-related problems, follow-up on any issues as described in the pharmacist discharge care plan, and provide patient education. The patients will then meet with their community pharmacist for counseling and patient education at monthly intervals for 6 months following hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- admitted to hospital with a primary or secondary diagnosis of heart failure or COPD
- anticipated eventual discharge to home
- agreeable to participate in monthly counseling sessions (if randomized to intervention group) from a participating community pharmacist
Key exclusion criteria (7 listed)
- presence of cognitive impairment or dementia that would significantly prevent effective patient education and counseling
- non English-speaking
- anticipated discharge to a long-term care or skilled nursing facility on a permanent basis
- permanent long-term care facility residents
- surgical patients
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 CounselingThe hospital pharmacist will meet with the patient and complete medication reconciliation, assess the patient's understanding of the medications, and identify medication-related problems. The hospital pharmacist will complete a pharmacist discharge care plan and a copy will be sent to the participating community pharmacist. The patients will be scheduled for the first meeting with their community pharmacist within 1 week of hospital discharge. The community pharmacist will interview the patient about their general health and any current symptoms of heart failure or COPD, identify any additional medication-related problems, follow-up on any issues as described in the pharmacist discharge care plan, and provide patient education. The patients will then meet with their community pharmacist for counseling and patient education at monthly intervals for 6 months following hospital discharge. | Procedure or surgery | Pharmacist Counseling |
Primary outcome
Medication Adherence
Time frame: 6 months
The primary endpoint will be medication adherence as measured by the Proportion of Days Covered (PDC) calculation. This is calculated by dividing the total days' supply dispensed by 180 days. Medications considered in this calculation will include those used for the treatment of heart failure or COPD and known to improve outcomes. The composite PDC will be an average of the individual PDC for each drug class.
3 secondary outcomes
Medication related problems
Time frame: 6 months
Patient Satisfaction
Time frame: 6 months
Hospital readmissions or ED visits
Time frame: 6 months
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 2 May 2017.
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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.
Judith Kristeller, PharmD principal investigator
Wilkes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pharmacist Counseling in people with Pulmonary Disease, Chronic Obstructive and Heart Failure, run by Wilkes University at 1 site in United States.
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 7 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 2 May 2017. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Medication Adherence (time frame: 6 months). 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 2 May 2017.