Medication AdherenceNCT01351441
Minimizing Risk and Maximizing Outcomes in Geriatric Patients Through Integrated Clinical Pharmacy Services in an Innovative Model of Community Practice
A study testing Medication adherence consultation, Medication problems assessment and Beer's Criteria Assessment in people with Medication Adherence and Health Literacy, run by VascuScript Pharmacy at 1 site in United States.
Trial summary
It has been shown that patients can improve their safety through informed choice, safe medication use, and complication reporting. This includes not only the potential problems that occur from prescription medication use but also issues that may arise through the improper use of over-the-counter medications. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence, Health Literacy, Geriatric Patient Care Improvement
- What is being tested?
- Medication adherence consultation, Medication problems assessment and Beer's Criteria Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Nov 2012
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients who are at least 65 years of age
- Have at least 5 medications that they take on a chronic basis
- Willing to have their prescriptions filled by VascuScript Pharmacy
- Understand the terms of the informed consent
Who cannot join
- Any patient who does not meet the requirements of the Inclusion Criteria
Trial locations and contacts
1 site in 1 country.
About this study
It has been shown that patients can improve their safety through informed choice, safe medication use, and complication reporting. This includes not only the potential problems that occur from prescription medication use but also issues that may arise through the improper use of over-the-counter medications. The willingness of a patient to take on safety action is known to be complicated by an unwillingness to behave in a manner that might challenge a physician's judgment or actions. Community pharmacists are in the unique position to provide perspective on the physician's recommendation and act as an advocate to facilitate necessary change. Through supportive and repeated interaction with their community pharmacist patients will develop assertiveness toward their own health care, an increased frequency and quality of interaction with their physician, and thus a minimized risk of harm and maximized opportunity to optimize clinical outcomes.
Read the detailed description
This is a single center, observational study to determine if geriatric patients who are on five or more chronic medications will have a difference in clinical, humanistic, and/or economic outcome through an integrated clinical pharmacy service intervention. The primary efficacy objective will be assessed through a single cohort, paired research design measuring the change from baseline in the adherence rate, number of medication related problems, and Beers criteria medications. The primary economic objective will be assessed through prescription revenue to validate the employment of a 0.5-1.0 Full-time equivalent (FTE). Secondary efficacy objectives will be assessed through a single cohort, paired research design measuring the change from baseline in the health literacy, optimization in the anthropometrics, and health related quality of life (HRQOL).
- Conditions
- Medication Adherence, Health Literacy, Geriatric Patient Care Improvement, Pharmacy Economic Improvement
- Being tested
- Medication adherence consultation, Medication problems assessment, Beer's Criteria Assessment, Health Literacy Assessment
- Keywords
- Geriatric, Pharmacoeconomics, Health Literacy, Adherence
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication adherence consultationBehavioural
Patients will be counseled in person on day 0 then telephonically every month after until day 365.
Medication problems assessmentOther
Patients will be asked if they are having any issues that may be attributable to their current drug therapy on a monthly basis. Any issue that is identified will be addressed by the pharmacist.
Beer's Criteria AssessmentOther
The patient's drug therapy will be reviewed for Beer's criteria medications and possible alternatives will be addressed by the pharmacist if deemed appropriate.
Health Literacy AssessmentBehavioural
Patients will be given a Health Literacy Assessment on day 0 and day 365 using the Realm-SF.
| Study group | Role | What they receive |
|---|---|---|
| Age 65 years or over AND at least 5 chronic medications | Other | Not described Receives: Behavioral: Medication adherence consultation; Other: Medication problems assessment; Other: Beer's Criteria Assessment; Behavioral: Health Literacy Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
To determine if an integrated clinical pharmacy service program in geriatric patients can maintain a medication adherence rate ≥80%.
Measured: Every 30 days for 12 months
Medication related problems
To determine if an integrated clinical pharmacy service program in geriatric patients can reduce the number of medication related problems by ≥10%.
Measured: Every 30 days for 12 months
Beers criteria medications
To determine if an integrated clinical pharmacy service program in geriatric patients can reduce the number of Beers criteria medications by ≥10%.
Measured: Every month for 12 months
Economic impact
To determine the number of patients required to validate a part-time or full-time pharmacist to perform the required clinical functions of the clinical pharmacy service geriatric program.
Measured: 12 months
Secondary outcomes (3)
Health literacy
To determine if an integrated clinical pharmacy service program in geriatric patients can improve health literacy as evidenced by the REALM-SF.
Measured: 12 months
Optimizing Anthropometrics
To determine if an integrated clinical pharmacy service program in geriatric patients can demonstrate ≥10% improvement and/or greater optimization of patient weight, blood pressure, cholesterol, and blood glucose (if applicable).
Measured: 12 months
Quality of Life
To determine if an integrated clinical pharmacy service program in geriatric patients can improve quality of life as evidenced by the CDC HRQOL Healthy Days Core Module.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VascuScript Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Community Pharmacy Foundation
- Responsible party
- Principal investigator, Scott V. Monte, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351441
- Sponsor's protocol ID
- PHP1140411E
- Status last verified
- Jun 2020
- First submitted
- 9 May 2011
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Risk and Maximizing Outcomes in Geriatric Patients Through Integrated Clinical Pharmacy Services in an Innovative Model of Community Practice
- ClinicalTrials.gov ID
- NCT01351441
- Acronym / sponsor ID
- PHP1140411E
- Conditions
- Medication Adherence, Health Literacy, Geriatric Patient Care Improvement, Pharmacy Economic Improvement
- Keywords
- Geriatric, Pharmacoeconomics, Health Literacy, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VascuScript PharmacyUniversity, hospital or other
- Collaborators
- Community Pharmacy Foundation
- Study start
- May 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 May 2011 (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.
It has been shown that patients can improve their safety through informed choice, safe medication use, and complication reporting. This includes not only the potential problems that occur from prescription medication use but also issues that may arise through the improper use of over-the-counter medications. The willingness of a patient to take on safety action is known to be complicated by an unwillingness to behave in a manner that might challenge a physician's judgment or actions. Community pharmacists are in the unique position to provide perspective on the physician's recommendation and act as an advocate to facilitate necessary change. Through supportive and repeated interaction with their community pharmacist patients will develop assertiveness toward their own health care, an increased frequency and quality of interaction with their physician, and thus a minimized risk of harm and maximized opportunity to optimize clinical outcomes.
Detailed description
This is a single center, observational study to determine if geriatric patients who are on five or more chronic medications will have a difference in clinical, humanistic, and/or economic outcome through an integrated clinical pharmacy service intervention. The primary efficacy objective will be assessed through a single cohort, paired research design measuring the change from baseline in the adherence rate, number of medication related problems, and Beers criteria medications. The primary economic objective will be assessed through prescription revenue to validate the employment of a 0.5-1.0 Full-time equivalent (FTE). Secondary efficacy objectives will be assessed through a single cohort, paired research design measuring the change from baseline in the health literacy, optimization in the anthropometrics, and health related quality of life (HRQOL).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age 65 years or over AND at least 5 chronic medications | Other | Behavioral: Medication adherence consultation, Other: Medication problems assessment, Other: Beer's Criteria Assessment, Behavioral: Health Literacy Assessment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients who are at least 65 years of age
- Have at least 5 medications that they take on a chronic basis
- Willing to have their prescriptions filled by VascuScript Pharmacy
- Understand the terms of the informed consent
Key exclusion criteria (1 listed)
- Any patient who does not meet the requirements of the Inclusion Criteria
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 |
|---|---|---|
| Medication adherence consultationPatients will be counseled in person on day 0 then telephonically every month after until day 365. | Behavioural | Age 65 years or over AND at least 5 chronic medications |
| Medication problems assessmentPatients will be asked if they are having any issues that may be attributable to their current drug therapy on a monthly basis. Any issue that is identified will be addressed by the pharmacist. | Other | Age 65 years or over AND at least 5 chronic medications |
| Beer's Criteria AssessmentThe patient's drug therapy will be reviewed for Beer's criteria medications and possible alternatives will be addressed by the pharmacist if deemed appropriate. | Other | Age 65 years or over AND at least 5 chronic medications |
| Health Literacy AssessmentPatients will be given a Health Literacy Assessment on day 0 and day 365 using the Realm-SF. | Behavioural | Age 65 years or over AND at least 5 chronic medications |
Primary outcome
Medication adherence
Time frame: Every 30 days for 12 months
To determine if an integrated clinical pharmacy service program in geriatric patients can maintain a medication adherence rate ≥80%.
Medication related problems
Time frame: Every 30 days for 12 months
To determine if an integrated clinical pharmacy service program in geriatric patients can reduce the number of medication related problems by ≥10%.
Beers criteria medications
Time frame: Every month for 12 months
To determine if an integrated clinical pharmacy service program in geriatric patients can reduce the number of Beers criteria medications by ≥10%.
Economic impact
Time frame: 12 months
To determine the number of patients required to validate a part-time or full-time pharmacist to perform the required clinical functions of the clinical pharmacy service geriatric program.
3 secondary outcomes
Health literacy
Time frame: 12 months
Optimizing Anthropometrics
Time frame: 12 months
Quality of Life
Time frame: 12 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 4 Jun 2020.
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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 Medication adherence consultation, Medication problems assessment and Beer's Criteria Assessment in people with Medication Adherence and Health Literacy, run by VascuScript Pharmacy 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 4 inclusion and 1 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 4 Jun 2020. 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.
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: Every 30 days for 12 months). The study lists 4 primary outcomes in all. 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 4 Jun 2020.