Medication Adherence & Literacy to Predict ReadmissionNCT02031406
Impact of Pharmacist Post-discharge Phone Calls on Hospital Readmission and Patient Medication Literacy and Adherence
A study testing Post-discharge counseling on medication adherence & literacy in people with Medication Adherence & Literacy to Predict Readmission and Post-discharge Pharmacist Counseling to Prevent Readmissions, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
A significant portion of avoidable healthcare expenditures has been attributed to preventable hospital readmissions; thus, reducing hospital readmission rates has become a national healthcare agenda item. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence & Literacy to Predict Readmission, Post-discharge Pharmacist Counseling to Prevent Readmissions
- What is being tested?
- Post-discharge counseling on medication adherence & literacy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jul 2014
- 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
- ≥10 chronic prescription medications On anticoagulants Diagnosis of CHF, AMI On narrow therapeutic index drugs E.g. valproic acid, phenytoin, lithium, digoxin History of transplant AND not admitted by transplant team
Who cannot join
- Trauma patients Pediatric patients History of transplant and admitted to the transplant team Patients admitted from or discharged to a SNF or hospice Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 91604
About this study
A significant portion of avoidable healthcare expenditures has been attributed to preventable hospital readmissions; thus, reducing hospital readmission rates has become a national healthcare agenda item. Despite much study of this topic, efforts to date have not been especially fruitful in either predicting which patients will require hospital readmission. Preventing readmissions has been even more difficult.
We recently examined a pharmacist intervention that assessed patients' medication literacy and adherence at hospital admission. In this retrospective data, low medication adherence levels were predictive of hospital readmission. There was a non-significant trend between low medication literacy and increased hospital readmissions.
Read more
We have now decided to prospectively study this intervention. Prospective study will allow for several improvements on our prior work.
- We have consulted the literature to more carefully examine existing instruments to measure medication adherence and literacy. Based on this review, and based on our prior results, we have made adjustments to these instruments which should improve reliability, validity, and granularity.
- In our retrospective work, our intervention of pharmacist counseling was not randomized. Although there were large differences in readmission rates between the patients selected to receive counseling and those who were not thought to require it, there may have been unmeasured confounding variables. Randomizing this intervention will greatly enhance the likelihood that we are comparing two similar groups of patients.
- Conditions
- Medication Adherence & Literacy to Predict Readmission, Post-discharge Pharmacist Counseling to Prevent Readmissions
- Being tested
- Post-discharge counseling on medication adherence & literacy
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-discharge counseling on medication adherence & literacyOther
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | No extra post-discharge pharmacist counseling is explicitly provided to patients, although some patients may receive it depending on their care setting |
| Post-discharge pharmacist counseling | Experimental | Patients will receive post-discharge telephonic pharmacist counseling at around 72 hours after hospital discharge. Receives: Other: Post-discharge counseling on medication adherence & literacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmissions
Measured: 30 days
Secondary outcomes (2)
Medication Adherence
Using the Morisky Medication Adherence Scale
Measured: 30 days after discharge
Medication Literacy
Using a novel measure of medication literacy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
- Study completionJul 2014
Why it stopped: Trial initiated, but data collection was inadequate. Analysis was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Adherence & Literacy to Predict ReadmissionStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Josh Pevnick, Cedars-Sinai Medical Center
- Investigators
- Josh Pevnick, MD, MSHS, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031406
- Sponsor's protocol ID
- KL2TR000122-00034358
- Other IDs
- KL2TR000122
- Status last verified
- Jan 2018
- First submitted
- 7 Jan 2014
- Last updated
- 25 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pharmacist Post-discharge Phone Calls on Hospital Readmission and Patient Medication Literacy and Adherence
- ClinicalTrials.gov ID
- NCT02031406
- Acronym / sponsor ID
- KL2TR000122-00034358
- Conditions
- Medication Adherence & Literacy to Predict Readmission, Post-discharge Pharmacist Counseling to Prevent Readmissions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial initiated, but data collection was inadequate. Analysis was terminated.
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 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.
A significant portion of avoidable healthcare expenditures has been attributed to preventable hospital readmissions; thus, reducing hospital readmission rates has become a national healthcare agenda item. Despite much study of this topic, efforts to date have not been especially fruitful in either predicting which patients will require hospital readmission. Preventing readmissions has been even more difficult.
We recently examined a pharmacist intervention that assessed patients' medication literacy and adherence at hospital admission. In this retrospective data, low medication adherence levels were predictive of hospital readmission. There was a non-significant trend between low medication literacy and increased hospital readmissions.
We have now decided to prospectively study this intervention. Prospective study will allow for several improvements on our prior work.
- We have consulted the literature to more carefully examine existing instruments to measure medication adherence and literacy. Based on this review, and based on our prior results, we have made adjustments to these instruments which should improve reliability, validity, and granularity.
- In our retrospective work, our intervention of pharmacist counseling was not randomized. Although there were large differences in readmission rates between the patients selected to receive counseling and those who were not thought to require it, there may have been unmeasured confounding variables. Randomizing this intervention will greatly enhance the likelihood that we are comparing two similar groups of patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –No extra post-discharge pharmacist counseling is explicitly provided to patients, although some patients may receive it depending on their care setting |
| Post-discharge pharmacist counseling | Experimental | Other: Post-discharge counseling on medication adherence & literacyPatients will receive post-discharge telephonic pharmacist counseling at around 72 hours after hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥10 chronic prescription medications On anticoagulants Diagnosis of CHF, AMI On narrow therapeutic index drugs E.g. valproic acid, phenytoin, lithium, digoxin History of transplant AND not admitted by transplant team
Key exclusion criteria (1 listed)
- Trauma patients Pediatric patients History of transplant and admitted to the transplant team Patients admitted from or discharged to a SNF or hospice Non-English speaking 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 |
|---|---|---|
| Post-discharge counseling on medication adherence & literacy | Other | Post-discharge pharmacist counseling |
Primary outcome
Readmissions
Time frame: 30 days
2 secondary outcomes
Medication Adherence
Time frame: 30 days after discharge
Medication Literacy
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Trial initiated, but data collection was inadequate. Analysis was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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.
Josh Pevnick, MD, MSHS principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-discharge counseling on medication adherence & literacy in people with Medication Adherence & Literacy to Predict Readmission and Post-discharge Pharmacist Counseling to Prevent Readmissions, run by Cedars-Sinai Medical Center 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 1 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: stopped early, as of the sponsor's last update on 25 Jan 2018. 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 was stopped early (reason given: Trial initiated, but data collection was inadequate. Analysis was terminated.). 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?
Readmissions (time frame: 30 days). 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 25 Jan 2018.