Impact of Pharmacist Post-discharge Phone Calls on Hospit... | NCT02031406

Studies
Impact of Pharmacist Post-discharge Phone Calls on Hospital Readmission and Patient Medication Literacy and Adherence

NCT02031406

Sponsor

Cedars-Sinai Medical Center

Status

Terminated

Last Update Posted

Jan 25, 2018Actual

Enrollment

155Actual

Phase

Not Applicable

Conditions

Medication Adherence & Literacy to Predict Readmission
Post-discharge Pharmacist Counseling to Prevent Readmissions

Interventions

Post-discharge counseling on medication adherence & literacy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
KL2TR000122	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Trial initiated, but data collection was inadequate. Analysis was terminated.

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Feb 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jan 7, 2014

First Submission Date that Met QC Criteria

Jan 7, 2014

First Posted Date

Jan 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2018

Last Update Posted Date

Jan 25, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Josh Pevnick, Assistant Professor, Cedars-Sinai Medical CenterPrincipal Investigator

Lead Sponsor

Cedars-Sinai Medical CenterOTHER

Collaborators

Name	Class
National Center for Advancing Translational Sciences (NCATS)	NIH

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

155Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: Post-discharge counseling on medication adherence & literacy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Post-discharge counseling on medication adherence & literacy	Other		Post-discharge pharmacist counseling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Readmissions		30 days

Secondary Outcomes

Measure	Description	Time Frame
Medication Adherence	Using the Morisky Medication Adherence Scale	30 days after discharge
Medication Literacy	Using a novel measure of medication literacy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Josh Pevnick, MD, MSHS	Cedars-Sinai Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center		Los Angeles	California	91604	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010349	Patient Compliance
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior