- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02752997
Reducing 30-day Readmissions in Patients With Heart Failure Through Pharmacist Discharge Medication Services
April 23, 2016 updated by: Sarah Lessard, Mayo Clinic
Patients admitted for heart failure that are provided discharge medication services by a pharmacist are less likely to be readmitted within 30 days of primary admission.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
La Crosse, Wisconsin, United States, 54601
- Mayo Clinic Health System - Franciscan Healthcare
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of heart failure, discharged from any medical service
Exclusion Criteria:
- Unwilling to participate, discharged to nursing/rehab facility, non-English speaking, resident unavailable
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Discharge medication services included:
|
Included in arm descriptions
|
|
No Intervention: Comparator
Current standard of care provided by nursing staff.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients readmitted to the hospital within 30 days of primary heart failure admission
Time Frame: 30 Days
|
Fisher's T-test
|
30 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients who visit the emergency department within 30 days of primary heart failure admission
Time Frame: 30 Days
|
Fisher's T-test
|
30 Days
|
|
Number of medication discrepancies identified and the number of medication discrepancies resolved by the pharmacist at discharge.
Time Frame: 30 Days
|
Fisher's T-test
|
30 Days
|
|
Number of short term goals set by patient's at discharge and the number of short term goals met by patient's at the 7-10 follow up phone call.
Time Frame: 30 days
|
Number of short term goals set will be compared to the number of goals patients achieved, comparison will be calculated by percentage
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah R Lessard, Pharm.D., Mayo Clinic Health System - Franciscan Healthcare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Roger VL. Epidemiology of heart failure. Circ Res. 2013 Aug 30;113(6):646-59. doi: 10.1161/CIRCRESAHA.113.300268.
- Albert NM, Barnason S, Deswal A, Hernandez A, Kociol R, Lee E, Paul S, Ryan CJ, White-Williams C; American Heart Association Complex Cardiovascular Patient and Family Care Committee of the Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Transitions of care in heart failure: a scientific statement from the American Heart Association. Circ Heart Fail. 2015 Mar;8(2):384-409. doi: 10.1161/HHF.0000000000000006. Epub 2015 Jan 20.
- Emmons KM, Rollnick S. Motivational interviewing in health care settings. Opportunities and limitations. Am J Prev Med. 2001 Jan;20(1):68-74. doi: 10.1016/s0749-3797(00)00254-3.
- WRITING COMMITTEE MEMBERS; Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):e240-327. doi: 10.1161/CIR.0b013e31829e8776. Epub 2013 Jun 5. No abstract available.
- Ni H, Xu J. Recent Trends in Heart Failure-related Mortality: United States, 2000-2014. NCHS Data Brief. 2015 Dec;(231):1-8.
- Dharmarajan K, Hsieh AF, Lin Z, Bueno H, Ross JS, Horwitz LI, Barreto-Filho JA, Kim N, Bernheim SM, Suter LG, Drye EE, Krumholz HM. Diagnoses and timing of 30-day readmissions after hospitalization for heart failure, acute myocardial infarction, or pneumonia. JAMA. 2013 Jan 23;309(4):355-63. doi: 10.1001/jama.2012.216476.
- Gianos E, Schoenthaler A, Mushailov M, Fisher EA, Berger JS. Rationale and design of the Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets (IMPACT) trial. Am Heart J. 2015 Sep;170(3):430-7.e9. doi: 10.1016/j.ahj.2015.06.001. Epub 2015 Jun 6.
- Bishop MA, Cohen BA, Billings LK, Thomas EV. Reducing errors through discharge medication reconciliation by pharmacy services. Am J Health Syst Pharm. 2015 Sep 1;72(17 Suppl 2):S120-6. doi: 10.2146/sp150021.
- Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Dis Mon. 2002 Apr;48(4):239-48. doi: 10.1016/s0011-5029(02)90031-3.
- Eggink RN, Lenderink AW, Widdershoven JW, van den Bemt PM. The effect of a clinical pharmacist discharge service on medication discrepancies in patients with heart failure. Pharm World Sci. 2010 Dec;32(6):759-66. doi: 10.1007/s11096-010-9433-6. Epub 2010 Sep 1.
- Farris KB, Carter BL, Xu Y, Dawson JD, Shelsky C, Weetman DB, Kaboli PJ, James PA, Christensen AJ, Brooks JM. Effect of a care transition intervention by pharmacists: an RCT. BMC Health Serv Res. 2014 Sep 18;14:406. doi: 10.1186/1472-6963-14-406.
- Gunadi S, Upfield S, Pham ND, Yea J, Schmiedeberg MB, Stahmer GD. Development of a collaborative transitions-of-care program for heart failure patients. Am J Health Syst Pharm. 2015 Jul 1;72(13):1147-52. doi: 10.2146/ajhp140563.
- Hall MJ, Levant S, DeFrances CJ. Hospitalization for congestive heart failure: United States, 2000-2010. NCHS Data Brief. 2012 Oct;(108):1-8.
- Harrison PL, Hara PA, Pope JE, Young MC, Rula EY. The impact of postdischarge telephonic follow-up on hospital readmissions. Popul Health Manag. 2011 Feb;14(1):27-32. doi: 10.1089/pop.2009.0076. Epub 2010 Nov 19.
- Linden A, Butterworth SW, Prochaska JO. Motivational interviewing-based health coaching as a chronic care intervention. J Eval Clin Pract. 2010 Feb;16(1):166-74. doi: 10.1111/j.1365-2753.2009.01300.x.
- May CS, Russell CS. Health coaching: adding value in healthcare reform. Glob Adv Health Med. 2013 May;2(3):92-4. doi: 10.7453/gahmj.2013.032.
- Warden BA, Freels JP, Furuno JP, Mackay J. Pharmacy-managed program for providing education and discharge instructions for patients with heart failure. Am J Health Syst Pharm. 2014 Jan 15;71(2):134-9. doi: 10.2146/ajhp130103.
- Szkiladz A, Carey K, Ackerbauer K, Heelon M, Friderici J, Kopcza K. Impact of pharmacy student and resident-led discharge counseling on heart failure patients. J Pharm Pract. 2013 Dec;26(6):574-9. doi: 10.1177/0897190013491768.
- Stawnychy M, Masterson Creber R, Riegel B. Using brief motivational interviewing to address the complex needs of a challenging patient with heart failure. J Cardiovasc Nurs. 2014 Sep-Oct;29(5):E1-6. doi: 10.1097/JCN.0000000000000098.
- Sarangarm P, London MS, Snowden SS, Dilworth TJ, Koselke LR, Sanchez CO, D'Angio R, Ray G. Impact of pharmacist discharge medication therapy counseling and disease state education: Pharmacist Assisting at Routine Medical Discharge (project PhARMD). Am J Med Qual. 2013 Jul-Aug;28(4):292-300. doi: 10.1177/1062860612461169. Epub 2012 Oct 2.
- Salvo MC, Cannon-Breland ML. Motivational interviewing for medication adherence. J Am Pharm Assoc (2003). 2015 Jul-Aug;55(4):e354-61; quiz e362-3. doi: 10.1331/JAPhA.2015.15532.
- Salas CM, Miyares MA. Implementing a pharmacy resident run transition of care service for heart failure patients: Effect on readmission rates. Am J Health Syst Pharm. 2015 Jun 1;72(11 Suppl 1):S43-7. doi: 10.2146/sp150012.
- Wang H, Robinson RD, Johnson C, Zenarosa NR, Jayswal RD, Keithley J, Delaney KA. Using the LACE index to predict hospital readmissions in congestive heart failure patients. BMC Cardiovasc Disord. 2014 Aug 7;14:97. doi: 10.1186/1471-2261-14-97.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
April 14, 2016
First Submitted That Met QC Criteria
April 23, 2016
First Posted (Estimate)
April 27, 2016
Study Record Updates
Last Update Posted (Estimate)
April 27, 2016
Last Update Submitted That Met QC Criteria
April 23, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-008286
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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