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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02752997
Other study ID # 15-008286
Secondary ID
Status Completed
Phase N/A
First received April 14, 2016
Last updated April 23, 2016
Start date December 2015
Est. completion date March 2016

Study information

Verified date April 2016
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Pharmacist discharge medication services
Included in arm descriptions

Locations

Country Name City State
United States Mayo Clinic Health System - Franciscan Healthcare La Crosse Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (23)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Emmons KM, Rollnick S. Motivational interviewing in health care settings. Opportunities and limitations. Am J Prev Med. 2001 Jan;20(1):68-74. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hall MJ, Levant S, DeFrances CJ. Hospitalization for congestive heart failure: United States, 2000-2010. NCHS Data Brief. 2012 Oct;(108):1-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ni H, Xu J. Recent Trends in Heart Failure-related Mortality: United States, 2000-2014. NCHS Data Brief. 2015 Dec;(231):1-8. — View Citation

Roger VL. Epidemiology of heart failure. Circ Res. 2013 Aug 30;113(6):646-59. doi: 10.1161/CIRCRESAHA.113.300268. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients readmitted to the hospital within 30 days of primary heart failure admission Fisher's T-test 30 Days No
Secondary Number of patients who visit the emergency department within 30 days of primary heart failure admission Fisher's T-test 30 Days No
Secondary Number of medication discrepancies identified and the number of medication discrepancies resolved by the pharmacist at discharge. Fisher's T-test 30 Days No
Secondary 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. Number of short term goals set will be compared to the number of goals patients achieved, comparison will be calculated by percentage 30 days No
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