NCT02752997

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

April 14, 2016

Last Update Submit

April 23, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients readmitted to the hospital within 30 days of primary heart failure admission

    Fisher's T-test

    30 Days

Secondary Outcomes (3)

  • Number of patients who visit the emergency department within 30 days of primary heart failure admission

    30 Days

  • Number of medication discrepancies identified and the number of medication discrepancies resolved by the pharmacist at discharge.

    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.

    30 days

Study Arms (2)

Intervention

EXPERIMENTAL

Discharge medication services included: * Discharge medication reconciliation * Identification of medication discrepancies and resolution * Medication counseling using health coaching techniques with short term goal setting and follow up phone call

Other: Pharmacist discharge medication services

Comparator

NO INTERVENTION

Current standard of care provided by nursing staff.

Interventions

Included in arm descriptions

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of heart failure, discharged from any medical service

You may not qualify if:

  • Unwilling to participate, discharged to nursing/rehab facility, non-English speaking, resident unavailable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Health System - Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (23)

  • 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.

    PMID: 26272892BACKGROUND
  • 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.

    PMID: 23340637BACKGROUND
  • 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.

    PMID: 12021756BACKGROUND
  • 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.

    PMID: 11137778BACKGROUND
  • 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.

    PMID: 20809276BACKGROUND
  • 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.

    PMID: 25234932BACKGROUND
  • 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.

    PMID: 26385025BACKGROUND
  • 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.

    PMID: 26092965BACKGROUND
  • Hall MJ, Levant S, DeFrances CJ. Hospitalization for congestive heart failure: United States, 2000-2010. NCHS Data Brief. 2012 Oct;(108):1-8.

    PMID: 23102190BACKGROUND
  • 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.

    PMID: 21090991BACKGROUND
  • 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.

    PMID: 20367828BACKGROUND
  • 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.

    PMID: 24416677BACKGROUND
  • Ni H, Xu J. Recent Trends in Heart Failure-related Mortality: United States, 2000-2014. NCHS Data Brief. 2015 Dec;(231):1-8.

    PMID: 26727546BACKGROUND
  • Roger VL. Epidemiology of heart failure. Circ Res. 2013 Aug 30;113(6):646-59. doi: 10.1161/CIRCRESAHA.113.300268.

    PMID: 23989710BACKGROUND
  • 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.

    PMID: 23741058BACKGROUND
  • 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.

    PMID: 24375606BACKGROUND
  • 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.

    PMID: 23797199BACKGROUND
  • 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.

    PMID: 24231890BACKGROUND
  • 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.

    PMID: 23033542BACKGROUND
  • 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.

    PMID: 26161493BACKGROUND
  • 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.

    PMID: 25991595BACKGROUND
  • 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.

    PMID: 25099997BACKGROUND
  • 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.

    PMID: 25604605BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Sarah R Lessard, Pharm.D.

    Mayo Clinic Health System - Franciscan Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 27, 2016

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 27, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations