Heart FailureNCT02752997
Reducing 30-day Readmissions in Patients With Heart Failure Through Pharmacist Discharge Medication Services
A study testing Pharmacist discharge medication services in people with Heart Failure and Patient Readmission, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Patient Readmission
- What is being tested?
- Pharmacist discharge medication services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Mar 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of heart failure, discharged from any medical service
Who cannot join
- Unwilling to participate, discharged to nursing/rehab facility, non-English speaking, resident unavailable
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Health System - Franciscan Healthcare
La Crosse, Wisconsin, 54601
About this study
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.
- Conditions
- Heart Failure, Patient Readmission
- Being tested
- Pharmacist discharge medication services
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist discharge medication servicesOther
Included in arm descriptions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pharmacist discharge medication services |
| Comparator | No intervention | Current standard of care provided by nursing staff. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients readmitted to the hospital within 30 days of primary heart failure admission
Fisher's T-test
Measured: 30 Days
Secondary outcomes (3)
Number of patients who visit the emergency department within 30 days of primary heart failure admission
Fisher's T-test
Measured: 30 Days
Number of medication discrepancies identified and the number of medication discrepancies resolved by the pharmacist at discharge.
Fisher's T-test
Measured: 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.
Number of short term goals set will be compared to the number of goals patients achieved, comparison will be calculated by percentage
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 posted27 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Lessard, Mayo Clinic
- Investigators
- Sarah R Lessard, Pharm.D., Principal investigator, Mayo Clinic Health System - Franciscan Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752997
- Sponsor's protocol ID
- 15-008286
- Status last verified
- Apr 2016
- First submitted
- 14 Apr 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26272892Dharmarajan 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.
PubMed 23340637Dudas 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.
PubMed 12021756Emmons 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.
PubMed 11137778Eggink 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.
PubMed 20809276Farris 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.
PubMed 25234932Gianos 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.
PubMed 26385025Gunadi 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.
PubMed 26092965Hall MJ, Levant S, DeFrances CJ. Hospitalization for congestive heart failure: United States, 2000-2010. NCHS Data Brief. 2012 Oct;(108):1-8.
PubMed 23102190Harrison 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.
PubMed 21090991Linden 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.
PubMed 20367828May 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.
PubMed 24416677Ni H, Xu J. Recent Trends in Heart Failure-related Mortality: United States, 2000-2014. NCHS Data Brief. 2015 Dec;(231):1-8.
PubMed 26727546Roger VL. Epidemiology of heart failure. Circ Res. 2013 Aug 30;113(6):646-59. doi: 10.1161/CIRCRESAHA.113.300268.
PubMed 23989710WRITING 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.
PubMed 23741058
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing 30-day Readmissions in Patients With Heart Failure Through Pharmacist Discharge Medication Services
- ClinicalTrials.gov ID
- NCT02752997
- Acronym / sponsor ID
- 15-008286
- Conditions
- Heart Failure, Patient Readmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Apr 2016 (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.
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 design
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Pharmacist discharge medication servicesDischarge 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 |
| Comparator | No intervention | –Current standard of care provided by nursing staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of heart failure, discharged from any medical service
Key exclusion criteria (1 listed)
- Unwilling to participate, discharged to nursing/rehab facility, non-English speaking, resident unavailable
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 |
|---|---|---|
| Pharmacist discharge medication servicesIncluded in arm descriptions | Other | Intervention |
Primary outcome
Number of patients readmitted to the hospital within 30 days of primary heart failure admission
Time frame: 30 Days
Fisher's T-test
3 secondary outcomes
Number of patients who visit the emergency department within 30 days of primary heart failure admission
Time frame: 30 Days
Number of medication discrepancies identified and the number of medication discrepancies resolved by the pharmacist at discharge.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Background: PubMed 26272892Bishop 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.
- Background: PubMed 23340637Dharmarajan 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.
- Background: PubMed 12021756Dudas 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.
- Background: PubMed 11137778Emmons 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.
- Background: PubMed 20809276Eggink 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.
- Background: PubMed 25234932Farris 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.
- Background: PubMed 26385025Gianos 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.
- Background: PubMed 26092965Gunadi 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.
- Background: PubMed 23102190Hall MJ, Levant S, DeFrances CJ. Hospitalization for congestive heart failure: United States, 2000-2010. NCHS Data Brief. 2012 Oct;(108):1-8.
- Background: PubMed 21090991Harrison 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.
- Background: PubMed 20367828Linden 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.
- Background: PubMed 24416677May 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.
- Centers for Medicare and Medicaid Services WebsiteLink provided by the sponsor.
- Centers for Medicare and Medicaid Services WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sarah R Lessard, Pharm.D. principal investigator
Mayo Clinic Health System - Franciscan Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist discharge medication services in people with Heart Failure and Patient Readmission, run by Mayo Clinic 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: finished, as of the sponsor's last update on 27 Apr 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients readmitted to the hospital within 30 days of primary heart failure admission (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02752997, which also lists 23 linked publications.
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 27 Apr 2016.