NCT02874183

Brief Summary

To assess the effectiveness of pharmacist's provided education in HF patients, in improving patients' knowledge and self-efficacy, and to assess the impact of this intervention on the rate of hospital readmission and emergency visits at 30-days, 60-days and 90-days after discharge.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable heart-failure

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

August 2, 2016

Last Update Submit

July 30, 2018

Conditions

Heart Failure

Keywords

Heart FailureHFCHFRCTSelf-efficacyPharmacyPharmacistTransition of CareReadmission

Outcome Measures

Primary Outcomes (2)

  • change in knowledge

    The investigators will measure patient's knowledge about heart failure using a 15 item questionnaire, at baseline (at recruitment) before they get the discharge counseling at West Kendall Baptist Hospital (WKBH), then the investigators will measure it again 30 days, 60 days, and 90 days after discharge to evaluate the change in the patient's knowledge and how much information did the patients retain after the discharge counseling.

    at baseline, 30 days, 60 days and 90 days after hospital discharge

  • change in self-efficacy using a 16 items scale

    the investigators will measure patient's self-efficacy, using a 16 items scale, at baseline (at recruitment) before the patients get the discharge counseling at West Kendall Baptist Hospital (WKBH), then the investigators will measure it again 30 days, 60 days, and 90 days after discharge to evaluate the change in the patient's self-efficacy and ability to take care of themselves before and after they receive the discharge counseling and be educated about heart failure and how to manage it.

    at baseline, 30 days, 60 days and 90 days after hospital discharge

Secondary Outcomes (6)

  • hospital readmission rate

    30 days after hospital discharge

  • hospital readmission rate

    60 days after hospital discharge

  • hospital readmission rate

    90 days after hospital discharge

  • number of emergency visits

    30 days after hospital discharge

  • number of emergency visits

    60 days after hospital discharge

  • +1 more secondary outcomes

Study Arms (2)

Pharmacist intervention group

EXPERIMENTAL

The intervention group will receive: 1. A phone call 48h-72h after discharge from the hospital to ensure that the patient filled their prescriptions and started taking their medication. 2. A phone call five to seven days after discharge to reinforce the education using the "teach back technique"1. Patients will be asked about their medications, what are they for, how to use them, and what side effects to watch for, based on the education and information that was provided to them at discharge.

Behavioral: Pharmacist intervention

usual care group

NO INTERVENTION

The control group will receive the usual standard care available at West Kendall Baptist Hospital.

Interventions

Pharmacist interventionBEHAVIORAL

Pharmacist counseling and follow-up phone calls

Pharmacist intervention group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted HF patients at WKBH
  • Patients with primary or secondary diagnosis of HF
  • Discharged to Home
  • years old or older

You may not qualify if:

  • ≥ 90 years old
  • Patients with major comorbidities such as cancer, end-stage kidney disease, and liver failure
  • Patients with memory problems such as dementia and Alzheimer's disease
  • Patients discharged to places other than home
  • Patients who are unable to understand or follow discharge instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Coleman EA. Falling through the cracks: challenges and opportunities for improving transitional care for persons with continuous complex care needs. J Am Geriatr Soc. 2003 Apr;51(4):549-55. doi: 10.1046/j.1532-5415.2003.51185.x.

    PMID: 12657078BACKGROUND

  • Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available.

    PMID: 18086926BACKGROUND

  • Aminzadeh F, Dalziel WB. Older adults in the emergency department: a systematic review of patterns of use, adverse outcomes, and effectiveness of interventions. Ann Emerg Med. 2002 Mar;39(3):238-47. doi: 10.1067/mem.2002.121523.

    PMID: 11867975BACKGROUND

  • Hawes EM, Maxwell WD, White SF, Mangun J, Lin FC. Impact of an outpatient pharmacist intervention on medication discrepancies and health care resource utilization in posthospitalization care transitions. J Prim Care Community Health. 2014 Jan 1;5(1):14-8. doi: 10.1177/2150131913502489. Epub 2013 Sep 17.

    PMID: 24327590BACKGROUND

  • Bellone JM, Barner JC, Lopez DA. Postdischarge interventions by pharmacists and impact on hospital readmission rates. J Am Pharm Assoc (2003). 2012 May-Jun;52(3):358-62. doi: 10.1331/JAPhA.2012.10172.

    PMID: 22618976BACKGROUND

  • Thomas R, Huntley AL, Mann M, Huws D, Elwyn G, Paranjothy S, Purdy S. Pharmacist-led interventions to reduce unplanned admissions for older people: a systematic review and meta-analysis of randomised controlled trials. Age Ageing. 2014 Mar;43(2):174-87. doi: 10.1093/ageing/aft169. Epub 2013 Nov 5.

    PMID: 24196278BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. candidate at Nova Southeastern University - College of Pharmacy

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 22, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 1, 2018

Record last verified: 2018-07