Clinical trial NCT02874183: Pharmacist Role in HF Patients Transition of Care
Official title: Pharmacist Role in HF Patients Transition of Care: Randomized Clinical Trial (RCT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
HF
CHF
RCT
Self-efficacy
Pharmacy
Pharmacist
Transition of Care
Readmission
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: Baptist Health South Florida
First posted: 2016-08-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: "Transition of care" is one of the new disciplines that pharmacists have been involved-in within the healthcare system. It is a process where a patient's care is shifting from one setting to another. During this process, transitional care is designed to ensure continuity of patient care across different sites or across different levels of care within the same facility. For example, from Intensive Care Unit (ICU) to the ward, from hospital to home, or from hospital to rehab centers. Many stakeholders are involved in this process, and coordination between them is necessary to have successful one, in addition to logistical arrangements, and patient education. Otherwise, poor communication, inadequate patient education, and lack of access to healthcare services, will produce failure of having a smooth transition and could result in negative health outcomes including complications in the patient's disease status, emergency room visits or hospital readmissions. Not only that these negative health outcomes are affecting the patient, they are also negatively affecting the healthcare spending in the United States. For instance, inadequate care coordination and management of care transitions accounted for $25 to $45 billion in wasteful spending in 2011 through preventable adverse events and hospital readmissions. Therefore, cost containment and reducing the excessive spending in healthcare is an important aim of "transition of care", secondary to improving patient outcomes.

Pharmacist's role in Transition of care:

Pharmacists have the knowledge, training and expertise to play a major role in the transition of care process. They are involved in dispensing the patient's medications at the hospital, ensuring that the patient's medication chart is updated, identify any medication discrepancy, provide medication reconciliation, medication education, patient counseling at discharge and they could follow-up with the patients after discharge to check if they filled their prescription, what side effects are they having, and monitor their adherence to their treatment plan. These pharmacist's interventions have been applied, among other approaches, by hospitals to improve the quality of their services and minimize the rate of readmissions.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* ≥ 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

Primary outcomes:
measure: change in knowledge
timeFrame: at baseline, 30 days, 60 days and 90 days after hospital discharge
measure: change in self-efficacy using a 16 items scale
timeFrame: at baseline, 30 days, 60 days and 90 days after hospital discharge
Secondary outcomes:
measure: hospital readmission rate
timeFrame: 30 days after hospital discharge
measure: hospital readmission rate
timeFrame: 60 days after hospital discharge
measure: hospital readmission rate
timeFrame: 90 days after hospital discharge
measure: number of emergency visits
timeFrame: 30 days after hospital discharge
measure: number of emergency visits
timeFrame: 60 days after hospital discharge
measure: number of emergency visits
timeFrame: 90 days after hospital discharge
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.