Heart FailureNCT02874183
Pharmacist Role in HF Patients Transition of Care
A study testing Pharmacist intervention in people with Heart Failure, run by Nova Southeastern University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pharmacist intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted HF patients at WKBH
- Patients with primary or secondary diagnosis of HF
- Discharged to Home
- 18 years old or older
Who cannot join
- ≥ 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
About this study
Official title: Pharmacist Role in HF Patients Transition of Care: Randomized Clinical Trial (RCT)
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Pharmacist intervention
- Keywords
- Heart Failure, HF, CHF, RCT, Self-efficacy, Pharmacy, Pharmacist, Transition of Care, Readmission
- 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 interventionBehavioural
Pharmacist counseling and follow-up phone calls
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pharmacist intervention |
| usual care group | No intervention | The control group will receive the usual standard care available at West Kendall Baptist Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at baseline, 30 days, 60 days and 90 days after hospital discharge
Secondary outcomes (6)
hospital readmission rate
Measured: 30 days after hospital discharge
hospital readmission rate
Measured: 60 days after hospital discharge
hospital readmission rate
Measured: 90 days after hospital discharge
number of emergency visits
Measured: 30 days after hospital discharge
number of emergency visits
Measured: 60 days after hospital discharge
number of emergency visits
Measured: 90 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Collaborating site had difficulty with approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Baptist Health South Florida
- Responsible party
- Principal investigator, Fatimah M. Sherbeny, PharmD,MS., Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874183
- Sponsor's protocol ID
- 16-052
- Status last verified
- Jul 2018
- First submitted
- 2 Aug 2016
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12657078Rosamond 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.
PubMed 18086926Aminzadeh 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.
PubMed 11867975Hawes 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.
PubMed 24327590Bellone 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.
PubMed 22618976Thomas 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.
PubMed 24196278
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist Role in HF Patients Transition of Care: Randomized Clinical Trial (RCT)
- ClinicalTrials.gov ID
- NCT02874183
- Acronym / sponsor ID
- 16-052
- Conditions
- Heart Failure
- Keywords
- Heart Failure, HF, CHF, RCT, Self-efficacy, Pharmacy, Pharmacist, Transition of Care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Collaborating site had difficulty with approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- Baptist Health South Florida
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 Aug 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist intervention group | Experimental | Behavioral: Pharmacist interventionThe 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. |
| usual care group | No intervention | –The control group will receive the usual standard care available at West Kendall Baptist Hospital. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted HF patients at WKBH
- Patients with primary or secondary diagnosis of HF
- Discharged to Home
- 18 years old or older
Key exclusion criteria (5 listed)
- ≥ 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
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 interventionPharmacist counseling and follow-up phone calls | Behavioural | Pharmacist intervention group |
Primary outcome
change in knowledge
Time frame: at baseline, 30 days, 60 days and 90 days after hospital discharge
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.
change in self-efficacy using a 16 items scale
Time frame: at baseline, 30 days, 60 days and 90 days after hospital discharge
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.
6 secondary outcomes
hospital readmission rate
Time frame: 30 days after hospital discharge
hospital readmission rate
Time frame: 60 days after hospital discharge
hospital readmission rate
Time frame: 90 days after hospital discharge
number of emergency visits
Time frame: 30 days after hospital discharge
number of emergency visits
Time frame: 60 days after hospital discharge
number of emergency visits
Time frame: 90 days after hospital discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Background: PubMed 12657078Coleman 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.
- Background: PubMed 18086926Rosamond 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.
- Background: PubMed 11867975Aminzadeh 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.
- Background: PubMed 24327590Hawes 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.
- Background: PubMed 22618976Bellone 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.
- Background: PubMed 24196278Thomas 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist intervention in people with Heart Failure, run by Nova Southeastern University.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
change in knowledge (time frame: at baseline, 30 days, 60 days and 90 days after hospital discharge). The study lists 2 primary outcomes in all. 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 NCT02874183, which also lists 6 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 1 Aug 2018.