Readmission, HospitalPhase 2NCT00332514
Post-Discharge Follow-Up Phone Call by a Pharmacist and Impact on Patient Care
A Phase 2 study testing telephone call by a pharmacist in people with Readmission, Hospital, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose is to analyze whether a follow-up telephone call by a pharmacist after patient discharge from the hospital can improve patient outcomes. Patients will be interviewed via telephone within 72 hours of being discharged home from the hospital. Patients will be questioned on three main topics. They are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Readmission, Hospital
- What is being tested?
- telephone call by a pharmacist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jan 2008
- Phase
- Phase 2
- 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
- admission to Internal Medicine Service on the Menino Pavilion, either Firm A or B at Boston Medical Center located in Boston, MA
- age greater than or equal to 18 years
- discharge to home from the inpatient General Medical Service
- English-speaking or lives with English-speaking person
- access to a working phone
Who cannot join
- admission to any other service at Boston Medical Center located in Boston, MA besides Internal Medicine Firms A or B
- age less than 18 years
- discharge to site other than home
- non-English-speaking or does not live with an English-speaking person
- no access to a working phone
Trial locations and contacts
1 site in 1 country.
About this study
The purpose is to analyze whether a follow-up telephone call by a pharmacist after patient discharge from the hospital can improve patient outcomes.
Patients will be interviewed via telephone within 72 hours of being discharged home from the hospital. Patients will be questioned on three main topics. They are:
Read more
- Medical care
- Medications
- Follow-up appointments
The purpose is to find out if people understand discharge medications, have obtained those medications, are having any problems with their medications and have scheduled necessary follow-up appointments. It will be determined if a telephone call by a pharmacist will prevent patients from needing to go to the Emergency Room or being admitted back to the hospital.
Read the detailed description
There is a time between hospital discharge and patient follow-up that has been deemed by many healthcare workers as a "black hole " (1). It is a time during which continuity of care is of utmost importance, yet there is no effective uniform system in place to ensure this vital continuity. During the post-discharge period (time from when the patient leaves the hospital to the time of first follow-up appointment), new medical problems can arise and old ones can be exacerbated. Additionally, patients can encounter innumerable barriers to healthcare, including difficulty obtaining medications and securing appointments with physicians or specialists. Also, patients may not have received proper counseling on new discharge medications, including proper use and potential side effects. Despite this important aspect of patient care, only a paucity of literature on the topic exists. Of the literature that does exist, it suggests that patient education concerning discharge planning and the post-discharge period is an aspect of care that is in great need of improvement and an excellent opportunity for intervention by a pharmacist.
This led to our research hypothesis, can a follow-up phone call from a pharmacist improve patient outcomes?
The primary endpoint of this study is a reduction in the number of hospital readmissions (any cause) during the 30-day post-discharge period. Thirty-day readmission rates will be compared to see if there is a difference between the intervention group (follow-up phone call) and control group (no phone call). The secondary outcomes include the number of patients in the study group for whom medication errors, complications or misuse could be identified.
References: (1). Kathuria, et al. Post-discharge follow-up: hospitalists dial into the "black hole". Hospitalist and Inpatient Management Report, June 2003
- Conditions
- Readmission, Hospital
- Being tested
- telephone call by a pharmacist
- Keywords
- pharmacist intervention, post-discharge telephone call, black hole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone call by a pharmacistBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Patients offered follow-up phone call | Other | Patients offered follow-up telephone call Receives: Behavioral: telephone call by a pharmacist |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is a reduction in the number of hospital readmissions (any cause) during the 30-day post-discharge period.
Secondary outcomes (1)
The secondary outcomes include the number of patients in the study group for whom medication errors, complications or misuse could be identified.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startMar 2004
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Readmission, HospitalStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gail M Burniske, PharmD, BCPS, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332514
- Sponsor's protocol ID
- H-23071
- Status last verified
- Mar 2006
- First submitted
- 31 May 2006
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Discharge Follow-Up Phone Call by a Pharmacist and Impact on Patient Care
- ClinicalTrials.gov ID
- NCT00332514
- Acronym / sponsor ID
- H-23071
- Conditions
- Readmission, Hospital
- Keywords
- pharmacist intervention, post-discharge telephone call, black hole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 1 Jun 2006 (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.
The purpose is to analyze whether a follow-up telephone call by a pharmacist after patient discharge from the hospital can improve patient outcomes.
Patients will be interviewed via telephone within 72 hours of being discharged home from the hospital. Patients will be questioned on three main topics. They are:
- Medical care
- Medications
- Follow-up appointments
The purpose is to find out if people understand discharge medications, have obtained those medications, are having any problems with their medications and have scheduled necessary follow-up appointments. It will be determined if a telephone call by a pharmacist will prevent patients from needing to go to the Emergency Room or being admitted back to the hospital.
Detailed description
There is a time between hospital discharge and patient follow-up that has been deemed by many healthcare workers as a "black hole " (1). It is a time during which continuity of care is of utmost importance, yet there is no effective uniform system in place to ensure this vital continuity. During the post-discharge period (time from when the patient leaves the hospital to the time of first follow-up appointment), new medical problems can arise and old ones can be exacerbated. Additionally, patients can encounter innumerable barriers to healthcare, including difficulty obtaining medications and securing appointments with physicians or specialists. Also, patients may not have received proper counseling on new discharge medications, including proper use and potential side effects. Despite this important aspect of patient care, only a paucity of literature on the topic exists. Of the literature that does exist, it suggests that patient education concerning discharge planning and the post-discharge period is an aspect of care that is in great need of improvement and an excellent opportunity for intervention by a pharmacist.
This led to our research hypothesis, can a follow-up phone call from a pharmacist improve patient outcomes?
The primary endpoint of this study is a reduction in the number of hospital readmissions (any cause) during the 30-day post-discharge period. Thirty-day readmission rates will be compared to see if there is a difference between the intervention group (follow-up phone call) and control group (no phone call). The secondary outcomes include the number of patients in the study group for whom medication errors, complications or misuse could be identified.
References: (1). Kathuria, et al. Post-discharge follow-up: hospitalists dial into the "black hole". Hospitalist and Inpatient Management Report, June 2003
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients offered follow-up phone call | Other | Behavioral: telephone call by a pharmacistPatients offered follow-up telephone call |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- admission to Internal Medicine Service on the Menino Pavilion, either Firm A or B at Boston Medical Center located in Boston, MA
- age greater than or equal to 18 years
- discharge to home from the inpatient General Medical Service
- English-speaking or lives with English-speaking person
- access to a working phone
Key exclusion criteria (5 listed)
- admission to any other service at Boston Medical Center located in Boston, MA besides Internal Medicine Firms A or B
- age less than 18 years
- discharge to site other than home
- non-English-speaking or does not live with an English-speaking person
- no access to a working phone
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 |
|---|---|---|
| telephone call by a pharmacist | Behavioural | Patients offered follow-up phone call |
Primary outcome
The primary endpoint of this study is a reduction in the number of hospital readmissions (any cause) during the 30-day post-discharge period.
1 secondary outcome
The secondary outcomes include the number of patients in the study group for whom medication errors, complications or misuse could be identified.
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 23 Feb 2016.
Related trials for Readmission, Hospital
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Recruiting
Conducting Wound, Ostomy, and Continence (WOC) Nurse Telephone Follow-up for Post-discharge Ostomy Patients to Reduce Hospital Readmission
Ostomy
Not yet recruiting
A Clinician-Patient Dual Behavior Change Framework to Leverage Informed Digital Nudges to Reduce Hospital Readmissions and Improve Patient Outcomes: A Trial for Scalable Strategy to Reduce Readmissions (PREVENT-R)
Readmission, Readmission Rates
Recruiting
Pericardiotomy in Cardiac Surgery
Atrial Fibrillation, Atrial Flutter
Recruiting
COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury (CONNECT-AKI)
Acute Kidney Injury, Acute Kidney Injury (AKI)
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.
Gail M Burniske, PharmD, BCPS principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing telephone call by a pharmacist in people with Readmission, Hospital, run by Boston Medical Center 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 5 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: finished, as of the sponsor's last update on 23 Feb 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary endpoint of this study is a reduction in the number of hospital readmissions (any cause) during the 30-day post-discharge period.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2016.