Discharge PlanningNCT01893931
Use of a Brief Phone Call After ED Discharge
A study testing ED Discharge & Medication Call in people with Discharge Planning and Emergency Medicine, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a phone call from a nurse within 1-3 days after discharge from the Emergency Department (ED) decreases return visits to the ED/ hospital admissions/ death (combined outcome) in patients age 65 and above. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Discharge Planning, Emergency Medicine, Geriatrics
- What is being tested?
- ED Discharge & Medication Call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,003 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to May 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All patients age 65 and above discharged from the ED
- English speaking
Who cannot join
- Younger than 65 years of age
- Unable to pass 6-item memory screener
- Lives in skilled nursing facility
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Discharge Planning for Older Adults in the Emergency Department: Use of a Brief Phone Call After Discharge to Decrease Return Visits to the Emergency Department and Re-admissions to the Hospital
The purpose of this study is to determine whether a phone call from a nurse within 1-3 days after discharge from the Emergency Department (ED) decreases return visits to the ED/ hospital admissions/ death (combined outcome) in patients age 65 and above. As secondary outcomes, time to follow up appointment with physician and economic impact of this intervention will be assessed.
Patients 65 years of age and older will be randomized following discharge from the ED into one of two groups. Group 1(Intervention) will receive a phone call collecting information about understanding of ED discharge instructions and guiding patient through the discharge instructions, and Group 2 (Placebo) will receive a follow up phone call for a satisfaction survey.
We hypothesize return visits to the ED and readmission to the hospital will decrease as a result of the nurse phone call intervention.
Read the detailed description
Procedures: All patients age 65 and above will be randomized to one of two groups within 1-3 days after discharge from the UNC ED: 1) Interventional follow-up phone call; or 2) Placebo phone call, implementing only a satisfaction survey.
The intervention phone call will ask whether patients have obtained the newly prescribed medicines, ask if the patient understands the instructions for taking the medicines and inquire if a patient has made an appointment with his/her personal physician. The caller will attempt to answer questions about the medicines, and encourage patients to take the medicines as directed. The caller will also encourage the patients to follow-up with their own physician in a timely manner and offer to help with setting up follow up appointments if needed.
Subsequently, 30-35 days after ED discharge, all patients will receive a phone call to evaluate rates of compliance with medicines and scheduling follow-up appointments. All calls will be made by trained nurses.
Using an α 0.05 and β 0.80 we will need to enroll 2235 patients to detect a decrease in ED return visits/re-admission/ death of 6%. There will be one interim analysis 1 year into the two year planned study.
- Being tested
- ED Discharge & Medication Call, Placebo Comparator
- Keywords
- Geriatrics, Emergency Medicine, Care Transitions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED Discharge & Medication CallBehavioural
Patients will receive a follow up phone call from a nurse to review discharge instructions and provide any necessary patient navigation.
Placebo ComparatorBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Satisfaction Survey | Placebo comparator | Within 1-3 days after ED discharge, patients will be called by a nurse to complete a brief satisfaction survey. Receives: Behavioral: Placebo Comparator |
| ED Discharge and Medication Call | Active comparator | Within 1-3 days after ED discharge, patients will receive a follow up phone call from a nurse to review discharge instructions, review medication instructions, and provide any necessary patient navigation. Receives: Behavioral: ED Discharge & Medication Call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first occurrence of hospital readmission, emergency department visit, or death.
Measured by (1) Self-report via a phone call to the patient or care giver up to 35 days post-discharge, and (2) Utilization of existing medical records.
Measured: 0-35 days
Secondary outcomes (2)
Time elapsed from initial emergency department visit to Physician follow up
Measured: 0-35 Days
Patient satisfaction as reported by phone survey
Measured: 0-35 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Discharge PlanningStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- The William R. Kenan, Jr. Charitable Trust
- Responsible party
- Sponsor
- Investigators
- John S Kizer, M.D., Principal investigator, University of North Carolina, Chapel HillKevin Biese, M.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893931
- Sponsor's protocol ID
- 12-1278
- Status last verified
- Jul 2016
- First submitted
- 24 Jun 2013
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Biese KJ, Busby-Whitehead J, Cai J, Stearns SC, Roberts E, Mihas P, Emmett D, Zhou Q, Farmer F, Kizer JS. Telephone Follow-Up for Older Adults Discharged to Home from the Emergency Department: A Pragmatic Randomized Controlled Trial. J Am Geriatr Soc. 2018 Mar;66(3):452-458. doi: 10.1111/jgs.15142. Epub 2017 Dec 22.
PubMed 29272029
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discharge Planning for Older Adults in the Emergency Department: Use of a Brief Phone Call After Discharge to Decrease Return Visits to the Emergency Department and Re-admissions to the Hospital
- ClinicalTrials.gov ID
- NCT01893931
- Acronym / sponsor ID
- 12-1278
- Keywords
- Geriatrics, Emergency Medicine, Care Transitions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,003 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- The William R. Kenan, Jr. Charitable Trust
- Study start
- Aug 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 9 Jul 2013 (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 of this study is to determine whether a phone call from a nurse within 1-3 days after discharge from the Emergency Department (ED) decreases return visits to the ED/ hospital admissions/ death (combined outcome) in patients age 65 and above. As secondary outcomes, time to follow up appointment with physician and economic impact of this intervention will be assessed.
Patients 65 years of age and older will be randomized following discharge from the ED into one of two groups. Group 1(Intervention) will receive a phone call collecting information about understanding of ED discharge instructions and guiding patient through the discharge instructions, and Group 2 (Placebo) will receive a follow up phone call for a satisfaction survey.
We hypothesize return visits to the ED and readmission to the hospital will decrease as a result of the nurse phone call intervention.
Detailed description
Procedures: All patients age 65 and above will be randomized to one of two groups within 1-3 days after discharge from the UNC ED: 1) Interventional follow-up phone call; or 2) Placebo phone call, implementing only a satisfaction survey.
The intervention phone call will ask whether patients have obtained the newly prescribed medicines, ask if the patient understands the instructions for taking the medicines and inquire if a patient has made an appointment with his/her personal physician. The caller will attempt to answer questions about the medicines, and encourage patients to take the medicines as directed. The caller will also encourage the patients to follow-up with their own physician in a timely manner and offer to help with setting up follow up appointments if needed.
Subsequently, 30-35 days after ED discharge, all patients will receive a phone call to evaluate rates of compliance with medicines and scheduling follow-up appointments. All calls will be made by trained nurses.
Using an α 0.05 and β 0.80 we will need to enroll 2235 patients to detect a decrease in ED return visits/re-admission/ death of 6%. There will be one interim analysis 1 year into the two year planned study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Satisfaction Survey | Placebo comparator | Behavioral: Placebo ComparatorWithin 1-3 days after ED discharge, patients will be called by a nurse to complete a brief satisfaction survey. |
| ED Discharge and Medication Call | Active comparator | Behavioral: ED Discharge & Medication CallWithin 1-3 days after ED discharge, patients will receive a follow up phone call from a nurse to review discharge instructions, review medication instructions, and provide any necessary patient navigation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- All patients age 65 and above discharged from the ED
- English speaking
Key exclusion criteria (3 listed)
- Younger than 65 years of age
- Unable to pass 6-item memory screener
- Lives in skilled nursing facility
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 |
|---|---|---|
| ED Discharge & Medication CallPatients will receive a follow up phone call from a nurse to review discharge instructions and provide any necessary patient navigation. | Behavioural | ED Discharge and Medication Call |
| Placebo Comparator | Behavioural | Satisfaction Survey |
Primary outcome
Time to the first occurrence of hospital readmission, emergency department visit, or death.
Time frame: 0-35 days
Measured by (1) Self-report via a phone call to the patient or care giver up to 35 days post-discharge, and (2) Utilization of existing medical records.
2 secondary outcomes
Time elapsed from initial emergency department visit to Physician follow up
Time frame: 0-35 Days
Patient satisfaction as reported by phone survey
Time frame: 0-35 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 11 Jul 2016.
- Derived from this study: PubMed 29272029Biese KJ, Busby-Whitehead J, Cai J, Stearns SC, Roberts E, Mihas P, Emmett D, Zhou Q, Farmer F, Kizer JS. Telephone Follow-Up for Older Adults Discharged to Home from the Emergency Department: A Pragmatic Randomized Controlled Trial. J Am Geriatr Soc. 2018 Mar;66(3):452-458. doi: 10.1111/jgs.15142. Epub 2017 Dec 22.
- 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.
John S Kizer, M.D. principal investigator
University of North Carolina, Chapel Hill
Kevin Biese, M.D. principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ED Discharge & Medication Call in people with Discharge Planning and Emergency Medicine, run by University of North Carolina, Chapel Hill 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 2 inclusion and 3 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 11 Jul 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. Some participants in this study may receive a placebo. 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?
Time to the first occurrence of hospital readmission, emergency department visit, or death. (time frame: 0-35 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 NCT01893931, which also lists 1 linked publication.
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 11 Jul 2016.