A Patient Discharged From an Acute-care Hospital Who Had an Acute IllnessNCT03178513
Post-Acute Physician Home Visit Program
A study testing Home visit in people with A Patient Discharged From an Acute-care Hospital Who Had an Acute Illness, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
New or worsening symptoms following discharge from the hospital likely leads to unplanned readmission. These rates are higher than desired and costly to patients, payers, and providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- A Patient Discharged From an Acute-care Hospital Who Had an Acute Illness
- What is being tested?
- Home visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jun 2017to 20 Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resides within either a 5-mile or 20-minute driving radius of Brigham and Women's Hospital (BWH) or Brigham and Women's Faulkner Hospital (BWFH) emergency room
- Has capacity to consent to study
- >=18 years old
Who cannot join
- Undomiciled
- In police custody
- Domestic violence screen positive
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
About this study
Official title: Post-Acute Physician Home Visits: A Randomized Controlled Trial
New or worsening symptoms following discharge from the hospital likely leads to unplanned readmission. These rates are higher than desired and costly to patients, payers, and providers. Many interventions have unsuccessfully attempted to reduce readmissions, but few have provided in-home personnel to patients transitioning from acute care back to ambulatory care. Still fewer have involved a physician in the home. We therefore will test the effect of a physician home visit to a patient's home who was discharged in the last 4 days.
- Being tested
- Home visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visitOther
The visit will be entirely patient tailored, last approximately one hour, and at a minimum will entail:
- Medical assessment
- Psychosocial assessment
- Medication reconciliation
- Follow-up of inpatient primary team's specific recommendations
- Follow-up, as needed, with primary care team or inpatient team
| Study group | Role | What they receive |
|---|---|---|
| Home visit | Experimental | A participant in this arm will receive a home visit after discharge from the hospital. Receives: Other: Home visit |
| Usual Care | No intervention | A participant in this arm will not receive a home visit after discharge from the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
New or worsening symptoms
"Since you got home from the hospital, have you had any symptoms at all?" If no, stop. If yes, continue.
"I'm going to read off a list of symptoms, and I want you to tell me if that symptom is new or has gotten worse since you left the hospital. Please don't include symptoms that have stayed the same since you were in the hospital." For each affirmative, double check if the symptom is new or has gotten worse since getting out of the hospital. Only if new or worse, mark yes.
Measured: 30 days after discharge from hospital
Secondary outcomes (9)
Total cost, 30-days post discharge
Measured: Day of discharge to 30 days later
Total reimbursement, 30-days post discharge
Measured: Day of discharge to 30 days later
3-item Care Transition Measure, score
Measured: 30 days after discharge
Primary care provider follow-up within 14 days, y/n
Measured: Day of discharge to 14 days later
Ability to carry out the discharge plan, score
I would like to ask you about some more problems that you might have faced after you left the hospital one month ago. I will read some statements and ask if you agree or disagree.
Measured: 30 days after discharge
Change in medication list due to home visit, y/n
Physician-initiated medication change during home visit
Measured: Day of home visit
Receipt of prescribed medicines following discharge, y/n
Pharmacy confirmation
Measured: 30 days after discharge
Unplanned 30-day readmission(s) after index hospitalization, y/n
Measured: 30 days after discharge
Unplanned 30-day readmission(s) after index hospitalization, #
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start6 Jun 2017
- Primary completion20 Jan 2018
- Study completion20 Jan 2018
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 A Patient Discharged From an Acute-care Hospital Who Had an Acute IllnessStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
- Investigators
- Jeffrey Schnipper, MD MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178513
- Sponsor's protocol ID
- P000719
- Status last verified
- Aug 2019
- First submitted
- 5 Jun 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Epstein K, Juarez E, Loya K, Gorman MJ, Singer A. Frequency of new or worsening symptoms in the posthospitalization period. J Hosp Med. 2007 Mar;2(2):58-68. doi: 10.1002/jhm.170.
PubMed 17431881Boling PA. Care transitions and home health care. Clin Geriatr Med. 2009 Feb;25(1):135-48, viii. doi: 10.1016/j.cger.2008.11.005.
PubMed 19217498Meyer GS, Gibbons RV. House calls to the elderly--a vanishing practice among physicians. N Engl J Med. 1997 Dec 18;337(25):1815-20. doi: 10.1056/NEJM199712183372507.
PubMed 9400040Wong FK, Chow SK, Chan TM, Tam SK. Comparison of effects between home visits with telephone calls and telephone calls only for transitional discharge support: a randomised controlled trial. Age Ageing. 2014 Jan;43(1):91-7. doi: 10.1093/ageing/aft123. Epub 2013 Aug 26.
PubMed 23978408Branowicki PM, Vessey JA, Graham DA, McCabe MA, Clapp AL, Blaine K, O'Neill MR, Gouthro JA, Snydeman CK, Kline NE, Chiang VW, Cannon C, Berry JG. Meta-Analysis of Clinical Trials That Evaluate the Effectiveness of Hospital-Initiated Postdischarge Interventions on Hospital Readmission. J Healthc Qual. 2017 Nov/Dec;39(6):354-366. doi: 10.1097/JHQ.0000000000000057.
PubMed 27631713Wolff JL, Meadow A, Boyd CM, Weiss CO, Leff B. Physician evaluation and management of Medicare home health patients. Med Care. 2009 Nov;47(11):1147-55. doi: 10.1097/MLR.0b013e3181b58e30.
PubMed 19786916
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Acute Physician Home Visits: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03178513
- Acronym / sponsor ID
- P000719
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 7 Jun 2017 (actual)
- 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.
New or worsening symptoms following discharge from the hospital likely leads to unplanned readmission. These rates are higher than desired and costly to patients, payers, and providers. Many interventions have unsuccessfully attempted to reduce readmissions, but few have provided in-home personnel to patients transitioning from acute care back to ambulatory care. Still fewer have involved a physician in the home. We therefore will test the effect of a physician home visit to a patient's home who was discharged in the last 4 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home visit | Experimental | Other: Home visitA participant in this arm will receive a home visit after discharge from the hospital. |
| Usual Care | No intervention | –A participant in this arm will not receive a home visit after discharge from the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Resides within either a 5-mile or 20-minute driving radius of Brigham and Women's Hospital (BWH) or Brigham and Women's Faulkner Hospital (BWFH) emergency room
- Has capacity to consent to study
- >=18 years old
Key exclusion criteria (3 listed)
- Undomiciled
- In police custody
- Domestic violence screen positive
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 |
|---|---|---|
| Home visitThe visit will be entirely patient tailored, last approximately one hour, and at a minimum will entail: * Medical assessment * Psychosocial assessment * Medication reconciliation * Follow-up of inpatient primary team's specific recommendations * Follow-up, as needed, with primary care team or inpatient team | Other | Home visit |
Primary outcome
New or worsening symptoms
Time frame: 30 days after discharge from hospital
"Since you got home from the hospital, have you had any symptoms at all?" If no, stop. If yes, continue. "I'm going to read off a list of symptoms, and I want you to tell me if that symptom is new or has gotten worse since you left the hospital. Please don't include symptoms that have stayed the same since you were in the hospital." For each affirmative, double check if the symptom is new or has gotten worse since getting out of the hospital. Only if new or worse, mark yes.
9 secondary outcomes
Total cost, 30-days post discharge
Time frame: Day of discharge to 30 days later
Total reimbursement, 30-days post discharge
Time frame: Day of discharge to 30 days later
3-item Care Transition Measure, score
Time frame: 30 days after discharge
Primary care provider follow-up within 14 days, y/n
Time frame: Day of discharge to 14 days later
Ability to carry out the discharge plan, score
Time frame: 30 days after discharge
Change in medication list due to home visit, y/n
Time frame: Day of home visit
Receipt of prescribed medicines following discharge, y/n
Time frame: 30 days after discharge
Unplanned 30-day readmission(s) after index hospitalization, y/n
Time frame: 30 days after discharge
Unplanned 30-day readmission(s) after index hospitalization, #
Time frame: 30 days after discharge
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 13 Aug 2019.
- Background: PubMed 17431881Epstein K, Juarez E, Loya K, Gorman MJ, Singer A. Frequency of new or worsening symptoms in the posthospitalization period. J Hosp Med. 2007 Mar;2(2):58-68. doi: 10.1002/jhm.170.
- Background: PubMed 19217498Boling PA. Care transitions and home health care. Clin Geriatr Med. 2009 Feb;25(1):135-48, viii. doi: 10.1016/j.cger.2008.11.005.
- Background: PubMed 9400040Meyer GS, Gibbons RV. House calls to the elderly--a vanishing practice among physicians. N Engl J Med. 1997 Dec 18;337(25):1815-20. doi: 10.1056/NEJM199712183372507.
- Background: PubMed 23978408Wong FK, Chow SK, Chan TM, Tam SK. Comparison of effects between home visits with telephone calls and telephone calls only for transitional discharge support: a randomised controlled trial. Age Ageing. 2014 Jan;43(1):91-7. doi: 10.1093/ageing/aft123. Epub 2013 Aug 26.
- Background: PubMed 27631713Branowicki PM, Vessey JA, Graham DA, McCabe MA, Clapp AL, Blaine K, O'Neill MR, Gouthro JA, Snydeman CK, Kline NE, Chiang VW, Cannon C, Berry JG. Meta-Analysis of Clinical Trials That Evaluate the Effectiveness of Hospital-Initiated Postdischarge Interventions on Hospital Readmission. J Healthc Qual. 2017 Nov/Dec;39(6):354-366. doi: 10.1097/JHQ.0000000000000057.
- Background: PubMed 19786916Wolff JL, Meadow A, Boyd CM, Weiss CO, Leff B. Physician evaluation and management of Medicare home health patients. Med Care. 2009 Nov;47(11):1147-55. doi: 10.1097/MLR.0b013e3181b58e30.
- Individual participant dataSharing planned: No
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.
Jeffrey Schnipper, MD MPH principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visit in people with A Patient Discharged From an Acute-care Hospital Who Had an Acute Illness, run by Brigham and Women's Hospital at 2 sites 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 3 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
New or worsening symptoms (time frame: 30 days after discharge from hospital). 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 NCT03178513, 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 13 Aug 2019.