Adverse EventsNCT02130570
Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions
A study testing Multi-Model Intensive Discharge Intervention in people with Adverse Events and Readmissions, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
The objective of this study is to design and implement a set of procedures (the intervention) to improve patients' experiences when they are discharged home from the hospital. Second, this study aims to look at how the intervention affects problems that are known to occur after discharge, including medication issues… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Events, Readmissions, Patient Engagement
- What is being tested?
- Multi-Model Intensive Discharge Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,679 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Potential subjects will be adult patients admitted to medical and surgical services at BWH and MGH, likely to be discharged back to the community, and whose PCP belongs to one of the Partners Community Healthcare, Inc. (PCHI) primary care practices that has met "Primed" criteria for being a PCMH, admits at least 2 patients to BWH or MGH, and has agreed to participate. Primed criteria are a standard set of requirements that cover 6 essential building blocks of PCMH practices: electronic health record, patient portal, team-based care, practice redesign, care management, and identification of high-risk patients. We estimate that of the approximately 300 PCHI adult primary care practices, 150 of them will meet PCMH criteria during the study and that 20 of them will qualify and be willing to participate in the study. We estimate that 12,000 such patients will be admitted to BWH and MGH over the 18-month study period, of which we will enroll 1700 patients. These patients are broadly representative of hospitalized patients and include several vulnerable populations, including the elderly (33% 65 or older), patients with multiple chronic conditions (47% with Elixhauser comorbidity score 5 or more), and racial and ethnic minorities (14% African American, 13% Latino).
Who cannot join
- Likely discharge to a location other than home (or to a caregiver's home)
- Police custody
- No telephone or homeless
- Previous enrolment in the study
- Patient unable to communicate in either English or Spanish
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The objective of this study is to design and implement a set of procedures (the intervention) to improve patients' experiences when they are discharged home from the hospital. Second, this study aims to look at how the intervention affects problems that are known to occur after discharge, including medication issues, worsening medical problems, or readmission to the hospital. The investigators will study how well patients recover the ability to do the things they could before they were admitted to the hospital and their opinions of the discharge process. Lastly, this study will look to understand the best way to implement the intervention into different hospitals and practices, and which types of patients benefit from it most.
Read the detailed description
The specific aims of this study are:
- To develop, implement, and refine a multi-faceted, multi-disciplinary transitions intervention with contributions from hospital and Patient-Centered Medical Home (PCMH) personnel. Hypothesis: a collaborative transitions intervention can be designed and implemented within an ACO that reliably provides the components of an ideal transition in care.
- To evaluate the effects of this intervention on post-discharge adverse events, functional status, patient engagement, and emergency department and hospital utilization within 30 days of discharge. Hypothesis: compared with usual care, a collaborative transitions intervention will decrease post discharge adverse events, improve post-discharge functional status, increase patient engagement, and reduce emergency department and hospital utilization in the post-discharge period.
- To understand barriers to and facilitators of successful implementation of this intervention across practices.
Hypothesis: several barriers to and facilitators of implementation can be identified and used to create lessons learned for other health systems to successfully implement this type of intervention.
- Conditions
- Adverse Events, Readmissions, Patient Engagement
- Being tested
- Multi-Model Intensive Discharge Intervention
- Keywords
- Adverse events, Readmissions, Patient Centered Medical Home (PCMH), Accountable Care Organizations (ACO), Medication reconciliation, Discharge Advocate, Patient engagement, Transitions of care, Transitions coach, Pharmacist intervention
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Model Intensive Discharge InterventionOther
- Inpatient medication safety interventions
- Inpatient "discharge advocate"
- Structured visiting nurse (VNA) appointments
- Post-discharge phone call by primary care personnel within 2 business days of discharge
- Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge
- Improved communication between inpatient and primary care teams
- High-risk patients will receive additional interventions as needed:
- Home pharmacist visit
- Enrollment in the Partners integrated Care Management Program (iCMP)
- Enrollment in telemedicine programs for patients with CHF
- Palliative care consultation regarding goals of care
- Novel health information technology to facilitate communication and transfer of clinical information
| Study group | Role | What they receive |
|---|---|---|
| Multi-Model Intensive Discharge Program | Experimental | Multi-Model Intensive Discharge Program Receives: Other: Multi-Model Intensive Discharge Intervention |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With an Adverse Event Within 30 Days After Index Discharge Date
Proportion of Participants With an Adverse Event Within 30 Days after Index Discharge Date
Measured: 30 days after discharge
Secondary outcomes (5)
Proportion of Participants With New or Worsening Signs/Symptoms Within 30 Days of Discharge
New or worsening signs or symptoms, i.e. unpleasant symptoms, loss of function, abnormal lab results, and/or additional medical care within 30 days after discharge.
Measured: 30 days after discharge
Number of Patients With a Nonelective Readmission Within 30 Days of the Index Discharge Date
Nonelective readmission within 30 days of the index discharge date
Measured: 30 days after discharge
Change in Functional Status on the Modified Medical Outcomes Survey Short Form-12 (SF-12v2) From One Month Prior to Admission to 30 Days After Discharge.
During the inpatient enrollment period, patients will complete a modified Medical Outcomes Survey Short Form-12 (SF-12v2). The SF-12v2 measures a patient's functional status and health-related quality of life one month prior to admission. 30 days after discharge, SF12 questions will be repeated so that functional status and health-related quality of life can be compared to prior to admission.
This measure is a 12-item measure. Each item 5 possible responses with a value from 1 to 5 (with higher scores indicating worse outcomes). A summary score is computed by summing the score on each item. Therefore, the range of summary scores for the SF-12v2 is a minimum of 12 and a maximum of 60.
Measured: One month prior to admission to 30 days after discharge.
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process
During the 30 day post-discharge follow-up phone call we asked patients about their participation in, understanding of, and ability to carry out the post-discharge plan. These questions include questions from the Interpersonal Processes of Care survey and several additional questions from the HOMERUN study of readmitted patients.
In the table below, we have abbreviated each survey question since the number of characters is limited in this field in the table. We have pasted below the full survey question.
- When you were getting ready to leave the hospital one month ago, how often did your care team use medical terminology that you did not understand?
- How often did you feel confused about what was going on with your medical care because they did not explain things well?
- How often did they give you enough time to say what you thought was important regarding your medical care?
- How often did they listen carefully to what you had to say?
- How often did you feel p
Measured: 30 days after discharge
Post-Discharge Health Care Utilization
We will measure emergency department visits and hospital readmissions within 30 days of discharge using a combination of administrative data for all Partners hospitals plus patient report for all utilization outside the Partners system.
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 posted5 May 2014 (estimated)
- Study startJun 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adverse EventsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a stepped-wedge design, where each primary care practice starts in usual care, and then at a randomly selected point in time switches to the intervention arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,679 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Massachusetts General Hospital
- Responsible party
- Principal investigator, Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
- Investigators
- Jeffrey L Schnipper, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130570
- Sponsor's protocol ID
- 2012P000096
- Status last verified
- Aug 2019
- First submitted
- 1 May 2014
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Voluntarily participating in PCORI's Open Science Pilot
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions
- ClinicalTrials.gov ID
- NCT02130570
- Acronym / sponsor ID
- 2012P000096
- Conditions
- Adverse Events, Readmissions, Patient Engagement
- Keywords
- Adverse events, Readmissions, Patient Centered Medical Home (PCMH), Accountable Care Organizations (ACO), Medication reconciliation, Discharge Advocate, Patient engagement, Transitions of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,679 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Massachusetts General Hospital
- Study start
- Jun 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 May 2014 (estimated)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to design and implement a set of procedures (the intervention) to improve patients' experiences when they are discharged home from the hospital. Second, this study aims to look at how the intervention affects problems that are known to occur after discharge, including medication issues, worsening medical problems, or readmission to the hospital. The investigators will study how well patients recover the ability to do the things they could before they were admitted to the hospital and their opinions of the discharge process. Lastly, this study will look to understand the best way to implement the intervention into different hospitals and practices, and which types of patients benefit from it most.
Detailed description
The specific aims of this study are:
- To develop, implement, and refine a multi-faceted, multi-disciplinary transitions intervention with contributions from hospital and Patient-Centered Medical Home (PCMH) personnel. Hypothesis: a collaborative transitions intervention can be designed and implemented within an ACO that reliably provides the components of an ideal transition in care.
- To evaluate the effects of this intervention on post-discharge adverse events, functional status, patient engagement, and emergency department and hospital utilization within 30 days of discharge. Hypothesis: compared with usual care, a collaborative transitions intervention will decrease post discharge adverse events, improve post-discharge functional status, increase patient engagement, and reduce emergency department and hospital utilization in the post-discharge period.
- To understand barriers to and facilitators of successful implementation of this intervention across practices.
Hypothesis: several barriers to and facilitators of implementation can be identified and used to create lessons learned for other health systems to successfully implement this type of intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a stepped-wedge design, where each primary care practice starts in usual care, and then at a randomly selected point in time switches to the intervention arm.
| Arm | Type | Receives |
|---|---|---|
| Multi-Model Intensive Discharge Program | Experimental | Other: Multi-Model Intensive Discharge InterventionMulti-Model Intensive Discharge Program |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Potential subjects will be adult patients admitted to medical and surgical services at BWH and MGH, likely to be discharged back to the community, and whose PCP belongs to one of the Partners Community Healthcare, Inc. (PCHI) primary care practices that has met "Primed" criteria for being a PCMH, admits at least 2 patients to BWH or MGH, and has agreed to participate. Primed criteria are a standard set of requirements that cover 6 essential building blocks of PCMH practices: electronic health record, patient portal, team-based care, practice redesign, care management, and identification of high-risk patients. We estimate that of the approximately 300 PCHI adult primary care practices, 150 of them will meet PCMH criteria during the study and that 20 of them will qualify and be willing to participate in the study. We estimate that 12,000 such patients will be admitted to BWH and MGH over the 18-month study period, of which we will enroll 1700 patients. These patients are broadly representative of hospitalized patients and include several vulnerable populations, including the elderly (33% 65 or older), patients with multiple chronic conditions (47% with Elixhauser comorbidity score 5 or more), and racial and ethnic minorities (14% African American, 13% Latino).
Key exclusion criteria (5 listed)
- Likely discharge to a location other than home (or to a caregiver's home)
- Police custody
- No telephone or homeless
- Previous enrolment in the study
- Patient unable to communicate in either English or Spanish
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 |
|---|---|---|
| Multi-Model Intensive Discharge Intervention1. Inpatient medication safety interventions 2. Inpatient "discharge advocate" 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed: 1. Home pharmacist visit 2. Enrollment in the Partners integrated Care Management Program (iCMP) 3. Enrollment in telemedicine programs for patients with CHF 4. Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information | Other | Multi-Model Intensive Discharge Program |
Primary outcome
Proportion of Participants With an Adverse Event Within 30 Days After Index Discharge Date
Time frame: 30 days after discharge
Proportion of Participants With an Adverse Event Within 30 Days after Index Discharge Date
5 secondary outcomes
Proportion of Participants With New or Worsening Signs/Symptoms Within 30 Days of Discharge
Time frame: 30 days after discharge
Number of Patients With a Nonelective Readmission Within 30 Days of the Index Discharge Date
Time frame: 30 days after discharge
Change in Functional Status on the Modified Medical Outcomes Survey Short Form-12 (SF-12v2) From One Month Prior to Admission to 30 Days After Discharge.
Time frame: One month prior to admission to 30 days after discharge.
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process
Time frame: 30 days after discharge
Post-Discharge Health Care Utilization
Time frame: 30 days after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Voluntarily participating in PCORI's Open Science Pilot
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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.
Jeffrey L 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 Multi-Model Intensive Discharge Intervention in people with Adverse Events and Readmissions, 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 1 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 20 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?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants With an Adverse Event Within 30 Days After Index Discharge Date (time frame: 30 days after discharge). 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 20 Aug 2019.