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Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions

Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02130570
Enrollment
1679
Registered
2014-05-05
Start date
2013-06-30
Completion date
2015-11-30
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Events, Patient Engagement, Readmissions

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

Brief 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, 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: 1. 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. 2. 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. 3. 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.

Interventions

OTHERMulti-Model Intensive Discharge Intervention

1. 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

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Massachusetts General Hospital
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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).

Exclusion criteria

1. Likely discharge to a location other than home (or to a caregiver's home) 2. Police custody 3. No telephone or homeless 4. Previous enrolment in the study 5. Patient unable to communicate in either English or Spanish

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Participants With an Adverse Event Within 30 Days After Index Discharge Date30 days after dischargeProportion of Participants With an Adverse Event Within 30 Days after Index Discharge Date

Secondary

MeasureTime frameDescription
Proportion of Participants With New or Worsening Signs/Symptoms Within 30 Days of Discharge30 days after dischargeNew 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.
Number of Patients With a Nonelective Readmission Within 30 Days of the Index Discharge Date30 days after dischargeNonelective readmission within 30 days of the index discharge date
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.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.
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process30 days after dischargeDuring 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. 1. 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? 2. How often did you feel confused about what was going on with your medical care because they did not explain things well? 3. How often did they give you enough time to say what you thought was important regarding your medical care? 4. How often did they listen carefully to what you had to say? 5. How often did you feel p
Post-Discharge Health Care Utilization30 days after dischargeWe 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.

Countries

United States

Participant flow

Recruitment details

BWH participants were enrolled from 8/21/2013 to 5/15/2015. MGH participants were enrolled from 9/18/2013 to 10/13/2015. Participants were recruited while they were inpatients on the medical or surgical services at either BWH or MGH.

Pre-assignment details

A total of 141 eligible participants were enrolled to 1 pilot practice at Brigham and Women's Hospital and 1 pilot practice at Massachusetts General Hospital. These participants received the study Intervention so that we could troubleshoot and refine the Intervention procedures. These participants are NOT counted in the final enrollment number.

Participants by arm

ArmCount
Multi-Model Intensive Discharge Program
Multi-Model Intensive Discharge Intervention: 1. 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
978
Usual Care
Patients receive the same care they would normally receive.
679
Total1,657

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath35
Overall StudyPart of practice that discontinued study05
Overall StudyWithdrawal by Subject63

Baseline characteristics

CharacteristicMulti-Model Intensive Discharge ProgramUsual CareTotal
Age, Customized
>=70 years
278 participants202 participants480 participants
Age, Customized
Between 18 and 69 years
700 participants477 participants1177 participants
Sex: Female, Male
Female
540 Participants364 Participants904 Participants
Sex: Female, Male
Male
438 Participants315 Participants753 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 9780 / 679
serious
Total, serious adverse events
0 / 9780 / 679

Outcome results

Primary

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

Time frame: 30 days after discharge

Population: 1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission).

ArmMeasureValue (NUMBER)
Multi-Model Intensive Discharge ProgramProportion of Participants With an Adverse Event Within 30 Days After Index Discharge Date0.18 proportion of participants
Usual CareProportion of Participants With an Adverse Event Within 30 Days After Index Discharge Date0.23 proportion of participants
p-value: 0.0295% CI: [0.3, 0.91]Regression poissant
Secondary

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.

Time frame: One month prior to admission to 30 days after discharge.

Population: 1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission).

ArmMeasureValue (MEAN)Dispersion
Multi-Model Intensive Discharge ProgramChange 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.47.25 units on a scaleStandard Deviation 7.85
Usual CareChange 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.46.14 units on a scaleStandard Deviation 8.11
p-value: 0.91Regression, Linear
Secondary

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

Time frame: 30 days after discharge

Population: 1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission).

ArmMeasureValue (NUMBER)
Multi-Model Intensive Discharge ProgramNumber of Patients With a Nonelective Readmission Within 30 Days of the Index Discharge Date107 participants
Usual CareNumber of Patients With a Nonelective Readmission Within 30 Days of the Index Discharge Date78 participants
p-value: 0.7795% CI: [0.64, 1.85]Regression, Logistic
Secondary

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.

Time frame: 30 days after discharge

Population: Post Discharge ED visits within 30 days of discharge were not able to be obtained from the second site MGH. Post discharge readmissions were obtained, however, without the ED visit data from MGH we are unable to create a count for Post-Discharge Health Care Utilization (ED plus readmissions).

Secondary

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.

Time frame: 30 days after discharge

Population: 1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission).

ArmMeasureValue (NUMBER)
Multi-Model Intensive Discharge ProgramProportion of Participants With New or Worsening Signs/Symptoms Within 30 Days of Discharge0.90 proportion of participants
Usual CareProportion of Participants With New or Worsening Signs/Symptoms Within 30 Days of Discharge0.92 proportion of participants
p-value: 0.0195% CI: [0.64, 0.95]Regression poissant
Secondary

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. 1. 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? 2. How often did you feel confused about what was going on with your medical care because they did not explain things well? 3. How often did they give you enough time to say what you thought was important regarding your medical care? 4. How often did they listen carefully to what you had to say? 5. How often did you feel p

Time frame: 30 days after discharge

Population: 1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission). Not all patients answered the 30-day patient survey.

ArmMeasureGroupValue (NUMBER)
Multi-Model Intensive Discharge ProgramProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessNot given enough time to say what was important.92 proportion of participants
Multi-Model Intensive Discharge ProgramProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessAble to take medications correctly every day.95 proportion of participants
Multi-Model Intensive Discharge ProgramProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessUsed medical terminology you did not understand.86 proportion of participants
Multi-Model Intensive Discharge ProgramProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessKnew danger signs to watch and what to do.96 proportion of participants
Multi-Model Intensive Discharge ProgramProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessHow often did care team listen carefully to you.94 proportion of participants
Multi-Model Intensive Discharge ProgramProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessKnew how to contact my doctor if needed.98 proportion of participants
Multi-Model Intensive Discharge ProgramProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessFelt pressured to have treatment not sure about.95 proportion of participants
Multi-Model Intensive Discharge ProgramProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessAble to get to my doctor's appointment or tests.95 proportion of participants
Multi-Model Intensive Discharge ProgramProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessFelt confused because things not explained well.86 proportion of participants
Multi-Model Intensive Discharge ProgramProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessAble to follow diet team ordered for me.41 proportion of participants
Multi-Model Intensive Discharge ProgramProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessAsked if you might have problems w/ recommended tx.41 proportion of participants
Multi-Model Intensive Discharge ProgramProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessHad enough support from friends, family or others.97 proportion of participants
Multi-Model Intensive Discharge ProgramProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessUnderstood what to do to care for self.98 proportion of participants
Usual CareProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessHad enough support from friends, family or others.96 proportion of participants
Usual CareProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessHow often did care team listen carefully to you.92 proportion of participants
Usual CareProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessUsed medical terminology you did not understand.85 proportion of participants
Usual CareProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessNot given enough time to say what was important.90 proportion of participants
Usual CareProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessAsked if you might have problems w/ recommended tx.34 proportion of participants
Usual CareProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessFelt pressured to have treatment not sure about.95 proportion of participants
Usual CareProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessUnderstood what to do to care for self.97 proportion of participants
Usual CareProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessAble to take medications correctly every day.95 proportion of participants
Usual CareProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessKnew danger signs to watch and what to do.94 proportion of participants
Usual CareProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessKnew how to contact my doctor if needed.96 proportion of participants
Usual CareProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessAble to get to my doctor's appointment or tests.95 proportion of participants
Usual CareProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessAble to follow diet team ordered for me.52 proportion of participants
Usual CareProportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge ProcessFelt confused because things not explained well.88 proportion of participants
p-value: 0.5795% CI: [0.47, 1.51]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026