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OpenTrials
Completed

NCT Number: NCT02130570

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

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.

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Key information

Conditions

Adverse Events Behavior Health Behavior Patient Acceptance of Health Care Patient Engagement Patient Participation Readmissions Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Multi-Model Intensive Discharge Intervention

Other
  • 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

Primary outcomes

  1. 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

Secondary outcomes

  1. Proportion of Participants With New or Worsening Signs/Symptoms Within 30 Days of Discharge

    Time frame: 30 days after 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.

  2. Number of Patients With a Nonelective Readmission Within 30 Days of the Index Discharge Date

    Time frame: 30 days after discharge

    Nonelective readmission within 30 days of the index discharge date

  3. 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.

    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.

  4. Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process

    Time frame: 30 days after discharge

    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

  5. Post-Discharge Health Care Utilization

    Time frame: 30 days after discharge

    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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Massachusetts General Hospital
  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 5, 2014
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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