Community Health Worker Care Transitions Study
Condition: Hospitalism
Study type: Interventional

Summary: 
      This study focuses on pairing community health workers (CHWs) with patients that are high
      risk for readmission prior to hospital discharge in order to assess differences in hospital
      readmission rates, ED visits, patient satisfaction and provider satisfaction as compared to
      patients without community health worker pairings at discharge.
    

Detailed description: 
      This study is a randomized controlled trial of 1200 adult patients admitted to internal
      medicine units that will examine the effectiveness of pairing patients that are high risk for
      readmission with community health workers at the time of hospital discharge on hospital
      readmission rates, emergency room visits, adherence to post-discharge medical appontments,
      and satisfaction with care. During this study, community health workers will partner with
      patients for 30 days after discharge from the hospital to address barriers to care via phone
      contacts, home visits, and accompanying patients to medical appointments/other non-clinical
      supportive care.

      AIM 1) Determine if patients randomly assigned to the intervention group have lower rates of
      hospital readmission than the control group at the end of the intervention.

      Hypothesis 1.1 Study participants in the intervention group will have lower rates of
      post-discharge thirty day readmission than the study participants in the control group at the
      end of the intervention.

      AIM 2) Determine if patients randomly assigned to the intervention group will have less
      emergency room visits than the control group at the end of the intervention

      Hypothesis 2.1 Study participants in the intervention group will have less emergency room
      visits than the study participants in the control group at the end of the intervention.

      AIM 3) Determine if patients randomly assigned to the intervention group have more adherence
      to post-discharge appointments that study group participants in the control group at the end
      of the intervention

      Hypothesis: 3.1 Study participants in the intervention group will have higher rates of
      attendance at post-discharge medical appointments than the study participants in the control
      group at the end of the intervention.

      AIM 4) Determine if patients randomly assigned to the intervention group have higher levels
      of patient psychosocial support and satisfaction with post-discharge care than the control
      group

      Hypothesis 4.1: Study participants in the intervention group will have higher levels of
      patient psychosocial support and satisfaction with post-discharge care than the study
      participants in the control group at the end of the intervention.

      AIM 5) Determine if Primary Care Physicians of patients randomly assigned to the intervention
      group have higher levels of satisfaction with post-discharge care than Primary Care Providers
      of patients in the control group

      Hypothesis 5.1: Primary Care Physicians of patients randomly assigned to the intervention
      group have higher levels of satisfaction with post-discharge care than Primary Care Providers
      of patients in the control group

      After reviewing the fact sheet and consenting to enrollment by signing the informed consent
      form, patients will randomized to the intervention or control groups of the study.

      STUDY PROCEDURES

      Intervention Arm Group:

      Patients randomized to the intervention group will be paired with community health workers
      prior to discharge from the hospital and patient- centered program goals will be established.
      A patient questionnaire (10-15 minutes) will be administered to intervention study
      participants by a study coordinator prior to discharge. A chart review will be performed for
      all intervention group participants by study coordinators prior to patient discharge.
      Patient-CHW pairings will continue for thirty days post-discharge and will include phone
      contacts, home visits, accompanying patients to medical appointments and other non-clinical
      supportive care. Both intervention group participants and primary care providers (PCPs) of
      intervention study participants will complete questionnaires 30-60 days after hospital
      discharge to assess certain patient ( 10 minute questionnaire; via phone) and primary care
      provider ( 5 minute questionnaire via email) perceptions (Please see Aim 4 and Aim 5). CHWs
      will document patient encounters in a REDCap database and complete patient care notes in
      EPIC. All intervention study participants readmitted within thirty days of prior discharge
      will be administered a readmission questionnaire by study coordinators. A chart review for
      readmitted study participants will also be performed by study staff. A REDCap database will
      be used to store all questionnaire and chart review data. Readmission rates, ED visits, PCP
      appointment compliance, patient/ PCP will be tracked.

      Control Arm Group:

      Those randomized to the control group will receive usual care without a community heath
      worker pairing. A patient questionnaire (10-15 minutes) will be administered to intervention
      study participants by a study coordinator prior to discharge. A chart review will be
      performed for all control group participants by study coordinators prior to patient
      discharge. Both control group participants and primary care providers (PCPs) of intervention
      study participants will complete questionnaires 30-60 days after hospital discharge to assess
      certain patient ( 10 minute questionnaire; via phone) and primary care provider ( 5 minute
      questionnaire via email) perceptions (Please see Aim 4 and Aim 5). A REDCap database will be
      used to store all questionnaire and chart review data. Readmission rates, ED visits, PCP
      appointment compliance, patient/ PCP perceptions will be tracked.

      Three groups of research subjects will be assessed: the intervention study group, the control
      study group, and the PCPs of the patients enrolled in the study.
    

Intervention name(s): Community Health Worker
Intervention type(s): Behavioral
Intervention description(s): Community Health Workers calls, texts and visits patient to support them in pre-established care plans as well as medication compliance/appointment attendance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Prevention