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IMPaCT (Individualized Management Towards Patient-Centered Targets) (PaCT)

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ClinicalTrials.gov Identifier: NCT01346462
Recruitment Status : Completed
First Posted : May 3, 2011
Last Update Posted : May 1, 2014
Sponsor:
Information provided by (Responsible Party):
Shreya Kangovi, University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE April 29, 2011
First Posted Date  ICMJE May 3, 2011
Last Update Posted Date May 1, 2014
Study Start Date  ICMJE May 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2011)
Completion of Follow-up Appointment with PCP [ Time Frame: 14 days post discharge ]
We hypothesize that compared to patients who receive usual discharge planning, PaCT patients will have a higher proportion of follow-up to PCP within two weeks post-discharge, compared with usual discharge planning.
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2011)
Completion of Follow-up Appointment with PCP [ Time Frame: 14 days post discharge ]
We hypothesize that compared to patients who receive usual discharge planning, PaCT patients will have a higher proportion of follow-up to PCP within the time recommended by inpatient medical team, compared with usual discharge planning.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2013)
  • Morisky Medication Adherence scale. [ Time Frame: 14 days post-discharge ]
    We hypothesize that compared to patients with usual discharge planning, PaCT patients will have higher medication adherence as measured by the Morisky Medication Adherence scale.
  • Patient Activation Measure [ Time Frame: 14 days post discharge ]
    We hypothesize that compared to patients with usual discharge planning, PaCT patients will exhibit a higher level of patient activation as measured by the Patient Activation Measure.
  • Self-rated Health [ Time Frame: 14 days post-discharge ]
    We hypothesize that compared with usual discharge planning, PaCT patients will report better health as measured by the Short Form Health Survey (SF-12) at 14 days post-discharge.
  • Patient Satisfaction Questionnaire [ Time Frame: 14 days post discharge ]
    We hypothesize that compared with usual discharge planning, PaCT patients will report higher satisfaction as measured by the Patient Satisfaction Questionnaire (PSQ) at 14 days post-discharge.
  • Acute Care Reutilization [ Time Frame: 30 days post-discharge ]
    We hypothesize that compared with usual discharge planning, PaCT patients will have lower combined rates of unplanned readmissions at 30 days post-discharge
  • Quality of Discharge Planning [ Time Frame: 14 days post-discharge ]
    Hospital Consumer Assessment of Healthcare Providers and Systems Survey item pertaining to quality of verbal discharge communication
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2011)
  • Morisky Medication Adherence scale. [ Time Frame: 14 days post-discharge ]
    We hypothesize that compared to patients with usual discharge planning, PaCT patients will have higher medication adherence as measured by the Morisky Medication Adherence scale.
  • Patient Activation Measure [ Time Frame: 14 days post discharge ]
    We hypothesize that compared to patients with usual discharge planning, PaCT patients will exhibit a higher level of patient activation as measured by the Patient Activation Measure.
  • Self-rated Health [ Time Frame: 14 days post-discharge ]
    We hypothesize that compared with usual discharge planning, PaCT patients will report better health as measured by the Short Form Health Survey (SF-12) at 14 days post-discharge.
  • Patient Satisfaction Questionnaire [ Time Frame: 14 days post discharge ]
    We hypothesize that compared with usual discharge planning, PaCT patients will report higher satisfaction as measured by the Patient Satisfaction Questionnaire (PSQ) at 14 days post-discharge.
  • Acute Care Reutilization [ Time Frame: 30 days post-discharge ]
    We hypothesize that compared with usual discharge planning, PaCT patients will have lower combined rates of emergency room visits and unplanned readmissions at 30 days post-discharge
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IMPaCT (Individualized Management Towards Patient-Centered Targets)
Official Title  ICMJE A Randomized Controlled Trial of a Novel Community Health Worker Care Transitions Intervention.
Brief Summary The investigators propose a pilot randomized controlled trial of a care transitions intervention in which trained Community Health Workers will act as supports for socioeconomically vulnerable patients who are being discharged from the Hospital of the University of Pennsylvania and Presbyterian Hospital. CHWs or IMPaCT Partners will help patients to overcome the challenges of transition, including arranging primary care provider (PCP) follow-up, filling medication prescriptions and obtaining referrals to community-based social services. As our primary outcome, the investigators will examine the effect of the IMPaCT intervention on rates of primary care follow-up. The investigators will also examine the effect of IMPaCT on secondary outcome variables including patients' satisfaction with the experience of transition, quality of discharge communication, medication adherence, self- rated health, and inpatient readmission within 30 days after discharge.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE General Medical Inpatient Conditions
Intervention  ICMJE Behavioral: Patient-Centered Transition Intervention
Community Health Workers will act as PaCT Partners for uninsured/Medicaid patients who are being discharged from the Hospital of the University of Pennsylvania and Presbyterian Hospital. PaCT Partners will help patients to overcome the challenges of transition, including arranging primary care provider (PCP) follow-up, filling medication prescriptions and obtaining referrals to community-based social services.
Study Arms  ICMJE
  • Experimental: PaCT
    The Patient-Centered Transition Arm
    Intervention: Behavioral: Patient-Centered Transition Intervention
  • No Intervention: Control
    Control group patients will receive routine care from the admitting hospital, including routine patient management, and discharge planning.
Publications * Kangovi S, Mitra N, Grande D, White ML, McCollum S, Sellman J, Shannon RP, Long JA. Patient-centered community health worker intervention to improve posthospital outcomes: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):535-43. doi: 10.1001/jamainternmed.2013.14327.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 2, 2011)
513
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participant admitted to the General Medicine services of the Hospital of the University of Pennsylvania (HUP), or Presbyterian Hospital during the enrollment period
  2. Participant uninsured or insured by Medicaid at the time of discharge from the hospital
  3. Participant is 18-65 years old
  4. Participant is willing to participate and be contacted at 14 days post-discharge by telephone or through a home visit by research personnel (if no functioning telephone is present in the household)
  5. Participant resides in one of the following zip codes: 19104, 19131, 19139, 19143, 19146. These zip codes have the highest frequency of readmissions to HUP and Presbyterian Hospital
  6. Participant is English speaking

Exclusion Criteria:

  1. Patients with insurance other than Medicaid will be excluded as they are outside of the population of interest for this intervention targeted specifically at socioeconomically vulnerable patients. Dual eligible patients (Medicaid and Medicare) will be excluded. Patients older than 65 are eligible for the Transitional Care Model Intervention, which is a separate intervention offered at Penn Medicine hospitals.
  2. Non-English speaking participants will be excluded because in this pilot study, the study only has English-speaking PaCT personnel. In future studies, it will be important to study the effect of PaCT in non-English speaking populations.
  3. Patients outside of the target zipcodes are being excluded for feasibility reasons during this pilot study: with only two PaCT Partners, we are choosing to focus our resources on a geographic area that has the highest rates of readmissions in order to facilitate home visits.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01346462
Other Study ID Numbers  ICMJE IRB 813426
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Shreya Kangovi, University of Pennsylvania
Original Responsible Party Shreya Kangovi, MD, University of Pennsylvania
Current Study Sponsor  ICMJE University of Pennsylvania
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Pennsylvania
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP