IMPaCT (Individualized Management Towards Patient-Centered Targets)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shreya Kangovi, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01346462
First received: April 29, 2011
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
General Medical Inpatient Conditions
Behavioral: Patient-Centered Transition Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial of a Novel Community Health Worker Care Transitions Intervention.

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Completion of Follow-up Appointment with PCP [ Time Frame: 14 days post discharge ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Morisky Medication Adherence scale. [ Time Frame: 14 days post-discharge ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Hospital Consumer Assessment of Healthcare Providers and Systems Survey item pertaining to quality of verbal discharge communication


Estimated Enrollment: 513
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PaCT
The Patient-Centered Transition Arm
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.
No Intervention: Control
Control group patients will receive routine care from the admitting hospital, including routine patient management, and discharge planning.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346462

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shreya Kangovi, Philadelphia Veterans Affairs Medical Center Special Fellow, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01346462     History of Changes
Other Study ID Numbers: IRB 813426
Study First Received: April 29, 2011
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014