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

A Randomized Controlled Trial of a Novel Community Health Worker Care Transitions Intervention.

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.

Study Overview

• Status: Completed
• Conditions: General Medical Inpatient Conditions
• Intervention / Treatment: Behavioral: Patient-Centered Transition Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 513
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of Follow-up Appointment with PCP	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.	14 days post discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morisky Medication Adherence scale.	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.	14 days post-discharge
Patient Activation Measure	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.	14 days post discharge
Self-rated Health	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.	14 days post-discharge
Patient Satisfaction Questionnaire	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.	14 days post discharge
Acute Care Reutilization	We hypothesize that compared with usual discharge planning, PaCT patients will have lower combined rates of unplanned readmissions at 30 days post-discharge	30 days post-discharge
Quality of Discharge Planning	Hospital Consumer Assessment of Healthcare Providers and Systems Survey item pertaining to quality of verbal discharge communication	14 days post-discharge

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 29, 2011
• First Submitted That Met QC Criteria: May 2, 2011
• First Posted (Estimate): May 3, 2011

Study Record Updates

• Last Update Posted (Estimate): May 1, 2014
• Last Update Submitted That Met QC Criteria: April 30, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: IRB 813426