Clinical trial NCT01346462: IMPaCT (Individualized Management Towards Patient-Centered Targets)
Official title: A Randomized Controlled Trial of a Novel Community Health Worker Care Transitions Intervention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Medical Inpatient Conditions
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2011-05-03
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: Completion of Follow-up Appointment with PCP
timeFrame: 14 days post discharge
Secondary outcomes:
measure: Morisky Medication Adherence scale.
timeFrame: 14 days post-discharge
measure: Patient Activation Measure
timeFrame: 14 days post discharge
measure: Self-rated Health
timeFrame: 14 days post-discharge
measure: Patient Satisfaction Questionnaire
timeFrame: 14 days post discharge
measure: Acute Care Reutilization
timeFrame: 30 days post-discharge
measure: Quality of Discharge Planning
timeFrame: 14 days post-discharge
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
citation: 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.