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OpenTrials
Completed

NCT Number: NCT01346462

IMPaCT (Individualized Management Towards Patient-Centered Targets)

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.

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Key information

Conditions

General Medical Inpatient Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant admitted to the General Medicine services of the Hospital of the University of Pennsylvania (HUP), or Presbyterian Hospital during the enrollment period
  • Participant uninsured or insured by Medicaid at the time of discharge from the hospital
  • Participant is 18-65 years old
  • 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)
  • 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
  • Participant is English speaking

Exclusion criteria

  • 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.
  • 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.
  • 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.

Treatment and study plan

Patient-Centered Transition Intervention

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: PaCT

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 3, 2011
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.