General Medical Inpatient ConditionsPaCTNCT01346462
IMPaCT (Individualized Management Towards Patient-Centered Targets)
A study testing Patient-Centered Transition Intervention in people with General Medical Inpatient Conditions, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Medical Inpatient Conditions
- What is being tested?
- Patient-Centered Transition Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 513 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19103
About this study
Official title: 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.
- Conditions
- General Medical Inpatient Conditions
- Being tested
- Patient-Centered Transition Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Centered Transition InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| PaCT | Experimental | The Patient-Centered Transition Arm Receives: Behavioral: Patient-Centered Transition Intervention |
| Control | No intervention | Control group patients will receive routine care from the admitting hospital, including routine patient management, and discharge planning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days post discharge
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 14 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General Medical Inpatient ConditionsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 513 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shreya Kangovi, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346462
- Sponsor's protocol ID
- IRB 813426
- Acronym
- PaCT
- Status last verified
- Apr 2014
- First submitted
- 29 Apr 2011
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24515422
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Novel Community Health Worker Care Transitions Intervention.
- ClinicalTrials.gov ID
- NCT01346462
- Acronym / sponsor ID
- PaCT / IRB 813426
- Conditions
- General Medical Inpatient Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 513 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PaCT | Experimental | Behavioral: Patient-Centered Transition InterventionThe Patient-Centered Transition Arm |
| Control | No intervention | –Control group patients will receive routine care from the admitting hospital, including routine patient management, and discharge planning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-Centered Transition InterventionCommunity 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. | Behavioural | PaCT |
Primary outcome
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.
6 secondary outcomes
Morisky Medication Adherence scale.
Time frame: 14 days post-discharge
Patient Activation Measure
Time frame: 14 days post discharge
Self-rated Health
Time frame: 14 days post-discharge
Patient Satisfaction Questionnaire
Time frame: 14 days post discharge
Acute Care Reutilization
Time frame: 30 days post-discharge
Quality of Discharge Planning
Time frame: 14 days post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
- Derived from this study: PubMed 24515422Kangovi 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Centered Transition Intervention in people with General Medical Inpatient Conditions, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Follow-up Appointment with PCP (time frame: 14 days post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01346462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.