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Effectiveness of Patient-centered Community Health Worker Support to Help Patients Control Chronic Disease

2 mei 2017 bijgewerkt door: University of Pennsylvania

Community Health Worker Support to Help Patients Control Chronic Disease

The purpose of this proposal is to compare the effectiveness of community health worker (CHW) support vs. usual primary care for helping chronically-ill, low-SES patients to improve control of chronic conditions. Upon enrollment each patient will select one of their multiple chronic conditions as a focus for the trial and work with his/her PCP to set a chronic disease management goal. Patients are then randomized to receive usual primary care vs. CHW support for moving towards that goal.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

302

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • University of Pennsylvania

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Patient of target practices for at least 1 yr defined as having one office visit within preceding 12 month
  • Home ZIP code including ANY of the following: 1. 19104 2. 19131 3. 19139 4. 19143 5. 19146
  • 2 or more of the following conditions: 1. Obesity (BMI greater than 30), 2. HTN (ICD9 relating to HTN in EMR), 3. DM (ICD9 relating to DM in EMR), 4. Asthma/COPD and tobacco dependence (ICD9 for asthma or COPD in EMR AND documentation of tobacco use)
  • Uninsured, insured by Medicaid or dually eligible for Medicaid/Managed Medicare
  • Patients who have scheduled appointments in the future.

Exclusion Criteria:

  • Will not provide informed consent for this study.
  • Does not have the capacity to provide informed consent for this study.
  • Previously enrolled in this study

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: CHW Goal Support
IMPaCT CHWs will perform the following functions, depending on the needs of the participants: 1) Deconstructing Distal Goals into Proximal Goals: IMPaCT CHWs will help patients to deconstruct collaborative distal clinical goals into patient driven proximal goals and develop strategies for achieving each proximal goal.2) Creating Roadmaps: Roadmaps are individualized strategies for achieving each proximal goal identified by patients. 3) IMPaCT CHWs conduct weekly follow-up with patients through either telephone or home visit in order to support the achievement of proximal goals. As part of these followup encounters, CHWs ask patients to measure their chronic disease control during their weekly followup calls/visits. 4) Group: CHWs and their Project Manager run a group session for patients in the IMPaCT arm. This group meets weekly and is a forum for patients to discuss common issues around chronic disease management and form a social support network.
IMPaCT CHWs will perform the following functions, depending on the needs of the participants: 1) Deconstructing Distal Goals into Proximal Goals: IMPaCT CHWs will help patients to deconstruct collaborative distal clinical goals into patient driven proximal goals and develop strategies for achieving each proximal goal.2) Creating Roadmaps: Roadmaps are individualized strategies for achieving each proximal goal identified by patients. 3) IMPaCT Partners conduct weekly follow-up with patients through either telephone or home visit in order to support the achievement of proximal goals. As part of these followup encounters, CHWs ask patients to measure their chronic disease control during their weekly followup calls/visits. 4) Group: CHWs and their Project Manager run a group session for patients in the IMPaCT arm. This group meets weekly and is a forum for patients to discuss common issues around chronic disease management and form a social support network.
Andere namen:
  • IMPaCT
Geen tussenkomst: Usual Primary Care
Patients will be encouraged to make follow-up appointments as needed with their primary care clinic for support towards their health goals. During these appointments, clinicians will help patients determine progress made on existing proximal goals, adjust goals based on self-efficacy, and help patients to create new proximal goals as needed. They will also work with PCPs to adjust medications when appropriate, provide health behavior education and make referrals to community-based services based on patient need.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in standardized score
Tijdsspanne: Six months after enrollment
Six months after enrollment, the IMPaCT arm will have a higher (more negative) mean change in standardized score for chronic disease outcome of interest compared with usual care
Six months after enrollment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Goal achievement
Tijdsspanne: Six months after enrollment
Six months after enrollment, patients in the IMPaCT group will have higher proportion of patients who achieve their individualized chronic disease management goal compared with usual care
Six months after enrollment
SF-12
Tijdsspanne: Six months after enrollment,
Six months after enrollment, patients in the IMPaCT group will greater improvements in their self-rated health (as measured by mean change in MCS and PCS of the SF-12) than patients receiving usual care.
Six months after enrollment,
CAHPS PCMH (Communication, Self-Management Support, Comprehensiveness of Care)
Tijdsspanne: Six months after enrollment
Six months after enrollment, the IMPaCT arm will have higher perceived quality of patient-centered medical care (as measured by the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey) than the usual care arm. Specifically, we will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care.
Six months after enrollment
Hospitalization
Tijdsspanne: 6 months after enrollment
Patients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 6 months after enrollment.
6 months after enrollment
Patient Activation
Tijdsspanne: Six months after enrollment
Six months after enrollment, patients in the IMPaCT arm will have greater improvements in their activation (as measured by mean change in PAM score) compared with patients in the usual care arm.
Six months after enrollment

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hospitalizations at 12 months
Tijdsspanne: 12 months after enrollment
Patients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 12 months after enrollment.
12 months after enrollment
Medical Adherence
Tijdsspanne: Six months after enrollment
Six months after enrollment, patients in the IMPaCT arm will have higher levels of adherence to medical recommendations than the usual care arm, as measured by the Medical Outcomes Study (MOS) Measures of Patient Adherence.
Six months after enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Shreya Kangovi, University of Pennsylvania

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2013

Primaire voltooiing (Werkelijk)

1 mei 2015

Studie voltooiing (Werkelijk)

1 februari 2017

Studieregistratiedata

Eerst ingediend

11 juli 2013

Eerst ingediend dat voldeed aan de QC-criteria

11 juli 2013

Eerst geplaatst (Schatting)

16 juli 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 mei 2017

Laatste update ingediend die voldeed aan QC-criteria

2 mei 2017

Laatst geverifieerd

1 mei 2017

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op CHW Goal Support

3
Abonneren