Coordinating Pragmatic Primary Care Population Management for Obesity (C3PO)
28. januar 2022 oppdatert av: Ronald Ackermann, Northwestern University
The C3PO pilot and feasibility study uses a rigorous, mixed-method research design to provide information needed to refine and implement a technology-mediated primary care outreach intervention approach before conducting a larger and more definitive future intervention trial.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study will implement and evaluate a pragmatic and generalizable framework for population management of obesity by the primary care sector.
With patient and other stakeholder input, the C3PO intervention will be designed to leverage existing primary care professionals and technologies to implement a scalable framework for population obesity management that coordinates primary care services with extant intensive lifestyle interventions in community settings to achieve wider reach and population-level effectiveness.
A rigorous, mixed-method pilot and feasibility study will provide critical information needed to optimize the intervention design and prepare us for a larger and definitive future trial.
Studietype
Intervensjonell
Registrering (Faktiske)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern Medicine
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- BMI ≥ 27 kg/m2
- ≥ 1 CVD risk condition (hypertension, dyslipidemia, prediabetes or type 2 diabetes)
- Registered in Northwestern Medical Group's EpicCare MyChart patient portal
- Received and completed MyChart survey of weight loss interest
- Affirms interest in weight loss goal setting and receiving additional resource information and electronic Scale.
Exclusion Criteria:
- Evidence of hospitalization in past 30 days
- Most recent blood pressure >180/105
- Cancer (non-skin) treatment within the past 2 years
- Encounter diagnosis for hypoglycemia in past 30 days
- Actively receiving care from the bariatric surgery service or a bariatric medication order in the past 100 days
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Basic Resources and Services
Patients will receive outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community
|
Patients will receive a MyChart activation message assessing weight loss interest that invites them to complete a MyChart Survey encouraging a weight loss goal using principles adapted from Brief Action Planning.
Patients will then receive a cellular network-enabled electronic body weight scale, and weighing data transmitted by the scale will be received and integrated into the electronic health record for access by the patient's primary care team.
Patients will receive via MyChart information and decision support designed to encourage linkages to and participation in intensive lifestyle programs available in the community.
Patients who request information or clinical referrals will also receive them.
"Refreshes" of community linkage information will be sent by MyChart every 1 to 4 weeks.
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Eksperimentell: Coordinated Primary Care Population Management (C3PO)
Patients will receive outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
Patients will receive a MyChart activation message assessing weight loss interest that invites them to complete a MyChart Survey encouraging a weight loss goal using principles adapted from Brief Action Planning.
Patients will then receive a cellular network-enabled electronic body weight scale, and weighing data transmitted by the scale will be received and integrated into the electronic health record for access by the patient's primary care team.
Patients will receive via MyChart information and decision support designed to encourage linkages to and participation in intensive lifestyle programs available in the community.
Patients who request information or clinical referrals will also receive them.
"Refreshes" of community linkage information will be sent by MyChart every 1 to 4 weeks.
Data received into the electronic health record from the cellular network-enabled electronic scale will categorize each patient based on their daily self-weighing behaviors and rate of progress towards their weight loss goal.
Patients who are not engaged in daily self-weighing or are not making progress towards their goal will receive more intensive outreach support in the form of automated weekly MyChart problem solving messages, more frequent encouragement to access a broader array of community resources, and telephonic support from a nurse care coordinator who is an existing member of the primary care team.
Support from this nurse care coordinator will be facilitated by the incorporation of each patient's self-weighing data into an EpicCare patient dashboard accessible to the nurse coordinator and other members of the care team
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months
Tidsramme: Baseline - 6 Months
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Proportion of Participants who Reach a 5% Weight Loss Goal at 6 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 6 months (kg))/(Baseline body mass (kg))
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Baseline - 6 Months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Costs to Implement the Intervention
Tidsramme: Baseline - 12 Months
|
Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components
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Baseline - 12 Months
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Change in Hemoglobin A1C
Tidsramme: Baseline - 12 Months
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Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months
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Baseline - 12 Months
|
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Change in Systolic Blood Pressure
Tidsramme: Baseline - 12 Months
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Mean change in systolic blood pressure (mmHg) from baseline to 12 months
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Baseline - 12 Months
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Change in Total Cholesterol
Tidsramme: Baseline - 12 Months
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Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months
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Baseline - 12 Months
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Change in Non-HDL Cholesterol
Tidsramme: Baseline - 12 Months
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Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months
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Baseline - 12 Months
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Body Mass Change at 6 Months
Tidsramme: Baseline - 6 Months
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Mean Change in Body Mass (kg) from Baseline to 6 Months
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Baseline - 6 Months
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Body Mass Change at 12 Months
Tidsramme: Baseline - 12 Months
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Mean Change in Body Mass (kg) from Baseline to 12 Months
|
Baseline - 12 Months
|
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Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months
Tidsramme: Baseline - 12 Months
|
Proportion of Participants who Reach a 5% Weight Loss Goal at 12 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 12 months (kg))/(Baseline body mass (kg))
|
Baseline - 12 Months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
16. desember 2019
Primær fullføring (Faktiske)
30. juni 2020
Studiet fullført (Faktiske)
30. juni 2021
Datoer for studieregistrering
Først innsendt
21. juni 2019
Først innsendt som oppfylte QC-kriteriene
24. juni 2019
Først lagt ut (Faktiske)
25. juni 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. februar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. januar 2022
Sist bekreftet
1. januar 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STU00207153
- R34DK114773 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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