- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01237561
Translating The GOLD COPD Guidelines Into Primary Care Practice (LungAge)
31. mars 2017 oppdatert av: Donna R. Parker, Memorial Hospital of Rhode Island
This project will evaluate the translation of the Gold (the Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) COPD guidelines into primary care practice.
During phase I, a needs assessment will evaluate barriers and facilitators to implementation of COPD guidelines into clinical practice through focus groups of primary care patients and providers.
Using formative evaluation and feedback from the focus groups, three tools will be developed, refined and pilot tested.
The effectiveness of the materials developed in phase I will be tested in phase II (a randomized clinical trial conducted with one year of intervention within non-academic primary care practices) regarding physician performance of COPD guideline implementation and improvement in the clinically relevant outcomes (appropriate screening, diagnosis and management of COPD) compared to usual care.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
This project will evaluate the translation of the GOLD (the Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) COPD guidelines into primary care practice.
This study is based upon the premise that an informed, activated patient will interact with a prepared, proactive team to improve appropriate COPD screening, diagnosis and management.
During phase I, a needs assessment will evaluate barriers and facilitators to implementation of COPD guidelines into clinical practice through focus groups of primary care patients and providers.
Using formative evaluation and feedback from the focus groups, three tools will be developed, refined and pilot tested.
These include: a computerized patient activation tool that will be used by the patient either in the waiting room or in the examination room; a web-based, interactive COPD guidelines tool to be used by primary care providers as a decision support tool at the point of care and a COPD patient education toolbox to be used by the practice team.
During phase II, a block, randomized design cluster trial will be performed with one year of intervention within non-academic primary care practices (30 practices) throughout the state of Rhode Island and southeastern MA.
The effectiveness of the materials developed in phase I will be tested in phase II regarding physician performance of COPD guideline implementation and the improvement in the clinically relevant outcomes (appropriate screening, diagnosis and management of COPD) compared to usual care.
The investigators will also examine the use of a patient activation tool -'MyLungAge' to prompt patients to talk with their health care provider regarding their lung health and risk for COPD.
Products for dissemination from this grant will include the results of the focus groups barriers and facilitators to implementation and adherence to COPD guidelines, a computerized data collection module for quality of care assessment regarding COPD guidelines, a refined computerized patient activation tool, an enhanced web-based COPD interactive guideline tool, tailored academic detailing materials, and the results of the randomized clinical trial on the effectiveness of these tools to improve COPD guideline adherence in primary care practice.
Studietype
Intervensjonell
Registrering (Faktiske)
3593
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Rhode Island
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Pawtucket, Rhode Island, Forente stater, 02860
- Memorial Hospital of Rhode Island
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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
40 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- All patients 40 years or older
- Seen at least once in the past 2 years (active patients) by their PCP
- And/or 40 years of age and less than 81 years of age who smoke.
Exclusion Criteria:
- < 40 years of age
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: spirometry, patient activation tool
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Patient Activation Tool, Provider Web-based decision support tool, academic detailing
Andre navn:
|
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Ingen inngripen: Usual Care
Spirometer and spirometry training of staff
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adherence to COPD guidelines
Tidsramme: Twelve months post intervention
|
An adherence tool will be developed and reviewed by an expert panel.
They will review the suggested criterion and make recommendations regarding an item's status on the tool.
The panel may also suggest additional criteria for inclusion in the tool.
The tool will be modified based on expert consensus.
Once the tool is finalized, a detailed algorithm will be developed for scoring the primary care practice data which will include an adherence score for each visit and an overall adherence score and will be piloted the first 2 months of chart review.
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Twelve months post intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
patient activation
Tidsramme: Baseline and 12 months post intervention
|
A patient activation measure (PAM) developed by Hibbard et al. will be used to assess a patient's knowledge, skills and behaviors necessary to create an activated patient for managing their own health care.
The patient activation tool will also measure other co-morbidities and will be assessed during a telephone survey at baseline and on a subsample 12 months post-intervention.
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Baseline and 12 months post intervention
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Donna R Parker, Sc.D., MHRhode Island
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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)
1. oktober 2010
Primær fullføring (Faktiske)
25. oktober 2013
Studiet fullført (Faktiske)
25. oktober 2013
Datoer for studieregistrering
Først innsendt
8. november 2010
Først innsendt som oppfylte QC-kriteriene
8. november 2010
Først lagt ut (Anslag)
9. november 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. april 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. mars 2017
Sist bekreftet
1. mars 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 08-19
- R01HL093090 (U.S. NIH-stipend/kontrakt)
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