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Effects of an Active Implementation of a Guideline for Chronic Obstructive Pulmonary Disease

27. mars 2012 oppdatert av: University of Aarhus

Effects of an Active Implementation of a Chronic Disease Management Programme for Patients With Chronic Obstructive Pulmonary Disease (COPD)

Aims:

To design a proactive implementation strategy for a chronic-disease-management-programme.

To describe effects of the active implementation of a programme for COPD-patients measured on patient-related goals and use of health resources.

To describe stakeholders' evaluation of the implementation.

Materials and method:

An intervention study with 3000 COPD-patients cluster-randomized after a bloc-randomization of their GP-practice. 18 GP-practices in Ringkøbing-Skjern-Municipality are randomized to receive an active implementation or to an "as usual" group. A neighboring municipality acts as "sleeping" control. With data from registers and a questionnaire-survey the effect on COPD-patients self reported-health, evaluation of health system and changes in distribution of health resources is analyzed. How health professionals perceive the implementation and how it influences their conception, interactions and culture is illustrated by interviews with stakeholders.

We expect to see improved health related quality of life, enhanced evaluation of the health system and a more appropriate distribution of health resources in the intervention group.

Studieoversikt

Detaljert beskrivelse

BACKGROUND:

Health systems will manage more and more people with chronic diseases as life-expectancy increases and treatment options improve. As the need for resources increases, it will be vital that a targeted strategy for health care to this growing group is developed so all are offered a professional and efficient treatment and that resources are used equitable. A proactive strategy will secure that not only acute needs of patients, but the need of the whole population is served.

AIM:

To describe the process of implementation and the effects of Central Denmark Region's chronic disease management programme for COPD-patients.

METHOD:

This is an intervention study, where approximately 3000 COPD-patients will be cluster-randomized after a bloc-randomization of their GP-practice. 15 GP-practices in Ringkøbing-Skjern Municipality will be randomized to receive the focused implementation or to an "as usual" group.

Approximately 4000 COPD patients from a neighboring municipality with a similar profile will be a control group without any active implementation in any GP-practice and any contamination between GP-practices will therefore be eliminated.

THE INTERVENTION:

A proactive implementation strategy for the chronic disease management programme will be designed based on the literature and methods which have proven effective in implementing new ways of working when different stakeholders and cultures are involved.

Core intervention elements: GP-practice visits and education with focus on registration of smoking status and offering of smoking cessation, stratification of COPD patients according to health level or disease status, written referral from GP to community initiatives and written feedback to GP, discharge notice to GP from hospital, home visit by GP or practice nurse together with community nurse to plan care with newly discharged frail patients,

With data from registers and a questionnaire-survey the effect on COPD-patients self reported health, evaluation of the health system and changes in the distribution of health resources will be analyzed. How the health professionals in hospital, community-care and in GP-practices perceive the implementation and how it influences their conception, interactions and culture will be illustrated in an interview-survey of stakeholders.

Studietype

Intervensjonell

Registrering (Faktiske)

3021

Fase

  • Ikke aktuelt

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

35 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • People who live in either Ringkoebing-Skjern or Ikast-Brande municipalities and have a GP in the municipality and have been in hospital during the last 5 years with a lung related diagnosis or has redeemed a prescription for medication for lung related problems twice during the last year or has had at least two spirometries done during the last year.

Exclusion Criteria:

  • People who do not fit the above inclusion criteria

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Intervention
Patients from half the GP practices in Ringkoebing-Skjern municipality that participates in an active implementation of a guideline for COPD
Smoking cessation courses Remuneration to GPs for the planned follow-up and joint home visits Action card and sputum colour advice Webpage on "How to live with COPD" and the support the health system can provide Database with patients with COPD Feed-back from health centre to GPs, when patients have finished courses Fax from hospital to GPs, when patients with COPD is discharged Routines to recall patients for follow-ups Team audit, evaluate and adjust the strategies every 3rd month Joint home visit with GP and community nurse when a patient with COPD is discharged to plan future care Practice staff do part of follow-ups and monitoring Practice supervision with consultant in lung diseases Podcast with advice from specialists Guideline for COPD
Ingen inngripen: Control group
Patients from the half of the GP practice in Ringkoebing-Skjern that do not participate in the active implementation of a guideline for COPD. The GPs are however in postgraduate training groups with intervention groups GPs
Ingen inngripen: External control
Patients with GP practice in neighboring county Ikast-Brande where there have been no information or contact at all from the investigators

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Changes in COPD-patients self reported-health, their evaluation of the health system and in the distribution of health resources.
Tidsramme: 14 months
14 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Health professionals
Tidsramme: 14 months
How health professionals perceive the implementation and how it influences their conception, interactions and culture.
14 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Margrethe IC Smidth, PT MSc, The Research Unit for General Practice Aarhus

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

1. august 2009

Primær fullføring (Faktiske)

1. oktober 2010

Studiet fullført (Faktiske)

1. november 2011

Datoer for studieregistrering

Først innsendt

25. oktober 2010

Først innsendt som oppfylte QC-kriteriene

25. oktober 2010

Først lagt ut (Anslag)

26. oktober 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. mars 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. mars 2012

Sist bekreftet

1. mars 2012

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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