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

Primary Purpose

Implementation of a Chronic Disease Management Programme, COPD

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active implementation of a guideline for chronic disease
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Implementation of a Chronic Disease Management Programme focused on measuring Implementation strategy, Chronic disease management programme, COPD

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    No Intervention

    No Intervention

    Arm Label

    Intervention

    Control group

    External control

    Arm Description

    Patients from half the GP practices in Ringkoebing-Skjern municipality that participates in an active implementation of a guideline for COPD

    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

    Patients with GP practice in neighboring county Ikast-Brande where there have been no information or contact at all from the investigators

    Outcomes

    Primary Outcome Measures

    Changes in COPD-patients self reported-health, their evaluation of the health system and in the distribution of health resources.

    Secondary Outcome Measures

    Health professionals
    How health professionals perceive the implementation and how it influences their conception, interactions and culture.

    Full Information

    First Posted
    October 25, 2010
    Last Updated
    March 27, 2012
    Sponsor
    University of Aarhus
    Collaborators
    Research Unit for General Practice, Aarhus University, Ringkoebing-Skjern Municipality, Denmark., Region MidtJylland Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01228708
    Brief Title
    Effects of an Active Implementation of a Guideline for Chronic Obstructive Pulmonary Disease
    Official Title
    Effects of an Active Implementation of a Chronic Disease Management Programme for Patients With Chronic Obstructive Pulmonary Disease (COPD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    November 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus
    Collaborators
    Research Unit for General Practice, Aarhus University, Ringkoebing-Skjern Municipality, Denmark., Region MidtJylland Denmark

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Implementation of a Chronic Disease Management Programme, COPD
    Keywords
    Implementation strategy, Chronic disease management programme, COPD

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3021 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Active Comparator
    Arm Description
    Patients from half the GP practices in Ringkoebing-Skjern municipality that participates in an active implementation of a guideline for COPD
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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
    Arm Title
    External control
    Arm Type
    No Intervention
    Arm Description
    Patients with GP practice in neighboring county Ikast-Brande where there have been no information or contact at all from the investigators
    Intervention Type
    Other
    Intervention Name(s)
    Active implementation of a guideline for chronic disease
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Changes in COPD-patients self reported-health, their evaluation of the health system and in the distribution of health resources.
    Time Frame
    14 months
    Secondary Outcome Measure Information:
    Title
    Health professionals
    Description
    How health professionals perceive the implementation and how it influences their conception, interactions and culture.
    Time Frame
    14 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Margrethe IC Smidth, PT MSc
    Organizational Affiliation
    The Research Unit for General Practice Aarhus
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24090189
    Citation
    Smidth M, Christensen MB, Fenger-Gron M, Olesen F, Vedsted P. The effect of an active implementation of a disease management programme for chronic obstructive pulmonary disease on healthcare utilization--a cluster-randomised controlled trial. BMC Health Serv Res. 2013 Oct 3;13:385. doi: 10.1186/1472-6963-13-385.
    Results Reference
    derived
    PubMed Identifier
    24088417
    Citation
    Smidth M, Olesen F, Fenger-Gron M, Vedsted P. Patient-experienced effect of an active implementation of a disease management programme for COPD - a randomised trial. BMC Fam Pract. 2013 Oct 3;14:147. doi: 10.1186/1471-2296-14-147.
    Results Reference
    derived
    PubMed Identifier
    23882169
    Citation
    Smidth M, Christensen MB, Olesen F, Vedsted P. Developing an active implementation model for a chronic disease management program. Int J Integr Care. 2013 Jun 17;13:e020. doi: 10.5334/ijic.994. Print 2013 Apr.
    Results Reference
    derived
    PubMed Identifier
    22616576
    Citation
    Smidth M, Sokolowski I, Kaersvang L, Vedsted P. Developing an algorithm to identify people with Chronic Obstructive Pulmonary Disease (COPD) using administrative data. BMC Med Inform Decis Mak. 2012 May 22;12:38. doi: 10.1186/1472-6947-12-38.
    Results Reference
    derived

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

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