NCT01228708

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,021

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

1.2 years

First QC Date

October 25, 2010

Last Update Submit

March 27, 2012

Conditions

Keywords

Implementation strategyChronic disease management programmeCOPD

Outcome Measures

Primary Outcomes (1)

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

    14 months

Secondary Outcomes (1)

  • Health professionals

    14 months

Study Arms (3)

Intervention

ACTIVE COMPARATOR

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

Other: Active implementation of a guideline for chronic disease

Control group

NO INTERVENTION

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

External control

NO INTERVENTION

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

Interventions

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

Intervention

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Margrethe IC Smidth, PT MSc

    The Research Unit for General Practice Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 26, 2010

Study Start

August 1, 2009

Primary Completion

October 1, 2010

Study Completion

November 1, 2011

Last Updated

March 28, 2012

Record last verified: 2012-03