Implementation Study of Dementia Guidelines in Primary Care

Dementia Clinical Trial

Official title:

How to Reach Evidence Based Practice in Diagnostic Assessment and Management of Dementia by General Practitioners and Primary Care Nurses? The Effectiveness of an EASYcare Based Educational Program.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00459784
• Other study ID #: EASYcareGIDS study
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2007
• Last updated: April 12, 2007
• Start date: November 2006
• Est. completion date: March 2008

Study information

• Verified date: April 2007
• Source: Radboud University
• Contact: Marieke Perry, MD
• Phone: 0031-24-3610142
• Email: m.perry[@]ger.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a specially developed Dementia Training Program for duos of general practitioners and primary care nurses is able to increase the number dementia diagnoses in elderly people living in the community and increase the adherence to clinical dementia guidelines

Description:

Background Early diagnosis of dementia benefits both patient and caregiver. Nevertheless, dementia in primary care is currently under-diagnosed in developed countries. In several countries educational interventions were developed to improve dementia diagnosis and management in primary care. Some of these interventions were successful in increasing the number of dementia diagnoses and in changing attitudes and knowledge of health care staff. However, none of these interventions focussed on collaboration between GPs and nurses in dementia care. We developed a Dementia Training Program (DTP) aimed at stimulating collaboration in dementia primary care. We expect it to increase the number of cognitive assessments and dementia diagnoses, as well as to improve attitudes and knowledge of GPs and nurses.

Methods/Design The DTP is a complex educational intervention and consists of 2 workshops, a coaching program, and case-based consultations either face-to-face or by phone or e-mail, access to an internet forum, and a Computerized Clinical Decision Support System on dementia diagnostics and management. 100 duos of GPs and nurses will be recruited, from which 2/3 will be allocated to the intervention group and 1/3 to the control group. The effects of implementation of the DTP will be studied in an assessor blinded cluster-randomised controlled trial. Primary outcomes are the number of cognitive assessments and dementia diagnosis in a period of 9 months, starting after workshop participation of the duos. Secondary outcomes are measured on GP and nurse level: rate of adherence to national guidelines for dementia diagnosis, attitude, confidence and knowledge regarding dementia diagnosis and management; on patient level: number of emergency calls, visits and consultations and patient satisfaction; and on caregiver level: informal caregiver burden and satisfaction. Data will be collected from GPs’ electronic medical dossiers, self registration forms and questionnaires. Statistical analysis will be performed by using MANOVA-method. Also, exploratory analyses will be performed, in order to gain insight into barriers and facilitators for implementation and the causal relations between the rate of success of the intervention components and the outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• GP and practice or district nurse must participate as a duo

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Dementia

Intervention

Procedure:
• Dementia Training Program

Locations

Country	Name	City	State
Netherlands	Geriatrie 925, Postbus 9101	Nijmegen

Sponsors (8)

Lead Sponsor	Collaborator
Radboud University	County of Gelderland, Health Valley, Netherlands, Kruiswerk West Veluwe, Sensire Winterwijk, Stichting Thuiszorgorganisatie Mawe Rivierenland, Stichting Thuiszorgorganisatie Midden-Gelderland, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of dementia diagnoses and cognitive assessments during 9 months
Secondary	Accuracy tot dementia guidelines, GP and nurse knowlegde and attitude and competence regarding dementia. Patient satisfaction, caregiver burden and satisfaction