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Tailored Implementation Intervention for Managing Depressed Elderly Patients in Primary Care (TICD)

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ClinicalTrials.gov Identifier: NCT01913236
Recruitment Status : Completed
First Posted : August 1, 2013
Last Update Posted : August 3, 2016
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Sykehuset Innlandet HF

Tracking Information
First Submitted Date  ICMJE July 29, 2013
First Posted Date  ICMJE August 1, 2013
Last Update Posted Date August 3, 2016
Study Start Date  ICMJE September 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2013)
General practitioners'adherence to treatment recommendations [ Time Frame: 3-6 months after end of intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2013)
  • Patient improvement [ Time Frame: 3-6 months after end of intervention ]
    General practitioners' assessment of improvement
  • Patient improvement [ Time Frame: 3-6 months after end of intervention ]
    Patients' assessment of improvement from depressive and anxiety symptoms, assessment of sleep, adherence to medication, physical exercise and problem-solving abilities
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tailored Implementation Intervention for Managing Depressed Elderly Patients in Primary Care
Official Title  ICMJE A Pragmatic Cluster Randomised Trial of a Tailored Intervention for Implementing Recommendations for Managing Depressed Elderly Patients in Primary Care: Protocol
Brief Summary

Background The prevalence of depression is high and the elderly have an increased risk of developing a chronic course. International data suggest that depression in the elderly is under-recognised, the latency before clinicians provide a treatment plan is longer, and elderly patients with depression are not offered psychotherapy to the same degree as younger patients. Although recommendations for the treatment of elderly patients with depression exist, health care professionals adhere to these recommendations to a limited degree only. Investigators conducted a systematic review to identify recommendations for managing depression in the elderly and prioritised six recommendations. Investigators identified and prioritised determinants of practice related to implementation of these recommendations in primary care, and subsequently discussed and prioritised interventions to address the identified determinants. The objective of this study is to evaluate the effectiveness of these tailored implementation interventions to implement six recommendations for the management of elderly patients with depression in primary care.

Methods/design Investigators will conduct a pragmatic cluster randomised trial comparing implementation of the six recommendations using tailored interventions with usual care. Investigators will randomize 80 municipalities into one of two groups: an intervention group, to which investigators will deliver tailored interventions to implement the six recommendations, and a control group, to which investigators will not deliver any intervention. Investigators will randomise municipalities rather than patients, individual clinicians or practices because we will deliver the intervention for the first three recommendations at the municipal level and investigators want to minimise the risk of contamination across practices for the other three recommendations. The primary outcome is the proportion of general practitioners' behaviours which are consistent with the recommendations.

Discussion This trial will investigate whether a tailored implementation approach is an effective strategy to improve collaborative care in the municipalities and health care professionals' practice towards elderly patients with depression in primary care. The effectiveness evaluation described in this protocol will be accompanied with a process evaluation exploring why and how the interventions were effective or ineffective.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Depression
Intervention  ICMJE Other: Implementation intervention
Investigators will provide a comprehensive package of interventions to assist health care professionals to adhere to the recommendations. The package will include support for developing a collaborative care plan in the municipality, resources for general practitioners and other health care professionals, resources for patients, their relatives and volunteers,outreach visits to general practitioners' practices and their educational groups, educational resources and web-based resources.
Study Arms  ICMJE
  • Experimental: Implementation intervention
    Tailored implementation intervention to address determinants of practice in primary care
    Intervention: Other: Implementation intervention
  • No Intervention: Control
    Treatment as usual provided by general practitioners to elderly patients with depression
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2013)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Home-dwelling patients aged 65 or higher, who have a diagnosis of depression, according to International Statistical Classification of Diseases and Related Health Problems, Tenth Revision

Exclusion Criteria:

Patients will be excluded if they have a diagnosis of dementia, bipolar disorder or reside in nursing homes or is assessed by their practitioner to have low life expectancy.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 100 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01913236
Other Study ID Numbers  ICMJE 150204
258837 ( Other Grant/Funding Number: European Union Seventh Framework Program 2007-2013 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sykehuset Innlandet HF
Study Sponsor  ICMJE Sykehuset Innlandet HF
Collaborators  ICMJE European Union
Investigators  ICMJE
Principal Investigator: Michel Wensing, Professor
PRS Account Sykehuset Innlandet HF
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP