Tailored Implementation Intervention for Managing Depressed Elderly Patients in Primary Care

NCT ID: NCT01913236

Last Updated: 2016-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-02-28

Brief Summary

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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

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Implementation intervention

Tailored implementation intervention to address determinants of practice in primary care

Group Type EXPERIMENTAL

Implementation intervention

Intervention Type OTHER

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.

Control

Treatment as usual provided by general practitioners to elderly patients with depression

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Union

OTHER

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel Wensing, Professor

Role: PRINCIPAL_INVESTIGATOR

Locations

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Knowledge Centre for the Health Services

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

References

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Wensing M, Oxman A, Baker R, Godycki-Cwirko M, Flottorp S, Szecsenyi J, Grimshaw J, Eccles M. Tailored Implementation For Chronic Diseases (TICD): a project protocol. Implement Sci. 2011 Sep 7;6:103. doi: 10.1186/1748-5908-6-103.

Reference Type BACKGROUND
PMID: 21899753 (View on PubMed)

Flottorp SA, Oxman AD, Krause J, Musila NR, Wensing M, Godycki-Cwirko M, Baker R, Eccles MP. A checklist for identifying determinants of practice: a systematic review and synthesis of frameworks and taxonomies of factors that prevent or enable improvements in healthcare professional practice. Implement Sci. 2013 Mar 23;8:35. doi: 10.1186/1748-5908-8-35.

Reference Type BACKGROUND
PMID: 23522377 (View on PubMed)

Aakhus E, Flottorp SA, Oxman AD. Implementing evidence-based guidelines for managing depression in elderly patients: a Norwegian perspective. Epidemiol Psychiatr Sci. 2012 Sep;21(3):237-40. doi: 10.1017/S204579601200025X. Epub 2012 May 22.

Reference Type BACKGROUND
PMID: 22793810 (View on PubMed)

Aakhus E, Granlund I, Odgaard-Jensen J, Oxman AD, Flottorp SA. A tailored intervention to implement guideline recommendations for elderly patients with depression in primary care: a pragmatic cluster randomised trial. Implement Sci. 2016 Mar 9;11:32. doi: 10.1186/s13012-016-0397-3.

Reference Type BACKGROUND
PMID: 26956726 (View on PubMed)

Aakhus E, Granlund I, Oxman AD, Flottorp SA. Tailoring interventions to implement recommendations for the treatment of elderly patients with depression: a qualitative study. Int J Ment Health Syst. 2015 Sep 12;9:36. doi: 10.1186/s13033-015-0027-5. eCollection 2015.

Reference Type BACKGROUND
PMID: 26366193 (View on PubMed)

Aakhus E, Oxman AD, Flottorp SA. Determinants of adherence to recommendations for depressed elderly patients in primary care: a multi-methods study. Scand J Prim Health Care. 2014 Dec;32(4):170-9. doi: 10.3109/02813432.2014.984961. Epub 2014 Nov 28.

Reference Type BACKGROUND
PMID: 25431340 (View on PubMed)

Aakhus E, Granlund I, Odgaard-Jensen J, Wensing M, Oxman AD, Flottorp SA. Tailored interventions to implement recommendations for elderly patients with depression in primary care: a study protocol for a pragmatic cluster randomised controlled trial. Trials. 2014 Jan 9;15:16. doi: 10.1186/1745-6215-15-16.

Reference Type DERIVED
PMID: 24405891 (View on PubMed)

Other Identifiers

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258837

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

150204

Identifier Type: -

Identifier Source: org_study_id

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