DepressionTICDNCT01913236
Tailored Implementation Intervention for Managing Depressed Elderly Patients in Primary Care
A study testing Implementation intervention in people with Depression, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Depression
- What is being tested?
- Implementation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pragmatic Cluster Randomised Trial of a Tailored Intervention for Implementing Recommendations for Managing Depressed Elderly Patients in Primary Care: Protocol
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.
- Conditions
- Depression
- Being tested
- Implementation intervention
- Keywords
- Tailored implementation interventions, Primary care, Depression in the elderly
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation interventionOther
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 group | Role | What they receive |
|---|---|---|
| Implementation intervention | Experimental | Tailored implementation intervention to address determinants of practice in primary care Receives: Other: Implementation intervention |
| Control | No intervention | Treatment as usual provided by general practitioners to elderly patients with depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
General practitioners'adherence to treatment recommendations
Measured: 3-6 months after end of intervention
Secondary outcomes (2)
Patient improvement
General practitioners' assessment of improvement
Measured: 3-6 months after end of intervention
Patient improvement
Patients' assessment of improvement from depressive and anxiety symptoms, assessment of sleep, adherence to medication, physical exercise and problem-solving abilities
Measured: 3-6 months after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Michel Wensing, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913236
- Sponsor's protocol ID
- 150204
- Other IDs
- 258837
- Acronym
- TICD
- Status last verified
- Jul 2013
- First submitted
- 29 Jul 2013
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21899753Flottorp 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.
PubMed 23522377Aakhus 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.
PubMed 22793810Aakhus 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.
PubMed 26956726Aakhus 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.
PubMed 26366193Aakhus 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.
PubMed 25431340Aakhus 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.
PubMed 24405891
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Cluster Randomised Trial of a Tailored Intervention for Implementing Recommendations for Managing Depressed Elderly Patients in Primary Care: Protocol
- ClinicalTrials.gov ID
- NCT01913236
- Acronym / sponsor ID
- TICD / 150204
- Conditions
- Depression
- Keywords
- Tailored implementation interventions, Primary care, Depression in the elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Sep 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation intervention | Experimental | Other: Implementation interventionTailored implementation intervention to address determinants of practice in primary care |
| Control | No intervention | –Treatment as usual provided by general practitioners to elderly patients with depression |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation interventionInvestigators 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. | Other | Implementation intervention |
Primary outcome
General practitioners'adherence to treatment recommendations
Time frame: 3-6 months after end of intervention
2 secondary outcomes
Patient improvement
Time frame: 3-6 months after end of intervention
Patient improvement
Time frame: 3-6 months after end of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Background: PubMed 21899753Wensing 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.
- Background: PubMed 23522377Flottorp 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.
- Background: PubMed 22793810Aakhus 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.
- Background: PubMed 26956726Aakhus 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.
- Background: PubMed 26366193Aakhus 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.
- Background: PubMed 25431340Aakhus 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.
- Derived from this study: PubMed 24405891Aakhus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Wensing, Professor principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation intervention in people with Depression, run by Sykehuset Innlandet HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General practitioners'adherence to treatment recommendations (time frame: 3-6 months after end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01913236, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.