DepressionNCT01031134
Shared Decision-Making for Elderly Depressed Primary Care Patients
A study testing Shared Decision Making in people with Depression, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
Shared decision-making (SDM), in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Depression
- What is being tested?
- Shared Decision Making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age: 65 years and older;
- Medical outpatient presenting to Lincoln Hospital, Bronx NY, the New York City Health and Hospitals Corporation (HHC);
- Screen positive (PHQ-9 score>9 for depression, in addition to primary care physician recommendation for depression treatment.
Who cannot join
- Presence of significant alcohol or substance abuse, psychotic disorder, or bipolar disorder;
- High suicide risk, i.e. intent or plan to attempt suicide in near future;
- Current treatment with antidepressant medication or psychotherapy prior to index physician visit (with the exception of low doses of antidepressant medication for pain disorders);
- Cognitive impairment: MMSE score <20 or clinical diagnosis of dementia;
- Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver, or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs often causing depression, e.g., steroids, reserpine, alpha-methyl-dopa, tamoxifen, vincristine;
- Aphasia interfering with communication.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lincoln Hospital - the New York City Health and Hospitals Corporation (HHC)
The Bronx, New York, 10451
Cornell Institute of Geriatric Psychiatry
White Plains, New York, 10605
About this study
Shared decision-making (SDM), in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The proposed study will evaluate the impact of a brief SDM nursing intervention among elderly, depressed primary care patient subjects in comparison to physician recommended Usual Care. The focus of the SDM intervention is to empower depressed patients and help them arrive at a treatment decision that can be successfully carried out.
Read the detailed description
Shared Decision Making (SDM) may be particularly relevant for depressed individuals, as it seeks to enhance their autonomy and empowerment in a manner that directly addresses the helplessness and hopelessness associated with depression. Shared decision-making interventions are being developed for depression in primary care, but have yet to be adequately tested. It is also unknown whether the same premises regarding shared decision-making's ability to enhance autonomy and empowerment pertain to elderly populations.
This randomized study will recruit elderly depressed primary care patient subjects and evaluate the impact of a three-session SDM nursing intervention on their (1) adherence to antidepressant medication or psychotherapy and on (2) their reduction in depressive symptoms. The comparison group will be physician-recommended Usual Care (UC). The focus of the SDM intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
The study randomizes physicians to provide their depressed patients with SDM or UC. A total of 210 elderly depressed patient subjects whose physicians recommend starting depression treatment, will receive either Shared Decision-Making (SDM) or the physician recommended Usual Care (UC) comparison condition. Participants will be assessed at baseline and at weeks 4, 8, 12, and 24 to determine treatment adherence and depressive status. Nurses currently employed by the participating physicians will administer the SDM intervention.
- Conditions
- Depression
- Being tested
- Shared Decision Making, Usual Care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision MakingBehavioural
Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
Usual CareOther
Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision Making | Experimental | 1 in person session followed by 2 telephone calls 1 and 2 weeks later. Receives: Behavioral: Shared Decision Making |
| Usual Care | Active comparator | Physician Usual Care of depressed patients. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Adhered to Physician Recommended Treatment
Any mental health service use over 12 weeks.
Measured: 12 weeks
Secondary outcomes (1)
Change in Hamilton Depression Rating Scale Scores
Hamilton Depression Rating Scale change score from baseline to 12 weeks. This scale measures severity of depressive symptoms (range 0-76), with higher scores indicating more severe symptomatology.
Measured: Baseline and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startApr 2010
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Patrick J. Raue, Ph.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031134
- Sponsor's protocol ID
- 1R01MH084872-01A1
- Other IDs
- 1R01MH084872-01A1
- Status last verified
- Mar 2017
- First submitted
- 11 Dec 2009
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Raue PJ, Schulberg HC, Bruce ML, Banerjee S, Artis A, Espejo M, Catalan I, Romero S. Effectiveness of Shared Decision-Making for Elderly Depressed Minority Primary Care Patients. Am J Geriatr Psychiatry. 2019 Aug;27(8):883-893. doi: 10.1016/j.jagp.2019.02.016. Epub 2019 Mar 1.
PubMed 30967321
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision-Making for Elderly Depressed Primary Care Patients
- ClinicalTrials.gov ID
- NCT01031134
- Acronym / sponsor ID
- 1R01MH084872-01A1
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2010 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Dec 2009 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shared decision-making (SDM), in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The proposed study will evaluate the impact of a brief SDM nursing intervention among elderly, depressed primary care patient subjects in comparison to physician recommended Usual Care. The focus of the SDM intervention is to empower depressed patients and help them arrive at a treatment decision that can be successfully carried out.
Detailed description
Shared Decision Making (SDM) may be particularly relevant for depressed individuals, as it seeks to enhance their autonomy and empowerment in a manner that directly addresses the helplessness and hopelessness associated with depression. Shared decision-making interventions are being developed for depression in primary care, but have yet to be adequately tested. It is also unknown whether the same premises regarding shared decision-making's ability to enhance autonomy and empowerment pertain to elderly populations.
This randomized study will recruit elderly depressed primary care patient subjects and evaluate the impact of a three-session SDM nursing intervention on their (1) adherence to antidepressant medication or psychotherapy and on (2) their reduction in depressive symptoms. The comparison group will be physician-recommended Usual Care (UC). The focus of the SDM intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
The study randomizes physicians to provide their depressed patients with SDM or UC. A total of 210 elderly depressed patient subjects whose physicians recommend starting depression treatment, will receive either Shared Decision-Making (SDM) or the physician recommended Usual Care (UC) comparison condition. Participants will be assessed at baseline and at weeks 4, 8, 12, and 24 to determine treatment adherence and depressive status. Nurses currently employed by the participating physicians will administer the SDM intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared Decision Making | Experimental | Behavioral: Shared Decision Making1 in person session followed by 2 telephone calls 1 and 2 weeks later. |
| Usual Care | Active comparator | Other: Usual CarePhysician Usual Care of depressed patients. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age: 65 years and older;
- Medical outpatient presenting to Lincoln Hospital, Bronx NY, the New York City Health and Hospitals Corporation (HHC);
- Screen positive (PHQ-9 score>9 for depression, in addition to primary care physician recommendation for depression treatment.
Key exclusion criteria (6 listed)
- Presence of significant alcohol or substance abuse, psychotic disorder, or bipolar disorder;
- High suicide risk, i.e. intent or plan to attempt suicide in near future;
- Current treatment with antidepressant medication or psychotherapy prior to index physician visit (with the exception of low doses of antidepressant medication for pain disorders);
- Cognitive impairment: MMSE score <20 or clinical diagnosis of dementia;
- Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver, or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs often causing depression, e.g., steroids, reserpine, alpha-methyl-dopa, tamoxifen, vincristine;
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 |
|---|---|---|
| Shared Decision MakingShared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented. | Behavioural | Shared Decision Making |
| Usual CareUsual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual. | Other | Usual Care |
Primary outcome
Number of Participants Who Adhered to Physician Recommended Treatment
Time frame: 12 weeks
Any mental health service use over 12 weeks.
1 secondary outcome
Change in Hamilton Depression Rating Scale Scores
Time frame: Baseline and 12 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30967321Raue PJ, Schulberg HC, Bruce ML, Banerjee S, Artis A, Espejo M, Catalan I, Romero S. Effectiveness of Shared Decision-Making for Elderly Depressed Minority Primary Care Patients. Am J Geriatr Psychiatry. 2019 Aug;27(8):883-893. doi: 10.1016/j.jagp.2019.02.016. Epub 2019 Mar 1.
- Individual participant dataSharing planned: No
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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.
Patrick J. Raue, Ph.D. principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision Making in people with Depression, run by Weill Medical College of Cornell University at 2 sites in United States.
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 3 inclusion and 6 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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Adhered to Physician Recommended Treatment (time frame: 12 weeks). 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 NCT01031134, which also lists 1 linked publication.
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 16 Jun 2017.