Depression
Conditions
Brief 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. 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.
Interventions
BEHAVIORALShared Decision Making
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.
OTHERUsual Care
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.
Sponsors
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Adhered to Physician Recommended Treatment | 12 weeks | Any mental health service use over 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale Scores | Baseline and 12 week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Shared Decision Making 1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Shared Decision Making: 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. | 114 |
| Usual Care Physician Usual Care of depressed patients.
Usual Care: 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. | 88 |
| Total | 202 |
Baseline characteristics
| Characteristic | Shared Decision Making | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 114 Participants | 88 Participants | 202 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 101 Participants | 83 Participants | 184 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 5 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 25 Participants | 59 Participants |
| Race (NIH/OMB) More than one race | 22 Participants | 9 Participants | 31 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 58 Participants | 53 Participants | 111 Participants |
| Region of Enrollment United States | 114 Participants | 88 Participants | 202 Participants |
| Sex: Female, Male Female | 92 Participants | 72 Participants | 164 Participants |
| Sex: Female, Male Male | 22 Participants | 16 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 114 | 0 / 88 |
| other Total, other adverse events | 0 / 114 | 0 / 88 |
| serious Total, serious adverse events | 49 / 114 | 47 / 88 |
Outcome results
Primary
Number of Participants Who Adhered to Physician Recommended Treatment
Any mental health service use over 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Shared Decision Making | Number of Participants Who Adhered to Physician Recommended Treatment | 40 Participants |
| Usual Care | Number of Participants Who Adhered to Physician Recommended Treatment | 16 Participants |
Secondary
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.
Time frame: Baseline and 12 week
Population: fewer number of participants in comparison to primary outcome measure reflect greater numbers of missing observations for the Hamilton outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shared Decision Making | Change in Hamilton Depression Rating Scale Scores | -6.05 units on a scale | Standard Deviation 7.03 |
| Usual Care | Change in Hamilton Depression Rating Scale Scores | -7.35 units on a scale | Standard Deviation 6.97 |