N/A
N=202
Shared Decision-Making for Elderly Depressed Primary Care Patients
Depression
Bottom Line
View on ClinicalTrials.gov: NCT01031134 ↗Enrolled (actual)
202
Serious AEs
47.5%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants Who Adhered to Physician Recommended Treatment — 40; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Shared Decision Making (Behavioral); Usual Care (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Adhered to Physician Recommended Treatment |
40; 16 | — |
| SECONDARY Change in Hamilton Depression Rating Scale Scores |
-6.05; -7.35 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01031134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.