Bogner 2008.
Methods | Study design: Pilot randomised controlled trial | |
Participants | Setting: Primary care Diagnosis: A diagnosis of depression or a prescription for an antidepressant medication within the past year Inclusion criteria: Aged 50 years and older, a systolic blood pressure of 140 mm Hg or greater or diastolic blood pressure of 90 mm Hg or greater for non‐diabetic patients, or a systolic blood pressure of 130 mm Hg or greater or a diastolic blood pressure of 80 mm Hg or greater for patients with diabetes on at least 2 visits in the previous year, or a prescription for an antihypertensive medication within the past year Exclusion criteria: Cognitive impairment, unable to communicate in English, residing in a care facility that provides medications on a schedule, unable to use Medication Event Monitoring System (MEMS) caps (AARDEX, Zug, Switzerland), which are microelectronic monitoring devices Age: Mean 58.6 (SD 6.8) years Gender: 77% female Ethnicity: 83% African American Country: Unitd States Sample size (randomised): Total participants 64, intervention 32, control 32 |
|
Interventions | Intervention: Integrated care Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Family physician (PCP), research co‐ordinator (CM), academic PCP (MH specialist) 2) a structured management plan: Intervention focused on depression and hypertension and aimed to promote patients’ adherence to antihypertensive and AD treatment. CM collaborated with physicians to help patients understand and recognise depression in the context of hypertension, offered patients guideline‐based treatment recommendations, monitored treatment adherence and clinical status, assessed for side‐effects and assistance in their management, and provided appropriate follow‐up or referral. Individualised programme congruent with patients’ social and cultural context. 3) scheduled patient follow‐ups: 3 face‐to‐face, 2 phone contacts in 4‐week period 4) enhanced inter‐professional communication: CM acted as liaison between the PCP and patient to help patients recognise depression in the context of hypertension. CM received weekly supervision from MH specialist Control: Treatment as usual |
|
Outcomes | Depression (CES‐D): 2, 4, 6, 12 weeks Medication use: 2, 4, 6 weeks |
|
Notes | AD: antidepressant; CES‐D: Centre for Epidemiological Studies Depression; CM: case manager; MH: mental health; PCP: primary care provider; SD: standard deviation | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information available to assess |
Allocation concealment (selection bias) | Unclear risk | Insufficient information available to assess |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Short‐term loss to follow‐up based on primary depression outcome (CES‐D) was: overall 0/64 (0%), 0/32 (0%) intervention and 0/32 (0%) control Intention‐to‐treat analysis not reported |
Selective reporting (reporting bias) | Unclear risk | Insufficient information available to assess |
Other bias | Unclear risk | Insufficient information available to assess |
Implementation Integrity | Low risk | Attempts were made to assess implementation integrity (e.g. direct observation or rating of tapes) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel could not be blinded, outcome likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information available to assess |