Margolis 2013.
Methods | Randomised trial | |
Participants | 450 participants with hypertension (intervention 228: control 222) 16 primary care clinics in an integrated health system Minneapolis‐St. Paul, Minnesota, USA Year of study: March 2009 to not stated. |
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Interventions | Pharmacist telemonitoring intervention with remote BP measurement. Intervention patients received home monitors that store and transmit blood pressure (BP) data to a secure website through a modem. Pharmacists met with patients for 1 hour during which they reviewed the patient's relevant history, covered general points about hypertension, instructed them on using the home BP telemonitor system and the individualised home BP goal (i.e. < 135/85 mmHg or < 125/75 mmHg for patients with diabetes or kidney disease). 20 patients were instructed to transmit at least 6 BP measurements weekly (3 morning and evening). During the first 6 months of intervention, patients and pharmacists spoke every 2 weeks by phone until BP control was sustained for 6 weeks, then frequency was reduced to monthly. During intervention months 7 ‐ 12, phone visits were every 2 months. During telephone calls, pharmacists emphasised lifestyle changes and medication adherence. They assessed and adjusted antihypertensive drug therapy based on an algorithm using the percentage of home BP readings meeting the goal. Pharmacists communicated with patients' primary care teams through the electronic medical record following each visit. Duration: 12 months intervention, 18 months follow‐up |
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Outcomes | Systolic BP Diastolic BP |
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Notes | Study is cluster‐randomised by clinic, but all data after that is at patient level. Funding source: Grant received from the National Heart, Lung, and Blood Institute (R01HL090965). Conflict of interest: The sponsor had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; and preparation, review or approval of the manuscript. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The 16 primary care clinics were randomised to either the usual care (n = 8) or intervention (n = 8) arms. Clinics were blocked by size and clinic‐level baseline BP control in 2008 in order to balance those factors across study arms. Patients were linked to their primary care clinic by self‐report and were assigned to the intervention based on which clinic they attended, resulting in 228 patients assigned to TI and 222 patients assigned to UC. |
Allocation concealment (selection bias) | Low risk | All consenting patients and primary care providers were blinded to the study design and intervention assignment of the clinics, although each patient and their primary care provider were informed of their treatment assignment after randomisation. |
Blinding of participants and personnel (performance bias) All Outcomes/Outcome 1 | Low risk | Objective outcome measures. also, Quote: "Research clinic coordinators were not blinded to clinics’ treatment assignments, but were trained to treat patients in both study arms identically". |
Blinding of outcome assessment (detection bias) All Outcomes/Outcome 1 | Low risk | Quote: "Research clinic coordinators were not blinded to clinics’ treatment assignments, but were trained to treat patients in both study arms identically." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Between group attrition < 10%. Quote: "To account for missing data on continuous outcomes we used maximum likelihood based ignorable methods that yield valid inference when the outcome data are missing at random. We conducted sensitivity analyses adjusting for race and hypertension treatment, which showed some imbalance by study group" |
Selective reporting (reporting bias) | Low risk | All reported |
Other bias | Low risk | None |