Title {1} | Reach Out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial |
Trial registration {2a and 2b}. | Identifier: NCT03422718 |
Protocol version [1] | Version 9.0; January 17, 2020 |
Funding {4} | Funded by National Institutes of Health, National Institutes of Minority Health and Disparities R01 MD011516 |
Author details {5a} | William J. Meurer1,2,3,4,5; Mackenzie Dinh1; Kelley M. Kidwell6; Adam Flood1; Emily Champoux2; Candace Whitfield1; Deborah Trimble1; Joan Cowdery7; Dominic Borgialli1,8; Sacha Montas1; Rebecca Cunningham1; Lorraine R. Buis4,9; Devin Brown2,3; Lesli Skolarus2,3 1. Department of Emergency Medicine, University of Michigan 2. Department of Neurology, University of Michigan 3. Stroke Program, University of Michigan 4. Institute for Healthcare Policy and Innovation, University of Michigan 5. Michigan Institute for Integrative Research in Critical Care (MCIRCC), University of Michigan 6. Department of Biostatistics, School of Public Health, University of Michigan 7. School of Health Promotion and Human Performance, Eastern Michigan University 8. Department of Emergency Medicine, Hurley Medical Center 9. Department of Family Medicine, University of Michigan |
Name and contact information for the trial sponsor {5b} | National Institute on Minority Health and Health Disparities (NIMHD) National Institutes of Health 6707 Democracy Boulevard, Suite 800 Bethesda, MD 20892–5465 Telephone: 301–402-1366 Fax: 301–480-4049 Email: NIMHDinfo@NIMHD.NIH.gov |
Role of sponsor {5c} | The study sponsor and funders provided peer review of the study design. The sponsor had/will have no role in the collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication. They will not have ultimate authority over any of these activities. |
Introduction
Background and rationale {6a}
Existing and preliminary data
Overview of reach out
Objectives {7}
Trial design {8}
Arm | Healthy behavior text | Prompted BP self-monitoring frequency | Facilitated Primary Care appointment scheduling and transportation |
---|---|---|---|
1 | No | Low | No |
2 | Yes | Low | No |
3 | No | High | No |
4 | Yes | High | No |
5 | No | Low | Yes |
6 | Yes | Low | Yes |
7 | No | High | Yes |
8 | Yes | High | Yes |
Texts | Comparison levels | Tailoring variables | Mechanism for BP reduction |
---|---|---|---|
Healthy behavior text | Daily vs. none | -No | -Decrease salt intake -Increase physical activity -Increase fruit and vegetable intake |
-Medical provider -BP medication -Self-efficacy | -Discuss with provider -Increase medication adherence | ||
Prompted BP self-monitoring frequency | Daily vs. weekly | -BP change (most recent self-reported BP) -BP control | -Participant activation -Participant autonomy -Participant competence |
Facilitated Primary Care appointment scheduling and transportation | Yes vs. none | -Medical provider -BP control | -Improve access to medical care -Opportunities for medication optimization |
METHODS: Participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion criteria
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Age of 18 or greater
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At least one BP with SBP ≥ 160 mmHG or DBP ≥ 100 mmHG (Criterion 1)
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If the patient has repeated measurements after achieving Criterion 1, at least one of the repeat BPs has a SBP ≥140 mmHG or DBP ≥90 mmHG
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Must have a cell phone with text-messaging capability and willingness to send and receive texts
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Likely to be discharged from the ED (not already admitted to hospital and medical provider from clinical team anticipates home disposition)
Exclusion criteria
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Unable to read English (< 1% anticipated at study site)
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Prisoner
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Pregnancy
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Pre-existing condition making 1-year follow-up unlikely
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Terminal illness with death expected within 90 days
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Current use of three or more antihypertensive agents
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Patients with other serious medical conditions that prevent self-monitoring of BP
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Critical illness with placement in resuscitation bay
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Dementia/cognitive impairment
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
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Proportion of participants achieving BP control
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Eighth Joint National Committee (JNC-8) targets for BP (< 140/90 mmHg)
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2017 American Heart Association (AHA) guidelines targets for BP (< 130/80 mmHg)
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Change in DBP and mean arterial pressure
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Change in 6-month SBP
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Number of interactions (such as calls/texts) required to schedule participants’ initial PCP visit
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Number of interactions to schedule all additional PCP visits
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Proportion of responses to BP request messages by the study system
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Proportion of participants enrolled but not randomized
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Establishment of a PCP among those without
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Number and proportion of PCP visits attended
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Proportion of transportation vouchers used
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Frequency and number of Hurley ED and other healthcare visits
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Self-reported follow-up within the Flint health system – Hurley, Hamilton, or community clinics
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Follow-up outside of the Flint health system – urgent care, outside clinics, outside EDs
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Self-reported changes in antihypertensive regimen
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Medication adherence (Hill-Bone Scale, and modified Hill-Bone instrument asking, “How often do you forget to take your BP medicine?”)
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Social Cognitive Theory (SCT) measures
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Modified one-question self-efficacy measure, “I am confident that I can take my blood pressure and text it to the Reach Out Team”)
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Questions querying self-efficacy, motivation, social support, and expertise.
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I am confident that I can control my blood pressure
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It is worthwhile for me to control my blood pressure
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My friends and family care if I control my blood pressure
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I know the right steps to take to control my blood pressure
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General intervention feedback
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Acceptability of Intervention Measure (AIM)
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Feasibility of Intervention Measure (FIM)
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