Pragmatic trial of behavioral interventions for insomnia in hypertensive patients

University Of Pittsburgh At Pittsburgh, Pittsburgh PA

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): Insomnia is a prevalent, chronic, and inadequately-treated chronic medical condition associated with comorbid conditions such as hypertension (HTN) and a range of adverse health outcomes. Hypnotic medications are efficacious and widely available, but they have potentially serious adverse effects. Patients and providers prefer non-drug treatments such as Cognitive-Behavioral Treatment of Insomnia (CBT-I), which is safe, efficacious, and durable-but not widely available. Innovative use of electronic health records (EHR) to identify patients, and the availability of new technologies that enable cognitive-behavioral interventions to be delivered at scale, with high treatment fidelity, and at low cost, offer exciting opportunities to address these critical problems. In response to RFA-HL-14-019, we propose a low-cost, pragmatic, patient-centered, randomized controlled trial comparing two CBT-I-based interventions for insomnia with comorbid hypertension (INS+HTN) to primary care physicians' (PCP) usual care (UC). The setting will be University of Pittsburgh Medical Center (UPMC) primary care practices. Participants will be 625 adults with INS+HTN. Recruitment will be conducted using alerts in the EpicCare EHR triggered by patient characteristics (hypertension; hypnotic medications or insomnia diagnosis/problem). We will compare 3 interventions: Brief Behavioral Treatment of Insomnia (BBTI), involving electronic educational material and 4 telephone/web sessions with a live interventionist; Sleep Healthy Using The Internet (SHUTi), a self-guided, 8-module, Internet version of CBT-I, with no human contact; and UC. The primary outcome will be self-reported sleep at 3 months. Other outcomes include domains of symptoms, health, and patient/provider satisfaction obtained by self-report, home blood pressure monitoring (HBPM), and EHR. Specific Aims for the UH2 phase are: (1) To finalize institutional infrastructure and (2) To finalize the trial infrastructure. Specific Aims fr the UH3 phase are: (1) To compare interventions on patient-reported symptoms at 3, 6, and 12 months. The primary outcome is the PROMIS Sleep Disturbance scale at 3 months. Hypothesis: BBTI and CBT-I will be superior to UC on patient-reported outcomes. (2) To compare interventions on health indicators including self-report, HBPM, and EHR measures at 6 and 12 months. Hypothesis: BBTI and CBT-I will be superior to UC on each health outcome. (3) To compare patient and provider-level satisfaction with the 3 interventions. Hypothesis: BBTI and CBT-I will be superior to UC on patient and provider satisfaction. (4) Exploratory Aim: To compare BBTI and CBT-I on each outcome domain and intervention adherence/drop-outs. This proposal capitalizes on our expertise in traditional and internet insomnia interventions, collaboration with UPMC and primary care practices, and EHR-based recruitment; it addresses a significant health problem using a scalable model of screening and treatment; it assesses outcomes relevant to patients, providers, and health systems; it uses an innovative EHR recruitment strategy; and it integrates efficacious, low-cost, scalable, pragmatic sleep interventions into primary care settings.