CPAP Population Management

NCT04559737 | Unknown

• 1 other identifier: KPSleep-005
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a study to formally compare two Continuous Positive Airway Pressure (CPAP) follow-up pathways: 1) Usual care - follow-up visits reflect standard care practice and we rely on patients to reach out to us if they are struggling with therapy (there will be no active outreach); 2) Case Management - in addition to "Usual Care" visits, patients CPAP use will be monitored and further encounters may be initiated with "struggler" CPAP users while "successful" users are passively followed. The investigators will evaluate measures of CPAP adherence, patient engagement and cost-effectiveness for the duration of 1 year. Our hypothesis is that "Case Management" will improve CPAP adherence and cost-effectiveness compared to "Usual Care". The investigators also hypothesize that targeting "strugglers" only in a management by exception (MBE) approach will be equally effective, but require less personnel time compared to targeting "all" patients.

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

Case Management (CM); Management by Exception; Continuous Positive Airway Pressure (CPAP); CPAP Adherence; Auto-monitoring; Patient Engagement; Patient Acceptance; Cost-Effective

Outcome Measures

Primary Outcomes (1)

• PAP Adherence

  Evaluate the impact each arm (Usual Care \& Case Management) has on PAP adherence.

  1 year

Secondary Outcomes (1)

• Healthcare Provider Effort

  1 year

Other Outcomes (1)

• Patient Satisfaction

  1 year

Study Arms (2)

Usual Care

NO INTERVENTION

Patients will receive Auto-Monitoring text messages. The Auto-Monitoring tool that will be used is a function within Somnoware (Somnoware, Inc.) patient management platform, which is the national KP benchmarked platform for sleep management software. Fixed scheduled follow-up visits will be scheduled at 1-month (telephone encounter), 3-months (in-person or video encounter), and 1-year (in-person or video encounter). This sequence of follow-up visits reflects current real-world practice. Patients are eligible for additional visits when self-initiated. Sleep questionnaires will be delivered at 1, 3, and 6 months and at 1 year.

Case Management

ACTIVE COMPARATOR

Patients will undergo the same follow-up process as described in the Usual Care Pathway. A population CM dashboard (Somnoware, Inc.) will be used to automatically identify PAP strugglers (defined as \<70% nights with ≥4 hours use during the preceding month) for 1 year. Video encounters will be triggered for these select patients for troubleshooting. Additionally, throughout this 1-year period, Q1 window of \<70% nights \>4 hours will trigger a phone call and at the discretion of the case manager convert to video or in-person encounter for troubleshooting. CPAP Follow-Up Questionnaire will also be delivered to patient at 3 months and 1 year.

Other: Case Management

Interventions

Case Management OTHER

Population management platforms capable of automatically risk stratifying patients (eg, automatically identifying poor users) may be another cost-effective technology-based tool by enabling a "management by exception" (MBE) follow-up intervention. This intervention concentrates provider effort on patients most at need by allowing providers to passively observe successful users and actively intervene only in CPAP strugglers. Therefore, in addition to "Usual Care" we will implement this population management process by identifying CPAP strugglers only and further follow-up encounters will be triggered for these select patients for troubleshooting. Additionally, throughout the 1-year period, Q1 window of \<70% nights \>4 hours will trigger a phone call and at the discretion of the sleep provider convert to video or in-person encounter for troubleshooting. CPAP Follow-Up Questionnaire will also be delivered to patient at 3 months and 1 year.

Case Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kaiser Permanente member
• Moderate-Severe Obstructive Sleep Apnea diagnosis (AHI4%≥15 on home sleep apnea test \[Nox T3 or WatchPAT\] or polysomnography (in-lab study)
• PAP therapy clinically recommended and prescribed for home therapy of OSA
• Adults (age ≥ 18 years)

You may not qualify if:

• Chronic respiratory failure requiring bilevel PAP ventilatory support or addition of oxygen supplementation.
• Prior use of PAP prescribed for home therapy.
• Inability wirelessly connect patient's PAP device.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Sleep Center

Fontana, California, 92335, United States

Location

Related Publications (5)

• The Economic Cost of Sleep Disorders in Australia. Sleep Health Foundation. Deloitte Access Economics. 2010.

  BACKGROUND

• Kribbs NB, Pack AI, Kline LR, Smith PL, Schwartz AR, Schubert NM, Redline S, Henry JN, Getsy JE, Dinges DF. Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea. Am Rev Respir Dis. 1993 Apr;147(4):887-95. doi: 10.1164/ajrccm/147.4.887.

  PMID: 8466125 BACKGROUND

• Iftikhar IH, Valentine CW, Bittencourt LR, Cohen DL, Fedson AC, Gislason T, Penzel T, Phillips CL, Yu-sheng L, Pack AI, Magalang UJ. Effects of continuous positive airway pressure on blood pressure in patients with resistant hypertension and obstructive sleep apnea: a meta-analysis. J Hypertens. 2014 Dec;32(12):2341-50; discussion 2350. doi: 10.1097/HJH.0000000000000372.

  PMID: 25243523 BACKGROUND

• Iftikhar IH, Hoyos CM, Phillips CL, Magalang UJ. Meta-analyses of the Association of Sleep Apnea with Insulin Resistance, and the Effects of CPAP on HOMA-IR, Adiponectin, and Visceral Adipose Fat. J Clin Sleep Med. 2015 Apr 15;11(4):475-85. doi: 10.5664/jcsm.4610.

  PMID: 25700870 BACKGROUND

• Fox N, Hirsch-Allen AJ, Goodfellow E, Wenner J, Fleetham J, Ryan CF, Kwiatkowska M, Ayas NT. The impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. 2012 Apr 1;35(4):477-81. doi: 10.5665/sleep.1728.

  PMID: 22467985 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Patient Participation

Interventions

Case Management

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Dennis Hwang, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Hwang, MD

CONTACT

909-427-4432; dennis.x.hwang@kp.org

Jessica Arguelles, BS

CONTACT

909-427-3032; jessica.arguelles@kp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Service

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: September 23, 2020
• Study Start: July 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 6, 2022

Record last verified: 2022-07

Locations

US (1)