Peer-Driven Intervention for Sleep Apnea (PCORI)
|First Received Date ICMJE||February 3, 2014|
|Last Updated Date||February 4, 2014|
|Start Date ICMJE||January 2014|
|Estimated Primary Completion Date||January 2017 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Patient rating of sleep-specific services (Usual Care, Peer Buddy System) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
Patients will rate their global satisfaction of how satisfied they are with the care received from their sleep physician and sleep center on a 5-point scale: very satisfied, satisfied, neutral, dissatisfied, very dissatisfied
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT02056002 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Peer-Driven Intervention for Sleep Apnea|
|Official Title ICMJE||Peer-Driven Intervention as an Alternate Model of Care Delivery and Coordination for Sleep Apnea|
Fragmentation of care can lead to poor treatment adherence in patients with chronic medical conditions which can, in turn, lead to adverse health consequences, poor quality of life, and patient dissatisfaction. Poor treatment adherence may be due to lack of sufficient patient education, time delays in delivery of care, lack of adequate healthcare coordination, or difficulty accessing various healthcare providers across a front desk which serves as a "healthcare bottle-neck". Better efficiency in healthcare delivery, with greater connectivity through knowledgeable and trained peer volunteers and inexpensive cell-phones integrated by a smart telephone exchange may alleviate some of the care and communication burden faced by the healthcare system. Specifically, such community health education volunteers ("peer-buddies") who are experienced in managing their disease condition may be able to impart knowledge and confidence to a recently diagnosed patient in a much more personalized manner than that of a group therapy session. An additional important advantage is the peer-buddy's ability to relate to the patient in a manner consistent with their social, ethnic, and cultural believes without language barriers or differences that may stem from socioeconomic strata. We will use sleep apnea as an example condition to test the effect of a peer-buddy helper (combined with the universal availability of personal cell phones) on the problem of poor care coordination and treatment adherence to the "CPAP" treatment for sleep apnea. Sleep apnea is a very common condition that affects 7-12% of the US population, and if left untreated, can lead to poor health and even death through its effects on high blood pressure, heart disease, stroke, and motor vehicle accidents. Fortunately, CPAP therapy can lead to a 3-fold reduction in such consequences, but patient adherence to such CPAP treatment is generally poor. We have recently completed a small study that demonstrated improved usage of CPAP treatment by patients receiving help from a peer-buddy with excellent results. We propose to further enhance the "peer-buddy" community-volunteer concept in our proposed research by combining this with cell-phone technology and a telephone exchange that improves access to healthcare providers, technicians, and home care companies. We hope to show that active community participation by experienced "lay individuals" assisted by the universal availability of cheap cell-phones can improve the reach and effectiveness of our healthcare system in improving the health and well-being of our patients. If successful, such an innovative and community-based approach can be applied to other chronic medical conditions.
Hypothesis #1: We hypothesize that patients in the peer-driven intervention with interactive voice response (PDI-IVR) group will experience a greater patient satisfaction (measured by Likert scale64,70 and PACIC71,72) and perception of care coordination (measured by CPCQ72,73) than patients in the usual care (control) group.
Hypothesis #2: We hypothesize that patients in the PDI-IVR group will experience a greater CPAP adherence (measured by device download), patient activation (PAM), and self-efficacy (SEMSA) than patients in the usual care (control) group.
Hypothesis #3: We hypothesize that patients in the PDI-IVR group will experience greater improvements in HR-QOL (measured by FOSQ) vigilance (psychomotor vigilance testing) and blood pressure than patients in the usual care (control) group.
Peer-buddy system: Selection and Training of Peer-buddies: Fifty peer-buddies will be recruited from the four sleep clinics who are adherent to CPAP therapy. Peer buddies will be consented and compensated for their role in the research study ($350 for 6 month participation per subject). Each buddy may be paired with up to 12 subjects over the length of the study.
Training: PI and research staff will educate the peer buddy and provide them with guidelines for their interactions with the research participants. They will be instructed to share their experiences and not to provide medical advice. The sharing of coping strategies will fall under the following categories:
(i) Promote self efficacy: Strategies to deal with CPAP device and equipment (such as pressure ramp feature, humidifier settings, mask and strap application; and cleaning of device and related equipment). (ii) Promote outcome expectancies: Share their positive experiences with regards to effects of CPAP on energy level or vigilance, sense of well-being, hypertension control and other medical benefits that they possibly derived from CPAP therapy. (iii) Risk perception: Share their knowledge of perceived vulnerabilities due to untreated sleep apnea. Share methods for improving efficacy of CPAP equipment and interface (patient education). (iv) Patient activation: Share experiences of how to prepare for upcoming physician or respiratory therapist appointments, such as what questions to ask the healthcare provider, what to take with them (e.g., CPAP adherence card or malfunctioning device, humidifier, or mask, and what to expect at a given provider visit. At the end of the training, a mock interaction between the peer-buddy and PI (playing the role of the patient with OSA) will be undertaken before "certifying" or "graduating" the peer-buddy as competent.
Potential for inter-personal conflicts and management plan: The peer-buddy and research participant will be informed that they can withdraw from participation if there is a potential conflict or difficult situation (they feel threatened, face verbal abuse from subject, individual is too demanding, frequent calls or late night calls). The peer-buddy and subject starting CPAP will provide the research coordinator with an availability sheet as to when they are available to take phone calls and/or appear in person. Each peer-buddy will be paired up with one research participant, and may choose to take on up to 3 patients at a time and take on a new assignment at the end of the 6-month participation period. Peer-buddy and participant will be matched by age, gender, race, ethnicity, and socioeconomic status. The peer-buddies will be instructed not to offer medical advice. If a medical need or problem were to arise, the peer-buddies will be instructed to provide the research participant with the phone number to call the PI (via call operator) who will assess their medical needs and situation.
Fidelity assessments: Twenty percent of the telephonic communications between the peer-buddy and patient will be randomly recorded by IVR system for fidelity assessments by the behavioral therapist (Haynes, Co-investigator). Similarly, 20% of in-person visits will be assessed by the behavioral therapist. Such fidelity assessments will be used to increase fidelity (efficacy) during study.
In-person interactions: In-person interaction will occur on 2 occasions (30-minutes each) within the first 10 days of CPAP initiation. The research coordinator will be present during this interaction but will not be facilitating or running the interaction. A clean CPAP device and related supplies for the patient will need to be present during these interactions for demonstration purposes.
Telephonic IVR interactions: Once a week for the first month followed by 4 phone conversations over the subsequent 2 month period (8 scheduled telephonic interactions) and as needed in the subsequent 3 months. There will be no more than 10 such "as-needed" phone calls in the latter 3-months between participant and peer-buddy. Therefore, over the 6-months, there will not be in excess of 18 phone calls per subject assigned to peer-buddy. Each phone conversation will last a maximum of 30 minutes. The PDI-IVR system will be programmed to recognize the peer-buddy's phones (cell or home) and be programmed to link this with the patient's phones (cell or home) and thereby protect the privacy of both participants. The dyad of the peer-buddy and participant will introduce themselves on a first name basis and will not be required to provide other personal information. However, the study does not preclude them from sharing such information or developing long-lasting friendships. For each dyad, the research coordinator may monitor a few calls (with the participants' knowledge and random IVR-based recording) in order to monitor the content and level of participation between the dyad; however, the coordinators will not direct the participation in any way. Peer-buddies will share their experiences that would promote self-efficacy, outcome expectations, risk perception and patient activation. During in-person interactions, greater emphasis on promotion of self-efficacy will be placed, considering the physicality of the medical device (CPAP) therapy, masks, hoses, humidifiers, and filters. During phone interactions, greater emphasis on promotion of outcome expectancies, risk perception, and patient activation will be undertaken. The research coordinators may provide feedback to the peer-buddy regarding their performance and remind them to cover topics that were not covered in order to ensure fidelity. Either the patient or the peer-buddy (on behalf of the patient) can initiate calls to other members of the inter-disciplinary team, including obtaining CPAP adherence data through the IVR that was derived from the industry server (figure 2). Call backs from any of the providers (physician, RT, RN, DME representative, or sleep tech) will be connected back to the initiator of the call (Patient or peer-buddy). IVR-initiated queries regarding CPAP device - for adherence, leak, and efficacy [residual obstructive events] data - will be faxed to the sleep physician's office (or designee [RN or RT]) by the IVR with a note for patient call back. Content of interactions will pertain to OSA and CPAP therapy and related supplies (mask, hose, filters and humidifier). Content will include aspects pertaining to mask fitting, using ramp function on CPAP unit, using the CPAP humidification system, etc. Conversations regarding erectile dysfunction or a similar sensitive matter will be discouraged. Both peer-buddy and subject would have provided voluntary consent for sharing their experiences with CPAP therapy and sleep apnea. A checklist of content areas will be provided to the peer-buddy to ensure that such topical areas were discussed by the peer-subject pair. We will refrain from writing a script for the peer-buddy as we believe that would detract from the sense of bond or trust within the dyad.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Condition ICMJE||Obstructive Sleep Apnea|
|Study Arm (s)||
|Publications *||Parthasarathy S, Wendel C, Haynes PL, Atwood C, Kuna S. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. J Clin Sleep Med. 2013 Jun 15;9(6):543-50. doi: 10.5664/jcsm.2744.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||257|
|Estimated Completion Date||January 2017|
|Estimated Primary Completion Date||January 2017 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Inclusion Criteria for Subject:
Inclusion Criteria for Peer Buddy:
Exclusion Criteria for Subject:
Exclusion Criteria for Peer Buddy:
|Ages||18 Years to 85 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT02056002|
|Other Study ID Numbers ICMJE||R-IHS-1306-02505, PCORI|
|Has Data Monitoring Committee||Yes|
|Responsible Party||University of Arizona|
|Study Sponsor ICMJE||University of Arizona|
|Collaborators ICMJE||PCORI ( Patient Centered Outcomes Research Institute)|
|Information Provided By||University of Arizona|
|Verification Date||February 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP