Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
684 participants
INTERVENTIONAL
2021-06-01
2023-11-01
Brief Summary
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The Engage Model is a chronic care approach to support hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist.
Detailed Description
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1. allowing the clinical teams to roll out the intervention in a small number of facilities in a timely, systematic manner (interventions are not part of the research protocol)
2. possibly increasing participation and buy-in since all facilities will eventually implement the intervention during the study
3. possible increase in statistical power compared to a cluster randomized trial due to increase in data collection and within cluster comparisons.
Our intervention is applied at the facility level (cluster) but the primary outcomes are obtained at the resident level. In this open cohort design, all residents in a facility are identified to participate but some may leave the facility and others will move into the facility over the course of the study. The interventions are standard care at UPMC and are at the facility and individual level regardless of participation in the research project by any individual.
The 10 facilities participating in the study all currently receive the Consult Model of care. These same facilities are targeted to receive the Engage Model of care over the next three years as part of the standard care in these facilities. Residents enrolled in the study during any time period will be followed until the end of the study or until they are no longer a resident of the facility, whichever comes first. This implies that crossover to the intervention is not only at the facility level but also the resident level. Once the intervention is available at a facility, residents will be exposed to the intervention continuously regardless of enrollment for the study measures. The resident level outcomes of satisfaction with social participation and hearing-specific HRQoL will be measured every 5 months for the duration of the study. In addition, staff satisfaction and family burden will be surveyed every 5 months.
NOTE: The clinicaltrials.gov record was updated after data collection ended to correct the study arms and interventions. The study arms were originally and incorrectly documented in clinicaltrials.gov as the resident, caregiver, and staff cohorts rather than the interventions.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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HearCARE (Consult+Engage)
Residents will be exposed to the Consult Model and the Engage Model.
Consult Model
The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.
Engage Model
The Engage Model is a chronic care approach to supportive hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist.
Consult Model
The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.
Consult Model
The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.
Interventions
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Consult Model
The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.
Engage Model
The Engage Model is a chronic care approach to supportive hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist.
Eligibility Criteria
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Inclusion Criteria
* Being a resident, staff member or family member of a resident at one of the participating Assisted Living/Personal Care Facilities.
Exclusion Criteria
* Not being a Resident, staff member or family member of a resident at one of eight Assisted Living/Personal Care Facilities.
60 Years
ALL
Yes
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Catherine Palmer
Professor
Principal Investigators
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Catherine Palmer, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HL-2019C1-16067
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY19120233
Identifier Type: -
Identifier Source: org_study_id