Clinical trial NCT04575051: Hearing for Communication and Resident Engagement
Official title: HearCARE: Hearing for Communication and Resident Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Age-Related
Keywords: hearing loss, communication, social participation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-10-05
Enrollment: 684
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open cohort stepped-wedge cluster randomized design with a phased, randomized roll out
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Amplification is a well-established, evidence-based front-line treatment for those with impaired communication secondary to Age Related Hearing Loss (ARHL). ARHL is the most prevalent cause of communication impairment among older adults. The challenge in treating ARHL is identifying a care model that effectively promotes adherence to individualized-treatment recommendations allowing the end-user to self-manage hearing loss with appropriate support. This proposal compares the two most common models of care for ARHL provided to adults in assisted living/personal care communities. The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.

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: The study is employing an open cohort stepped-wedge cluster randomized design with a phased, randomized roll out. The stepped wedge design is a useful design for the evaluation of complex health care interventions particularly when the intervention is believed to be beneficial with minimal risk. This design is increasingly being used to evaluate interventions involving health care delivery and has several advantages:

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.

Eligibility criteria: Inclusion Criteria:

* Willingness to participate and
* Being a resident, staff member or family member of a resident at one of the participating Assisted Living/Personal Care Facilities.

Exclusion Criteria:

* Unwillingness to participate
* Not being a Resident, staff member or family member of a resident at one of eight Assisted Living/Personal Care Facilities.

Primary outcomes:
measure: Satisfaction With Social Participation
timeFrame: Baseline (T0), at 5 (T1), 10 (T2), 15 (T3), 20 (T4) and 25 (T5) months
measure: Hearing-Specific Health-Related Quality of Life
timeFrame: Baseline, at 5, 10, 15, 20 and 25 months
Secondary outcomes:
measure: Family Burden
timeFrame: Baseline, at 5, 10, 15, 20 and 25 months
measure: Staff Satisfaction
timeFrame: Baseline, at 5, 10, 15, 20 and 25 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Catherine Palmer, PhD
role: PRINCIPAL_INVESTIGATOR
References: