HearCARE: Hearing for Communication and Resident Engagement

Sponsor
University of Pittsburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT04575051
Collaborator
Patient-Centered Outcomes Research Institute (Other)
520
Enrollment
1
Location
3
Arms
23
Anticipated Duration (Months)
22.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Consult followed by Engage Model at 5 Months
  • Behavioral: Consult followed by Engage Model at 10 Months
  • Behavioral: Consult followed by Engage Model at 15 Months
  • Behavioral: Consult followed by Engage Model at 20 Months
N/A

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 8 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
520 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Open cohort stepped-wedge cluster randomized design with a phased, randomized roll outOpen cohort stepped-wedge cluster randomized design with a phased, randomized roll out
Masking:
Single (Outcomes Assessor)
Masking Description:
The data collectors will be masked to which phase the facility is in.
Primary Purpose:
Health Services Research
Official Title:
HearCARE: Hearing for Communication and Resident Engagement
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Residents

Residents will be exposed to the Consult Model and then the Engage Model. Hearing Specific Quality of Life and Satisfaction with Social Participation are the outcome measures. Hearing Specific Quality of Life is measured using the HHIE with a range of scores from 0-40 with a lower score revealing less handicap. Satisfaction with Social Participation is measured using the Satisfaction with Participation in Discretionary Social Activities Short form 7a with a range of scores from 7-35 with a higher score meaning higher satisfaction.

Behavioral: Consult followed by Engage Model at 5 Months
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 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.
Other Names:
  • Time 1
  • Behavioral: Consult followed by Engage Model at 10 Months
    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 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.
    Other Names:
  • Time 2
  • Behavioral: Consult followed by Engage Model at 15 Months
    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 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.
    Other Names:
  • Time 3
  • Behavioral: Consult followed by Engage Model at 20 Months
    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 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.
    Other Names:
  • Time 4
  • Active Comparator: Family

    Families will be surveyed related to burden during the Consult and Engage Model of Care. Family Burden will be measured using the Zarit Burden scale with a range of scores from 0-16 and a lower scoring revealing less burden.

    Behavioral: Consult followed by Engage Model at 5 Months
    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 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.
    Other Names:
  • Time 1
  • Behavioral: Consult followed by Engage Model at 10 Months
    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 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.
    Other Names:
  • Time 2
  • Behavioral: Consult followed by Engage Model at 15 Months
    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 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.
    Other Names:
  • Time 3
  • Behavioral: Consult followed by Engage Model at 20 Months
    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 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.
    Other Names:
  • Time 4
  • Active Comparator: Staff

    Staff of the Assisted Living/Personal Care Facilities will be surveyed related to work satisfaction during the Consult and Engage Model of Care. Staff work satisfaction will be measured with the Michigan Organizational Assessment Questionnaire (MOAQ) with a range of scores from 3-18 and a lower score revealing higher satisfaction.

    Behavioral: Consult followed by Engage Model at 5 Months
    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 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.
    Other Names:
  • Time 1
  • Behavioral: Consult followed by Engage Model at 10 Months
    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 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.
    Other Names:
  • Time 2
  • Behavioral: Consult followed by Engage Model at 15 Months
    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 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.
    Other Names:
  • Time 3
  • Behavioral: Consult followed by Engage Model at 20 Months
    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 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.
    Other Names:
  • Time 4
  • Outcome Measures

    Primary Outcome Measures

    1. Aim 1: Satisfaction with Social Participation assessed through surveys [Baseline (enrollment), at 5 months/10 months/ 15 months and 20 months from Baseline]

      Compare the effectiveness of a Consult Model versus an Engage Model in changing satisfaction with participation in social activities for all residents. This will be measured through surveys administered to participants over the course of the study.

    2. Aim 2: Hearing-Specific Health-Related Quality of Life assessed through surveys [Baseline (enrollment), at 5 months/10 months/ 15 months and 20 months from Baseline]

      Compare the effectiveness of a Consult Model versus an Engage Model in changing hearing-specific health-related quality of life (HRQoL) in residents with measured hearing loss. This will be measured through surveys administered to participants over the course of the study.

    Secondary Outcome Measures

    1. Secondary Outcome: Family Burden [Baseline (enrollment), at 5 months/10 months/ 15 months and 20 months from Baseline]

      Secondary Aims will explore the impact of interventions on family burden through surveys administered to resident's familys.

    2. Secondary Outcome: Staff Satisfaction [Baseline (enrollment), at 5 months/10 months/ 15 months and 20 months from Baseline]

      Secondary Aims will explore the impact of interventions on staff satisfaction through surveys administered to staff of the facilities.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of PittsburghPittsburghPennsylvaniaUnited States15260

    Sponsors and Collaborators

    • University of Pittsburgh
    • Patient-Centered Outcomes Research Institute

    Investigators

    • Principal Investigator: Catherine Palmer, PhD, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Catherine Palmer, Professor, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT04575051
    Other Study ID Numbers:
    • STUDY19120233
    • HL-2019C1-16067
    First Posted:
    Oct 5, 2020
    Last Update Posted:
    Jun 8, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Catherine Palmer, Professor, University of Pittsburgh
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 8, 2021