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Hearing for Communication and Resident Engagement (HearCARE)

Primary Purpose

Hearing Loss, Age-Related

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Consult followed by Engage Model at 5 Months
Consult followed by Engage Model at 10 Months
Consult followed by Engage Model at 15 Months
Consult followed by Engage Model at 20 Months
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hearing Loss, Age-Related focused on measuring hearing loss, communication, social participation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Residents

Family

Staff

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Aim 1: Satisfaction with Social Participation assessed through surveys
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.
Aim 2: Hearing-Specific Health-Related Quality of Life assessed through surveys
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

Secondary Outcome: Family Burden
Secondary Aims will explore the impact of interventions on family burden through surveys administered to resident's familys.
Secondary Outcome: Staff Satisfaction
Secondary Aims will explore the impact of interventions on staff satisfaction through surveys administered to staff of the facilities.

Full Information

First Posted
September 21, 2020
Last Updated
May 2, 2023
Sponsor
University of Pittsburgh
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04575051
Brief Title
Hearing for Communication and Resident Engagement
Acronym
HearCARE
Official Title
HearCARE: Hearing for Communication and Resident Engagement
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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: 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) possibly increasing participation and buy-in since all facilities will eventually implement the intervention during the study 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Age-Related
Keywords
hearing loss, communication, social participation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Open cohort stepped-wedge cluster randomized design with a phased, randomized roll out
Masking
Outcomes Assessor
Masking Description
The data collectors will be masked to which phase the facility is in.
Allocation
Randomized
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Residents
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Family
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Staff
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Consult followed by Engage Model at 5 Months
Other Intervention Name(s)
Time 1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Consult followed by Engage Model at 10 Months
Other Intervention Name(s)
Time 2
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Consult followed by Engage Model at 15 Months
Other Intervention Name(s)
Time 3
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Consult followed by Engage Model at 20 Months
Other Intervention Name(s)
Time 4
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aim 1: Satisfaction with Social Participation assessed through surveys
Description
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.
Time Frame
Baseline (enrollment), at 5 months/10 months/ 15 months and 20 months from Baseline
Title
Aim 2: Hearing-Specific Health-Related Quality of Life assessed through surveys
Description
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.
Time Frame
Baseline (enrollment), at 5 months/10 months/ 15 months and 20 months from Baseline
Secondary Outcome Measure Information:
Title
Secondary Outcome: Family Burden
Description
Secondary Aims will explore the impact of interventions on family burden through surveys administered to resident's familys.
Time Frame
Baseline (enrollment), at 5 months/10 months/ 15 months and 20 months from Baseline
Title
Secondary Outcome: Staff Satisfaction
Description
Secondary Aims will explore the impact of interventions on staff satisfaction through surveys administered to staff of the facilities.
Time Frame
Baseline (enrollment), at 5 months/10 months/ 15 months and 20 months from Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Palmer, PhD
Phone
4126476089
Email
cvp@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Gilchrist, BS
Phone
4123834647
Email
EGG6@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Palmer, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Palmer, PhD
Phone
412-647-6089
Email
cvp@pitt.edu
First Name & Middle Initial & Last Name & Degree
Erin Gilchrist, BS
Phone
4123834647
Email
egg6@pitt.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data, including protocol, statistical analysis and full data set may be shared with investigators conducting similar research or for educational purposes. No identifiable data will be shared.
IPD Sharing Time Frame
Data will become available after the conclusion of the study and will be available
IPD Sharing Access Criteria
Access to the data will be determined by the PIs and funding agency (PCORI). Requests for the data can be made to them and will be considered before dissemination.

Learn more about this trial

Hearing for Communication and Resident Engagement

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