Hearing for Communication and Resident Engagement (HearCARE)

• ClinicalTrials.gov Identifier: NCT04575051
• Recruitment Status: Recruiting
• First Posted: October 5, 2020
• Last Update Posted: June 8, 2021
• Sponsor: University of Pittsburgh
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Catherine Palmer, University of Pittsburgh

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 disease	Intervention/treatment	Phase
Hearing Loss, Age-Related	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	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 520 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Open 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: June 1, 2021
• Estimated Primary Completion Date: May 1, 2023
• Estimated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Time 4

Outcome Measures

Primary Outcome Measures :

1. Aim 1: Satisfaction with Social Participation assessed through surveys [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Catherine Palmer, PhD; 4126476089; cvp@pitt.edu

Contact: Erin Gilchrist, BS; 4123834647; EGG6@pitt.edu

Locations

United States, Pennsylvania

University of Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contact: Catherine Palmer, PhD 412-647-6089 cvp@pitt.edu

Contact: Erin Gilchrist, BS 4123834647 egg6@pitt.edu

Sponsors and Collaborators

University of Pittsburgh

Patient-Centered Outcomes Research Institute

Investigators

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

More Information

• Responsible Party: Catherine Palmer, Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04575051
• Other Study ID Numbers: STUDY19120233; HL-2019C1-16067 ( Other Grant/Funding Number: PCORI )
• First Posted: October 5, 2020
• Last Update Posted: June 8, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: Data will become available after the conclusion of the study and will be available
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catherine Palmer, University of Pittsburgh:

hearing loss, communication, social participation

Additional relevant MeSH terms:

Hearing Loss; Deafness; Presbycusis; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Hearing Loss, Sensorineural