Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 2

ConditionsAging Preventive Care Multimorbidity Palliative Care

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMassachusetts General Hospital

About this trial

This study consists of three aims focused on examining the feasibility of adding the Geriatric Resources and Assessment for the Care of Elders (GRACE) model to structured Annual Wellness Visits (AWVs) to improve patient and caregiver outcomes and reduce hospitalizations in older adults with complex health needs. The objectives are to:

1. Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms 2. Develop a referral pathway and algorithm to optimize enrollment of eligible participants 3. Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 65 years or older

Eligible for an AWV (Medicare/Medicare Advantage) during the study period

Residential mailing address within a radius of the practice that can be achievably reached via a home visit

English or Spanish speaking

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Annual Wellness Visit
Other intervention
Completion of a structured Annual Wellness Visit (AWV) questionnaire administered by an assigned practice staff member for Medicare beneficiaries deemed by study algorithm as high-risk. Those responses will then be used by the primary care team to place any needed referrals and offer any indicated personal health advice and create a care plan for the coming year. Routine usual care from the primary care practice will occur.
Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)
Other intervention
The practice will initiate the Geriatric Resources and Assessment for the Care of Elders (GRACE) program for Medicare beneficiaries deemed by study algorithm as high-risk and meeting other study criteria (see below). After completion of the in-home structured annual wellness visit (AWV) and GRACE assessment by the NP/SW team, responses will be reviewed and applied to construct an individualized care plan using the GRACE protocols inclusive of advance care planning, health maintenance, medication management, assistance with any difficulty walking, falls, dementia, depression, chronic pain, malnutrition, weight loss, urinary incontinence, visual impairment, hearing impairment, or caregiver burden.

Treatment groups

7,140 Participants

are divided into 2 treatment groups

Group A: Annual Wellness Visits (AWV)Active comparator 1 intervention

Group B: Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

Hospitalizations

Count of hospitalizations during the observation period, evaluated at the participant level.

Time frame

12, 18, and 24 months.

Patient experience: Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) with Patient Centered Medical Home 1.0 supplement (PCMH CAHPS)

The CAHPS Clinician \& Group Survey (CG-CAHPS) asks patients to report on their experiences with providers and staff in primary care and specialty care settings, using a 6 month recall period. The Patient-Centered Medical Home (PCMH) Item Set is a set of supplemental questions that is added to the adult version of the CAHPS Clinician \& Group Survey (CG-CAHPS) to gather more information on patient experience with the domains of primary care that define a medical home. Scoring for most items is on a 4 point scale 1=never 2=sometimes 3=usually 4=Always. Minimum and Maximum scores vary with the number of items used. The Provider Rating item is on a 11 point scale from 0 to 10,where 9,10 are considered "high" scores.

Time frame

Baseline and 18 months.

Secondary outcomes

Physical health

PROMIS Global PH

Time frame

Baseline and 18 months.

Mental health

PROMIS Global MH

Time frame

Baseline and 18 months.

Caregiver strain

Modified Caregiver Strain Index

Time frame

Baseline and 18 months.

Professional Fulfillment

Professional Fulfillment Index

Time frame

Baseline and 18 months.

Other outcomes

Exploratory Geriatric Outcomes - Number of participants with new ICD-10 diagnosis codes

New ICD-10 diagnosis codes in cognitive status, physical function status or mood categories

Time frame

36 months

Exploratory Geriatric Outcomes- number of participants that complete advanced care planning

Number of participants with advanced care planning encounters

Time frame

36 months

Exploratory Geriatric Outcomes - number of participants with inappropriate medications

Number of participants with Medicare Part D with potentially inappropriate medications

Time frame

36 months

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

Brandeis University

Collaborator

Indiana University

Collaborator

Dartmouth-Hitchcock Medical Center

Collaborator

Atrium Health Wake Forest Baptist

Collaborator

Griffin Hospital

Collaborator

Patient-Centered Outcomes Research Institute

Collaborator

Baylor Scott and White Health

Collaborator

Source ClinicalTrials.gov

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