SAGE: Safer ageing through geriatrics-informed evidence-based practices
| ISRCTN | ISRCTN60657985 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60657985 |
| Secondary identifying numbers | eRA# 1 I50 HX003201-01 |
- Submission date
- 08/03/2021
- Registration date
- 21/05/2021
- Last edited
- 13/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Currently, there are more than 4 million Veterans in the United States aged 65 and older, yet the healthcare systems most widely used by this population are not optimized to provide them with the most consistent, highest quality care. A large body of research shows that inappropriate care and unmet care needs among older adults can lead to reduced quality of life, more frequent hospital visitation, and premature nursing home admission.
To address these gaps in care, we seek to create an ageing friendly healthcare system that incorporates four high-quality health care factors known as the "four M's": 1) what Matters (i.e., attending to each person’s goals and preferences); 2) avoiding harms related to Medication; 3) preventing, identifying, treating, and managing dementia, depression, and delirium across settings of care (Mentation); and 4) promoting safe movement to maintain function and independence (Mobility).
Who can participate?
Veterans age 65 or older, attending a VA Medical Center or clinic within the Veterans Integrated System Network (VISN-4) can participate. Additional project-specific requirements apply.
What does the study involve?
Depending on project eligibility, participation might include consultation of goals prior to an elected surgery, receiving a mailed pamphlet on reducing medication harms, activities to increase mental acuity, or home visits to increase mobility and address safety concerns within the home.
What are the possible benefits and risks of participating?
There are no direct benefits of participating. Possible risks are dependent on specific study participation but could include withdrawal symptoms from reducing medication. Consultation with your primary care physician prior to reducing or stopping medication is recommended.
Where is the study being run from?
Self-electing clinics and medical centers within the VISN-4 area (https://www.visn4.va.gov/VISN4/locations/directions.asp)
When is the study starting and how long is it expected to run for?
October 2020 to September 2025
Who is funding the study?
The Department of Veteran Affairs (USA)
Who is the main contact?
Tanisha Dicks, tanisha.dicks@va.gov
Contact information
Public
3900 Woodland Ave
Philadelphia
19104
United States of America
| Phone | +1 2152222592 |
|---|---|
| tanisha.dicks@va.gov |
Study information
| Study design | Multicenter randomized type 3 hybrid effectiveness-implementation study with a stepped wedge design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Implementing the age-friendly health system in VHA: using evidence based practice to improve outcomes in older adults |
| Study acronym | SAGE |
| Study objectives | Currently, there are more than 4 million Veterans in the United States aged 65 and older, yet the healthcare systems most widely used by this population are not optimized to provide them with the most consistent, highest quality care. A large body of research shows that inappropriate care and unmet care needs among older adults accelerates cognitive and functional decline and increases medical harms, leading to poorer quality of life, more frequent hospital utilization, and premature nursing home admission. To address these gaps in care, we seek to create an aging friendly healthcare system which incorporates four overarching dimensions of high-quality health care factors known as the "four M's": 1) what Matters (i.e., attending to each person’s goals and preferences); 2) avoiding harms related to Medication; 3) preventing, identifying, treating, and managing dementia, depression, and delirium across settings of care (Mentation); and 4) promoting safe movement to maintain function and independence (Mobility). This project will support internal implementation and evaluation efforts in implementing these four evidence-based practices (EBP), and will involve use of secondary and primary VA data collected using assessments that are part of routine care and/or clinical management. The information gathered from these initiatives will be used to design additional quality improvement initiatives to further improve clinical outcomes for older adults. |
| Ethics approval(s) | This project has been approved as non-research, 25/11/2019, by the Chief Medical Officer and Associate Chief of Staff for Research and Development, VISN-4 Pittsburgh, PA |
| Health condition(s) or problem(s) studied | Implementation of age-friendly health systems within the Veterans Affairs healthcare system for veterans 65 or older |
| Intervention | To improve clinical outcomes for older adult veterans, four evidence-based practices will be implemented across the Veterans' Integrated Service Network (VISN-4) in a type 3 hybrid effectiveness-implementation trial using a stepped-wedge design. The four evidence-based practices are aligned with each of the "4Ms" of the Age-Friendly Health System model: what Matters, Medications, Mobility, and Mentation. They include: 1. Initiate a preoperative frailty screening program, triggering referral of frail patients for a structured goal clarification conversation to ensure surgical treatment aligns with patient goals and values, ("Surgical Pause") 2. Implement a direct-to-consumer intervention that has been shown to more than triple the rate of discontinuation of high-risk medications among older adults ("Empower") 3. Conduct a home-based intervention to improve the function of Veterans with dementia and reduces caregiver burden ("TAP") 4. Conduct a home-based intervention to improve the ability of functionally impaired older Veterans to age in place ("CAPABLE"). There are two implementation strategies being compared in the trial: implementation as usual (using usual dissemination channels), and facilitation We will conduct a randomized type III hybrid effectiveness- implementation study with a stepped wedge design consisting of 5 consecutive phases: Implementation as usual (IU), pre-implementation (Pre-I), active implementation (active I), consolidation (Consol) and evaluation. IU ranges 3-21 months, depending on site. This phase will include communication strategies (i.e. email blasts, website development) implemented at all 54 sites, and will serve as the baseline for outcome data. Pre-I will last 6 months, and will include site visits, interviews with stakeholders to identify barriers and facilitators to implementation, and relationship building. Active-I will last 6 months, and include focusing on facilitation of the 4 evidence based practices at sites. We will use the implementation strategy RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) to guide activities. Consolidation expands over 6 months, and include promoting maintenance of the 4 EBPs. This phase includes ongoing audit and feedback, as well as providing technical assistance. Evaluation will follow the remaining 12 months to asses nationally available VHA specific datapoints, with a focus on comparing IU to Active-I efforts. Randomization of sites: Unlike typical cluster trials that assign clusters of sites to a control/comparison condition or an active treatment condition, all sites in the stepped wedge design receive both the comparison condition and the active treatment condition at some point during the study. Clusters are randomized to start time for Active Implementation. |
| Intervention type | Behavioural |
| Primary outcome measure | Data collected from the following nationally available datasets: VA administrative health records stored in the VA Corporate Data Warehouse, and Medicare claims records 1. The proportion of all eligible Veterans who received one (or more) of our interventions per clinical site, data collected monthly 2. The proportion of all eligible Veterans who are referred to the interventions, data collected monthly 3. The number of "facility-free days," or the number of days older Veterans remain alive and outside the hospital or nursing home, data collected annually |
| Secondary outcome measures | Measured monthly using the VA administrative health records stored in the VA Corporate Data Warehouse, and Medicare claims records: 1. Postoperative mortality 2. Length of stay (at hospital and ICU) 3. Index hospital discharge disposition Intervention specific outcome measures: 4. "Surgical Pause": Readmission rates 5. "EMPOWER": 5.1. Number of cessation prescription fills for target medication reduction 5.2. Number of mailed brochures to eligible Veterans 6. TAP and CAPABLE: 6.1. Hospitalization and nursing home placement rates 6.2. Percentage of trained occupational therapists and registered nurses delivering the program |
| Overall study start date | 01/10/2020 |
| Completion date | 30/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | We aim to implement these initiatives within 9 of the Veteran Affairs Medical Centers and 45 affiliated clinics within the VISN-4 district. There is no target recruitment number of participants. The sites will be randomized in three clusters. |
| Key inclusion criteria | 1. Community-dwelling veteran 2. Age 65 or older either receiving a treatment targeted by one of our EBPs (for example, are referred for a surgical procedure or prescribed a high-risk medication), or have risk factors targeted by one of our EBPs ( for example, carrying a diagnosis of dementia or with functional impairments that prevent completion of activities of daily living) 3. Each EBP has additional eligibility criteria specific to its purpose: 3.1. Surgical Pause, will include anyone with a score indicating frailty who is also considering an elective surgery 3.2. EMPOWER, Veterans must have been receiving a high-risk medication for at least 90 of the 120 days prior to implementation 3.3. TAP, Veterans must have a diagnosis of dementia 3.4. CAPABLE, Veterans must have 1 Activity of Daily Living or 2 Instrumental Activities of Daily Living deficiencies |
| Key exclusion criteria | 1. Receipt of hospice care or being in long-term nursing home care 2. Veterans with severe mental illness will be excluded from EMPOWER 3. Veterans without a caregiver will be excluded from TAP |
| Date of first enrolment | 21/07/2021 |
| Date of final enrolment | 01/04/2025 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Altoona
16602
United States of America
Butler
16001
United States of America
Coatesville
19320
United States of America
Erie
16504
United States of America
Lebanon
17042
United States of America
Philadelphia
19104
United States of America
Wilkes-Barre
18711
United States of America
Wilmington
19805
United States of America
Pittsburgh
15240
United States of America
Sponsor information
Government
HSR&D Central Office (14RDH) 810 Vermont Avenue, NW
Washington
20402
United States of America
| Phone | 2024435726 |
|---|---|
| vacoqueri@va.gov | |
| Website | http://www.dva.gov.au/ |
"ROR" |
https://ror.org/05dbx6743 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Department of Veterans Affairs, United States Department of Veterans Affairs, US Department of Veterans Affairs, U.S. Dept. of Veterans Affairs, Veterans Affairs, Veterans Affairs Department, VA, USDVA
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We plan to disseminate through the Institute for Healthcare Improvement, the Hartford Foundation, the Leonard Davis Institute of Health Economics, and the VA in addition to traditional academic channels (presentations and publications). VA personally identifiable data is not shareable but de-identified datasets will be maintained. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentality. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 25/05/2023 | 26/05/2023 | Yes | No | |
| Other publications | 12/03/2025 | 13/03/2025 | Yes | No |
Editorial Notes
13/03/2025: Publication reference added.
07/06/2024: The overall study end date was changed from 01/10/2025 to 30/09/2025. Study website added.
26/05/2023: Publication reference added.
06/04/2023: The recruitment start date was changed from 01/04/2021 to 21/07/2021.
25/03/2021: Trial's existence confirmed by Department of Veterans Affairs.
