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Early AmbulationSTRIDENCT03300336

Optimizing Function and Independence Through STRIDE

A study testing STRIDE in people with Early Ambulation, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Optimizing Function and Independence Through STRIDE aims to implement the STRIDE inpatient hospital mobility program at 8 VAMC sites in a stepped-wedge design and evaluate patient outcomes before and after the program is implemented, as well as the efficacy of a usual vs enhanced implementation design. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Early Ambulation
What is being tested?
STRIDE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13,857 participants
Where
1 siteUnited States
Study dates
5 Oct 2017to 30 Oct 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inclusion/Exclusion listed here apply to subset of patients providing consent for telephone interviews:
  • Able and willing to provide informed consent (does not lack decision-making capacity)
  • Discharged from a participating hospital within the preceding 30 days
  • Age >= 60
  • Index admission for medical illness
  • Community-dwelling (i.e. not in a nursing home or institutional care) prior to hospital visit
Show all 10Show fewer
  • Ability to ambulate safely and independently (does not need help walking across a small room)
  • Valid telephone number in the medical record
  • Admitted to a STRIDE ward and discharged from a STRIDE ward
  • Index hospital stay was in a ward identified to participate in the STRIDE program

Who cannot join

  • Patient deceased
  • Index hospital stay was < 2 business days
  • Currently hospitalized
  • Current high-risk suicide flag in medical record
  • Diagnosis of cognitive impairment or dementia
  • Difficulty with or unable to communicate on the telephone, or no telephone access
Show all 9Show fewer
  • Discharged to another hospital or acute care setting
  • Transferred into index hospital from another hospital
  • Bedrest order not lifted for at least 2 days on STRIDE ward

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875

Other trials in United States

About this study

Official title: Optimizing Function and Independence Through STRIDE (QUE 16-170)

Optimizing Function and Independence Through STRIDE aims to implement the STRIDE inpatient hospital mobility program at 8 VAMC sites in a stepped-wedge design and evaluate patient outcomes before and after the program is implemented, as well as the efficacy of a usual vs enhanced implementation design.

Read the detailed description

Background/Purpose. A key contributor to hospital-associated disability is immobility during hospitalization. While fewer than 5% of patients have physician orders for bed rest, hospitalized older adults spend only 3% of their time standing or walking. The hazards of immobility in the hospital have been recognized for more than two decades, but there are currently no VA-system wide approaches to address this important gap in clinical care.

STRIDE is a supervised inpatient walking program developed by an interdisciplinary team of investigators, clinicians and administrators at the Durham VA and funded by the VHA Office of GEC. STRIDE consists of a one-time gait and balance assessment conducted by a physical therapist, followed by daily supervised walks by a recreation therapy assistant for the duration of the hospital stay. Program evaluation has demonstrated high satisfaction among Veteran participants and reduced need for post-acute institutional care. As a result, the Durham VAMC funded STRIDE as a permanent program that currently serves over 650 Veterans annually, and the VHA Office of GEC funded a dissemination grant to launch the program at another medical center. The investigators' initial experience with STRIDE implementation suggests interprofessional relationships and team dynamics are key determinants to the success of a new hospital-based clinical program that requires collaborative processes involving multiple disciplines.

As part of the investigators' Optimizing Function and Independence QUERI, the investigators plan to implement the STRIDE clinical program at 8 VAMC sites in a stepped-wedge design with sites randomized to implementation strategy and start date.

Objectives. The investigators plan to conduct an evaluation to examine the impact of STRIDE on patient outcomes.

Key questions: Do STRIDE participants have fewer discharges to skilled nursing facilities and shorter lengths of stay? Do STRIDE participants have better physical function and higher health-related quality of life at 30 days post-discharge? What is the value of STRIDE from the Veteran's perspective? The investigators also plan to conduct a mixed method evaluation that examines implementation outcomes and provider team experience that will not be reported here.

Methodology. The investigators will compare patients discharged from sites before and after the STRIDE program is implemented to assess discharge to skilled nursing facilities and length of stay (approx. n=2000). A subset of patients participating in the STRIDE program and a comparison group will be surveyed 30 days post-hospital discharge to assess outcomes including health status, physical function, and quality of life. A subset of patients will be interviewed one week post-discharge to gain feedback about the STRIDE program and perceived benefits of a hospital inpatient mobility program.

In 2023, the following updates were made after results were initially uploaded to clinical trials as follows: primary outcome description and results were modified to reflect discharge to skilled nursing facility versus discharge to home and modifications were made to the sample and discharge to skilled nursing home and length of stay outcomes due to receipt of more complete data sources for use to determine eligibility and to assess the primary outcome.

Being tested
STRIDE
Keywords
Walking, Inpatients, Veterans, Early Ambulation, Quality of Life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STRIDEBehavioural

    Implementation of STRIDE inpatient hospital mobility program

Study groups in NCT03300336
Study groupRoleWhat they receive
InterventionExperimentalImplementation of STRIDE program
Receives: Behavioral: STRIDE
Usual CareNo interventionPre-implementation before STRIDE program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients Discharged to Skilled Nursing Facility

    Discharge to skilled nursing facility (versus home) will be assessed via administrative data pulls and chart review (not patient report).

    Measured: Assessed at hospital discharge, an average of 7 days

  2. Hospital Length of Stay (Days)

    Hospital length of stay will be assessed via administrative data pulls (not patient report)

    Measured: Assessed at hospital discharge, an average of 7 days

Secondary outcomes (7)
  1. Patient Physical Function - Disability

    Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Disability Component. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.

    Measured: 30 days following hospital discharge, hospital stay an average of 6 days

  2. Patient Physical Function - Limitations

    Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Limitations Component -Instrumental Role Domain. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.

    Measured: 30 days following hospital discharge, hospital stay an average of 6 days

  3. Patient Physical Function

    Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Function Component - Basic Lower Extremity Functioning Domain. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.

    Measured: 30 days following hospital discharge, hospital stay an average of 6 days

  4. Proportion Highly Satisfied With Care

    Analysis of satisfaction with care will be measured with the Consumer Assessment of Healthcare Providers and Systems (CAHPS)-based item "Would you recommend this hospital to other Veterans if they needed care for a condition such as yours?" Responses were categorized into two categories: highly satisfied (responses of "Definitely Yes") and less satisfied (responses of "Probably Yes", "Probably No", and "Definitely No").

    Measured: 30 days following hospital discharge, hospital stay an average of 6 days

  5. Health Utility

    Analysis of health utility, a health-related quality of life measure, will be assessed with the ICEpop CAPability measure for adults (ICECAP-A). Tariff values for an overall state are calculated by summing the values across the individual attributes (Feeling settled and secure; Love, friendship and support; Being independent; Achievement and progress; and Enjoyment and pleasure). Tariff values can range from 0 to 1, with higher values reflecting greater quality of life.

    Measured: 30 days following hospital discharge, hospital stay an average of 6 days

  6. Health-related Quality of Life

    Analysis of health-related quality of life will be measured by the Euroqol (EQ-5D). Response profiles are mapped to a score via a crosswalk. Scores range from -0.109 to 1.0, with higher scores reflecting a higher quality of life.

    Measured: 30 days following hospital discharge, hospital stay an average of 6 days

  7. Mobility in the Environment

    Analysis of mobility in the environment will be assessed by the Life Space Questionnaire. The composite score incorporates use of equipment, need for personal help, and frequency of movement. Scores range from 0-120 with higher scores reflecting greater mobility.

    Measured: 30 days following hospital discharge, hospital stay an average of 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2017
  2. Study start5 Oct 2017
  3. Primary completion29 Mar 2020
  4. Study completion30 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
Stepped Wedge Cluster Randomized Trial - a form of crossover design with unidirectional crossover (from control to experimental) but with randomization of when each cluster undertakes the transition. In the stepped wedge design, there is a staggered roll-out of the intervention, where the time and sequence of clusters that will start the intervention at each period determined by random allocation.
Masking
None (open label)
Enrolment
13,857 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03300336
Sponsor's protocol ID
QUX 16-015
Acronym
STRIDE
Status last verified
Sep 2023
First submitted
28 Sep 2017
Last updated
28 Sep 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored \& maintained in an approved, secured location as described in the VA Research Data Inventory Form. The study statistician will create de-identified, publication-specific datasets that includes all variables presented in the study publication. Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset.

Publications

  • Perfect CR, Seidenfeld J, Kilpatrick KW, Stechuchak KM, Kappler CB, Pavon JM, Hastings SN. Identifying Factors Associated With Prolonged Hospitalizations for Community-Dwelling Veterans Living With Dementia. J Am Geriatr Soc. 2026 Sep 2. doi: 10.1111/jgs.70694. Online ahead of print.

    PubMed 42686639
  • Kaufman BG, Hastings SN, Meyer C, Stechuchak KM, Choate A, Decosimo K, Sullivan C, Wang V, Allen KD, Van Houtven CH. The business case for hospital mobility programs in the veterans health care system: Results from multi-hospital implementation of the STRIDE program. Health Serv Res. 2024 Dec;59 Suppl 2(Suppl 2):e14307. doi: 10.1111/1475-6773.14307. Epub 2024 Apr 17.

    PubMed 38632179
  • Hastings SN, Stechuchak KM, Choate A, Van Houtven CH, Allen KD, Wang V, Colon-Emeric C, Jackson GL, Damush TM, Meyer C, Kappler CB, Hoenig H, Sperber N, Coffman CJ. Effects of Implementation of a Supervised Walking Program in Veterans Affairs Hospitals : A Stepped-Wedge, Cluster Randomized Trial. Ann Intern Med. 2023 Jun;176(6):743-750. doi: 10.7326/M22-3679. Epub 2023 Jun 6.

    PubMed 37276590
  • Wang V, D'Adolf J, Decosimo K, Robinson K, Choate A, Bruening R, Sperber N, Mahanna E, Van Houtven CH, Allen KD, Colon-Emeric C, Damush TM, Hastings SN. Adapting to CONNECT: modifying a nursing home-based team-building intervention to improve hospital care team interactions, functioning, and implementation readiness. BMC Health Serv Res. 2022 Jul 29;22(1):968. doi: 10.1186/s12913-022-08270-1.

    PubMed 35906589
  • Hastings SN, Stechuchak KM, Choate A, Mahanna EP, Van Houtven C, Allen KD, Wang V, Sperber N, Zullig L, Bosworth HB, Coffman CJ. Implementation of a stepped wedge cluster randomized trial to evaluate a hospital mobility program. Trials. 2020 Oct 16;21(1):863. doi: 10.1186/s13063-020-04764-7.

    PubMed 33076997
  • Wang V, Allen K, Van Houtven CH, Coffman C, Sperber N, Mahanna EP, Colon-Emeric C, Hoenig H, Jackson GL, Damush TM, Price E, Hastings SN. Supporting teams to optimize function and independence in Veterans: a multi-study program and mixed methods protocol. Implement Sci. 2018 Apr 20;13(1):58. doi: 10.1186/s13012-018-0748-3.

    PubMed 29678137

Questions about this trial

What is this clinical trial studying?

A study testing STRIDE in people with Early Ambulation, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Discharged to Skilled Nursing Facility (time frame: Assessed at hospital discharge, an average of 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03300336, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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