NCT03300336

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,857

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

October 5, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 19, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2.5 years

First QC Date

September 28, 2017

Results QC Date

April 16, 2021

Last Update Submit

September 21, 2023

Conditions

Early Ambulation

Keywords

WalkingInpatientsVeteransEarly AmbulationQuality of Life

Outcome Measures

Primary Outcomes (2)

  • 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).

    Assessed at hospital discharge, an average of 7 days

  • Hospital Length of Stay (Days)

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

    Assessed at hospital discharge, an average of 7 days

Secondary Outcomes (7)

  • Patient Physical Function - Disability

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

  • Patient Physical Function - Limitations

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

  • Patient Physical Function

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

  • Proportion Highly Satisfied With Care

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

  • Health Utility

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

  • +2 more secondary outcomes

Other Outcomes (4)

  • Sleep

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

  • Proportion of Participants Self-reporting at Least One Fall

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

  • PROMIS-29 Pain Subscale

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

  • +1 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Implementation of STRIDE program

Behavioral: STRIDE

Usual Care

NO INTERVENTION

Pre-implementation before STRIDE program

Interventions

STRIDEBEHAVIORAL

Implementation of STRIDE inpatient hospital mobility program

Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Related Publications (5)

  • 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.

    PMID: 38632179DERIVED

  • 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.

    PMID: 37276590DERIVED

  • 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.

    PMID: 35906589DERIVED

  • 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.

    PMID: 33076997DERIVED

  • 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.

    PMID: 29678137DERIVED

Related Links

Results Point of Contact

Title
S. Nicole Hastings
Organization
HSRD ADAPT
susan.hastings@va.gov
919-286-6936

Study Officials

  • Susan N. Hastings, MD MHSc

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

  • Courtney H Van Houtven, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

  • Virginia Wang, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 3, 2017

Study Start

October 5, 2017

Primary Completion

March 29, 2020

Study Completion

October 30, 2021

Last Updated

September 28, 2023

Results First Posted

July 19, 2021

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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.

Time Frame
Available upon request.
Access Criteria
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.

Locations

US(1)