Trial Outcomes & Findings for Optimizing Function and Independence Through STRIDE (NCT NCT03300336)

NCT ID: NCT03300336

Last Updated: 2023-09-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 13857 participants
• Primary outcome timeframe: Assessed at hospital discharge, an average of 7 days
• Results posted on: 2023-09-28

Participant Flow

Participant milestones

Measure	Intervention Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care Pre-implementation before STRIDE program
Overall Study STARTED	7134	6723
Overall Study COMPLETED	7134	6723
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optimizing Function and Independence Through STRIDE

Baseline characteristics by cohort

Measure	Intervention n=9070 patient hospitalizations Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=8167 patient hospitalizations Pre-implementation before STRIDE program	Total n=17237 patient hospitalizations Total of all reporting groups
Age, Continuous	73.0 years STANDARD_DEVIATION 8.6 • n=9070 patient hospitalizations	72.8 years STANDARD_DEVIATION 8.8 • n=8167 patient hospitalizations	72.9 years STANDARD_DEVIATION 8.7 • n=17237 patient hospitalizations
Sex: Female, Male Female	308 patient hospitalizations n=9070 patient hospitalizations	213 patient hospitalizations n=8167 patient hospitalizations	521 patient hospitalizations n=17237 patient hospitalizations
Sex: Female, Male Male	8762 patient hospitalizations n=9070 patient hospitalizations	7954 patient hospitalizations n=8167 patient hospitalizations	16716 patient hospitalizations n=17237 patient hospitalizations
Ethnicity (NIH/OMB) Hispanic or Latino	157 patient hospitalizations n=9070 patient hospitalizations	435 patient hospitalizations n=8167 patient hospitalizations	592 patient hospitalizations n=17237 patient hospitalizations
Ethnicity (NIH/OMB) Not Hispanic or Latino	8751 patient hospitalizations n=9070 patient hospitalizations	7626 patient hospitalizations n=8167 patient hospitalizations	16377 patient hospitalizations n=17237 patient hospitalizations
Ethnicity (NIH/OMB) Unknown or Not Reported	162 patient hospitalizations n=9070 patient hospitalizations	106 patient hospitalizations n=8167 patient hospitalizations	268 patient hospitalizations n=17237 patient hospitalizations
Race (NIH/OMB) American Indian or Alaska Native	56 patient hospitalizations n=9070 patient hospitalizations	46 patient hospitalizations n=8167 patient hospitalizations	102 patient hospitalizations n=17237 patient hospitalizations
Race (NIH/OMB) Asian	10 patient hospitalizations n=9070 patient hospitalizations	7 patient hospitalizations n=8167 patient hospitalizations	17 patient hospitalizations n=17237 patient hospitalizations
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	43 patient hospitalizations n=9070 patient hospitalizations	53 patient hospitalizations n=8167 patient hospitalizations	96 patient hospitalizations n=17237 patient hospitalizations
Race (NIH/OMB) Black or African American	2468 patient hospitalizations n=9070 patient hospitalizations	2418 patient hospitalizations n=8167 patient hospitalizations	4886 patient hospitalizations n=17237 patient hospitalizations
Race (NIH/OMB) White	6206 patient hospitalizations n=9070 patient hospitalizations	5417 patient hospitalizations n=8167 patient hospitalizations	11623 patient hospitalizations n=17237 patient hospitalizations
Race (NIH/OMB) More than one race	70 patient hospitalizations n=9070 patient hospitalizations	91 patient hospitalizations n=8167 patient hospitalizations	161 patient hospitalizations n=17237 patient hospitalizations
Race (NIH/OMB) Unknown or Not Reported	217 patient hospitalizations n=9070 patient hospitalizations	135 patient hospitalizations n=8167 patient hospitalizations	352 patient hospitalizations n=17237 patient hospitalizations
Region of Enrollment United States	9070 patient hospitalizations n=9070 patient hospitalizations	8167 patient hospitalizations n=8167 patient hospitalizations	17237 patient hospitalizations n=17237 patient hospitalizations

PRIMARY outcome

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

Population: Discharge to skilled nursing facility was analyzed for the first hospitalization for each patient during the study period. Patients can be in both intervention and usual care groups if hospitalized during the respective intervention and usual care time periods; however, for this outcome patients will be analyzed in only one group, based upon the earliest of their hospitalizations if had more than one.

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

Outcome measures

Measure	Intervention n=6141 Participants Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=6722 Participants Pre-implementation before STRIDE program
Proportion of Patients Discharged to Skilled Nursing Facility	0.16 proportion of patients Standard Error 0.02	0.20 proportion of patients Standard Error 0.03

PRIMARY outcome

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

Population: Length of stay was analyzed for the first hospitalization for each patient during the study period. Patients can be in both intervention and usual care groups if hospitalized during the respective intervention and usual care time periods; however, for this outcome patients will be analyzed in only one group, based upon the earliest of their hospitalizations if had more than one.

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

Outcome measures

Measure	Intervention n=6141 Participants Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=6722 Participants Pre-implementation before STRIDE program
Hospital Length of Stay (Days)	6.92 Days Standard Error 0.21	6.58 Days Standard Error 0.20

SECONDARY outcome

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

Population: Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.

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.

Outcome measures

Measure	Intervention n=399 Participants Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=227 Participants Pre-implementation before STRIDE program
Patient Physical Function - Disability	67.31 score on a scale Standard Error 1.55	65.99 score on a scale Standard Error 1.39

SECONDARY outcome

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

Population: Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.

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.

Outcome measures

Measure	Intervention n=399 Participants Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=227 Participants Pre-implementation before STRIDE program
Patient Physical Function - Limitations	65.67 score on a scale Standard Error 1.84	64.12 score on a scale Standard Error 1.66

SECONDARY outcome

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

Population: Patient telephone survey 30 days post discharge

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.

Outcome measures

Measure	Intervention n=399 Participants Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=227 Participants Pre-implementation before STRIDE program
Patient Physical Function	67.88 score on a scale Standard Error 1.64	68.40 score on a scale Standard Error 1.50

SECONDARY outcome

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

Population: Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.

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").

Outcome measures

Measure	Intervention n=399 Participants Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=227 Participants Pre-implementation before STRIDE program
Proportion Highly Satisfied With Care	0.85 proportion of patients Standard Error 0.04	0.84 proportion of patients Standard Error 0.04

SECONDARY outcome

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

Population: Patients completing a telephone survey 30 days post discharge

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.

Outcome measures

Measure	Intervention n=399 Participants Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=227 Participants Pre-implementation before STRIDE program
Health Utility	0.82 score on a scale Standard Error 0.02	0.80 score on a scale Standard Error 0.01

SECONDARY outcome

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

Population: Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.

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.

Outcome measures

Measure	Intervention n=399 Participants Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=227 Participants Pre-implementation before STRIDE program
Health-related Quality of Life	0.76 score on a scale Standard Error 0.02	0.73 score on a scale Standard Error 0.02

SECONDARY outcome

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

Population: Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.

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.

Outcome measures

Measure	Intervention n=399 Participants Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=227 Participants Pre-implementation before STRIDE program
Mobility in the Environment	58.81 score on a scale Standard Error 3.26	58.01 score on a scale Standard Error 3.02

OTHER_PRE_SPECIFIED outcome

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

Population: Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.

Analysis of sleep functioning will be assessed with the sleep subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Raw scores converted to t-scores ranging from 32.0 to 73.3. Higher scores indicate more sleep disturbance.

Outcome measures

Measure	Intervention n=399 Participants Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=227 Participants Pre-implementation before STRIDE program
Sleep	51.79 score on a scale Standard Error 0.98	50.33 score on a scale Standard Error 0.90

OTHER_PRE_SPECIFIED outcome

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

Population: Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.

Veterans self-reporting at least one fall in the 30 days since discharge from an eligible hospitalization, as queried during a telephone survey.

Outcome measures

Measure	Intervention n=399 Participants Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=227 Participants Pre-implementation before STRIDE program
Proportion of Participants Self-reporting at Least One Fall	0.18 proportion of patients Standard Error 0.02	0.16 proportion of patients Standard Error 0.03

OTHER_PRE_SPECIFIED outcome

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

Population: Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.

Analysis of pain will be assessed with the pain subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Raw scores converted to t-scores ranging from 41.6 to 75.6. Higher scores indicate higher (worse) pain interference.

Outcome measures

Measure	Intervention n=399 Participants Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=227 Participants Pre-implementation before STRIDE program
PROMIS-29 Pain Subscale	56.46 score on a scale Standard Error 0.96	55.47 score on a scale Standard Error 0.91

OTHER_PRE_SPECIFIED outcome

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

Population: Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.

Analysis of depression will be assessed with the Center for Epidemiologic Studies Depression Scale (CESD-10). Scores range from 0-30, with higher scores reflecting more depressive symptoms

Outcome measures

Measure	Intervention n=399 Participants Implementation of STRIDE program STRIDE: Implementation of STRIDE inpatient hospital mobility program	Usual Care n=227 Participants Pre-implementation before STRIDE program
Depression	9.04 score on a scale Standard Error 0.57	9.11 score on a scale Standard Error 0.53

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

S. Nicole Hastings

HSRD ADAPT

Phone: 919-286-6936

Email: susan.hastings@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place