Trial Outcomes & Findings for Skin Change Actions by Nursing (NCT NCT06127524)

NCT ID: NCT06127524

Last Updated: 2026-06-12

Results Overview

At least one Pressure Injury Prevention action newly initiated defined as electronic health record (EHR) documentation

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

4733 participants

Primary outcome timeframe

From date of newly identified skin damage through 3 days later, assessed up to 8 months for intervention period or up to 12 months for usual care (Lookback) period

Results posted on

2026-06-12

Participant Flow

The study used a step-wedge design. We enrolled 4,733 unique individuals. Because our study periods were sequential, some residents participated in both study arms, as they were resident in the facility during the relevant study periods.

Unit of analysis: Nursing Homes

Participant milestones

Participant milestones
Measure	Sequence 1: Weeks 1-52 of Usual Care, Weeks 53-87 of Intervention This group includes residents in Facility A. During Weeks 1-52, individuals resident in the facility received usual care. During Weeks 53-87, individuals resident in the facility received the intervention.	Sequence 2: Weeks 6-57 of Usual Care, Weeks 58-92 of Intervention This group includes residents in Facility B. During Weeks 6-57, individuals resident in the facility received usual care. During Weeks 58-92, individuals resident in the facility received the intervention.	Sequence 3: Weeks 8-59 of Usual Care, Weeks 60-94 of Intervention This group includes residents in Facility C. During Weeks 8-59, individuals resident in the facility received usual care. During Weeks 60-94, individuals resident in the facility received the intervention.	Sequence 4: Weeks 10-61 of Usual Care, Weeks 62-96 of Intervention This group includes residents in Facility D. During Weeks 10-61, individuals resident in the facility received usual care. Original plans during Weeks 62-96, individuals resident in the facility received the intervention. However, the facility withdrew from the study in Week 73.	Sequence 5: Weeks 15-66 of Usual Care, Weeks 67-101 of Intervention This group includes residents in Facility E. During Weeks 15-66, individuals resident in the facility received usual care. During Weeks 67-101, individuals resident in the facility received the intervention.	Sequence 6: Weeks 29-80 of Usual Care (Lookback), Weeks 81-115 of Intervention This group includes residents in Facility F. During Weeks 29-80, individuals resident in the facility received usual care (Lookback). During Weeks 81-115, individuals resident in the facility received the intervention.
Lookback STARTED	386 1	488 1	371 1	524 1	1009 1	656 1
Lookback COMPLETED	326 1	407 1	295 1	411 1	734 1	418 1
Lookback NOT COMPLETED	60 0	81 0	76 0	113 0	275 0	238 0
Intervention STARTED	320 1	390 1	250 1	190 1	556 1	349 1
Intervention Continued after Lookback Period	131 1	121 1	102 1	118 1	151 1	133 1
Intervention Enrolled after Intervention begun	189 1	269 1	148 1	72 1	405 1	216 1
Intervention COMPLETED	212 1	321 1	218 1	0 0	470 1	311 1
Intervention NOT COMPLETED	108 0	69 0	32 0	190 1	86 0	38 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sequence 1: Weeks 1-52 of Usual Care, Weeks 53-87 of Intervention This group includes residents in Facility A. During Weeks 1-52, individuals resident in the facility received usual care. During Weeks 53-87, individuals resident in the facility received the intervention.	Sequence 2: Weeks 6-57 of Usual Care, Weeks 58-92 of Intervention This group includes residents in Facility B. During Weeks 6-57, individuals resident in the facility received usual care. During Weeks 58-92, individuals resident in the facility received the intervention.	Sequence 3: Weeks 8-59 of Usual Care, Weeks 60-94 of Intervention This group includes residents in Facility C. During Weeks 8-59, individuals resident in the facility received usual care. During Weeks 60-94, individuals resident in the facility received the intervention.	Sequence 4: Weeks 10-61 of Usual Care, Weeks 62-96 of Intervention This group includes residents in Facility D. During Weeks 10-61, individuals resident in the facility received usual care. Original plans during Weeks 62-96, individuals resident in the facility received the intervention. However, the facility withdrew from the study in Week 73.	Sequence 5: Weeks 15-66 of Usual Care, Weeks 67-101 of Intervention This group includes residents in Facility E. During Weeks 15-66, individuals resident in the facility received usual care. During Weeks 67-101, individuals resident in the facility received the intervention.	Sequence 6: Weeks 29-80 of Usual Care (Lookback), Weeks 81-115 of Intervention This group includes residents in Facility F. During Weeks 29-80, individuals resident in the facility received usual care (Lookback). During Weeks 81-115, individuals resident in the facility received the intervention.
Lookback Death	43	62	34	51	49	58
Lookback Deemed ineligible after review of admission dates	17	19	42	62	226	180
Intervention Death	55	34	23	19	34	27
Intervention Deemed ineligible after review of admission dates	53	35	9	9	52	11
Intervention Facility withdrew from study	0	0	0	162	0	0

Baseline Characteristics

Residents later deemed ineligible due to dates in the facility are not included.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants in the Usual Care (Lookback) and Intervention Periods n=4054 Participants Residents later deemed ineligible due to dates resident in the facility are not included. Because some residents were resident in the facility during both study periods, the total number of unique participants is 3,982.
Age, Continuous Overall study	71.95 Years STANDARD_DEVIATION 13.98 • n=4054 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Age, Continuous Lookback Period	72.45 Years STANDARD_DEVIATION 13.74 • n=2888 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Age, Continuous Intervention Period	71.51 Years STANDARD_DEVIATION 14.05 • n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Sex: Female, Male Overall Study · Female	1934 Participants n=4054 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Sex: Female, Male Overall Study · Male	2120 Participants n=4054 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Sex: Female, Male Lookback Period · Female	1395 Participants n=2888 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Sex: Female, Male Lookback Period · Male	1493 Participants n=2888 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Sex: Female, Male Intervention Period · Female	894 Participants n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Sex: Female, Male Intervention Period · Male	992 Participants n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Overall Study · American Indian or Alaska Native	649 Participants n=4054 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Overall Study · Asian	25 Participants n=4054 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Overall Study · Native Hawaiian or Other Pacific Islander	3 Participants n=4054 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Overall Study · Black or African American	72 Participants n=4054 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Overall Study · White	2200 Participants n=4054 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Overall Study · More than one race	186 Participants n=4054 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Overall Study · Unknown or Not Reported	919 Participants n=4054 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Lookback Period · American Indian or Alaska Native	429 Participants n=2888 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Lookback Period · Asian	18 Participants n=2888 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Lookback Period · Native Hawaiian or Other Pacific Islander	3 Participants n=2888 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Lookback Period · Black or African American	47 Participants n=2888 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Lookback Period · White	1525 Participants n=2888 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Lookback Period · More than one race	129 Participants n=2888 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Lookback Period · Unknown or Not Reported	737 Participants n=2888 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Intervention Period · American Indian or Alaska Native	338 Participants n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Intervention Period · Asian	12 Participants n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Intervention Period · Native Hawaiian or Other Pacific Islander	0 Participants n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Intervention Period · Black or African American	43 Participants n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Intervention Period · White	1151 Participants n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Intervention Period · More than one race	122 Participants n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Race (NIH/OMB) Intervention Period · Unknown or Not Reported	220 Participants n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Ethnicity (NIH/OMB) Overall Study · Hispanic or Latino	1266 Participants n=4054 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Ethnicity (NIH/OMB) Overall Study · Not Hispanic or Latino	2788 Participants n=4054 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Ethnicity (NIH/OMB) Overall Study · Unknown or Not Reported	0 Participants n=4054 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Ethnicity (NIH/OMB) Lookback Period · Hispanic or Latino	862 Participants n=2888 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Ethnicity (NIH/OMB) Lookback Period · Not Hispanic or Latino	2026 Participants n=2888 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Ethnicity (NIH/OMB) Lookback Period · Unknown or Not Reported	0 Participants n=2888 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Ethnicity (NIH/OMB) Intervention Period · Hispanic or Latino	705 Participants n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Ethnicity (NIH/OMB) Intervention Period · Not Hispanic or Latino	1181 Participants n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Ethnicity (NIH/OMB) Intervention Period · Unknown or Not Reported	0 Participants n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.
Region of Enrollment United States	1886 Participants n=1886 Participants • Residents later deemed ineligible due to dates in the facility are not included.

PRIMARY outcome

Timeframe: From date of newly identified skin damage through 3 days later, assessed up to 8 months for intervention period or up to 12 months for usual care (Lookback) period

Population: Practices analyzed for participants presented in Baseline Characteristics.

At least one Pressure Injury Prevention action newly initiated defined as electronic health record (EHR) documentation

Outcome measures

Outcome measures
Measure	All Participants in the Usual Care (Lookback) and Intervention Periods n=260 assessments_with_skin_damage Residents later deemed ineligible due to dates resident in the facility are not included. Because some residents were resident in the facility during both study periods, the total number of unique participants is 3,982.
New Pressure Injury Prevention Initiated Overall study	118 assessments_with_skin_damage
New Pressure Injury Prevention Initiated Lookback Period	97 assessments_with_skin_damage
New Pressure Injury Prevention Initiated Intervention Period	21 assessments_with_skin_damage

SECONDARY outcome

Timeframe: Number of days from date of identified skin damage through 3 days later, assessed up to 8 months for intervention period or up to 12 months for baseline period

Number of Days from skin assessment until EHR documentation of Pressure Injury Prevention

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From at least 3 weeks since prior pressure injury occurrence (if ever), assessed up to 8 months for intervention period or up to 12 months for baseline period

Population: Number of participants with at least one sacral or heel pressure injury during study period

EHR documentation of sacral and/or heel PrI

Outcome measures

Outcome measures
Measure	All Participants in the Usual Care (Lookback) and Intervention Periods n=4054 Participants Residents later deemed ineligible due to dates resident in the facility are not included. Because some residents were resident in the facility during both study periods, the total number of unique participants is 3,982.
Sacral and/or Heel Pressure Injury Occurrence Overall Study	259 Participants
Sacral and/or Heel Pressure Injury Occurrence Lookback Period	141 Participants
Sacral and/or Heel Pressure Injury Occurrence Intervention Period	150 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Number of days from date of new pressure injury occurrence (from at least 3 weeks since prior pressure injury, if ever), assessed up to 8 months for intervention period or up to 12 months for baseline period

Number of pressure injury free days since prior pressure injury occurrence, if ever.

Outcome measures

Outcome data not reported

Adverse Events

All Participants in the Usual Care (Lookback) Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 297 deaths

All Participants in the Intervention Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 192 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Barbara M Bates-Jensen

School of Nursing, University of California, Los Angeles

Phone: 626-437-8543

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place