WoundNCT04649853
Wound Care and Pressure Injury Through the Continuum of Care
An observational study of Wound and Pressure Injury, run by Regional Medical Center of San Jose at 1 site in United States.
Trial summary
Our primary objective is to understand the impact of our quality improvement objectives on pressure injury and wound care outcomes. We will follow patients admitted to our facility who receive the standard of care for a up to a year. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound, Pressure Injury
- What is being tested?
- Standardized nursing care
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target study sample are adults who have either an acute wound, chronic wound, pressure injury or at risk for a pressure injury that are admitted to the acute care organization. The primary site is a community based acute-care organization. Patients will be identified upon admission.
Who may be able to join
- The inclusion criteria includes:
- 18 years and older
- admitted into acute care with acute wound
- admitted with chronic wound
- admitted with pressure injury
- at risk for pressure injury
Who cannot join
- pregnant patients
- patients under 18
- known vascular disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Regional Medical Center San Jose
San Jose, California, 95116
About this study
Our primary objective is to understand the impact of our quality improvement objectives on pressure injury and wound care outcomes. We will follow patients admitted to our facility who receive the standard of care for a up to a year. Patients to be followed will fall into one of four groups: acute wounds, chronic wounds, pressure injuries present at time of admission and at risk for pressure injuries.
Read the detailed description
Overall Objective The main objective is to understand the impact of an evidence-based best practice model for wounds and pressure injuries that follows a patient through the continuum of care.
Specific Aims The specific aim is to measure the rates of healing using tissue analytics and the rates of pressure injuries.
The secondary aim measured is patients understanding of their health and the impact on their wound healing, prevention of wound re-opening and pressure injury.
Once we identify the rates we can translate the impact of rates into healthcare dollars and begin to understand the fiscal impact of evidence based practice.
BACKGROUND AND SIGNIFICANCE
Over the past decade researchers published the benefit of advanced wound care and the need to implement pressure injury prevention. To date there is very little literature connecting the acute care and post-acute care as a continuum by following a patient. Little is known about what the outcomes for wound care and pressure injury would be if a patient were followed through the trajectory of care. The medical home model suggests that placing the patient at the center of care is the best practice for best outcomes. However, at times in the hustle of the healthcare system the patient is lost. Implementing evidence-based best practice that follows the patient through the continuum of care is one approach to keeping the patient at the center of care. Currently wound care and pressure injury care or prevention is practiced in silos between acute-care and post-acute care. There is little literature that links the impact of continuing care throughout the continuum.
RESEARCH DESIGN AND METHODS Overview This quantitative study will utilize both primary and secondary data. The secondary data source will come from chart review and be the comparison group for outcomes. Patients will be enrolled upon admission as they are identified as meeting criteria, which includes either having a chronic wound that is not followed by a vascular team or an acute wound or a pressure injury. The fourth group of individuals to be enrolled into the study are those patients who are immobile and are expected to remain immobile at the time of discharge. Patients will be identified by admitting clinical staff and then enrolled and consented by the study coordinator or principal investigator. Once enrolled in the study, patients will have evidence based best practice interventions implemented based on their needs while in the acute care setting. For patients with wounds this will include that their cover dressing will be an antimicrobial foam bordered dressing that minimizes dressing changes. For immobile patients they will have the evidence based best practice pressure injury prevention bundle implemented. During the acute care admission, the patient will receive education regarding their wound care and or pressure injury prevention. Once the target post-admission site is identified, education for the caregiver at the receiving site will be provided. The patient will continue to be followed in the post-acute setting until the wound is healed or six months has passed on a weekly basis for a maximum of time frame of one year. The wounds will be measured weekly using tissue analytics. Re-education and coaching will be provided to the post-acute care facility. As patients are discharged from the study, they will be asked to complete an evaluation survey of their satisfaction with the care and the impact on their lives. The caregivers in the post-acute care will be asked to complete a survey to evaluate the education and support provided.
- Conditions
- Wound, Pressure Injury
- Being tested
- Standardized nursing care
- Medical subject headings
- Wounds and Injuries, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized nursing careOther
All patients will receive standardized evidence based nursing care
| Study group | Role | What they receive |
|---|---|---|
| Acute Wounds | Patient with either traumatic or surgical wounds | |
| Chronic Wounds | Patient with chronic wounds either peripheral vascular disease related or surgical/traumatic wound | |
| Pressure Injuries Present on Admission | Patient admitted with one or more pressure injury of any stage on admission Receives: Other: Standardized nursing care | |
| At Risk for Pressure Injury | Patient admitted with risk for pressure injury and has no pressure injuries at time of admission. Identified as at risk for based on mobility. Receives: Other: Standardized nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The implementation of evidence-based best practice for wound care in the acute-care setting that is extended into post-acute care will improve outcomes.
Rate of wound healing
Measured: 1 year
The implementation of an evidence based pressure injury prevention bundle in acute care that is extended into post-acute care will prevent pressure injuries in high-risk patients.
Number of individuals who are at risk to develop a pressure injury actually develop pressure injuries
Measured: 1 year
The implementation of an evidence based pressure injury prevention bundle for patients with existing pressure injuries will prevent new pressure injuries from occurring
Measurement of occurrence of new pressure injuries for individuals with existing pressure injuries
Measured: 1 year
The extension of a best practice prevention bundle implemented in acute-care and extending into post-acute care will reduce fiscal expenditure.
Comparison of number of individuals admitted from post acute with pressure injuries to acute acute after receiving education and the fiscal impact.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start17 Aug 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regional Medical Center of San Jose
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charleen Singh, Regional Medical Center of San Jose
- Investigators
- Lee Thorpe, MSN, Study chair, Regional Medical Center San Jose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649853
- Sponsor's protocol ID
- 1267389
- Status last verified
- Nov 2020
- First submitted
- 17 Aug 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data is coded and stored on the hospital password protected server. We don't plan to share the data at this time.
Publications
Swietek KE, Domino ME, Beadles C, Ellis AR, Farley JF, Grove LR, Jackson C, DuBard CA. Do Medical Homes Improve Quality of Care for Persons with Multiple Chronic Conditions? Health Serv Res. 2018 Dec;53(6):4667-4681. doi: 10.1111/1475-6773.13024. Epub 2018 Aug 7.
PubMed 30088272Berkowitz SA, Terranova J, Hill C, Ajayi T, Linsky T, Tishler LW, DeWalt DA. Meal Delivery Programs Reduce The Use Of Costly Health Care In Dually Eligible Medicare And Medicaid Beneficiaries. Health Aff (Millwood). 2018 Apr;37(4):535-542. doi: 10.1377/hlthaff.2017.0999.
PubMed 29608345Van Eenoo L, van der Roest H, Onder G, Finne-Soveri H, Garms-Homolova V, Jonsson PV, Draisma S, van Hout H, Declercq A. Organizational home care models across Europe: A cross sectional study. Int J Nurs Stud. 2018 Jan;77:39-45. doi: 10.1016/j.ijnurstu.2017.09.013. Epub 2017 Sep 21.
PubMed 29032349Campbell Britton M, Petersen-Pickett J, Hodshon B, Chaudhry SI. Mapping the care transition from hospital to skilled nursing facility. J Eval Clin Pract. 2020 Jun;26(3):786-790. doi: 10.1111/jep.13238. Epub 2019 Jul 16.
PubMed 31309664Meehan R. Transitions From Acute Care to Long-Term Care: Evaluation of the Continued Access Model. J Appl Gerontol. 2019 Apr;38(4):510-529. doi: 10.1177/0733464817723565. Epub 2017 Aug 8.
PubMed 28786316Molloy MA, Cary MP Jr, Brennan-Cook J, Cantey DS, Tocchi C, Bailey DE Jr, Oermann MH. Preparing Clinicians for Transitioning Patients Across Care Settings and Into the Home Through Simulation. Home Healthc Now. 2018 Jul/Aug;36(4):225-231. doi: 10.1097/NHH.0000000000000667.
PubMed 29979303Nussbaum SR, Carter MJ, Fife CE, DaVanzo J, Haught R, Nusgart M, Cartwright D. An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. Value Health. 2018 Jan;21(1):27-32. doi: 10.1016/j.jval.2017.07.007. Epub 2017 Sep 19.
PubMed 29304937Pal A, Goswami D, Cuellar HE, Castro B, Kuang S, Martinez RV. Early detection and monitoring of chronic wounds using low-cost, omniphobic paper-based smart bandages. Biosens Bioelectron. 2018 Oct 15;117:696-705. doi: 10.1016/j.bios.2018.06.060. Epub 2018 Jul 5.
PubMed 30014943Brain D, Tulleners R, Lee X, Cheng Q, Graves N, Pacella R. Cost-effectiveness analysis of an innovative model of care for chronic wounds patients. PLoS One. 2019 Mar 6;14(3):e0212366. doi: 10.1371/journal.pone.0212366. eCollection 2019.
PubMed 30840658Olsson M, Jarbrink K, Divakar U, Bajpai R, Upton Z, Schmidtchen A, Car J. The humanistic and economic burden of chronic wounds: A systematic review. Wound Repair Regen. 2019 Jan;27(1):114-125. doi: 10.1111/wrr.12683. Epub 2018 Dec 2.
PubMed 30362646Padula WV, Pronovost PJ, Makic MBF, Wald HL, Moran D, Mishra MK, Meltzer DO. Value of hospital resources for effective pressure injury prevention: a cost-effectiveness analysis. BMJ Qual Saf. 2019 Feb;28(2):132-141. doi: 10.1136/bmjqs-2017-007505. Epub 2018 Aug 10.
PubMed 30097490Cheng Q, Graves N, Pacella RE. Economic Evaluations of Guideline-Based Care for Chronic Wounds: a Systematic Review. Appl Health Econ Health Policy. 2018 Oct;16(5):633-651. doi: 10.1007/s40258-018-0403-9.
PubMed 29968020Kapp S, Miller C, Santamaria N. The quality of life of people who have chronic wounds and who self-treat. J Clin Nurs. 2018 Jan;27(1-2):182-192. doi: 10.1111/jocn.13870. Epub 2017 Aug 9.
PubMed 28493644Holscher CM, Hicks CW, Canner JK, Sherman RL, Malas MB, Black JH 3rd, Mathioudakis N, Abularrage CJ. Unplanned 30-day readmission in patients with diabetic foot wounds treated in a multidisciplinary setting. J Vasc Surg. 2018 Mar;67(3):876-886. doi: 10.1016/j.jvs.2017.07.131. Epub 2017 Oct 7.
PubMed 29017807Martinengo L, Olsson M, Bajpai R, Soljak M, Upton Z, Schmidtchen A, Car J, Jarbrink K. Prevalence of chronic wounds in the general population: systematic review and meta-analysis of observational studies. Ann Epidemiol. 2019 Jan;29:8-15. doi: 10.1016/j.annepidem.2018.10.005. Epub 2018 Nov 12.
PubMed 30497932
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Care and Pressure Injury Through the Continuum of Care
- ClinicalTrials.gov ID
- NCT04649853
- Acronym / sponsor ID
- 1267389
- Conditions
- Wound, Pressure Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Regional Medical Center of San JoseUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our primary objective is to understand the impact of our quality improvement objectives on pressure injury and wound care outcomes. We will follow patients admitted to our facility who receive the standard of care for a up to a year. Patients to be followed will fall into one of four groups: acute wounds, chronic wounds, pressure injuries present at time of admission and at risk for pressure injuries.
Detailed description
Overall Objective The main objective is to understand the impact of an evidence-based best practice model for wounds and pressure injuries that follows a patient through the continuum of care.
Specific Aims The specific aim is to measure the rates of healing using tissue analytics and the rates of pressure injuries.
The secondary aim measured is patients understanding of their health and the impact on their wound healing, prevention of wound re-opening and pressure injury.
Once we identify the rates we can translate the impact of rates into healthcare dollars and begin to understand the fiscal impact of evidence based practice.
BACKGROUND AND SIGNIFICANCE
Over the past decade researchers published the benefit of advanced wound care and the need to implement pressure injury prevention. To date there is very little literature connecting the acute care and post-acute care as a continuum by following a patient. Little is known about what the outcomes for wound care and pressure injury would be if a patient were followed through the trajectory of care. The medical home model suggests that placing the patient at the center of care is the best practice for best outcomes. However, at times in the hustle of the healthcare system the patient is lost. Implementing evidence-based best practice that follows the patient through the continuum of care is one approach to keeping the patient at the center of care. Currently wound care and pressure injury care or prevention is practiced in silos between acute-care and post-acute care. There is little literature that links the impact of continuing care throughout the continuum.
RESEARCH DESIGN AND METHODS Overview This quantitative study will utilize both primary and secondary data. The secondary data source will come from chart review and be the comparison group for outcomes. Patients will be enrolled upon admission as they are identified as meeting criteria, which includes either having a chronic wound that is not followed by a vascular team or an acute wound or a pressure injury. The fourth group of individuals to be enrolled into the study are those patients who are immobile and are expected to remain immobile at the time of discharge. Patients will be identified by admitting clinical staff and then enrolled and consented by the study coordinator or principal investigator. Once enrolled in the study, patients will have evidence based best practice interventions implemented based on their needs while in the acute care setting. For patients with wounds this will include that their cover dressing will be an antimicrobial foam bordered dressing that minimizes dressing changes. For immobile patients they will have the evidence based best practice pressure injury prevention bundle implemented. During the acute care admission, the patient will receive education regarding their wound care and or pressure injury prevention. Once the target post-admission site is identified, education for the caregiver at the receiving site will be provided. The patient will continue to be followed in the post-acute setting until the wound is healed or six months has passed on a weekly basis for a maximum of time frame of one year. The wounds will be measured weekly using tissue analytics. Re-education and coaching will be provided to the post-acute care facility. As patients are discharged from the study, they will be asked to complete an evaluation survey of their satisfaction with the care and the impact on their lives. The caregivers in the post-acute care will be asked to complete a survey to evaluate the education and support provided.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute Wounds | – | –Patient with either traumatic or surgical wounds |
| Chronic Wounds | – | –Patient with chronic wounds either peripheral vascular disease related or surgical/traumatic wound |
| Pressure Injuries Present on Admission | – | Other: Standardized nursing carePatient admitted with one or more pressure injury of any stage on admission |
| At Risk for Pressure Injury | – | Other: Standardized nursing carePatient admitted with risk for pressure injury and has no pressure injuries at time of admission. Identified as at risk for based on mobility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target study sample are adults who have either an acute wound, chronic wound, pressure injury or at risk for a pressure injury that are admitted to the acute care organization. The primary site is a community based acute-care organization. Patients will be identified upon admission.
Key inclusion criteria (6 listed)
- 18 years and older
- admitted into acute care with acute wound
- admitted with chronic wound
- admitted with pressure injury
- at risk for pressure injury
Key exclusion criteria (3 listed)
- pregnant patients
- patients under 18
- known vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized nursing careAll patients will receive standardized evidence based nursing care | Other | At Risk for Pressure Injury, Pressure Injuries Present on Admission |
Primary outcome
The implementation of evidence-based best practice for wound care in the acute-care setting that is extended into post-acute care will improve outcomes.
Time frame: 1 year
Rate of wound healing
The implementation of an evidence based pressure injury prevention bundle in acute care that is extended into post-acute care will prevent pressure injuries in high-risk patients.
Time frame: 1 year
Number of individuals who are at risk to develop a pressure injury actually develop pressure injuries
The implementation of an evidence based pressure injury prevention bundle for patients with existing pressure injuries will prevent new pressure injuries from occurring
Time frame: 1 year
Measurement of occurrence of new pressure injuries for individuals with existing pressure injuries
The extension of a best practice prevention bundle implemented in acute-care and extending into post-acute care will reduce fiscal expenditure.
Time frame: 1 year
Comparison of number of individuals admitted from post acute with pressure injuries to acute acute after receiving education and the fiscal impact.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Results publication: PubMed 30088272Swietek KE, Domino ME, Beadles C, Ellis AR, Farley JF, Grove LR, Jackson C, DuBard CA. Do Medical Homes Improve Quality of Care for Persons with Multiple Chronic Conditions? Health Serv Res. 2018 Dec;53(6):4667-4681. doi: 10.1111/1475-6773.13024. Epub 2018 Aug 7.
- Results publication: PubMed 29608345Berkowitz SA, Terranova J, Hill C, Ajayi T, Linsky T, Tishler LW, DeWalt DA. Meal Delivery Programs Reduce The Use Of Costly Health Care In Dually Eligible Medicare And Medicaid Beneficiaries. Health Aff (Millwood). 2018 Apr;37(4):535-542. doi: 10.1377/hlthaff.2017.0999.
- Results publication: PubMed 29032349Van Eenoo L, van der Roest H, Onder G, Finne-Soveri H, Garms-Homolova V, Jonsson PV, Draisma S, van Hout H, Declercq A. Organizational home care models across Europe: A cross sectional study. Int J Nurs Stud. 2018 Jan;77:39-45. doi: 10.1016/j.ijnurstu.2017.09.013. Epub 2017 Sep 21.
- Results publication: PubMed 31309664Campbell Britton M, Petersen-Pickett J, Hodshon B, Chaudhry SI. Mapping the care transition from hospital to skilled nursing facility. J Eval Clin Pract. 2020 Jun;26(3):786-790. doi: 10.1111/jep.13238. Epub 2019 Jul 16.
- Results publication: PubMed 28786316Meehan R. Transitions From Acute Care to Long-Term Care: Evaluation of the Continued Access Model. J Appl Gerontol. 2019 Apr;38(4):510-529. doi: 10.1177/0733464817723565. Epub 2017 Aug 8.
- Results publication: PubMed 29979303Molloy MA, Cary MP Jr, Brennan-Cook J, Cantey DS, Tocchi C, Bailey DE Jr, Oermann MH. Preparing Clinicians for Transitioning Patients Across Care Settings and Into the Home Through Simulation. Home Healthc Now. 2018 Jul/Aug;36(4):225-231. doi: 10.1097/NHH.0000000000000667.
- Results publication: PubMed 29304937Nussbaum SR, Carter MJ, Fife CE, DaVanzo J, Haught R, Nusgart M, Cartwright D. An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. Value Health. 2018 Jan;21(1):27-32. doi: 10.1016/j.jval.2017.07.007. Epub 2017 Sep 19.
- Results publication: PubMed 30014943Pal A, Goswami D, Cuellar HE, Castro B, Kuang S, Martinez RV. Early detection and monitoring of chronic wounds using low-cost, omniphobic paper-based smart bandages. Biosens Bioelectron. 2018 Oct 15;117:696-705. doi: 10.1016/j.bios.2018.06.060. Epub 2018 Jul 5.
- Results publication: PubMed 30840658Brain D, Tulleners R, Lee X, Cheng Q, Graves N, Pacella R. Cost-effectiveness analysis of an innovative model of care for chronic wounds patients. PLoS One. 2019 Mar 6;14(3):e0212366. doi: 10.1371/journal.pone.0212366. eCollection 2019.
- Results publication: PubMed 30362646Olsson M, Jarbrink K, Divakar U, Bajpai R, Upton Z, Schmidtchen A, Car J. The humanistic and economic burden of chronic wounds: A systematic review. Wound Repair Regen. 2019 Jan;27(1):114-125. doi: 10.1111/wrr.12683. Epub 2018 Dec 2.
- Results publication: PubMed 30097490Padula WV, Pronovost PJ, Makic MBF, Wald HL, Moran D, Mishra MK, Meltzer DO. Value of hospital resources for effective pressure injury prevention: a cost-effectiveness analysis. BMJ Qual Saf. 2019 Feb;28(2):132-141. doi: 10.1136/bmjqs-2017-007505. Epub 2018 Aug 10.
- Results publication: PubMed 29968020Cheng Q, Graves N, Pacella RE. Economic Evaluations of Guideline-Based Care for Chronic Wounds: a Systematic Review. Appl Health Econ Health Policy. 2018 Oct;16(5):633-651. doi: 10.1007/s40258-018-0403-9.
- Individual participant dataSharing planned: Undecided. Data is coded and stored on the hospital password protected server. We don't plan to share the data at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Thorpe, MSN study chair
Regional Medical Center San Jose
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound and Pressure Injury, run by Regional Medical Center of San Jose 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Dec 2020. 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?
Results are not available in the source record.
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?
The implementation of evidence-based best practice for wound care in the acute-care setting that is extended into post-acute care will improve outcomes. (time frame: 1 year). The study lists 4 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 NCT04649853, which also lists 18 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 2 Dec 2020.