Pediatric ALLSM-THINkNCT03539978
Peds SM-THINk: Nursing Interventions to Improve Discharge Outcomes
An observational study of Pediatric ALL, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study focuses on the delivery of discharge education by clinical nurses to improve parent and family self-management in the home environment. This study tests an discharge method (SM-THINk protocol) designed to improve the quality of care for hospitalized pediatric patients at the time of discharge, enhance the… Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Pediatric ALL
- What is being tested?
- SM-THINk
- How many people
- 486 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2018to 20 Apr 2019
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We expect to enroll 300 patients and one legal guardian per patient (parent or caregiver who has guardianship of the patient) per unit (for a total of 900 patients and 900 parents). A high-risk discharge assessment based on Mayo Clinic criteria will be used to identify children with complex or chronic conditions. Based on conversations with hospital leadership it is expected that approximately 120 patients per unit (40%) will have a complex or chronic condition. Parent experience related to quality of discharge teaching and care coordination will be self-reported by parents using established, reliable and valid scales. Child and parent characteristics, length of hospitalization, readmission, and Emergency Department use data will be extracted from electronic medical records.
Who may be able to join
- the parent's/caregiver's child is inpatient on the selected study units
- the parent/caregiver is English speaking (to date the tools being used have been validated for English participants only)
- the parent/caregiver is 18 years of age or older
- the patient is 17 years of age or younger
Who cannot join
- presence of significant communication or cognitive impairment on the part of the parent/caregiver that would preclude completion of questionnaires based on self-report.
- the patient is a ward of the state or in foster care
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Peds SM-THINk (Self-Management Transition to Home INtervention): Nursing Interventions to Improve Discharge Outcomes
This study focuses on the delivery of discharge education by clinical nurses to improve parent and family self-management in the home environment. This study tests an discharge method (SM-THINk protocol) designed to improve the quality of care for hospitalized pediatric patients at the time of discharge, enhance the child's and family's experience, and decrease length of stay and health care utilization (ED visit or re-admission). The SM-THINk protocol is an enhancement to the standard clinical practice and will be implemented for all subjects on two Children's Hospital of Wisconsin (CHW) nursing units. This enhancement will require additional training of the nurses prior to implementation of the research project. This research determines the effectiveness of the training enhanced discharge method. The training is independent from the research project and will evaluate effectiveness of this training. For the enhanced discharge method, clinical nurses on the study units will be trained to deliver the Self-Management Transition to Home (SM-THINk protocol), which is based on the family self-management discharge preparation previously developed and tested by the study team.
Read the detailed description
This quasi-experimental study uses a cluster design with parents from 3 nursing units at the Children's Hospital of Wisconsin. Implementation of the SM-THINk protocol will occur on 2 pediatric inpatient units and a third unit will serve as the usual care control unit. The SM-THINk protocol will be implemented on the two implementation experimental units regardless of this study as a clinical practice change. The nurses will not serve as subjects in this study since they are expected to learn the protocol as part of their everyday jobs.
Plan to enroll 300 patients and one legal guardian per patient (parent or caregiver who has guardianship of the patient). 300 parents of patients per unit (for a total of 900 patients and 900 parents). A high-risk discharge assessment based on Mayo Clinic criteria is used to identify children with complex or chronic conditions. Approximately 120 patients per unit (40%) will have a complex or chronic condition. Parent experience related to quality of discharge teaching and care coordination will be self-reported by parents using established, reliable and valid scales. Child and parent characteristics, length of hospitalization, readmission, and Emergency Department use data will be extracted from electronic medical records.
Nurses on the three units will provide a brief information sheet to families at some point after admission and explain that if the subjects/families have questions that they should call the research team or ask the nurse to contact the research team on their behalf. This information sheet includes a summary of the research purposes and what questions will be asked. When a nurse on the implementation unit is ready to discharge a family who agree to participate, he/she will obtain the iPad, enter the patient code and write down which code corresponds to which patient on a log, perform the enhanced discharge method per clinical practice, then log out of the iPad. He/she will then log into the parent questionnaires (REDCap), enter the patient code, and provide the iPad to the subjects/families. The nurse will indicate that if they would like to participate, they should do so after he/she leaves the room and log out of the iPad when finished. Nurses on the control unit will perform their usual discharge and then obtain the iPad, enter the patient code and write down which code corresponds to which patient on a log. He/she will then log into the parent questionnaires (REDCap), enter the patient code, and provide the iPad to the subjects/families. The nurse will indicate that if they would like to participate, they should do so after he/she leaves the room and log out of the iPad when finished. After approximately 10 minutes the nurse will check to be sure the subject/family has left and if so, will pick up the iPad, ensure the family has logged out, and return the iPad to the storage area. If the subject/family has not left yet, the nurse will check back periodically until they have left. This design will ensure that nursing discharge time is not affected. The research team will pick up the list of patient codes on the next working day. There is a waiver for documentation of informed consent and assent. If the parent and child are interested, participation will serve as implied consent. A HIPAA waiver will be requested by the study team to abstract data from the patient's medical record to look for outcomes over time regarding readmissions and ED visits. Only the following data will be collected from the patient's medical record: the number of hospitalizations in the last 1 year, date of admission/discharge, and the reason for hospitalizations.
All units will ask the parents to complete the parent experience tools at time of discharge using the iPad. Both groups will receive standard post-discharge follow-up care including laboratory and clinic appointments.
The parent's age, insurance information and the child's chronic conditions will all be asked for in the REDCap questionnaires on the iPad. If the iPad is temporarily unavailable for subject/families, paper forms will be provided to them and they will be instructed by the nurses to fill out the forms and seal them in an envelope when they are finished. Nursing staff will provide the sealed envelopes to the research team.
- Conditions
- Pediatric ALL
- Being tested
- SM-THINk
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM-THINkOther
Patients will receive the SM-THINk enhanced discharge method.
| Study group | Role | What they receive |
|---|---|---|
| SM-THINk Unit | Two of the three inpatient floors will use the SM-THINk enhanced discharge method. This is part of a clinical practice change and not for research. Parents will complete a questionnaire at the time of the patient's discharge from the hospital. Receives: Other: SM-THINk | |
| Control Unit | One of the three inpatient floors will use the usual discharge method. Parents will also complete a questionnaire at the time of the patient's discharge from the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved parent experience
Parents of children with and without complex or chronic health conditions who received enhanced discharge preparation by the clinical nurse using the SM-THINk protocol would report increased parent experience (quality of discharge teaching delivered and care coordination).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start30 Aug 2018
- Primary completion20 Feb 2019
- Study completion20 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical & Translational Science Institute, Marquette University, Children's Hospital and Health System Foundation, Wisconsin, University of Wisconsin, Milwaukee
- Responsible party
- Principal investigator, Stacee Lerret, Medical College of Wisconsin
- Investigators
- Stacee Lerret, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539978
- Sponsor's protocol ID
- 1118599
- Acronym
- SM-THINk
- Status last verified
- Dec 2019
- First submitted
- 25 Apr 2018
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peds SM-THINk (Self-Management Transition to Home INtervention): Nursing Interventions to Improve Discharge Outcomes
- ClinicalTrials.gov ID
- NCT03539978
- Acronym / sponsor ID
- SM-THINk / 1118599
- Conditions
- Pediatric ALL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Clinical & Translational Science Institute, Marquette University, Children's Hospital and Health System Foundation, Wisconsin, University of Wisconsin, Milwaukee
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Apr 2019 (actual)
- First posted
- 30 May 2018 (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.
This study focuses on the delivery of discharge education by clinical nurses to improve parent and family self-management in the home environment. This study tests an discharge method (SM-THINk protocol) designed to improve the quality of care for hospitalized pediatric patients at the time of discharge, enhance the child's and family's experience, and decrease length of stay and health care utilization (ED visit or re-admission). The SM-THINk protocol is an enhancement to the standard clinical practice and will be implemented for all subjects on two Children's Hospital of Wisconsin (CHW) nursing units. This enhancement will require additional training of the nurses prior to implementation of the research project. This research determines the effectiveness of the training enhanced discharge method. The training is independent from the research project and will evaluate effectiveness of this training. For the enhanced discharge method, clinical nurses on the study units will be trained to deliver the Self-Management Transition to Home (SM-THINk protocol), which is based on the family self-management discharge preparation previously developed and tested by the study team.
Detailed description
This quasi-experimental study uses a cluster design with parents from 3 nursing units at the Children's Hospital of Wisconsin. Implementation of the SM-THINk protocol will occur on 2 pediatric inpatient units and a third unit will serve as the usual care control unit. The SM-THINk protocol will be implemented on the two implementation experimental units regardless of this study as a clinical practice change. The nurses will not serve as subjects in this study since they are expected to learn the protocol as part of their everyday jobs.
Plan to enroll 300 patients and one legal guardian per patient (parent or caregiver who has guardianship of the patient). 300 parents of patients per unit (for a total of 900 patients and 900 parents). A high-risk discharge assessment based on Mayo Clinic criteria is used to identify children with complex or chronic conditions. Approximately 120 patients per unit (40%) will have a complex or chronic condition. Parent experience related to quality of discharge teaching and care coordination will be self-reported by parents using established, reliable and valid scales. Child and parent characteristics, length of hospitalization, readmission, and Emergency Department use data will be extracted from electronic medical records.
Nurses on the three units will provide a brief information sheet to families at some point after admission and explain that if the subjects/families have questions that they should call the research team or ask the nurse to contact the research team on their behalf. This information sheet includes a summary of the research purposes and what questions will be asked. When a nurse on the implementation unit is ready to discharge a family who agree to participate, he/she will obtain the iPad, enter the patient code and write down which code corresponds to which patient on a log, perform the enhanced discharge method per clinical practice, then log out of the iPad. He/she will then log into the parent questionnaires (REDCap), enter the patient code, and provide the iPad to the subjects/families. The nurse will indicate that if they would like to participate, they should do so after he/she leaves the room and log out of the iPad when finished. Nurses on the control unit will perform their usual discharge and then obtain the iPad, enter the patient code and write down which code corresponds to which patient on a log. He/she will then log into the parent questionnaires (REDCap), enter the patient code, and provide the iPad to the subjects/families. The nurse will indicate that if they would like to participate, they should do so after he/she leaves the room and log out of the iPad when finished. After approximately 10 minutes the nurse will check to be sure the subject/family has left and if so, will pick up the iPad, ensure the family has logged out, and return the iPad to the storage area. If the subject/family has not left yet, the nurse will check back periodically until they have left. This design will ensure that nursing discharge time is not affected. The research team will pick up the list of patient codes on the next working day. There is a waiver for documentation of informed consent and assent. If the parent and child are interested, participation will serve as implied consent. A HIPAA waiver will be requested by the study team to abstract data from the patient's medical record to look for outcomes over time regarding readmissions and ED visits. Only the following data will be collected from the patient's medical record: the number of hospitalizations in the last 1 year, date of admission/discharge, and the reason for hospitalizations.
All units will ask the parents to complete the parent experience tools at time of discharge using the iPad. Both groups will receive standard post-discharge follow-up care including laboratory and clinic appointments.
The parent's age, insurance information and the child's chronic conditions will all be asked for in the REDCap questionnaires on the iPad. If the iPad is temporarily unavailable for subject/families, paper forms will be provided to them and they will be instructed by the nurses to fill out the forms and seal them in an envelope when they are finished. Nursing staff will provide the sealed envelopes to the research team.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SM-THINk Unit | – | Other: SM-THINkTwo of the three inpatient floors will use the SM-THINk enhanced discharge method. This is part of a clinical practice change and not for research. Parents will complete a questionnaire at the time of the patient's discharge from the hospital. |
| Control Unit | – | –One of the three inpatient floors will use the usual discharge method. Parents will also complete a questionnaire at the time of the patient's discharge from the hospital. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We expect to enroll 300 patients and one legal guardian per patient (parent or caregiver who has guardianship of the patient) per unit (for a total of 900 patients and 900 parents). A high-risk discharge assessment based on Mayo Clinic criteria will be used to identify children with complex or chronic conditions. Based on conversations with hospital leadership it is expected that approximately 120 patients per unit (40%) will have a complex or chronic condition. Parent experience related to quality of discharge teaching and care coordination will be self-reported by parents using established, reliable and valid scales. Child and parent characteristics, length of hospitalization, readmission, and Emergency Department use data will be extracted from electronic medical records.
Key inclusion criteria (4 listed)
- the parent's/caregiver's child is inpatient on the selected study units
- the parent/caregiver is English speaking (to date the tools being used have been validated for English participants only)
- the parent/caregiver is 18 years of age or older
- the patient is 17 years of age or younger
Key exclusion criteria (2 listed)
- presence of significant communication or cognitive impairment on the part of the parent/caregiver that would preclude completion of questionnaires based on self-report.
- the patient is a ward of the state or in foster care
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 |
|---|---|---|
| SM-THINkPatients will receive the SM-THINk enhanced discharge method. | Other | SM-THINk Unit |
Primary outcome
Improved parent experience
Time frame: 30 days
Parents of children with and without complex or chronic health conditions who received enhanced discharge preparation by the clinical nurse using the SM-THINk protocol would report increased parent experience (quality of discharge teaching delivered and care coordination).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Stacee Lerret, PhD principal investigator
Medical College of Wisconsin
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 Pediatric ALL, run by Medical College of Wisconsin 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 4 inclusion and 2 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 12 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improved parent experience (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2019.