Discharge Transition of Patients Discharged to HomeREADINCT01873118
READI (Readiness Evaluation And Discharge Interventions) Study
A study testing RN-RHDS protocol, RN-RHDS+PT-RHDS protocol and RN-RHDS + PT-RHDS + NIAF in people with Discharge Transition of Patients Discharged to Home, run by Marquette University at 1 site in United States.
Trial summary
Preparation of patients for discharge is a primary function of hospital-based nursing care and readiness for discharge is an important outcome of hospital care. Inadequacies in discharge preparation have been well-documented and linked to difficulty with self-management after hospital discharge and with increased… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Discharge Transition of Patients Discharged to Home
- What is being tested?
- RN-RHDS protocol, RN-RHDS+PT-RHDS protocol and RN-RHDS + PT-RHDS + NIAF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189,796 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical, surgical, or medical-surgical nursing units of Magnet designated hospitals
- Patients 18 years of age or more, English speaking,able to read and understand consent who are being discharged to home as the discharge destination.
- Nursing personnel (Registered Nurses or Licensed Practical Nurses) who are performing discharge instructions and procedures on the day of hospital discharge.
Who cannot join
- Patients discharged to home with hospice care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Marquette University
Milwaukee, Wisconsin, 53201-1881
About this study
Official title: READI (Readiness Evaluation And Discharge Interventions): Implementation as a Standard Nursing Practice for Hospital Discharge
Preparation of patients for discharge is a primary function of hospital-based nursing care and readiness for discharge is an important outcome of hospital care. Inadequacies in discharge preparation have been well-documented and linked to difficulty with self-management after hospital discharge and with increased likelihood of emergency department (ED) use and readmission. Prior studies by the research team have led to recommendations for implementation of discharge readiness assessment as a standard nursing practice for hospital discharge.
The investigators will conduct a multi-site study to determine the impact on post-discharge utilization (readmission and ED visits) and costs of implementing discharge readiness assessment as a standard nursing practice for adult medical-surgical patients discharged to home. The study tests, in a stepped approach, the impact of implementing discharge readiness assessment by the discharging nurse as standard nursing practice (RN-RHDS protocol), the incremental value of informing the nurse assessment with the patient's perspective (RN-RHDS+PT-RHDS protocol), and of requiring that the nurse initiates and documents risk-mitigating actions for patients with low readiness scores (RN-RHDS+PT-RHDS+NIAF protocol).
Read more
HYPOTHESIS 1: Patients discharged using the RN-RHDS protocol will have fewer hospital readmissions and ED visits within 30 days post-discharge compared to patients discharged under usual care conditions.
HYPOTHESIS 2: Patients discharged using the RN-RHDS+PT-RHDS protocol will have fewer hospital readmissions and ED visits within 30 days post-discharge compared to patients discharged using the RN-RHDS protocol.
HYPOTHESIS 3: Patients discharged by nurses using the RN-RHDS+PT-RHDS protocol plus a Nurse-Initiated Action Form [NIAF] (RN-RHDS+PT-RHDS+NIAF protocol) will have fewer post-discharge readmissions and ED visits than patients discharged using the RN-RHDS+PT-RHDS protocol; the effect will be strongest for patients with low RHDS scores.
Aim 4: Conduct cost-benefit analysis of implementing discharge readiness assessment as standard practice, by comparing cost-savings from reduced post-discharge utilization against implementation costs.
- Being tested
- RN-RHDS protocol, RN-RHDS+PT-RHDS protocol, RN-RHDS + PT-RHDS + NIAF
- Keywords
- hospital discharge, discharge readiness, readmission, Emergency Department visits, Nurse assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RN-RHDS protocolOther
The discharging nurse assesses each patient being discharged home using the Readiness for Hospital Discharge Scale (RN version)
RN-RHDS+PT-RHDS protocolOther
The discharging nurse obtains and reviews patient self-report of discharge readiness using the Readiness for Hospital Discharge Scale - Patient version and then completes the Readiness for Hospital Discharge Scale (RN version)
RN-RHDS + PT-RHDS + NIAFOther
The discharging nurse assesses each patient being discharged home using the Readiness for Hospital Discharge Scale (RN version)after reviewing the patients self-perception of discharge readiness (PT-RHDS) and then records any actions taken in response to the discharge readiness assessment on the Nurse Initiated Action form (NIAF). When any item on the RN-RHDS is less than 7, an action is required.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Control hospital unit | No intervention | This study involves implementation of interventions across entire hospital units. This arm is a usual care control unit paired to the intervention unit. |
| implementation unit | Experimental | 3 implementation protocols implemented sequentially:
1. RN-RHDS: implementation of discharge readiness assessment by the discharging nurse
2. RN-RHDS+PT-RHDS: implementation of discharge readiness assessment by the discharging nurse which is informed by patient self-assessment of discharge readiness
3. RN-RHDS+PT-RHDS+NIAF: implementation of discharge readiness assessment by the discharging nurse which is informed by patient self-assessment of discharge readiness followed by documentation of nurse actions initiated in response to the assessment. Nurse are instructed that action must be taken if any assessment item scores less than 7 ( on a 10 point scale). Receives: Other: RN-RHDS protocol; Other: RN-RHDS+PT-RHDS protocol; Other: RN-RHDS + PT-RHDS + NIAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-discharge Utilization within 30 days after hospital discharge
Readmissions and Emergency Department Visits within 30 days after hospital discharge
Measured: 30 days after hospital discharge
Secondary outcomes (1)
Nurse Initiated Action Form
Measures actions taken by the discharging nurse in response to discharge readiness assessment
Measured: measured on day of hospital discharge typically 1 to 30 days after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJul 2014
- Primary completionAug 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Discharge Transition of Patients Discharged to HomeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 189,796 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Weiss, Marquette University
- Investigators
- Marianne Weiss, DNSc, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873118
- Sponsor's protocol ID
- ANCC2013-01
- Acronym
- READI
- Status last verified
- Mar 2018
- First submitted
- 3 Jun 2013
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bahr SJ, Bang J, Yakusheva O, Bobay KL, Krejci J, Costa L, Hughes RG, Hamilton M, Siclovan DM, Weiss ME. Nurse Continuity at Discharge and Return to Hospital. Nurs Res. 2020 May/Jun;69(3):186-196. doi: 10.1097/NNR.0000000000000417.
PubMed 31934945Weiss ME, Yakusheva O, Bobay KL, Costa L, Hughes RG, Nuccio S, Hamilton M, Bahr S, Siclovan D, Bang J; READI Site Investigators. Effect of Implementing Discharge Readiness Assessment in Adult Medical-Surgical Units on 30-Day Return to Hospital: The READI Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e187387. doi: 10.1001/jamanetworkopen.2018.7387.
PubMed 30681712
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- READI (Readiness Evaluation And Discharge Interventions): Implementation as a Standard Nursing Practice for Hospital Discharge
- ClinicalTrials.gov ID
- NCT01873118
- Acronym / sponsor ID
- READI / ANCC2013-01
- Keywords
- hospital discharge, discharge readiness, readmission, Emergency Department visits, Nurse assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189,796 participants (actual)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 Jun 2013 (estimated)
- 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.
Preparation of patients for discharge is a primary function of hospital-based nursing care and readiness for discharge is an important outcome of hospital care. Inadequacies in discharge preparation have been well-documented and linked to difficulty with self-management after hospital discharge and with increased likelihood of emergency department (ED) use and readmission. Prior studies by the research team have led to recommendations for implementation of discharge readiness assessment as a standard nursing practice for hospital discharge.
The investigators will conduct a multi-site study to determine the impact on post-discharge utilization (readmission and ED visits) and costs of implementing discharge readiness assessment as a standard nursing practice for adult medical-surgical patients discharged to home. The study tests, in a stepped approach, the impact of implementing discharge readiness assessment by the discharging nurse as standard nursing practice (RN-RHDS protocol), the incremental value of informing the nurse assessment with the patient's perspective (RN-RHDS+PT-RHDS protocol), and of requiring that the nurse initiates and documents risk-mitigating actions for patients with low readiness scores (RN-RHDS+PT-RHDS+NIAF protocol).
HYPOTHESIS 1: Patients discharged using the RN-RHDS protocol will have fewer hospital readmissions and ED visits within 30 days post-discharge compared to patients discharged under usual care conditions.
HYPOTHESIS 2: Patients discharged using the RN-RHDS+PT-RHDS protocol will have fewer hospital readmissions and ED visits within 30 days post-discharge compared to patients discharged using the RN-RHDS protocol.
HYPOTHESIS 3: Patients discharged by nurses using the RN-RHDS+PT-RHDS protocol plus a Nurse-Initiated Action Form [NIAF] (RN-RHDS+PT-RHDS+NIAF protocol) will have fewer post-discharge readmissions and ED visits than patients discharged using the RN-RHDS+PT-RHDS protocol; the effect will be strongest for patients with low RHDS scores.
Aim 4: Conduct cost-benefit analysis of implementing discharge readiness assessment as standard practice, by comparing cost-savings from reduced post-discharge utilization against implementation costs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Control hospital unit | No intervention | –This study involves implementation of interventions across entire hospital units. This arm is a usual care control unit paired to the intervention unit. |
| implementation unit | Experimental | Other: RN-RHDS protocol, Other: RN-RHDS+PT-RHDS protocol, Other: RN-RHDS + PT-RHDS + NIAF3 implementation protocols implemented sequentially: 1. RN-RHDS: implementation of discharge readiness assessment by the discharging nurse 2. RN-RHDS+PT-RHDS: implementation of discharge readiness assessment by the discharging nurse which is informed by patient self-assessment of discharge readiness 3. RN-RHDS+PT-RHDS+NIAF: implementation of discharge readiness assessment by the discharging nurse which is informed by patient self-assessment of discharge readiness followed by documentation of nurse actions initiated in response to the assessment. Nurse are instructed that action must be taken if any assessment item scores less than 7 ( on a 10 point scale). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical, surgical, or medical-surgical nursing units of Magnet designated hospitals
- Patients 18 years of age or more, English speaking,able to read and understand consent who are being discharged to home as the discharge destination.
- Nursing personnel (Registered Nurses or Licensed Practical Nurses) who are performing discharge instructions and procedures on the day of hospital discharge.
Key exclusion criteria (1 listed)
- Patients discharged to home with hospice 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 |
|---|---|---|
| RN-RHDS protocolThe discharging nurse assesses each patient being discharged home using the Readiness for Hospital Discharge Scale (RN version) | Other | implementation unit |
| RN-RHDS+PT-RHDS protocolThe discharging nurse obtains and reviews patient self-report of discharge readiness using the Readiness for Hospital Discharge Scale - Patient version and then completes the Readiness for Hospital Discharge Scale (RN version) | Other | implementation unit |
| RN-RHDS + PT-RHDS + NIAFThe discharging nurse assesses each patient being discharged home using the Readiness for Hospital Discharge Scale (RN version)after reviewing the patients self-perception of discharge readiness (PT-RHDS) and then records any actions taken in response to the discharge readiness assessment on the Nurse Initiated Action form (NIAF). When any item on the RN-RHDS is less than 7, an action is required. | Other | implementation unit |
Primary outcome
Post-discharge Utilization within 30 days after hospital discharge
Time frame: 30 days after hospital discharge
Readmissions and Emergency Department Visits within 30 days after hospital discharge
1 secondary outcome
Nurse Initiated Action Form
Time frame: measured on day of hospital discharge typically 1 to 30 days after hospital admission
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 20 Mar 2018.
- Derived from this study: PubMed 31934945Bahr SJ, Bang J, Yakusheva O, Bobay KL, Krejci J, Costa L, Hughes RG, Hamilton M, Siclovan DM, Weiss ME. Nurse Continuity at Discharge and Return to Hospital. Nurs Res. 2020 May/Jun;69(3):186-196. doi: 10.1097/NNR.0000000000000417.
- Derived from this study: PubMed 30681712Weiss ME, Yakusheva O, Bobay KL, Costa L, Hughes RG, Nuccio S, Hamilton M, Bahr S, Siclovan D, Bang J; READI Site Investigators. Effect of Implementing Discharge Readiness Assessment in Adult Medical-Surgical Units on 30-Day Return to Hospital: The READI Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e187387. doi: 10.1001/jamanetworkopen.2018.7387.
Related trials for Discharge Transition of Patients Discharged to Home
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Self-Management Support for Acute Coronary Syndrome Patients After Hospital Discharge
Acute Coronary Syndrome (ACS)
Enrolling by invitation
Examining the Effectiveness and Implementation of the Emergency Department Patient-Activated Transition to Care At Home Tool
Emergency Department Discharge Communication
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.
Marianne Weiss, DNSc principal investigator
Marquette University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RN-RHDS protocol, RN-RHDS+PT-RHDS protocol and RN-RHDS + PT-RHDS + NIAF in people with Discharge Transition of Patients Discharged to Home, run by Marquette University 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 3 inclusion and 1 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 20 Mar 2018. 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?
Post-discharge Utilization within 30 days after hospital discharge (time frame: 30 days after hospital discharge). 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 NCT01873118, which also lists 2 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 20 Mar 2018.