Medical Intensive Care Unit (MICU) PatientsPROSPECTNCT02258594
Promoting Respect and Ongoing Safety Through Patient-centeredness, Engagement, Communication and Technology
A study testing Web-Based Patient Centered Toolkit (PCTK) and The Patient-SatisfActive® Model in people with Medical Intensive Care Unit (MICU) Patients and Oncology Unit Patients, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this project is to refine, implement, and evaluate a multi-component intervention that achieves sustainable and meaningful impact on healthcare quality, safety, and costs while ensuring dignity and respect for adult oncology and intensive care patients and their care partners. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Intensive Care Unit (MICU) Patients, Oncology Unit Patients
- What is being tested?
- Web-Based Patient Centered Toolkit (PCTK) and The Patient-SatisfActive® Model
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,368 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2015
- 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
- Age > 18
- Any patient admitted or transferred to designated care units
- Admitted or transferred to a MICU or Oncology service
- On the designated unit for at least 24 hours
Who cannot join
- Age < 18
- Any patient admitted or transferred to designated care unit but NOT on a MICU or Oncology service
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Transforming the Acute Care Environment: BWH PROSPECT Framework
The purpose of this project is to refine, implement, and evaluate a multi-component intervention that achieves sustainable and meaningful impact on healthcare quality, safety, and costs while ensuring dignity and respect for adult oncology and intensive care patients and their care partners. The PROSPECT (Promoting Respect and Ongoing Safety through Patient-centeredness, Engagement, Communication, and Technology) framework will achieve this by enhancing the patient-provider relationship and introducing patient-centered approaches to multi-disciplinary communication and patient education. The PROSPECT framework is based upon a validated structured, team-work training model and novel web-based technology. The overarching goals of this project are to achieve the following:
- Optimize the overall experience of patients (including their family/care partners) by promoting dignity/respect, encouraging engagement, improving care plan concordance, and enhancing satisfaction.
- Minimize preventable harms in two environments: intensive care and acute care oncology units.
- Reduce unnecessary healthcare resource utilization and associated costs.
Read the detailed description
This overarching project aims are to refine, implement, and evaluate a multi-faceted intervention composed of the Patient-SatisfActive® model, developed by Drs. Ronen Rozenblum and David Bates at Brigham and Women's Hospital, and a web-based Patient-Centered Toolkit (PCTK), developed by Drs. Dykes and Dalal, on quality, safety, and cost outcomes in the intensive care and oncology units at Brigham and Women's Hospital. The specific aims of the project are as follows:
- Aim 1: To refine and implement the Patient-SatisfActive® model to promote respect, dignity, and satisfaction of patients, care partners and staff on intensive care and oncology units.
- Aim 2: To refine and implement a web-based, Patient-Centered Toolkit (PCTK), comprised of an electronic bedside communication center (eBCC) and a patient-centered microblog, to promote tailored patient and care-partner education, communication, collaboration, and engagement.
- Aim 3: To evaluate the relative impact of this intervention compared to usual care on patient reported outcome measures, adverse events (harms), post-discharge healthcare utilization, concordance in understanding the care plan, and satisfaction among care team members (patients/care partners, profession providers).
- Aim 4: To identify the barriers and facilitators of implementing this intervention to support dissemination.
- Being tested
- Web-Based Patient Centered Toolkit (PCTK), The Patient-SatisfActive® Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Patient Centered Toolkit (PCTK)Other
The PCTK provides patients/care partners tailored health information regarding conditions, test results, and medications presented at a consumer health literacy level, and the ability to communicate with care team members via "patient-facing" tools accessible from bedside tablet computers. The PCTK allows patients to post questions to their care team members via a patient-centered microblog. The microblog facilitates development of a collaborative patient plan of care. The "provider-facing" PCTK includes tools that engage care team members in 1) completing a safety checklist and viewing a safety dashboard; 2) viewing patient-inputted information (goals, preferences, concerns) regarding the plan of care; 3) identifying clinical problems, care team goals, and patient schedules for education and multidisciplinary communication; 4) messaging patients on the "patient thread"; and 5) discussing patient's plan of care with other providers via the "provider thread".
The Patient-SatisfActive® ModelBehavioural
The Patient-SatisfActive Model is a structured, pro-active, patient-centered care model that aims at improving patient satisfaction by enhancing the degree to which patients' needs, concerns and expectations are met and by preserving dignity and respect. The model comprises steps that enhance interpersonal communication between clinicians and patients, incorporates clinicians' efforts to ascertain, address and document patients' needs, concerns, expectations and perceptions throughout hospitalization, and includes elements that empower and engage patients in their care.
| Study group | Role | What they receive |
|---|---|---|
| Baseline - Usual Care | No intervention | Usual Care on two Medical Intensive Care Units units Usual Care on four Oncology units |
| Post-Implementation - Intervention Units | Experimental | PROSPECT Intervention (Web-Based Patient Centered Toolkit (PCTK) + The Patient-SatisfActive® Model) on two MICU units
PROSPECT Intervention (Web-Based Patient Centered Toolkit (PCTK) + The Patient-SatisfActive® Model) on two Oncology units Receives: Other: Web-Based Patient Centered Toolkit (PCTK); Behavioral: The Patient-SatisfActive® Model |
| Post-Implementation - Usual Care | No intervention | Usual Care on two Oncology Units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventable Harms (Adverse Events) in the Acute Care Setting
Preventable adverse events in the acute care setting include medication errors, patient falls, veno-thromboembolism, hospital acquired infection, central line related bloodstream infection, ventilator associated pneumonia, catheter associated urinary tract infection, newly acquired physical harm/injury. We will measure the rate of adverse events acquired from the time of admission to study units through hospital discharge. Using an adaptation of the Institute for Healthcare Improvement (IHI) Global Trigger Tool, we will randomly sample charts of enrolled patients from intervention and control units during the pre-intervention and post-intervention periods to identify adverse events. The length of hospital stay for patients admitted to medical intensive care and oncology units at our institution is variable, typically ranging from 5 to 30 days.
Measured: Enrolled patients will be followed for the duration of hospital stay, typically ranging from 5 to 30 days.
Secondary outcomes (6)
Patient Experience & Satisfaction & Engagement
Randomly selected patients transferred from the MICU units will receive FS-ICU survey, semi-structured interviews, and 45-day post-hospitalization phone survey
Randomly selected patients discharged from Oncology units will receive semi-structured interviews and 45-day post-hospitalization phone survey. Data from national patient satisfaction survey, HCAHPS, will be collected and analyzed.
Measured: At time of transfer/discharger from study unit and up to 45-days post-hospitalization
Healthcare Resource Utilization
Inpatient healthcare utilization measures: Total cost of hospitalization and hospital length of stay (total, ICU, and non-ICU) from administrative data for each enrolled patient.
Post-discharge healthcare utilization measures: Rate of unscheduled utilization of health care resources (ambulatory/urgent care visits, emergency room visits, hospital readmissions) during the 30-day post-discharge period using the combination of administrative data and patient reports during their 30-day interview.
Measured: From time of hospital admission through 30-days post-discharge
Care Plan Concordance
Structured interviews (9-question survey) with patient/care partners, a member of the inpatient medical team (attending, resident, or intern), inpatient nurses, and one additional care team member (e.g., PCP, ambulatory specialists) will be conducted after admission to MICU or Oncology units. Concordance for each item of survey will be rated on a 3-point scale (0, 1, 2) for each dyad. The scores of all dyads will be summed as a global concordance score for each patient.
Measured: Approximately 48-72 hours after admission to study unit
Perceptions of Communication/Collaboration
Overall perception of collaboration and satisfaction with communication among the various members of the care team will be measured on a 5-point Likert scale via surveys administered during the baseline and intervention periods. Scores will be dichotomized.
Measured: Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months
Patient Safety Climate
The AHRQ Patient Safety Culture (PSC) survey will be used to control for differences across units and facilities that may impact incidence of adverse events (communication, leadership, teamwork, frequency of reporting, perceived patient safety score).
Measured: Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months
Dignity and Respect
Randomly selected patients transferred from the MICU will receive the FS-ICU survey, which contains several questions related to dignity and respect. Randomly selected patients will also receive semi-structured interviews to enhance understanding of dignity and respect.
Randomly selected patients discharged from Oncology units will receive semi-structured interviews regarding perceptions of dignity and respect and a 45-day post-hospitalization phone survey. Relevant data from national patient satisfaction survey, HCAHPS, will be collected and analyzed.
Measured: At time of transfer/discharger from study unit and up to 45-days post-hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2015
- Study completionJun 2015
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 Medical Intensive Care Unit (MICU) PatientsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Responsible party
- Principal investigator, David W. Bates, MD, MSc, Brigham and Women's Hospital
- Investigators
- David W Bates, MD, MSc, Principal investigator, Brigham and Women's HospitalPatricia Dykes, RN, DNSc, Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258594
- Sponsor's protocol ID
- 2013P001966
- Acronym
- PROSPECT
- Status last verified
- Feb 2022
- First submitted
- 1 Oct 2014
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Dalal AK, Dykes P, Samal L, McNally K, Mlaver E, Yoon CS, Lipsitz SR, Bates DW. Potential of an Electronic Health Record-Integrated Patient Portal for Improving Care Plan Concordance during Acute Care. Appl Clin Inform. 2019 May;10(3):358-366. doi: 10.1055/s-0039-1688831. Epub 2019 May 29.
PubMed 31141830Gazarian PK, Morrison CRC, Lehmann LS, Tamir O, Bates DW, Rozenblum R. Patients' and Care Partners' Perspectives on Dignity and Respect During Acute Care Hospitalization. J Patient Saf. 2021 Aug 1;17(5):392-397. doi: 10.1097/PTS.0000000000000353.
PubMed 28230575
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming the Acute Care Environment: BWH PROSPECT Framework
- ClinicalTrials.gov ID
- NCT02258594
- Acronym / sponsor ID
- PROSPECT / 2013P001966
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,368 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Study start
- Mar 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Oct 2014 (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.
The purpose of this project is to refine, implement, and evaluate a multi-component intervention that achieves sustainable and meaningful impact on healthcare quality, safety, and costs while ensuring dignity and respect for adult oncology and intensive care patients and their care partners. The PROSPECT (Promoting Respect and Ongoing Safety through Patient-centeredness, Engagement, Communication, and Technology) framework will achieve this by enhancing the patient-provider relationship and introducing patient-centered approaches to multi-disciplinary communication and patient education. The PROSPECT framework is based upon a validated structured, team-work training model and novel web-based technology. The overarching goals of this project are to achieve the following:
- Optimize the overall experience of patients (including their family/care partners) by promoting dignity/respect, encouraging engagement, improving care plan concordance, and enhancing satisfaction.
- Minimize preventable harms in two environments: intensive care and acute care oncology units.
- Reduce unnecessary healthcare resource utilization and associated costs.
Detailed description
This overarching project aims are to refine, implement, and evaluate a multi-faceted intervention composed of the Patient-SatisfActive® model, developed by Drs. Ronen Rozenblum and David Bates at Brigham and Women's Hospital, and a web-based Patient-Centered Toolkit (PCTK), developed by Drs. Dykes and Dalal, on quality, safety, and cost outcomes in the intensive care and oncology units at Brigham and Women's Hospital. The specific aims of the project are as follows:
- Aim 1: To refine and implement the Patient-SatisfActive® model to promote respect, dignity, and satisfaction of patients, care partners and staff on intensive care and oncology units.
- Aim 2: To refine and implement a web-based, Patient-Centered Toolkit (PCTK), comprised of an electronic bedside communication center (eBCC) and a patient-centered microblog, to promote tailored patient and care-partner education, communication, collaboration, and engagement.
- Aim 3: To evaluate the relative impact of this intervention compared to usual care on patient reported outcome measures, adverse events (harms), post-discharge healthcare utilization, concordance in understanding the care plan, and satisfaction among care team members (patients/care partners, profession providers).
- Aim 4: To identify the barriers and facilitators of implementing this intervention to support dissemination.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline - Usual Care | No intervention | –Usual Care on two Medical Intensive Care Units units Usual Care on four Oncology units |
| Post-Implementation - Intervention Units | Experimental | Other: Web-Based Patient Centered Toolkit (PCTK), Behavioral: The Patient-SatisfActive® ModelPROSPECT Intervention (Web-Based Patient Centered Toolkit (PCTK) + The Patient-SatisfActive® Model) on two MICU units PROSPECT Intervention (Web-Based Patient Centered Toolkit (PCTK) + The Patient-SatisfActive® Model) on two Oncology units |
| Post-Implementation - Usual Care | No intervention | –Usual Care on two Oncology Units |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18
- Any patient admitted or transferred to designated care units
- Admitted or transferred to a MICU or Oncology service
- On the designated unit for at least 24 hours
Key exclusion criteria (2 listed)
- Age < 18
- Any patient admitted or transferred to designated care unit but NOT on a MICU or Oncology service
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 |
|---|---|---|
| Web-Based Patient Centered Toolkit (PCTK)The PCTK provides patients/care partners tailored health information regarding conditions, test results, and medications presented at a consumer health literacy level, and the ability to communicate with care team members via "patient-facing" tools accessible from bedside tablet computers. The PCTK allows patients to post questions to their care team members via a patient-centered microblog. The microblog facilitates development of a collaborative patient plan of care. The "provider-facing" PCTK includes tools that engage care team members in 1) completing a safety checklist and viewing a safety dashboard; 2) viewing patient-inputted information (goals, preferences, concerns) regarding the plan of care; 3) identifying clinical problems, care team goals, and patient schedules for education and multidisciplinary communication; 4) messaging patients on the "patient thread"; and 5) discussing patient's plan of care with other providers via the "provider thread". | Other | Post-Implementation - Intervention Units |
| The Patient-SatisfActive® ModelThe Patient-SatisfActive Model is a structured, pro-active, patient-centered care model that aims at improving patient satisfaction by enhancing the degree to which patients' needs, concerns and expectations are met and by preserving dignity and respect. The model comprises steps that enhance interpersonal communication between clinicians and patients, incorporates clinicians' efforts to ascertain, address and document patients' needs, concerns, expectations and perceptions throughout hospitalization, and includes elements that empower and engage patients in their care. | Behavioural | Post-Implementation - Intervention Units |
Primary outcome
Preventable Harms (Adverse Events) in the Acute Care Setting
Time frame: Enrolled patients will be followed for the duration of hospital stay, typically ranging from 5 to 30 days.
Preventable adverse events in the acute care setting include medication errors, patient falls, veno-thromboembolism, hospital acquired infection, central line related bloodstream infection, ventilator associated pneumonia, catheter associated urinary tract infection, newly acquired physical harm/injury. We will measure the rate of adverse events acquired from the time of admission to study units through hospital discharge. Using an adaptation of the Institute for Healthcare Improvement (IHI) Global Trigger Tool, we will randomly sample charts of enrolled patients from intervention and control units during the pre-intervention and post-intervention periods to identify adverse events. The length of hospital stay for patients admitted to medical intensive care and oncology units at our institution is variable, typically ranging from 5 to 30 days.
6 secondary outcomes
Patient Experience & Satisfaction & Engagement
Time frame: At time of transfer/discharger from study unit and up to 45-days post-hospitalization
Healthcare Resource Utilization
Time frame: From time of hospital admission through 30-days post-discharge
Care Plan Concordance
Time frame: Approximately 48-72 hours after admission to study unit
Perceptions of Communication/Collaboration
Time frame: Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months
Patient Safety Climate
Time frame: Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months
Dignity and Respect
Time frame: At time of transfer/discharger from study unit and up to 45-days post-hospitalization
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 14 Mar 2022.
- Derived from this study: PubMed 31141830Dalal AK, Dykes P, Samal L, McNally K, Mlaver E, Yoon CS, Lipsitz SR, Bates DW. Potential of an Electronic Health Record-Integrated Patient Portal for Improving Care Plan Concordance during Acute Care. Appl Clin Inform. 2019 May;10(3):358-366. doi: 10.1055/s-0039-1688831. Epub 2019 May 29.
- Derived from this study: PubMed 28230575Gazarian PK, Morrison CRC, Lehmann LS, Tamir O, Bates DW, Rozenblum R. Patients' and Care Partners' Perspectives on Dignity and Respect During Acute Care Hospitalization. J Patient Saf. 2021 Aug 1;17(5):392-397. doi: 10.1097/PTS.0000000000000353.
Related trials for Medical Intensive Care Unit (MICU) Patients
Recruiting
Reestablishing Sleep and Circadian Alignment in Medical Intensive Care Unit (MICU) Patients Via a Mechanistic RCT of an Sleep Chronobundle
Critical Illness, Sleep Deprivation
RecruitingObservational study
SNUH MICU Cohort Study of PICS
Critical Care, Registries
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.
David W Bates, MD, MSc principal investigator
Brigham and Women's Hospital
Patricia Dykes, RN, DNSc study director
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Patient Centered Toolkit (PCTK) and The Patient-SatisfActive® Model in people with Medical Intensive Care Unit (MICU) Patients and Oncology Unit Patients, run by Brigham and Women's Hospital 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 14 Mar 2022. 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?
Preventable Harms (Adverse Events) in the Acute Care Setting (time frame: Enrolled patients will be followed for the duration of hospital stay, typically ranging from 5 to 30 days.). 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 NCT02258594, 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 14 Mar 2022.