Promoting Respect and Ongoing Safety Through Patient-centeredness, Engagement, Communication and Technology

Medical Intensive Care Unit (MICU) Patients Clinical Trial

— PROSPECT  

Official title:

Transforming the Acute Care Environment: BWH PROSPECT Framework

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02258594
• Other study ID #: 2013P001966
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: February 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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:

1. Optimize the overall experience of patients (including their family/care partners) by promoting dignity/respect, encouraging engagement, improving care plan concordance, and enhancing satisfaction.

2. Minimize preventable harms in two environments: intensive care and acute care oncology units.

3. Reduce unnecessary healthcare resource utilization and associated costs.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4368
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Age < 18

• Any patient admitted or transferred to designated care unit but NOT on a MICU or Oncology service

Related Conditions & MeSH terms

• Medical Intensive Care Unit (MICU) Patients
• Neoplasms
• Oncology Unit Patients

Intervention

Other:
• 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".

Behavioral:
• The Patient-SatisfActive® Model
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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Gordon and Betty Moore Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Enrolled patients will be followed for the duration of hospital stay, typically ranging from 5 to 30 days.
Secondary	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.	At time of transfer/discharger from study unit and up to 45-days post-hospitalization
Secondary	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.	From time of hospital admission through 30-days post-discharge
Secondary	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.	Approximately 48-72 hours after admission to study unit
Secondary	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.	Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months
Secondary	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).	Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months
Secondary	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.	At time of transfer/discharger from study unit and up to 45-days post-hospitalization