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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01298791
Other study ID # 34423
Secondary ID
Status Withdrawn
Phase N/A
First received February 16, 2011
Last updated October 7, 2016
Start date February 2011
Est. completion date August 2011

Study information

Verified date October 2016
Source Boston Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Patient satisfaction is affected by physician communication styles and communication at the bedside. The investigators are conducting a randomized controlled trial involving both providers and families to determine if providers sitting down while talking with families, will improve one aspect of quality care delivered during an inpatient stay as measured by patient/family satisfaction. The investigators will additionally study the affects of the intervention on the following outcomes: family assessment of provider communication, readmission rates, and length of stay.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 17 Years
Eligibility Inclusion Criteria:

- Providers: all attendings, residents, and medical students involved in the care of patients on the pediatric inpatient wards during the study period.

- Families (Parents or legal guardians and children):

- (1) inpatient admissions to the pediatrics medical service at Boston Medical Center

- (2) whose parents or guardian have agreed to participate in family centered walk rounds

- (3) patients age 17 or younger who have family members present at the bedside each morning of hospitalization

- (4) English speaking.

Exclusion Criteria:

- (1) All patients/families that as part of admission justification involves social assessment and concern by the patient care team, including patients with neonatal abstinence syndrome, child maltreatment, and concern for neglect.

- (2) All patients transferred to or from PICU as part of their inpatient care

- (3) All patients transferred from an outside institution to the inpatient ward for further care secondary to progression of disease.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Sitting
Providers will sit during inpatient family-centered walk rounds throughout the communication during rounds. The participating members of the care team (attending physician, resident and medical student) will remain seated while communicating with the patient and caregiver.
Standing
Providers will stand during inpatient family-centered walk rounds throughout the communication during rounds. The participating members of the care team (attending physician, resident and medical student) will remain standing while communicating with the patient and caregiver.

Locations

Country Name City State
United States Boston Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient/family satisfaction Questionnaire obtains basic provider information 4mo No
Primary Patient/family Satisfaction Caregiver questionnaire obtains baseline information on caregiver and patients 4 mo No
Primary Patient/family satisfaction PSQ-18: Assesses parental satisfaction with medical care 4 months No
Secondary Length of stay Chart review of length of inpatient hospitalization during intervention 4 months No
Secondary Readmission rate Chart review and parental contact regarding readmission for same reason of initial hospitalization 5 mo No
Secondary Family discharge preparedness Brief PREPARED instrument 4 mo No
Secondary Follow-up appointment attendance Chart review and communication with caregivers regarding keeping follow-up appointment 5 mo No
Secondary Family assessment of doctor-patient communication skills Crossley Communication Questionnaire 4 mo No