The HIP Impact Protection Program (HIP PRO)

Trochanteric Padding to Prevent Hip Fractures

HIP PRO is a multicenter randomized, controlled trial of an energy absorbing and distributing padding system designed to reduce the incidence of hip fractures in 546 nursing home (NH) residents. The trial is being conducted in three geographic regions of the US: Boston, St. Louis, and Baltimore. Non bed- or chair-bound residents over the age of 65 are given protective underwear containing a single pocket and hip pad so that each resident becomes his/her own control. During the trial, hip fracture incidence will be compared in padded and unpadded hips using an intent to treat analysis. A secondary aim is to identify resident and facility factors contributing to non-adherence with the use of the hip protector.

Study Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: Device: Energy absorbing and distributing trochanteric pad

Detailed Description

The HIP PRO Study is a randomized, controlled trial of the efficacy of a trochanteric padding system in the reduction of hip fractures in nursing home residents over the age of 65 in up to 45 nursing homes in three regions: Boston, MA, St. Louis, MO, and Baltimore, MD. Eligible residents of these facilities will be screened and then evaluated during a two week run-in period during which a hip protection compliance rate of at least 67% will be required for enrollment. Recruitment of all eligible residents entering each nursing home will continue throughout the 3.5 year follow-up period.

Each subject will be given a set of 4-6 protective underwear containing a single pocket and protective pad so that each resident becomes his/her own control. The side to be protected will be based on the randomization of nursing home facilities to either right or left-sided hip protection. The hip protection underwear is designed so that it may be worn during the day and while in bed at night. Several types of underwear have been designed for residents with special needs (e.g. incontinence, dementia). Compliance and efficacy are monitored at least three times weekly across all three nursing shifts.

A hip fracture adjudication committee, blinded to the side of the fracture, will review all information (including hospital records and radiologists' reports or hip radiographs) and issue a decision on whether a fracture has occurred. Primary analyses will be performed using an "intention to treat" approach. Secondary analyses will investigate resident and nursing home factors associated with hip protection compliance and effectiveness. An independent Data and Safety Monitoring Board (DSMB) has been convened and will review hip fracture rates and adverse event data at regular intervals.

Institutions participating in HIP PRO are: a Data Coordinating Center at Maryland Medical Research Institute in Baltimore, MD; three Clinical Centers at Washington University School of Medicine in St. Louis, MO, the University of Maryland in Baltimore, MD with the University of North Carolina in Chapel Hill, NC, and the Hebrew Rehabilitation Center for Aged in Boston, MA. The Data Coordinating Center will direct the overall administrative management of the trial.

• Study Type: Interventional
• Enrollment: 546
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Baltimore
    • Baltimore, Maryland, United States, 21210
      • Maryland Medical Research Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02131-1097
      • Hebrew Rehabilitation Center for Aged Research and Training Institute
  • Missouri
    • St. Louis, Missouri, United States, 63108
      • Washington University School of Medicine, Division of Geriatrics & Gerontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

• Resident of eligible nursing home for at least two weeks
• Occupying a non-Medicare, non-acute, non-rehabilitation bed in the nursing home
• Over age 65
• Capable of independent transfer, not chair- or bed-bound
• Must give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: National Institute on Aging (NIA)

Publications and helpful links

General Publications

• Kiel DP, Magaziner J, Zimmerman S, Ball L, Barton BA, Brown KM, Stone JP, Dewkett D, Birge SJ. Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA. 2007 Jul 25;298(4):413-22. doi: 10.1001/jama.298.4.413.

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: April 14, 2003
• First Submitted That Met QC Criteria: April 14, 2003
• First Posted (Estimate): April 15, 2003

Study Record Updates

• Last Update Posted (Estimate): February 27, 2009
• Last Update Submitted That Met QC Criteria: February 26, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: AG0001; 5R01AG018461-02 (U.S. NIH Grant/Contract)