Methodological Challenges of Multiple-Component Intervention: Lessons Learned from a Randomized Controlled Trial of Functional Recovery Following Hip Fracture


C. Ronald MacKenzie, MD

Attending Physician, Hospital for Special Surgery
Professor of Clinical Medicine, Weill Cornell Medical College
Professor of Clinical Public Health, Weill Cornell Medical College
Co-Medical Director, Center for Brachial Plexus and Traumatic Nerve Injury
Non-Operative Director, Spine Care Institute

Charles N. Cornell, MD

Clinical Director of Orthopedic Surgery, Hospital for Special Surgery
Attending Orthopaedic Surgeon, Hospital for Special Surgery
Professor of Clinical Orthopaedic Surgery, Weill Cornell Medical College

Laura Robbins, DSW, CSW, MSW

Senior Vice President, Education & Academic Affairs, Hospital for Special Surgery

Designated Institutional Officer, GME

Associate Research Professor of Social Work in Medicine, Weill Medical College of Cornell University

Associate Scientist, Research Division, Hospital for Special Surgery

Executive Editor, HSS Journal

Chair, Arthritis Foundation

John P. Allegrante, PhD
Department of Health and Behavior Studies
Teachers College, Columbia University

Roberta Horton, MSW
Department of Patient Care and Quality Management, Hospital for Special Surgery

Sandy B. Ganz, DSc
The Virginia F. and William R. Salomon Rehabilitation Department, Hospital for Special Surgery

Hirsch S. Ruchlin, PhD
Department of Public Health, Weill Medical College of Cornell University

Pamela Williams Russo, MD, MPH
The Robert Wood Johnson Foundation

Mary E. Charlson, MD
Department of Medicine, Weill Medical College of Cornell University

Margaret GE. Peterson, PhD

Abstract
We conducted a randomized controlled trial to assess the efficacy and safety of a multiple-component intervention designed to improve functional recovery following hip fracture.  One-hundred seventy-six patients who underwent surgery for a primary unilateral hip fracture were assigned randomly to receive usual care (control arm, n = 86) or a brief motivational videotape, supportive peer counseling, and high-intensity muscle-strength training (intervention arm, n = 90).  Between-group differences on the physical functioning, role-physical, and social functioning domains of the SF-36 were assessed postoperatively at 6 months.  At the end of the trial, 32 intervention and 27 control patients (34%) completed the 6-month outcome assessment.  Although patient compliance with all three components of the intervention was uneven, over 90% of intervention patients were exposed to the motivational videotape.  Intervention patients experienced a significant (P = .03) improvement in the role-physical domain (mean change, -11 + 33) compared to control patients (mean change, -37 + 41).  Change in general health (P = .2) and mental health (P = .1) domain scores was also directionally consistent with the study hypothesis.  Although our findings are consistent with previous reports of comprehensive rehabilitation efforts for hip fracture patients, the trial was undermined by high attrition and the possibility of self-selection bias at 6-month follow-up.  We discuss the methodological challenges and lessons learned in conducting a randomized controlled trial that sought to implement and assess the impact of a complex intervention in a population that proved difficult to follow up once they had returned to the community.

This article appears in HSS Journal: Volume 3, Number 1.
View the full article at springerlink.com.


About the HSS Journal
HSS Journal, an academic peer-reviewed journal, is published twice a year, February and September, and features articles by internal faculty and HSS alumni that present current research and clinical work in the field of musculoskeletal medicine performed at HSS, including research articles, surgical procedures, and case reports.


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