UMass Chan Medical School Faculty Publications

Title

Tailored system to deliver behavioral intervention and manage data in randomized trials

UMMS Affiliation

Department of Medicine, Division of Preventive and Behavioral Medicine; Department of Orthopedics and Physical Rehabilitation

Publication Date

2013-04-11

Document Type

Article

Subjects

Database Management Systems; Medical Informatics Applications; Randomized Controlled Trials; Intervention Studies; Arthroplasty, Replacement, Knee; Motor Activity

Disciplines

Behavior and Behavior Mechanisms | Clinical Epidemiology | Community Health and Preventive Medicine | Health and Medical Administration | Health Information Technology | Health Services Administration | Orthopedics

Abstract

BACKGROUND: The integrity of behavioral intervention trials depends on consistent intervention delivery, and uniform, comprehensive process data collection. It can be challenging in practice due to complex human interactions involved.

OBJECTIVE: We sought to design a system to support the fidelity of intervention delivery and efficient capture of qualitative and quantitative process data for a telephone-delivered behavioral counseling intervention to increase physical activity and function after total knee replacement surgery.

METHODS: A tailored system was designed to prompt the intervention coach in the delivery of a 5 step counseling protocol to support intervention fidelity across patients. System features included structured data components, automated data exchange functions, user-friendly data capture screens, and real-time surveillance reporting. The system structured the capture of patient goals and open-ended conversation.

RESULTS: The system recorded intervention process data from each of 12 sessions held with the 92 intervention patients. During the trial, 992 telephone sessions were conducted, and more than 97% (4816/4960) of intervention process data fields were completed in the system. The coach spent 5-10 minutes preparing for each counseling call using system-generated summaries of historical data and 10-15 minutes entering intervention process data following each telephone session.

CONCLUSIONS: This intervention delivery system successfully supported the delivery of a structured behavioral counseling intervention and collection of intervention process data. It addressed the unique needs of clinical behavioral intervention trials, and had promising potential to facilitate high-fidelity translation of the intervention to broad clinical practice and Web-based multicenter clinical trials in the future.

Rights and Permissions

This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

DOI of Published Version

10.2196/jmir.2375

Source

J Med Internet Res. 2013 Apr 11;15(4):e58. doi: 10.2196/jmir.2375. Link to article on publisher's site

Related Resources

Link to Article in PubMed

Journal/Book/Conference Title

Journal of medical Internet research

PubMed ID

23579207

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