Does Use of a Wound After-care Summary Improve Patient Satisfaction and Time to Wound Healing?

The purpose of this research study is to evaluate a patient education program for chronic wound care. The wound care nurse practitioner (NP) at the Ann Arbor VAMC will use a wound self-management "after-care summary" with approximately half of her patients. This study will examine whether using this patient education tool for self-management of wound care results in improved patient outcomes.

Study Overview

• Status: Withdrawn
• Conditions: Wounds
• Intervention / Treatment: Behavioral: After-care summary; Behavioral: Control group

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • VA Ann Arbor Healthcare System, Ann Arbor, MI
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All patients presenting for outpatient wound care at the Ann Arbor VA Medical Center NP wound care clinic, who meet the following inclusion criteria for chronic wounds: stage II, III, IV pressure ulcers; venous stasis ulcers, and diabetic ulcers.

Exclusion Criteria:

Cognitively impaired patients who cannot give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; These patients receive the experimental intervention--the after-care summary.	Behavioral: After-care summary; The wound care NP will measure the wound and assess adherence to the following self-management activities: visiting the wound care clinic as scheduled; offloading; applying dressings; obtaining assistance at home; and participating in social activities. This information will be entered into a computer database on a VA computer that will generate a summary chart showing the relationship between adherence and wound healing. The generated "after-care summary" will be discussed with the patient and used to set self-management goals.
Active Comparator: Arm 2; These patients are the control group and receive usual care.	Behavioral: Control group; Patients in the control group will receive usual counseling for self-management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
patient satisfaction, frequency of self-management activities, time to healing	Outcomes are measured at each participating patient's visit for one year or until the patient's wound is healed, whichever comes first.

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Julie C Lowery, PhD MHSA, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 29, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Estimate): May 6, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: self-management; patient education; wound healing
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: XVA 41-027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No