Readiness for Discharge Following Lobectomy

November 15, 2011 updated by: University of British Columbia

Readiness for Discharge Following Lobectomy: Effects of the Thoracic Risk Intervention and Management (T.R.I.M.) Protocol

This study aims to examine the relationship between the patient's perception of readiness for discharge after lobectomy and mobilization rates, frequency of visitation by family and friends, anxiety levels and pain levels. We will test the hypotheses that a) those patients who walk farther early after surgery and who have more visitors and decreased anxiety and pain levels will have a greater self-perceived readiness for discharge and b) that patients who receive daily ambulation goals and personal motivation will have higher step rates, and therefore have a greater self-perceived readiness for discharge, than those that do not. We will monitor patients, during the post-operative recovery period using pedometers to count steps taken, visitor log sheets, and questionnaires on the patients' anxiety, pain and perceived readiness for discharge. Furthermore, we will examine how the patient's self-perceived readiness for discharge is affected by study interventions which include ambulation goals and daily personal motivation.

Study Overview

Detailed Description

There is currently little information on indicators and factors of a patient's readiness for discharge. Vancouver General Hospital is attempting to create a standardized clinical pathway for individuals who have undergone a lobectomy, to increase patient satisfaction and decrease hospital stay and complication rates. This study aims examine the relationship between the patient's readiness for discharge after lobectomy and their mobilization rate (measured as the number of steps taken in a day), frequency of visitation by family and friends, the level of anxiety and the level of pain experienced by the patient. To do this, we will test the hypotheses that a) those patients with greater mobilization and visitation rates and decreased anxiety and pain levels will have a greater self-perceived readiness for discharge and b) that patients who receive daily mobilization goals and personal motivation will have higher step rates, and therefore have a greater self-perceived readiness for discharge, than those that do not.

Ninety-nine patients will be recruited to participate in this intervention-based study. Patients will be identified by the surgeons as potential participants, and referred to the study coordinator. The study coordinator will obtain informed signed consent after the patient's physician appointment in the clinical offices. At this point, participant medical information will be collected and participants will be asked to complete the EORTC QLQ C-30 Quality of Life (QOL) questionnaire. Participants will then be randomly assigned to one of three intervention groups. The intervention groups are: G0 (no intervention), G1 (minimal intervention) and G2 (maximal intervention). Participants in the G0 group will receive the standard clinical care outlined in the present nursing clinical pathway sheets, including a pre-operative video on what to expect post-operatively. G1 participants will receive the same standard clinical care as G0 patients, but will also receive a personal ambulation goal sheet and log book to help them monitor their rate of mobility and their achievement of daily goals. G2 participants will receive the same care as G1 patients, but will also receive a daily visit from the study coordinator to help them monitor their physical activity and motivate them to achieve their goals.

Patients from all levels of intervention will fill out a questionnaire (T.R.I.M Readiness for Discharge Questionnaire, titled T.R.I.M. Participant Questionnaire when handed to participants) on their pain, anxiety and their self-perceived readiness for discharge on post-operative days 3 and 5, day of discharge and on their follow-up visit. The T.R.I.M Readiness for Discharge Questionnaire contains the Short Form - McGill Pain Questionnaire [Melzack, 1987], the Short Form State-Trait Anxiety Index [Marteau & Bekker, 1992]. Moreover, the questionnaire asks the patient about their self-perceived readiness for discharge. They are asked to answer the question "Are you ready to go home?" by marking an X on a line (a visual analog scale, VAS) where one end of the line indicates "Not at all" and the other "Definitely". Patients will also be instructed to have their visitors sign-in and -out on a log sheet and be outfitted with a pedometer to measure the number of steps they take in a day. Also on the day of discharge, patients will be asked to fill out the EORTC Quality of Life questionnaire again. Finally, 1 month after discharge patients will be contacted for follow up and to complete the EORTC questionnaire a third time along with the Participant Questionnaire. All individuals will be visited daily by the study coordinator while they are in the hospital, who will record their daily steps. During these daily visits, the study coordinator will also examine the goals of the participants in the G2 intervention group. They will be verbally encouraged to meet their ambulation goals. Those in the G0 and G1 intervention groups will only have their daily steps recorded.

T-tests and Chi-Square analysis will be used on means and proportions respectively, to determine any differences between the intervention groups. Logistic regression analysis will be carried out and Pearson's correlation coefficients will be calculated to examine the factors that contribute to a patient's self-perceived readiness for discharge, their post-operative Quality of Life and their length of stay. Multivariate analysis of variance will be used on ambulation rates, visitation rates, pain scores, anxiety scores and readiness for discharge to examine differences between the different interventions and other factors describing the patient's clinical pathway (i.e. length of stay, days on analgesics, and hospital costs/patient).

Study Type

Interventional

Enrollment (Anticipated)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital Chest Centre
        • Contact:
        • Principal Investigator:
          • John Yee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Undergoing elective lobectomy,
  • speak, write and read English,
  • ambulate prior to surgery

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Experimental: 2
Self-directed motivation
Post-lobectomy patients are provided with a booklet that outlines expected physical activities (sitting up, walking arm exercises) to aim for each day after surgery. It also provides room for the patients to record what they have accomplished.
Experimental: 3
Personal motivational interviewing
Post-lobectomy patients receive daily visits from a study coordinator aimed to motivate the patient to complete various physical activities each day after surgery. The study coordinator goes through the same booklet that is given to Group 2 and helps patients set goals and record their accomplishments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Perceived readiness for discharge VAS score (at discharge)

Secondary Outcome Measures

Outcome Measure
Length of stay, physician's and nurses perceived readiness for discharge, visitation rates, anxiety score, pain score (at discharge), primary and secondary outcomes (at post-op days 3, 5 and follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John Yee, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

October 31, 2005

First Submitted That Met QC Criteria

October 31, 2005

First Posted (Estimate)

November 2, 2005

Study Record Updates

Last Update Posted (Estimate)

November 16, 2011

Last Update Submitted That Met QC Criteria

November 15, 2011

Last Verified

November 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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