The Effect of Feedback Regarding Illness Behavior on Patient Satisfaction in Hand Surgery

August 1, 2014 updated by: David C. Ring, MD, Massachusetts General Hospital
The investigators of this study would like to see whether providing feedback to patients regarding their illness behavior/coping strategies, using online questionnaires, improves patient-physician communication in orthopaedic surgery. The investigators aim to enroll 128 patients.

Study Overview

Detailed Description

Psychological and sociological factors are important in the human illness experience, but biomedical factors are the focus of most office visits, particularly in hand surgery. Both patients and surgeons can feel uncomfortable discussing emotions, stress, and coping strategies. Detmar et al. randomized patients in an oncology practice to receive feedback on a HRQL assessment or not during office visits. They observed that feedback on the HRQL assessment contributed to physicians' awareness of healthy issues and patient-physician communication. There was a difference in perceived emotional support, but not in overall satisfaction with the visit[1]. A retrospective study observed in patients with local prostate cancer, that pre-therapy HRQL assessment is associated with a better sexual function, sexual bother and bowel function according to post-therapy HRQL scores[2].

The investigators propose a two arm unblended, randomized (1:1) controlled trial to assess the effect of providing feedback to patients regarding illness behavior/coping strategies (using Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Testing (CAT) instruments) on patient satisfaction and patient-physician communication in orthopaedic surgery.

If the results of the study suggest that feedback of results from the questionnaires increases patients' satisfaction, such an intervention may be used in the future to benefit future patients.

Aim:

The aim of this study is to assess the effect of feedback regarding illness behavior measured with Patient Reported Outcomes Measurement Instrument System - Computerized Adaptive Testing (PROMIS- CAT) on patient satisfaction.

Primary Null Hypothesis:

There is no difference in satisfaction between patients who receive feedback about their illness behavior, measured with PROMIS-CAT, compared to patients who do not.

Secondary Null Hypotheses:

There is no difference in patient-physician communication about patient's illness behavior between patients who receive feedback about their illness behavior, measured with PROMISCAT, compared to patients who do not.

There are no predictors for patient satisfaction.

Study Type

Interventional

Enrollment (Actual)

128

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

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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:

  • All new patients visiting the Orthopaedic Hand and Upper Extremity Service
  • English fluency and literacy
  • Ability to provide informed consent

Exclusion Criteria:

  • age < 18
  • Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).

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: Health Services Research
  • Allocation: Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The intervention group will be comprised of patients who will complete the PROMIS- CAT for pain interference, pain behavior and physical function prior to the encounter with the physician and then will complete the MISS-21 after the encounter.
Experimental: Control
The control group will complete the PROMIS- CAT for pain interference, pain behavior and physical function after the encounter and after completing a satisfaction questionnaire (MISS-21).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS CAT Pain Interference
Time Frame: 1 day
A computerized assessment of pain interference measured at enrollment
1 day
PROMIS CAT Pain Behavior
Time Frame: 1 day
A computerized assessment of pain behavior measured at enrollment
1 day
PROMIS CAT Physical Function
Time Frame: 1 day
A computerized assessment of physical function measured at enrollment
1 day
Medical Interview Satisfaction Scale (MISS-21)
Time Frame: 1 day
Questionnaire
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-physician communication
Time Frame: 1 day
The research assistant determines whether the patient's coping strategies (pain interference and pain behavior) were discussed during the encounter or not.
1 day

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

July 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 1, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013P001425

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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