- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02209246
The Effect of Feedback Regarding Illness Behavior on Patient Satisfaction in Hand Surgery
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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|
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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).
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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
Sponsor
Publications and helpful links
General Publications
- Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002 Dec 18;288(23):3027-34. doi: 10.1001/jama.288.23.3027. Erratum In: JAMA. 2003 Feb 26;289(8):987.
- Chamie K, Sadetsky N, Litwin MS. Physician assessment of pretreatment functional status: a process-outcomes link. J Urol. 2011 Apr;185(4):1229-33. doi: 10.1016/j.juro.2010.11.087. Epub 2011 Feb 22.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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