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

Primary Purpose

Hand Surgery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PROMIS CAT Pain Interference
PROMIS CAT Pain Behavior
PROMIS CAT Physical Function
MISS-21
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hand Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention

Control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

PROMIS CAT Pain Interference
A computerized assessment of pain interference measured at enrollment
PROMIS CAT Pain Behavior
A computerized assessment of pain behavior measured at enrollment
PROMIS CAT Physical Function
A computerized assessment of physical function measured at enrollment
Medical Interview Satisfaction Scale (MISS-21)
Questionnaire

Secondary Outcome Measures

Patient-physician communication
The research assistant determines whether the patient's coping strategies (pain interference and pain behavior) were discussed during the encounter or not.

Full Information

First Posted
July 29, 2014
Last Updated
August 1, 2014
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02209246
Brief Title
The Effect of Feedback Regarding Illness Behavior on Patient Satisfaction in Hand Surgery
Official Title
The Effect of Feedback Regarding Illness Behavior on Patient Satisfaction in Hand Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Surgery

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
PROMIS CAT Pain Interference
Intervention Type
Other
Intervention Name(s)
PROMIS CAT Pain Behavior
Intervention Type
Other
Intervention Name(s)
PROMIS CAT Physical Function
Intervention Type
Other
Intervention Name(s)
MISS-21
Primary Outcome Measure Information:
Title
PROMIS CAT Pain Interference
Description
A computerized assessment of pain interference measured at enrollment
Time Frame
1 day
Title
PROMIS CAT Pain Behavior
Description
A computerized assessment of pain behavior measured at enrollment
Time Frame
1 day
Title
PROMIS CAT Physical Function
Description
A computerized assessment of physical function measured at enrollment
Time Frame
1 day
Title
Medical Interview Satisfaction Scale (MISS-21)
Description
Questionnaire
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Patient-physician communication
Description
The research assistant determines whether the patient's coping strategies (pain interference and pain behavior) were discussed during the encounter or not.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ring, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12479768
Citation
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.
Results Reference
background
PubMed Identifier
21334026
Citation
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.
Results Reference
background

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

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