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

Hand Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209246
• Other study ID #: 2013P001425
• Status: Completed
• Phase: N/A
• First received: July 29, 2014
• Last updated: August 1, 2014
• Start date: July 2013

Study information

• Verified date: August 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hand Surgery
• Illness Behavior

Intervention

Other:
• PROMIS CAT Pain Interference

• PROMIS CAT Pain Behavior

• PROMIS CAT Physical Function

• MISS-21

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Erratum in: JAMA. 2003 Feb 26;289(8):987.. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS CAT Pain Interference	A computerized assessment of pain interference measured at enrollment	1 day	No
Primary	PROMIS CAT Pain Behavior	A computerized assessment of pain behavior measured at enrollment	1 day	No
Primary	PROMIS CAT Physical Function	A computerized assessment of physical function measured at enrollment	1 day	No
Primary	Medical Interview Satisfaction Scale (MISS-21)	Questionnaire	1 day	No
Secondary	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.	1 day	No