Hand SurgeryNCT02209246
The Effect of Feedback Regarding Illness Behavior on Patient Satisfaction in Hand Surgery
A study testing PROMIS CAT Pain Interference, PROMIS CAT Pain Behavior and PROMIS CAT Physical Function in people with Hand Surgery, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Surgery
- What is being tested?
- PROMIS CAT Pain Interference, PROMIS CAT Pain Behavior and PROMIS CAT Physical Function
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All new patients visiting the Orthopaedic Hand and Upper Extremity Service
- English fluency and literacy
- Ability to provide informed consent
Who cannot join
- age < 18
- Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Hand Surgery
- Being tested
- PROMIS CAT Pain Interference, PROMIS CAT Pain Behavior, PROMIS CAT Physical Function, MISS-21
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMIS CAT Pain InterferenceOther
PROMIS CAT Pain BehaviorOther
PROMIS CAT Physical FunctionOther
MISS-21Other
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: PROMIS CAT Pain Interference; Other: PROMIS CAT Pain Behavior; Other: PROMIS CAT Physical Function; Other: MISS-21 |
| Control | Experimental | 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). Receives: Other: PROMIS CAT Pain Interference; Other: PROMIS CAT Pain Behavior; Other: PROMIS CAT Physical Function; Other: MISS-21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS CAT Pain Interference
A computerized assessment of pain interference measured at enrollment
Measured: 1 day
PROMIS CAT Pain Behavior
A computerized assessment of pain behavior measured at enrollment
Measured: 1 day
PROMIS CAT Physical Function
A computerized assessment of physical function measured at enrollment
Measured: 1 day
Medical Interview Satisfaction Scale (MISS-21)
Questionnaire
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJul 2013
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hand SurgeryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Ring, MD, Massachusetts General Hospital
- Investigators
- David Ring, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209246
- Sponsor's protocol ID
- 2013P001425
- Status last verified
- Aug 2014
- First submitted
- 29 Jul 2014
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 12479768Chamie 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.
PubMed 21334026
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Feedback Regarding Illness Behavior on Patient Satisfaction in Hand Surgery
- ClinicalTrials.gov ID
- NCT02209246
- Acronym / sponsor ID
- 2013P001425
- Conditions
- Hand Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: PROMIS CAT Pain Interference, Other: PROMIS CAT Pain Behavior, Other: PROMIS CAT Physical Function, Other: MISS-21The 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. |
| Control | Experimental | Other: PROMIS CAT Pain Interference, Other: PROMIS CAT Pain Behavior, Other: PROMIS CAT Physical Function, Other: MISS-21The 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All new patients visiting the Orthopaedic Hand and Upper Extremity Service
- English fluency and literacy
- Ability to provide informed consent
Key exclusion criteria (2 listed)
- age < 18
- Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROMIS CAT Pain Interference | Other | Control, Intervention |
| PROMIS CAT Pain Behavior | Other | Control, Intervention |
| PROMIS CAT Physical Function | Other | Control, Intervention |
| MISS-21 | Other | Control, Intervention |
Primary outcome
PROMIS CAT Pain Interference
Time frame: 1 day
A computerized assessment of pain interference measured at enrollment
PROMIS CAT Pain Behavior
Time frame: 1 day
A computerized assessment of pain behavior measured at enrollment
PROMIS CAT Physical Function
Time frame: 1 day
A computerized assessment of physical function measured at enrollment
Medical Interview Satisfaction Scale (MISS-21)
Time frame: 1 day
Questionnaire
1 secondary outcome
Patient-physician communication
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
- Background: PubMed 12479768Detmar 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.
- Background: PubMed 21334026Chamie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ring, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROMIS CAT Pain Interference, PROMIS CAT Pain Behavior and PROMIS CAT Physical Function in people with Hand Surgery, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS CAT Pain Interference (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02209246, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.