Hip OsteoarthritisNCT02625402

Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis

A study testing Brief interactive decision aid and Long video decision aid in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Massachusetts General Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Hip Osteoarthritis, Knee Osteoarthritis
What is being tested?: Brief interactive decision aid and Long video decision aid
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 2 sitesUnited States
Study dates: Dec 2015to Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of either hip or knee osteoarthritis
Scheduled visit with participating orthopedic surgeon

Who cannot join

Prior partial or total knee or hip replacement surgery
Hip fracture or aseptic necrosis in the last 12 months
Rheumatoid arthritis or psoriatic arthritis
Unable to read or speak English

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Newton Wellesley Hospital
Newton, Massachusetts, 02462

Other trials in United States

About this study

This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis.

Read the detailed description

This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis. The vendors employ different design features (e.g. use of video for patient narratives, interactive values clarification exercise) and the study will examine the relative impact of the different features on decision quality. Eligible subjects will be randomly assigned to receive one of two decision aids before their upcoming clinic visit with a participating provider. Immediately before the visit, participants will complete a short questionnaire about the decision aid. This pilot study will assist with determining the potential difference between these two decision aids on improving knowledge and use of decision aids.

Conditions: Hip Osteoarthritis, Knee Osteoarthritis
Being tested: Brief interactive decision aid, Long video decision aid
Keywords: decision making, decision aids, decision quality instruments, osteoarthritis, shared decision making
Medical subject headings: Osteoarthritis, Hip, Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brief interactive decision aidBehavioural
The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Long video decision aidBehavioural
Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis

Study groups in NCT02625402
Study group	Role	What they receive
Interactive decision aid	Experimental	Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise Receives: Behavioral: Brief interactive decision aid
Video decision aid	Experimental	Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog Receives: Behavioral: Long video decision aid

What is being measured

The primary outcome is the main question the study is designed to answer.

Hip and Knee Decision Quality Instruments Knowledge Subscale Scores
5 multiple choice knowledge items from the Hip and Knee Decision Quality Instruments will be averaged into a knowledge subscale score (0-100%) with higher scores indicating higher knowledge.
Measured: In clinic, immediately before the first visit with surgeon

Secondary outcomes (2)

Percentage of Participants Who Used the Decision Aid
1 item asking patients how much they reviewed the program (none, some. most, all). The percentage who report viewing most or all will be calculated.
Measured: In clinic, immediately before the first visit with surgeon
Percentage of Participants With a Clear Treatment Preference
1 item assessing patient's treatment preference (surgery, non-surgical options, or not sure). The percentage who have a clear preference (either for surgery or non surgical options) will be calculated.
Measured: In clinic, immediately before the first visit with surgeon

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2015Dec 2016

First posted9 Dec 2015 (estimated)
Study startDec 2015
Primary completionMar 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hip OsteoarthritisStudies 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
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02625402
Sponsor's protocol ID: 2013P001794
Status last verified: Sep 2018
First submitted: 4 Dec 2015
Last updated: 16 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Sepucha K, Feibelmann S, Chang Y, Clay CF, Kearing SA, Tomek I, Yang T, Katz JN. Factors associated with the quality of patients' surgical decisions for treatment of hip and knee osteoarthritis. J Am Coll Surg. 2013 Oct;217(4):694-701. doi: 10.1016/j.jamcollsurg.2013.06.002. Epub 2013 Jul 25.
PubMed 23891070

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults
Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy

All Hip Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis
ClinicalTrials.gov ID: NCT02625402
Acronym / sponsor ID: 2013P001794
Conditions: Hip Osteoarthritis, Knee Osteoarthritis
Keywords: decision making, decision aids, decision quality instruments, osteoarthritis, shared decision making
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Newton-Wellesley Hospital
Study start: Dec 2015 (actual)
Primary completion: Mar 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 9 Dec 2015 (estimated)
Results: Posted 18 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Interactive decision aid	Experimental	Behavioral: Brief interactive decision aidGroup receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise
Video decision aid	Experimental	Behavioral: Long video decision aidGroup receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of either hip or knee osteoarthritis
Scheduled visit with participating orthopedic surgeon

Key exclusion criteria (4 listed)

Prior partial or total knee or hip replacement surgery
Hip fracture or aseptic necrosis in the last 12 months
Rheumatoid arthritis or psoriatic arthritis
Unable to read or speak English

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
Brief interactive decision aidThe Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis	Behavioural	Interactive decision aid
Long video decision aidHealth Dialog DVD and booklet decision aids for hip and knee osteoarthritis	Behavioural	Video decision aid

Primary outcome

Hip and Knee Decision Quality Instruments Knowledge Subscale Scores
Time frame: In clinic, immediately before the first visit with surgeon
5 multiple choice knowledge items from the Hip and Knee Decision Quality Instruments will be averaged into a knowledge subscale score (0-100%) with higher scores indicating higher knowledge.

2 secondary outcomes

Percentage of Participants Who Used the Decision Aid
Time frame: In clinic, immediately before the first visit with surgeon
Percentage of Participants With a Clear Treatment Preference
Time frame: In clinic, immediately before the first visit with surgeon

Results and safety

Results posted to the registry on 18 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Interactive Decision Aid	42	33
Video Decision Aid	37	25

Primary outcome: Hip and Knee Decision Quality Instruments Knowledge Subscale Scores

Time frame: In clinic, immediately before the first visit with surgeon. Mean (Standard Deviation). Unit: units on a scale

Measure	Interactive Decision Aid n = 33	Video Decision Aid n = 25
Value	55.2 (25.5)	48.8 (32.2)

Interactive Decision Aid vs Video Decision Aid: Mean Difference (Final Values): 6.4 (95% CI -8.8 to 21.5), p <0.05, t-test, 2 sided

Population analysed: The total knowledge score of 5 multiple questions with a total score of 0-100% was generated for all study patients.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious and other (not including serious) adverse events were not collected/assessed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Interactive Decision Aid	0 of 0	0 of 0	Not reported
Video Decision Aid	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23891070Sepucha K, Feibelmann S, Chang Y, Clay CF, Kearing SA, Tomek I, Yang T, Katz JN. Factors associated with the quality of patients' surgical decisions for treatment of hip and knee osteoarthritis. J Am Coll Surg. 2013 Oct;217(4):694-701. doi: 10.1016/j.jamcollsurg.2013.06.002. Epub 2013 Jul 25.
Individual participant dataSharing planned: No

Related trials for Hip Osteoarthritis

Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults
Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy

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.

Karen R Sepucha, PhD principal investigator

Massachusetts General Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 4 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 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 18 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hip and Knee Decision Quality Instruments Knowledge Subscale Scores (time frame: In clinic, immediately before the first visit with surgeon). 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 NCT02625402, which also lists 1 linked publication.

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 16 Oct 2018.