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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02625402
• Collaborator: Newton-Wellesley Hospital (Other)
• Enrollment: 58
• Locations: 2
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site: 29
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hip Osteoarthritis; Knee Osteoarthritis	Behavioral: Brief interactive decision aid; Behavioral: Long video decision aid	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interactive decision aid Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise	Behavioral: Brief interactive decision aid; The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Experimental: Video decision aid 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	Behavioral: Long video decision aid; Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis

Outcome Measures

Primary Outcome Measures

1. Hip and Knee Decision Quality Instruments Knowledge Subscale Scores [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.

Secondary Outcome Measures

1. Percentage of Participants Who Used the Decision Aid [In clinic, immediately before the first visit with surgeon]

   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.

2. Percentage of Participants With a Clear Treatment Preference [In clinic, immediately before the first visit with surgeon]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of either hip or knee osteoarthritis

• Scheduled visit with participating orthopedic surgeon

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Newton Wellesley Hospital	Newton	Massachusetts	United States	02462

Sponsors and Collaborators

• Massachusetts General Hospital
• Newton-Wellesley Hospital

Investigators

• Principal Investigator: Karen R Sepucha, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Karen Sepucha, Associate Professor, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02625402
• Other Study ID Numbers: 2013P001794
• First Posted: Dec 9, 2015
• Last Update Posted: Oct 16, 2018
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Karen Sepucha, Associate Professor, Massachusetts General Hospital: decision making; decision aids; decision quality instruments; osteoarthritis; shared decision making
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip

Study Results

Participant Flow

Recruitment Details	Patient recruitment was conducted from December 2015 to March 2016. Patients were recruited at two hospitals. Consent for the study (or enrollment) was implied by completion of the survey, so the enrollment number is lower than the number that started the study and were assigned to a study arm.

Arm/Group Title	Interactive Decision Aid	Video Decision Aid
Arm/Group Description	Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis	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 Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
Period Title: Overall Study
STARTED	42	37
COMPLETED	33	25
NOT COMPLETED	9	12

Baseline Characteristics

Arm/Group Title	Interactive Decision Aid	Video Decision Aid	Total
Arm/Group Description	Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis	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 Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis	Total of all reporting groups
Overall Participants	33	25	58
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.3 (8.7)	62.8 (8.5)	63.7 (8.6)
Sex: Female, Male (Count of Participants)
Female	16 48.5%	14 56%	30 51.7%
Male	17 51.5%	11 44%	28 48.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Hip and Knee Decision Quality Instruments Knowledge Subscale Scores
Description	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.
Time Frame	In clinic, immediately before the first visit with surgeon

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Interactive Decision Aid	Video Decision Aid
Arm/Group Description	Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis	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 Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
Measure Participants	33	25
Mean (Standard Deviation) [units on a scale]	55.2 (25.5)	48.8 (32.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interactive Decision Aid, Video Decision Aid
	Comments
	Type of Statistical Test	Equivalence
	Comments	Knowledge scores within 10% points
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.4
	Confidence Interval	(2-Sided) 95%; -8.8 to 21.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 7.6
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants Who Used the Decision Aid
Description	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.
Time Frame	In clinic, immediately before the first visit with surgeon

Outcome Measure Data

Analysis Population Description

We wanted to assess how much patients reviewed whichever decision aid they were randomized to before their visit. As such, we assessed how much they reviewed of the program (none, some, most, all) and will share the categorical results.

Arm/Group Title	Interactive Decision Aid	Video Decision Aid
Arm/Group Description	Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis	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 Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
Measure Participants	33	25
Reviewed most or all of the DA	23 69.7%	14 56%
Reviewed none or some of the DA	8 24.2%	11 44%
Missing	2 6.1%	0 0%

3. Secondary Outcome

Title	Percentage of Participants With a Clear Treatment Preference
Description	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.
Time Frame	In clinic, immediately before the first visit with surgeon

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interactive Decision Aid	Video Decision Aid
Arm/Group Description	Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis	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 Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
Measure Participants	33	25
Clear preference	22 66.7%	15 60%
Not sure	11 33.3%	10 40%

Adverse Events

Time Frame	Serious and other (not including serious) adverse events were not collected/assessed.
Adverse Event Reporting Description	Adverse events were not collected as part of this survey study.
Arm/Group Title	Interactive Decision Aid		Video Decision Aid
Arm/Group Description	Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis		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 Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
All Cause Mortality
	Interactive Decision Aid		Video Decision Aid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Interactive Decision Aid		Video Decision Aid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Interactive Decision Aid		Video Decision Aid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.