Supporting Decision Making for Musculoskeletal Preference-Sensitive Care

• Sponsor: Health Dialog (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01345123
• Collaborator: Foundation for Informed Medical Decision Making (Other), University of Massachusetts, Boston (Other)
• Enrollment: 9,925
• Location: 1
• Arms: 3
• Duration (Months): 11
• Patients Per Site Per Month: 904.5

Study Details

Study Description

Brief Summary

The purpose of this study is to compare condition oriented whole person Health Coaching along with the provision of decision aids to decision aids without condition oriented Health Coaching to neither condition oriented health coaching nor decision aids on medical cost, preference sensitive surgeries and measures of subject knowledge, decision process and decision quality.

Condition or Disease	Intervention/Treatment	Phase
Knee Pain Chronic; Arthritis (Hip); Arthritis (Knee); Back Pain	Behavioral: Provision of condition specific shared decision making (SDM) aids only; Behavioral: Telephonic outreach and support by Health Coach	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 9925 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: A Prospective, Randomized Trial to Assess the Impact of Decision Aids and Health Coaching on Health Care Costs, Surgery Rates, and Decision Quality for Individuals At Risk for Musculoskeletal Preference-Sensitive Surgical Decisions
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Decision Aid with Health Coaching	Behavioral: Provision of condition specific shared decision making (SDM) aids only; Subjects are mailed decision aid digital video discs (DVDs) and pamphlets regarding lumbar back, hip osteoarthritis or knee osteoarthritis.; Behavioral: Telephonic outreach and support by Health Coach; Subjects are direct dial attempted by Health Coaches up to three attempts. If contacted, Health Coaches tailor support around health matters of importance to the subjects and to help individuals become active participants in their treatment plans, and make more informed decisions in consort with their health care providers. The number of total contacts is determined by mutual agreement between the subject and the Health Coach. Health Coaches may provide additional educational materials and resources.
Experimental: Decision Aid only	Behavioral: Provision of condition specific shared decision making (SDM) aids only; Subjects are mailed decision aid digital video discs (DVDs) and pamphlets regarding lumbar back, hip osteoarthritis or knee osteoarthritis.
No Intervention: No condition specific support

Outcome Measures

Primary Outcome Measures

1. Total Medical Costs Per Member Per Month [6 months]

   total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy.

2. Total Medical Costs That Can be Impacted Per Member Per Month [6 months]

   total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy. Costs that cannot be impacted include: Costs related to Trauma and Accident, Psychiatric/Substance Abuse, Malignant Neoplasm, Maternity and Childbirth excluded

Secondary Outcome Measures

1. Rate of Targeted Conditions Surgeries [6 months]

   rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery

2. Concordance [6 months]

   Self-reported consistency of choices with goals and concerns--extent to which the treatment choices subjects make are or are not consistent with the issues they state are priorities including avoiding surgery, reducing pain and regaining function

3. Quality of Decision Making Process [6 months]

   Self-reported measure of the extent to which subject interactions with providers involve discussions of the pros and cons of treatment options and provide an opportunity for subjects to have input into the decisions.

4. Knowledge [12 weeks]

   Subject self-reported knowledge about the risks and benefits of surgical options and likely outcomes with and without surgical interventions.Knowledge score calculated (score of 0-5, counting number of correct answers) for every respondent who completes at least 3 of the 5 items.

5. Decision Conflict [12 weeks]

   Self-reported measure of the extent to which subjects feel comfortable, supported and confident in choosing one treatment approach over others. Score computed on a scale of 1-3, where 1 = 'No', 2='Yes, somewhat', 3='Yes, completely' (3 indicates less conflict, 1 indicates most conflict) on a 4 item survey question set- asks whether respondents feel sure, have enough support, know and are clear about benefits and risks of treatment options.

6. Decision Satisfaction [6 months]

   Self-reported measure of subject satisfaction with decision as measured retrospectively, including how subjects feel their decision worked out and whether or not they would make the same decision again.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participants in two large, commercial Blue Cross and/or Blue Shield branded insurance products with eligibility for Health Dialog services

• Identified by distinct Health Dialog proprietary models for risk of lumbar back, knee or hip surgeries

• Selected by simple randomization for inclusion in an interactive voice response (IVR) administered screening survey

• Participated in an IVR-administered screener survey and responded affirmatively to questions on pain for any one of the three conditions, any current or planned treatment for the conditions, and responded negatively to having had a condition specific surgery within the past six months

Exclusion Criteria:

• People under 18 years of age at time of identification for the IVR filtering survey, approximately 6 weeks prior to the start of the study

• People with invalid phone numbers or invalid mailing addresses based on automated review of those fields

• People for whom Health Dialog has information of a request for no IVR, no Health Coach outreach, or mailings prior to the start of the study

• People with claims based indication of spinal stenosis prior to the start of the study

• People who have been targeted for any IVR outreach within 180 days of the initiation of the IVR filtering survey

• People who have a Health Coach communication record, as documented in the Health Coaching application within 90 days of the start of the study

• Any members of households who have a household member already selected for inclusion in the study

• People for whom there is claims evidence of any one of the targeted surgeries prior the start of the study

• People with no eligibility for services through insurer after the start of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health Dialog	Boston	Massachusetts	United States	02109

Sponsors and Collaborators

• Health Dialog
• Foundation for Informed Medical Decision Making
• University of Massachusetts, Boston

Investigators

• Principal Investigator: David R Veroff, MPP, Health Dialog Services Corporation
• Study Director: Patricia M Gallagher, PHD, Center for Survey Research, University of Massachusetts, Boston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Health Dialog
• ClinicalTrials.gov Identifier: NCT01345123
• Other Study ID Numbers: SDMBKH-HD012011
• First Posted: Apr 29, 2011
• Last Update Posted: Oct 30, 2013
• Last Verified: Aug 1, 2013

• Additional relevant MeSH terms: Arthritis

Study Results

Participant Flow

Recruitment Details	75,795 health plan members recruited via Interactive Voice Response Telephone Call Survey to screen for study eligibility. 30,556 persons completed the screen. 9,925 were study eligible (1. Reported pain in knee, hip, or back; 2. Considering treatment; 3. Had not already had surgery for pain; 4. Not on a 'Do Not Call' list).

Arm/Group Title	Decision Aid With Health Coaching	Decision Aid Only	No Condition Specific Support
Arm/Group Description	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	Study participants do not receive outreach on knee, hip or herniated disc condition.
Period Title: Overall Study
STARTED	3323	3311	3291
COMPLETED	3244	3226	3203
NOT COMPLETED	79	85	88

Baseline Characteristics

Arm/Group Title	Decision Aid With Health Coaching	Decision Aid Only	No Condition Specific Support	Total
Arm/Group Description	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	Study participants do not receive outreach on knee, hip or herniated disc condition.	Total of all reporting groups
Overall Participants	3323	3311	3291	9925
Age (Count of Participants)
<=18 years	0 0%	1 0%	0 0%	1 0%
Between 18 and 65 years	2880 86.7%	2922 88.3%	2861 86.9%	8663 87.3%
>=65 years	443 13.3%	388 11.7%	430 13.1%	1261 12.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.94 (10.37)	56.12 (9.73)	56.06 (10.14)	56.04 (10.08)
Sex: Female, Male (Count of Participants)
Female	1896 57.1%	1888 57%	1906 57.9%	5690 57.3%
Male	1427 42.9%	1423 43%	1385 42.1%	4235 42.7%
Region of Enrollment (participants) [Number]
United States	3323 100%	3311 100%	3291 100%	9925 100%

Outcome Measures

1. Primary Outcome

Title	Total Medical Costs Per Member Per Month
Description	total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Instituted >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.

Arm/Group Title	Decision Aid With Health Coaching	Decision Aid Only	No Condition Specific Support
Arm/Group Description	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Study participants receiving a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	Study participants do not receive outreach on knee, hip or herniated disc condition.
Measure Participants	2969	2942	2889
Mean (95% Confidence Interval) [Total dollars / member months]	965.63	1000.22	965.78

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Decision Aid With Health Coaching, No Condition Specific Support
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9602
	Comments
	Method	ANCOVA
	Comments	Covariates: age, gender, Charlson Comorbidity Index, prior year total medical costs pmpm
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.00199940
	Confidence Interval	(2-Sided) 95%; -.07658990 to .080588716
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .04009180
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Decision Aid Only, No Condition Specific Support
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7329
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.0137170
	Confidence Interval	(2-Sided) 95%; -0.0924947 to 0.06506063
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.04018791
	Estimation Comments

2. Secondary Outcome

Title	Rate of Targeted Conditions Surgeries
Description	rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.

Arm/Group Title	Decision Aid With Health Coaching	Decision Aid Only	No Condition Specific Support
Arm/Group Description	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	Study participants do not receive outreach on knee, hip or herniated disc condition.
Measure Participants	2969	2942	2889
Number [percentage of participants]	5.42 0.2%	6.66 0.2%	6.54 0.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Decision Aid With Health Coaching, No Condition Specific Support
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0511
	Comments
	Method	Regression, Logistic
	Comments	Covariates: Age, Gender, Charlson Comorbidity index, calculated risk of knee replacement, hip replacement, herniated disc surgery (score 1-99)
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.805
	Confidence Interval	() 95%; 0.647 to 1.001
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Concordance
Description	Self-reported consistency of choices with goals and concerns--extent to which the treatment choices subjects make are or are not consistent with the issues they state are priorities including avoiding surgery, reducing pain and regaining function
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Quality of Decision Making Process
Description	Self-reported measure of the extent to which subject interactions with providers involve discussions of the pros and cons of treatment options and provide an opportunity for subjects to have input into the decisions.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Knowledge
Description	Subject self-reported knowledge about the risks and benefits of surgical options and likely outcomes with and without surgical interventions.Knowledge score calculated (score of 0-5, counting number of correct answers) for every respondent who completes at least 3 of the 5 items.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents, 1124 received a knowledge score.

Arm/Group Title	Decision Aid With Health Coaching	Decision Aid Only	No Condition Specific Support
Arm/Group Description	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	Study participants do not receive outreach on knee, hip or herniated disc condition.
Measure Participants	550	354	273
Mean (95% Confidence Interval) [number of correct answers]	1.99	2.14	1.83

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Decision Aid Only, No Condition Specific Support
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0106
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.31257
	Confidence Interval	(2-Sided) 95%; 0.06895 to 0.55618
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Decision Aid With Health Coaching, No Condition Specific Support
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0106
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.15982
	Confidence Interval	(2-Sided) 95%; -0.06477 to 0.38441
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Decision Conflict
Description	Self-reported measure of the extent to which subjects feel comfortable, supported and confident in choosing one treatment approach over others. Score computed on a scale of 1-3, where 1 = 'No', 2='Yes, somewhat', 3='Yes, completely' (3 indicates less conflict, 1 indicates most conflict) on a 4 item survey question set- asks whether respondents feel sure, have enough support, know and are clear about benefits and risks of treatment options.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents.

Arm/Group Title	Decision Aid With Health Coaching	Decision Aid Only	No Condition Specific Support
Arm/Group Description	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	Study participants do not receive outreach on knee, hip or herniated disc condition.
Measure Participants	550	354	273
Mean (95% Confidence Interval) [units on a scale]	2.2206790	2.1876218	2.2006866

7. Secondary Outcome

Title	Decision Satisfaction
Description	Self-reported measure of subject satisfaction with decision as measured retrospectively, including how subjects feel their decision worked out and whether or not they would make the same decision again.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Primary Outcome

Title	Total Medical Costs That Can be Impacted Per Member Per Month
Description	total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy. Costs that cannot be impacted include: Costs related to Trauma and Accident, Psychiatric/Substance Abuse, Malignant Neoplasm, Maternity and Childbirth excluded
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.

Arm/Group Title	Decision Aid With Health Coaching	Decision Aid Only	No Condition Specific Support
Arm/Group Description	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).	Study participants do not receive outreach on knee, hip or herniated disc condition.
Measure Participants	2969	2942	2889
Mean (95% Confidence Interval) [Total dollars / member months]	679.13	735.96	726.88

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Decision Aid With Health Coaching, No Condition Specific Support
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8454
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.0091220
	Confidence Interval	(2-Sided) 95%; -0.1008434 to 0.08259938
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.04670910
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Decision Aid Only, No Condition Specific Support
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6956
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.0183548
	Confidence Interval	(2-Sided) 95%; -0.1102961 to 0.07358642
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.04690321
	Estimation Comments

Adverse Events

Arm/Group Title	Decision Aid With Health Coaching		Decision Aid Only		No Condition Specific Support
Arm/Group Description	Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.		Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).		Study participants do not receive outreach on knee, hip or herniated disc condition.
All Cause Mortality
	Decision Aid With Health Coaching		Decision Aid Only		No Condition Specific Support
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Decision Aid With Health Coaching		Decision Aid Only		No Condition Specific Support
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Decision Aid With Health Coaching		Decision Aid Only		No Condition Specific Support
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.