Knee Pain ChronicNCT01345123

Supporting Decision Making for Musculoskeletal Preference-Sensitive Care

A study testing Provision of condition specific shared decision making (SDM) aids only and Telephonic outreach and support by Health Coach in people with Knee Pain Chronic and Arthritis (Hip), run by Health Dialog at 1 site in United States.

Completed

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

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Knee Pain Chronic, Arthritis (Hip), Arthritis (Knee)
What is being tested?: Provision of condition specific shared decision making (SDM) aids only and Telephonic outreach and support by Health Coach
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9,925 participants
Where: 1 siteUnited States
Study dates: Jan 2011to Dec 2011
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Health Dialog
Boston, Massachusetts, 02109

Other trials in United States

About this study

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

Conditions: Knee Pain Chronic, Arthritis (Hip), Arthritis (Knee), Back Pain
Being tested: Provision of condition specific shared decision making (SDM) aids only, Telephonic outreach and support by Health Coach
Medical subject headings: Arthritis, Back Pain

What participants receive

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

Provision of condition specific shared decision making (SDM) aids onlyBehavioural
Subjects are mailed decision aid digital video discs (DVDs) and pamphlets regarding lumbar back, hip osteoarthritis or knee osteoarthritis.
Telephonic outreach and support by Health CoachBehavioural
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.

Study groups in NCT01345123
Study group	Role	What they receive
Decision Aid with Health Coaching	Experimental	Not described Receives: Behavioral: Provision of condition specific shared decision making (SDM) aids only; Behavioral: Telephonic outreach and support by Health Coach
Decision Aid only	Experimental	Not described Receives: Behavioral: Provision of condition specific shared decision making (SDM) aids only
No condition specific support	No intervention	Not described

What is being measured

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

Total Medical Costs Per Member Per Month
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.
Measured: 6 months
Total Medical Costs That Can be Impacted Per Member Per Month
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
Measured: 6 months

Secondary outcomes (6)

Rate of Targeted Conditions Surgeries
rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery
Measured: 6 months
Concordance
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
Measured: 6 months
Quality of Decision Making Process
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.
Measured: 6 months
Knowledge
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.
Measured: 12 weeks
Decision Conflict
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.
Measured: 12 weeks
Decision Satisfaction
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.
Measured: 6 months

Timeline

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

Jan 2011Dec 2011

First posted29 Apr 2011 (estimated)
Study startJan 2011
Primary completionNov 2011
Study completionDec 2011

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.
Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
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: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 9,925 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01345123
Sponsor's protocol ID: SDMBKH-HD012011
Status last verified: Aug 2013
First submitted: 28 Apr 2011
Last updated: 30 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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All Knee Pain Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01345123
Acronym / sponsor ID: SDMBKH-HD012011
Conditions: Knee Pain Chronic, Arthritis (Hip), Arthritis (Knee), Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 9,925 participants (actual)
Lead sponsor: Health DialogIndustry (pharma, biotech, devices)
Collaborators: Foundation for Informed Medical Decision Making, University of Massachusetts, Boston
Study start: Jan 2011
Primary completion: Nov 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 29 Apr 2011 (estimated)
Results: Posted 30 Oct 2013

Clinical summary

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

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Decision Aid with Health Coaching	Experimental	Behavioral: Provision of condition specific shared decision making (SDM) aids only, Behavioral: Telephonic outreach and support by Health Coach
Decision Aid only	Experimental	Behavioral: Provision of condition specific shared decision making (SDM) aids only
No condition specific support	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (9 listed)

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

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
Provision of condition specific shared decision making (SDM) aids onlySubjects are mailed decision aid digital video discs (DVDs) and pamphlets regarding lumbar back, hip osteoarthritis or knee osteoarthritis.	Behavioural	Decision Aid only, Decision Aid with Health Coaching
Telephonic outreach and support by Health CoachSubjects 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.	Behavioural	Decision Aid with Health Coaching

Primary outcome

Total Medical Costs Per Member Per Month
Time frame: 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.
Total Medical Costs That Can be Impacted Per Member Per Month
Time frame: 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

6 secondary outcomes

Rate of Targeted Conditions Surgeries
Time frame: 6 months
Concordance
Time frame: 6 months
Quality of Decision Making Process
Time frame: 6 months
Knowledge
Time frame: 12 weeks
Decision Conflict
Time frame: 12 weeks
Decision Satisfaction
Time frame: 6 months

Results and safety

Results posted to the registry on 30 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Decision Aid With Health Coaching	3,323	3,244
Decision Aid Only	3,311	3,226
No Condition Specific Support	3,291	3,203

Primary outcome: Total Medical Costs Per Member Per Month

Time frame: 6 months. Mean (95% Confidence Interval). Unit: Total dollars / member months

Measure	Decision Aid With Health Coaching n = 2969	Decision Aid Only n = 2942	No Condition Specific Support n = 2889
Value	965.63 (895.66 to 1035.61)	1000.22 (931.56 to 1068.88)	965.78 (896.33 to 1035.23)

Decision Aid With Health Coaching vs No Condition Specific Support: Mean Difference (Net): 0.00199940 (95% CI -.07658990 to .080588716), p = 0.9602, ANCOVA
Decision Aid Only vs No Condition Specific Support: Mean Difference (Net): -0.0137170 (95% CI -0.0924947 to 0.06506063), p = 0.7329, ANCOVA

Population analysed: 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.

Primary outcome: Total Medical Costs That Can be Impacted Per Member Per Month

Time frame: 6 months. Mean (95% Confidence Interval). Unit: Total dollars / member months

Measure	Decision Aid With Health Coaching n = 2969	Decision Aid Only n = 2942	No Condition Specific Support n = 2889
Value	679.13 (624.68 to 733.58)	735.96 (679.55 to 792.37)	726.88 (665.37 to 788.38)

Decision Aid With Health Coaching vs No Condition Specific Support: Mean Difference (Net): -0.0091220 (95% CI -0.1008434 to 0.08259938), p = 0.8454, ANCOVA
Decision Aid Only vs No Condition Specific Support: Mean Difference (Net): -0.0183548 (95% CI -0.1102961 to 0.07358642), p = 0.6956, ANCOVA

Population analysed: 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.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Decision Aid With Health Coaching	0 of 0	0 of 0	Not reported
Decision Aid Only	0 of 0	0 of 0	Not reported
No Condition Specific Support	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 30 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Knee Pain Chronic

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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 R Veroff, MPP principal investigator

Health Dialog Services Corporation

Patricia M Gallagher, PHD study director

University of Massachusetts, Boston

1 site 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 4 inclusion and 9 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 30 Oct 2013. 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?

Yes. Results are posted in the registry (first posted 30 Oct 2013). 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?

Total Medical Costs Per Member Per Month (time frame: 6 months). The study lists 2 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 NCT01345123.

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 30 Oct 2013.