Supporting Decision Making for Musculoskeletal Preference-Sensitive Care

Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345123
• Other study ID #: SDMBKH-HD012011
• Status: Completed
• Phase: N/A
• First received: April 28, 2011
• Last updated: August 26, 2013
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: August 2013
• Source: Health Dialog
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 subject knowledge, decision process and decision quality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9925
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Arthritis
• Arthritis (Hip)
• Arthritis (Knee)
• Back Pain
• Knee Pain Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Health Dialog	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Health Dialog	Foundation for Informed Medical Decision Making, University of Massachusetts, Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Primary	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	6 months	No
Secondary	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	6 months	No
Secondary	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	6 months	No
Secondary	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.	6 months	No
Secondary	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.	12 weeks	No
Secondary	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.	12 weeks	No
Secondary	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.	6 months	No