Supporting Decision Making for Musculoskeletal Preference-Sensitive Care

NCT01345123 | Completed Results

• 1 other identifier: SDMBKH-HD012011
• Study Type: interventional
• Target: 9,925
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (6)

• Rate of Targeted Conditions Surgeries

  6 months

• Concordance

  6 months

• Quality of Decision Making Process

  6 months

• Knowledge

  12 weeks

• Decision Conflict

  12 weeks

Study Arms (3)

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

Interventions

Provision of condition specific shared decision making (SDM) aids only BEHAVIORAL

Subjects are mailed decision aid digital video discs (DVDs) and pamphlets regarding lumbar back, hip osteoarthritis or knee osteoarthritis.

Decision Aid only; Decision Aid with Health Coaching

Telephonic outreach and support by Health Coach BEHAVIORAL

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.

Decision Aid with Health Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Health Dialog

Boston, Massachusetts, 02109, United States

Location

MeSH Terms

Conditions

Arthritis; Back Pain

Interventions

SDM

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: David R Veroff, MPP, SVP Analytic Development
• Organization: Health Dialog

dveroff@healthdialog.com

617-406-5219

Study Officials

• David R Veroff, MPP

  Health Dialog Services Corporation

  PRINCIPAL INVESTIGATOR

• Patricia M Gallagher, PHD

  University of Massachusetts, Boston

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: April 29, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 30, 2013
• Results First Posted: October 30, 2013

Record last verified: 2013-08

Locations

US (1)