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OpenTrials
Completed

NCT Number: NCT01345123

Supporting Decision Making for Musculoskeletal Preference-Sensitive Care

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.

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Key information

Conditions

Knee Pain Chronic Arthritis Arthritis (Hip) Arthritis (Knee) Back Pain Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Dialog

Boston, Massachusetts, 02109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Rate of Targeted Conditions Surgeries

    Time frame: 6 months

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

  2. Concordance

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Health Dialog

Industry

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 29, 2011
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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