CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9,925 enrolled
Drug / intervention
Provision of condition specific shared decision making (SDM) aids only +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01345123
NCT01345123N/ACompleted
CompareCT.gov

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

Health Dialog·interventional·Posted Apr 29, 2011·Updated Oct 30, 2013

In Brief

A clinical study evaluating Provision of condition specific shared decision making (SDM) aids only and Telephonic outreach and support by Health Coach for Knee Pain Chronic and 3 related conditions. Completed, enrolled 9,925 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Pain Chronic, Arthritis (Hip), Arthritis (Knee), Back Pain
CountriesUnited States
CollaboratorsFoundation for Informed Medical Decision Making, University of Massachusetts, Boston

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 29, 2011
Enrollment StartJan 1, 2011
Primary CompletionNov 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.2 years ago

Interventions

Provision of condition specific shared decision making (SDM) aids onlybehavioral

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 Coachbehavioral

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.