Arthritis (Hip), Arthritis (Knee), Back Pain, Knee Pain Chronic
Conditions
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.
Interventions
BEHAVIORALProvision 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.
BEHAVIORALTelephonic 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.
Sponsors
Foundation for Informed Medical Decision Making
University of Massachusetts, Boston
Health Dialog
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Medical Costs Per Member Per Month | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Decision Making Process | 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. |
| Knowledge | 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. |
| Rate of Targeted Conditions Surgeries | 6 months | rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery |
| Decision Satisfaction | 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. |
| Decision Conflict | 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. |
| Concordance | 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 |
Countries
United States
Participant flow
Recruitment details
75,795 health plan members recruited via Interactive Voice Response Telephone Call Survey to screen for study eligibility. 30,556 persons completed the screen. 9,925 were study eligible (1. Reported pain in knee, hip, or back; 2. Considering treatment; 3. Had not already had surgery for pain; 4. Not on a 'Do Not Call' list).
Participants by arm
| Arm | Count |
|---|---|
| Decision Aid With Health Coaching Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach. | 3,323 |
| Decision Aid Only Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you). | 3,311 |
| No Condition Specific Support Study participants do not receive outreach on knee, hip or herniated disc condition. | 3,291 |
| Total | 9,925 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | participants no longer with health plan | 79 | 85 | 88 |
Baseline characteristics
| Characteristic | Total | Decision Aid With Health Coaching | Decision Aid Only | No Condition Specific Support |
|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Age, Categorical >=65 years | 1261 Participants | 443 Participants | 388 Participants | 430 Participants |
| Age, Categorical Between 18 and 65 years | 8663 Participants | 2880 Participants | 2922 Participants | 2861 Participants |
| Age Continuous | 56.04 years STANDARD_DEVIATION 10.08 | 55.94 years STANDARD_DEVIATION 10.37 | 56.12 years STANDARD_DEVIATION 9.73 | 56.06 years STANDARD_DEVIATION 10.14 |
| Region of Enrollment United States | 9925 participants | 3323 participants | 3311 participants | 3291 participants |
| Sex: Female, Male Female | 5690 Participants | 1896 Participants | 1888 Participants | 1906 Participants |
| Sex: Female, Male Male | 4235 Participants | 1427 Participants | 1423 Participants | 1385 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decision Aid With Health Coaching | Total Medical Costs Per Member Per Month | 965.63 Total dollars / member months |
| Decision Aid Only | Total Medical Costs Per Member Per Month | 1000.22 Total dollars / member months |
| No Condition Specific Support | Total Medical Costs Per Member Per Month | 965.78 Total dollars / member months |
p-value: 0.960295% CI: [-0.0765899, 0.080588716]ANCOVA
p-value: 0.732995% CI: [-0.0924947, 0.06506063]ANCOVA
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
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decision Aid With Health Coaching | Total Medical Costs That Can be Impacted Per Member Per Month | 679.13 Total dollars / member months |
| Decision Aid Only | Total Medical Costs That Can be Impacted Per Member Per Month | 735.96 Total dollars / member months |
| No Condition Specific Support | Total Medical Costs That Can be Impacted Per Member Per Month | 726.88 Total dollars / member months |
p-value: 0.845495% CI: [-0.1008434, 0.08259938]ANCOVA
p-value: 0.695695% CI: [-0.1102961, 0.07358642]ANCOVA
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
Time frame: 6 months
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.
Time frame: 12 weeks
Population: Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decision Aid With Health Coaching | Decision Conflict | 2.2206790 units on a scale |
| Decision Aid Only | Decision Conflict | 2.1876218 units on a scale |
| No Condition Specific Support | Decision Conflict | 2.2006866 units on a scale |
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.
Time frame: 6 months
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.
Time frame: 12 weeks
Population: Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents, 1124 received a knowledge score.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decision Aid With Health Coaching | Knowledge | 1.99 number of correct answers |
| Decision Aid Only | Knowledge | 2.14 number of correct answers |
| No Condition Specific Support | Knowledge | 1.83 number of correct answers |
p-value: 0.010695% CI: [0.06895, 0.55618]ANOVA
p-value: 0.010695% CI: [-0.06477, 0.38441]ANOVA
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.
Time frame: 6 months
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
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decision Aid With Health Coaching | Rate of Targeted Conditions Surgeries | 5.42 percentage of participants |
| Decision Aid Only | Rate of Targeted Conditions Surgeries | 6.66 percentage of participants |
| No Condition Specific Support | Rate of Targeted Conditions Surgeries | 6.54 percentage of participants |
p-value: 0.051195% CI: [0.647, 1.001]Regression, Logistic